Helping Specialty Practices Increase Patient Access to Clinical Research Opportunities NOW AVAILABLE

volume 17, issue 4 - Winter 2018

Precision Medicine Center

The ION Solutions Precision Medicine Center is your gateway to a single, centralized library of precision medicine testing recommendations and resources. Access all of the testing recommendations created by our physician- and pharmacist-based advisory panel as well as resources curated by ION Solutions and our precision medicine partners to help you make informed decisions for your patients.

View testing recommendations by tumor categories: ■ Breast Cancer ■ NSCLC ■ Colorectal ■ Genitourinary ■ Lymphoma ■ Rare Disease

As precision medicine continues to evolve, ION will continue to provide the tools your practice needs.

Visit IONonline.com/Precision to learn more. 2 | Oncologistics NOW AVAILABLE

Precision Medicine Center

View testing recommendations by tumor categories: ■ Breast Cancer ■ NSCLC ■ Colorectal ■ Genitourinary ■ Lymphoma ■ Rare Disease

As precision medicine continues to evolve, ION will continue to provide the tools your practice needs.

Visit IONonline.com/Precision to learn more. Table of Contents Winter 2018

Helping Specialty Practices Increase Patient Access to 6 Clinical Research Opportunities By Tricia Musslewhite

14 MIPS Tips It’s Not Too Late to Ask for Help with 2018 MIPS Data Submission

20 What’s News at ION Michigan Healthcare Professionals Joins ION Solutions GPO Network Elevate business performance with InfoDive®

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■ Monitor drugs dispensed and billed to ensure claims accuracy with GapFinder®

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■ Utilize robust analytics to support success in value-based payment models such as OCM

■ And so much more

To learn what InfoDive can do to improve your operational efficiency, email us at [email protected] or contact your Oncology Supply sales representative. Helping Specialty Practices Increase Patient Access to Clinical Research Opportunities By Tricia Musslewhite

Patient enrollment into clinical trials is a significant clinical trials are increasingly designed around very small challenge as practices lack the specialized staff and genetically defined subsets of cancers, making finding dedicated time to support clinical research1. To ease this eligible patients even more difficult.2” burden, in 2016 IntrinsiQ Specialty Solutions, a part of “If a practice has a study in mind or they’re looking for a AmerisourceBergen, launched AdvanceIQ Network to specific study for a patient they can always contact us,” match independent community oncology and urology said Clinical Research Senior Manager Ganiat Mumuney. practices with clinical research opportunities to increase “We offer studies to practices, but we also want to patient access to the most advanced therapies and encourage our practices to reach out to us when they have treatment strategies. a patient in need of a new or different therapy option, for Of course, AdvanceIQ Network helps practices enroll which they do not have access.” patients in clinical trials, but it is much broader than Among current activities, the network is working with two that. The research network also facilitates investigator pharmaceutical companies on three rare tumor trials. With research, prospective patient registries, retrospective more than 30 million Americans with rare diseases, safe outcomes research studies and evidence-based studies and effective products are critical to those patients’ quality through a network of life sciences partners. Those of life. partners recognize that one of the networks strengths is its ability to connect with specialty practices and increase “It is hard to find appropriate patients. We are looking patient enrollment into the studies. This is important for more participation from our practices to better inform because “as science propels cancer treatments forward, available evidence,” said Mumuney.

6 | Oncologistics AdvanceIQ Network also is qualifying practices for a patient respond quickly then basically they lose those opportunities. registry trial that could begin as early as the end of 2018. Participating in a research network that is set up to have This study will compare the different drug delivery options access to those types of trials significantly changes the available for an existing marketed drug to see if there is an game from what it used to be,” said Susan Weidner, Senior impact on clinical and economic outcomes. Vice President, IntrinsiQ Specialty Solutions. Specialty practices want to offer patients access to clinical For more information about clinical research opportunities trials and other research, but a lack of resources often available through AdvanceIQ Network, send an email to creates an administrative burden. And keeping up with [email protected]. the volume of studies that are available can be difficult for research directors and coordinators. AdvanceIQ Network 1. Holcombe RF, Hollinger KJ. Mission-focused, productivity-based seeks to remove the obstacles practices face by significantly model for sustainable support of academic hematology/ oncology lowering administrative overhead, time commitment and faculty and divisions. J Oncol Pract. 2010;6(2):74-79. doi:10.1200/ associated costs and streamlining the process of identifying, JOP.091075 qualifying for and enrolling in clinical research. As part of 2. Barriers to Patient Enrollment in Therapeutic Clinical Trials for the program, participating practices and their physicians Cancer, https://www.fightcancer.org/policy-resources/clinical-trial- will receive support such as contract management barriers. Accessed December 13, 2018. resources, ongoing research education and training and grant submission coaching. “We’ve made so many advancements that enable practices to actively participate on studies more quickly. It used to be it would take nine to 12 months to even get into the study. Tricia Musslewhite is manager, marketing and Today it can be as little as 10 to 14 days. If a practice can’t communications, at AmerisourceBergen.

Oncologistics | 7 YEARS

ION SOLUTIONS

As true leaders in industry, true innovators in care and true partners in service, ION Solutions has been dedicated to fighting for community oncology for 20 years.

One of the ways we demonstrate our commitment to independent community oncology is through our advocacy efforts on Capitol Hill.

True leaders. True innovators. True partners.

CommunityCountsAdvocacy.org8 | Oncologistics YEARS EXTEND YOUR KNOWLEDGE ABOUT AN ALL-ORAL TRIPLET REGIMEN ION SOLUTIONS

Q&A WITH DR. KEN SHAIN* Multiple myeloma expert As true leaders in industry, true innovators in care and true partners in service, ION Solutions has The multiple myeloma treatment landscape has evolved over the past few years, and more options have emerged. been dedicated to fighting for community Dr. Shain discusses treatment with a proteasome inhibitor and explains how the NINLARO® (ixazomib) regimen may offer an option for myeloma patients who have received oncology for 20 years. at least 1 prior therapy. One of the ways we demonstrate our commitment to independent community oncology is through our advocacy efforts on Capitol Hill.

Since 2015, Community Counts has raised awareness on the impact of sequestration, the Part B Demo Project, and other issues paramount to the viability of the community setting. Just last year, more than 500 individuals contacted 280 legislators through this outreach program. NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

True leaders. Please see additional Important Safety Information continued on the following pages and the Brief Summary on the adjacent pages.

True innovators. *Dr. Shain is a paid consultant of Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. This content is intended for informational purposes only and is not a substitute for your clinical knowledge or professional judgment. True partners.

Important Safety Information Warnings and Precautions • Thrombocytopenia has been reported with NINLARO. During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the fi rst three cycles. Manage thrombocytopenia with dose modifi cations and platelet transfusions as per standard medical guidelines. Adjust dosing as needed. Platelet nadirs occurred between Days 14-21 of each 28-day cycle and typically recovered to baseline by the start of the next cycle.

CommunityCountsAdvocacy.org Oncologistics | 9

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NINLARO® (ixazomib) is indicated in combination with lenalidomide and dexamethasone for the My ultimate goal is to keep my patients’ treatment of patients with multiple myeloma who have received at least one prior therapy. disease under control for as long as possible.” —DR. KEN SHAIN Q. How do triplet regimens fit into your approach for Q. Is there a benefit of continuing PI-based treatment long-term* multiple myeloma care? until disease progression or unacceptable toxicity? A. Clinical studies show that triplet therapy improves A. This approach is associated with clinical benefits. The NINLARO regimen extended median progression-free survival (PFS) by ~6 months vs the placebo regimen. outcomes vs doublet therapy. Our goal is to gain control However, most patients who have had at least 1 prior of the disease with combination therapy that is specific therapy only receive a PI for 4 to 7 months. 5-7 In my to the individual needs of our patients. Data have shown experience, common reasons for this are cumulative TOURMALINE-MM1: a global, phase 3, randomized (1:1), double- NINLARO regimen Placebo regimen that triplet therapy may improve outcomes vs doublet toxicity and logistical issues. Toxicity becomes a key blind, placebo-controlled study that evaluated the safety and efficacy 1-4 consideration with triplet regimens, as are the logistical therapy for appropriate patients. of NINLARO (ixazomib+lenalidomide+dexamethasone) vs placebo challenges that patients may face with frequent visits to (placebo+lenalidomide+dexamethasone) until disease progression or 20.6 14.7 the clinic. For these reasons, many doctors may decide to VS Q. Why is long-term treatment with a proteasome unacceptable toxicity in 722 patients with relapsed and/or refractory switch to doublet therapy, often dropping the PI, even if Months Months inhibitor (PI) so important in multiple myeloma? multiple myeloma who received 1-3 prior therapies.1 the patient is showing improvement on a triplet regimen. median PFS median PFS Data show that long-term PI-based therapy can improve 95% CI, 17.0-NE and 95% CI, 12.9-17.6, respectively; A. Patients who were refractory to lenalidomide or PIs were excluded from the study. HR=0.74 (95% CI, 0.59-0.94); P=0.012 outcomes.1 While depth of response is important, my Q. What do you tell your patients when you place them ultimate goal is to try to keep my patients’ disease under on a treatment plan with the NINLARO regimen? control for as long as possible, which often means treating with a PI-based regimen until disease progression or A. I explain to my patients that while multiple myeloma is not a unacceptable toxicity. disease we can cure currently, we can do our best to control it for as long as possible. I let my patients know that they’re not alone, and we’ll walk alongside them on the path of their treatment journey. TO LEARN MORE ABOUT NINLARO, VISIT NINLAROHCP.COM

* Defined as treatment to progression or unacceptable toxicity.

Warnings and Precautions (cont’d) Adverse Reactions • Gastrointestinal Toxicities, including diarrhea, constipation, nausea and vomiting, were reported with NINLARO and may occasionally require The most common adverse reactions (≥ 20%) in the NINLARO regimen and greater than the placebo regimen, respectively, were diarrhea the use of antidiarrheal and antiemetic medications, and supportive care. Diarrhea resulted in the discontinuation of one or more of the three (42%, 36%), constipation (34%, 25%), thrombocytopenia (78%, 54%; pooled from adverse events and laboratory data), peripheral neuropathy drugs in 1% of patients in the NINLARO regimen and < 1% of patients in the placebo regimen. Adjust dosing for severe symptoms. (28%, 21%), nausea (26%, 21%), peripheral edema (25%, 18%), vomiting (22%, 11%), and back pain (21%, 16%). Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%). • Peripheral Neuropathy (predominantly sensory) was reported with NINLARO. The most commonly reported reaction was peripheral sensory neuropathy (19% and 14% in the NINLARO and placebo regimens, respectively). Peripheral motor neuropathy was not Special Populations commonly reported in either regimen (< 1%). Peripheral neuropathy resulted in discontinuation of one or more of the three drugs in 1% of patients in both regimens. Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed. • Hepatic Impairment: Reduce the NINLARO starting dose to 3 mg in patients with moderate or severe hepatic impairment. • Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring was reported with NINLARO. Monitor for fluid retention. Investigate for underlying causes when appropriate and • Peripheral Edema dialysis. NINLARO is not dialyzable. provide supportive care as necessary. Adjust dosing of dexamethasone per its prescribing information or NINLARO for Grade 3 or 4 • Lactation: Advise nursing women not to breastfeed during treatment with NINLARO and for 90 days after the last dose. symptoms. Drug Interactions: Avoid concomitant administration of NINLARO with strong CYP3A inducers. • Cutaneous Reactions: Rash, most commonly maculo-papular and macular rash, was reported with NINLARO. Rash resulted in discontinuation of one or more of the three drugs in < 1% of patients in both regimens. Manage rash with supportive care or with Moreau P, Masszi T, Grzasko N, et al; for TOURMALINE-MM1 Study Group. Oral ixazomib, lenalidomide, and dexamethasone for multiple dose modification. REFERENCES: 1. myeloma. N Engl J Med. 2016;374(17):1621-1634. 2. Lonial S, Dimopoulos M, Palumbo A, et al; for ELOQUENT-2 Investigators. Elotuzumab therapy for relapsed or • Hepatotoxicity has been reported with NINLARO. Drug-induced liver injury, hepatocellular injury, hepatic steatosis, hepatitis cholestatic and refractory multiple myeloma. N Engl J Med. 2015;373(7):621-631. 3. Palumbo A, Chanan-Kahn A, Weisel K, et al; for CASTOR Investigators. Daratumumab, hepatotoxicity have each been reported in < 1% of patients treated with NINLARO. Events of liver impairment have been reported (6% in the bortezomib, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(8):754-766. 4. Dimopoulos MA, Oriol A, Nahi H, et al; for POLLUX Investigators. Daratumumab, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(14):1319-1331. 5. Jagannath S, Roy A, Kish J, et al. Real-world NINLARO regimen and 5% in the placebo regimen). Monitor hepatic enzymes regularly during treatment and adjust dosing as needed. treatment patterns and associated progression-free survival in relapsed/refractory multiple myeloma among US community oncology practices. Expert Rev Hematol. 2016;9(7):707-717, Supplemental Table 2. https://www.tandfonline.com/doi/suppl/10.1080/17474086.2016.1195254?scroll=top. Accessed October 5, 2018. • Embryo-fetal Toxicity: NINLARO can cause fetal harm. Women should be advised of the potential risk to a fetus, to avoid becoming 6. Yong K, Delforge M, Driessen C, et al. Multiple myeloma: patient outcomes in real-world practice. Br J Haematol. 2016;175(2):252-264. 7. Romanus D, Raju A, pregnant, and to use contraception during treatment and for an additional 90 days after the final dose of NINLARO. Women using Yong C, et al. Duration of therapy in U.S. patients treated for relapsed/refractory multiple myeloma (RRMM) in the real world. Poster presented at: European hormonal contraceptives should also use a barrier method of contraception. Hematology Association 21st Congress; June 9-12, 2016; Copenhagen, Denmark. Please see the Brief Summary on the adjacent pages.

All trademarks are the property of their respective owners. ©2018 Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. All rights reserved. Printed in USA 11/18 MAT-USO-IXA-18-00016 10 | Oncologistics

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* Defined as treatment to progression or unacceptable toxicity.

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BRIEF SUMMARY OF PRESCRIBING INFORMATION NINLARO (ixazomib) capsules, for oral use

1 INDICATION Females of reproductive potential should be advised to avoid becoming pregnant NINLARO (ixazomib) is indicated in combination with lenalidomide and while being treated with NINLARO. If NINLARO is used during pregnancy or if the dexamethasone for the treatment of patients with multiple myeloma who have patient becomes pregnant while taking NINLARO, the patient should be apprised received at least one prior therapy. of the potential hazard to the fetus. Advise females of reproductive potential that they must use effective contraception during treatment with NINLARO and for 90 5 WARNINGS AND PRECAUTIONS days following the final dose. Women using hormonal contraceptives should also 5.1 Thrombocytopenia: Thrombocytopenia has been reported with NINLARO use a barrier method of contraception. with platelet nadirs typically occurring between Days 14-21 of each 28-day 6 ADVERSE REACTIONS cycle and recovery to baseline by the start of the next cycle. Three percent of patients in the NINLARO regimen and 1% of patients in the placebo The following adverse reactions are described in detail in other sections of the regimen had a platelet count ≤ 10,000/mm3 during treatment. Less than 1% of prescribing information: patients in both regimens had a platelet count ≤ 5000/mm3 during treatment. • Thrombocytopenia [see Warnings and Precautions (5.1)] Discontinuations due to thrombocytopenia were similar in both regimens (< 1% • Gastrointestinal Toxicities [see Warnings and Precautions (5.2)] of patients in the NINLARO regimen and 2% of patients in the placebo regimen • Peripheral Neuropathy [see Warnings and Precautions (5.3)] discontinued one or more of the three drugs).The rate of platelet transfusions • Peripheral Edema [see Warnings and Precautions (5.4)] was 6% in the NINLARO regimen and 5% in the placebo regimen. • Cutaneous Reactions [see Warnings and Precautions (5.5)] Monitor platelet counts at least monthly during treatment with NINLARO. • Hepatotoxicity [see Warnings and Precautions (5.6)] Consider more frequent monitoring during the first three cycles. Manage thrombocytopenia with dose modifications and platelet transfusions as per 6.1 CLINICAL TRIALS EXPERIENCE standard medical guidelines. Because clinical trials are conducted under widely varying conditions, adverse 5.2 Gastrointestinal Toxicities: Diarrhea, constipation, nausea, and vomiting, reaction rates observed in the clinical trials of a drug cannot be directly have been reported with NINLARO, occasionally requiring use of antidiarrheal compared to rates in the clinical trials of another drug and may not reflect the and antiemetic medications, and supportive care. Diarrhea was reported in 42% rates observed in practice. of patients in the NINLARO regimen and 36% in the placebo regimen, The safety population from the randomized, double-blind, placebo-controlled constipation in 34% and 25%, respectively, nausea in 26% and 21%, clinical study included 720 patients with relapsed and/or refractory multiple respectively, and vomiting in 22% and 11%, respectively. Diarrhea resulted in myeloma, who received NINLARO in combination with lenalidomide and discontinuation of one or more of the three drugs in 1% of patients in the dexamethasone (NINLARO regimen; N=360) or placebo in combination with NINLARO regimen and < 1% of patients in the placebo regimen. Adjust dosing lenalidomide and dexamethasone (placebo regimen; N=360). for Grade 3 or 4 symptoms. The most frequently reported adverse reactions (≥ 20%) in the NINLARO 5.3 Peripheral Neuropathy: The majority of peripheral neuropathy adverse regimen and greater than the placebo regimen were diarrhea, constipation, reactions were Grade 1 (18% in the NINLARO regimen and 14% in the placebo thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, regimen) and Grade 2 (8% in the NINLARO regimen and 5% in the placebo vomiting, and back pain. Serious adverse reactions reported in ≥ 2% of regimen). Grade 3 adverse reactions of peripheral neuropathy were reported at patients included thrombocytopenia (2%) and diarrhea (2%). For each

2% in both regimens; there were no Grade 4 or serious adverse reactions. adverse reaction, one or more of the three drugs was discontinued in ≤ 1% T:10” The most commonly reported reaction was peripheral sensory neuropathy (19% of patients in the NINLARO regimen. and 14% in the NINLARO and placebo regimen, respectively). Peripheral motor Table 4: Non-Hematologic Adverse Reactions Occurring in ≥ 5% of neuropathy was not commonly reported in either regimen (< 1%). Peripheral Patients with a ≥ 5% Difference Between the NINLARO Regimen and the neuropathy resulted in discontinuation of one or more of the three drugs in 1% Placebo Regimen (All Grades, Grade 3 and Grade 4) of patients in both regimens. Patients should be monitored for symptoms of neuropathy. Patients experiencing new or worsening peripheral neuropathy may NINLARO + Placebo + require dose modification. Lenalidomide and Lenalidomide and Dexamethasone Dexamethasone 5.4 Peripheral Edema: Peripheral edema was reported in 25% and 18% of N=360 N=360 patients in the NINLARO and placebo regimens, respectively. The majority of peripheral edema adverse reactions were Grade 1 (16% in the NINLARO System Organ Class / N (%) N (%) regimen and 13% in the placebo regimen) and Grade 2 (7% in the NINLARO Preferred Term regimen and 4% in the placebo regimen). Grade Grade All Grade Grade All Grade 3 peripheral edema was reported in 2% and 1% of patients in the 3 4 3 4 NINLARO and placebo regimens, respectively. There was no Grade 4 peripheral Infections and infestations edema reported. There were no discontinuations reported due to peripheral Upper respiratory tract edema. Evaluate for underlying causes and provide supportive care, as infection 69 (19) 1 (< 1) 0 52 (14) 2 (< 1) 0 necessary. Adjust dosing of dexamethasone per its prescribing information or NINLARO for Grade 3 or 4 symptoms. Nervous system disorders Peripheral neuropathies* 100 (28) 7 (2) 0 77 (21) 7 (2) 0 5.5 Cutaneous Reactions: Rash was reported in 19% of patients in the NINLARO regimen and 11% of patients in the placebo regimen. The majority of Gastrointestinal disorders the rash adverse reactions were Grade 1 (10% in the NINLARO regimen and 7% Diarrhea 151 (42) 22 (6) 0 130 (36) 8 (2) 0 in the placebo regimen) or Grade 2 (6% in the NINLARO regimen and 3% in the Constipation 122 (34) 1 (< 1) 0 90 (25) 1 (< 1) 0 Nausea 92 (26) 6 (2) 0 74 (21) 0 0 placebo regimen). Grade 3 rash was reported in 3% of patients in the NINLARO Vomiting 79 (22) 4 (1) 0 38 (11) 2 (< 1) 0 regimen and 1% of patients in the placebo regimen. There were no Grade 4 or serious adverse reactions of rash reported. The most common type of rash Skin and subcutaneous reported in both regimens included maculo-papular and macular rash. Rash tissue disorders resulted in discontinuation of one or more of the three drugs in < 1% of patients Rash* 68 (19) 9 (3) 0 38 (11) 5 (1) 0 in both regimens. Manage rash with supportive care or with dose modification Musculoskeletal and if Grade 2 or higher. connective tissue disorders 5.6 Hepatotoxicity: Drug-induced liver injury, hepatocellular injury, hepatic Back pain 74 (21) 2 (< 1) 0 57 (16) 9 (3) 0 steatosis, hepatitis cholestatic and hepatotoxicity have each been reported in General disorders and < 1% of patients treated with NINLARO. Events of liver impairment have been administration site reported (6% in the NINLARO regimen and 5% in the placebo regimen). Monitor conditions hepatic enzymes regularly and adjust dosing for Grade 3 or 4 symptoms. Edema peripheral 91 (25) 8 (2) 0 66 (18) 4 (1) 0 5.7 Embryo-Fetal Toxicity: NINLARO can cause fetal harm when administered to a pregnant woman based on the mechanism of action and findings in Note: Adverse reactions included as preferred terms are based on MedDRA animals. There are no adequate and well-controlled studies in pregnant women version 16.0. using NINLARO. Ixazomib caused embryo-fetal toxicity in pregnant rats and *Represents a pooling of preferred terms rabbits at doses resulting in exposures that were slightly higher than those observed in patients receiving the recommended dose. (Continued on next page)

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Brief Summary (cont’d)

Table 5: Thrombocytopenia and Neutropenia (pooled adverse event differences in responses between the elderly and younger patients, but greater and laboratory data) sensitivity of some older individuals cannot be ruled out. NINLARO + Placebo + 8.6 Hepatic Impairment: In patients with moderate or severe hepatic impairment, Lenalidomide and Lenalidomide and the mean AUC increased by 20% when compared to patients with normal hepatic Dexamethasone Dexamethasone function. Reduce the starting dose of NINLARO in patients with moderate or severe N=360 N=360 hepatic impairment. N (%) N (%) 8.7 Renal Impairment: In patients with severe renal impairment or ESRD requiring Any Grade Grade 3-4 Any Grade Grade 3-4 dialysis, the mean AUC increased by 39% when compared to patients with normal renal function. Reduce the starting dose of NINLARO in patients with severe renal Thrombocytopenia 281 (78) 93 (26) 196 (54) 39 (11) impairment or ESRD requiring dialysis. NINLARO is not dialyzable and therefore can be administered without regard to the timing of dialysis Neutropenia 240 (67) 93 (26) 239 (66) 107 (30) 10 OVERDOSAGE: There is no known specific antidote for NINLARO overdose. Herpes Zoster In the event of an overdose, monitor the patient for adverse reactions and Herpes zoster was reported in 4% of patients in the NINLARO regimen and 2% provide appropriate supportive care. of patients in the placebo regimen. Antiviral prophylaxis was allowed at the 17 PATIENT COUNSELING INFORMATION physician’s discretion. Patients treated in the NINLARO regimen who received Advise the patient to read the FDA-approved patient labeling (Patient Information). antiviral prophylaxis had a lower incidence (< 1%) of herpes zoster infection Dosing Instructions compared to patients who did not receive prophylaxis (6%). • Instruct patients to take NINLARO exactly as prescribed. Eye Disorders • Advise patients to take NINLARO once a week on the same day and at Eye disorders were reported with many different preferred terms but in approximately the same time for the first three weeks of a four week cycle. aggregate, the frequency was 26% in patients in the NINLARO regimen and • Advise patients to take NINLARO at least one hour before or at least two 16% of patients in the placebo regimen. The most common adverse reactions hours after food. were blurred vision (6% in the NINLARO regimen and 3% in the placebo • Advise patients that NINLARO and dexamethasone should not be taken at the regimen), dry eye (5% in the NINLARO regimen and 1% in the placebo regimen), same time, because dexamethasone should be taken with food and and conjunctivitis (6% in the NINLARO regimen and 1% in the placebo regimen). NINLARO should not be taken with food. Grade 3 adverse reactions were reported in 2% of patients in the NINLARO • Advise patients to swallow the capsule whole with water. The capsule should regimen and 1% in the placebo regimen. not be crushed, chewed or opened. The following serious adverse reactions have each been reported at a frequency • Advise patients that direct contact with the capsule contents should be of < 1%: acute febrile neutrophilic dermatosis (Sweet’s syndrome), Stevens- avoided. In case of capsule breakage, avoid direct contact of capsule Johnson syndrome, transverse myelitis, posterior reversible encephalopathy contents with the skin or eyes. If contact occurs with the skin, wash syndrome, tumor lysis syndrome, and thrombotic thrombocytopenic purpura. thoroughly with soap and water. If contact occurs with the eyes, flush thoroughly with water. 7 DRUG INTERACTIONS • If a patient misses a dose, advise them to take the missed dose as long as 7.1 Strong CYP3A Inducers: Avoid concomitant administration of NINLARO the next scheduled dose is ≥ 72 hours away. Advise patients not to take a with strong CYP3A inducers (such as rifampin, phenytoin, carbamazepine, and missed dose if it is within 72 hours of their next scheduled dose. St. John’s Wort). • If a patient vomits after taking a dose, advise them not to repeat the dose but T:10” 8 USE IN SPECIFIC POPULATIONS resume dosing at the time of the next scheduled dose. 8.1 Pregnancy: • Advise patients to store capsules in original packaging, and not to remove the capsule from the packaging until just prior to taking NINLARO. Risk Summary: Based on its mechanism of action and data from animal reproduction studies, NINLARO can cause fetal harm when administered to a Thrombocytopenia: Advise patients that they may experience low platelet pregnant woman. There are no human data available regarding the potential counts (thrombocytopenia). Signs of thrombocytopenia may include bleeding effect of NINLARO on pregnancy or development of the embryo or fetus. and easy bruising. Ixazomib caused embryo-fetal toxicity in pregnant rats and rabbits at doses Gastrointestinal Toxicities: Advise patients they may experience diarrhea, resulting in exposures that were slightly higher then those observed in patients constipation, nausea and vomiting and to contact their physician if these receiving the recommended dose. Advise women of the potential risk to a fetus adverse reactions persist. and to avoid becoming pregnant while being treated with NINLARO. In the Peripheral Neuropathy: Advise patients to contact their physicians if they U.S. general population, the estimated background risk of major birth defects experience new or worsening symptoms of peripheral neuropathy such as and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, tingling, numbness, pain, a burning feeling in the feet or hands, or weakness in respectively. Animal Data: In an embryo-fetal development study in pregnant the arms or legs. rabbits there were increases in fetal skeletal variations/abnormalities (caudal vertebrae, number of lumbar vertebrae, and full supernumerary ribs) at doses Peripheral Edema: Advise patients to contact their physicians if they that were also maternally toxic (≥ 0.3 mg/kg). Exposures in the rabbit at 0.3 mg/kg experience unusual swelling of their extremities or weight gain due to swelling. were 1.9 times the clinical time averaged exposures at the recommended dose Cutaneous Reactions: Advise patients to contact their physicians if they of 4 mg. In a rat dose range-finding embryo-fetal development study, at doses experience new or worsening rash that were maternally toxic, there were decreases in fetal weights, a trend Hepatotoxicity: Advise patients to contact their physicians if they experience towards decreased fetal viability, and increased post-implantation losses jaundice or right upper quadrant abdominal pain at 0.6 mg/kg. Exposures in rats at the dose of 0.6 mg/kg was 2.5 times the Other Adverse Reactions: Advise patients to contact their physicians if they clinical time averaged exposures at the recommended dose of 4 mg. experience signs and symptoms of acute febrile neutrophilic dermatosis 8.2 Lactation: No data are available regarding the presence of NINLARO or (Sweet’s syndrome), Stevens-Johnson syndrome, transverse myelitis, posterior its metabolites in human milk, the effects of the drug on the breast fed reversible encephalopathy syndrome, tumor lysis syndrome, and thrombotic infant, or the effects of the drug on milk production. Because the potential thrombocytopenic purpura for serious adverse reactions from NINLARO in breastfed infants is unknown, Pregnancy: Advise women of the potential risk to a fetus and to avoid becoming advise nursing women not to breastfeed during treatment with NINLARO and pregnant while being treated with NINLARO and for 90 days following the final for 90 days after the last dose. dose. Advise women using hormonal contraceptives to also use a barrier 8.3 Females and Males of Reproductive Potential: Contraception - Male and method of contraception. Advise patients to contact their physicians immediately female patients of childbearing potential must use effective contraceptive if they or their female partner become pregnant during treatment or within 90 measures during and for 90 days following treatment. Dexamethasone is known days of the final dose. to be a weak to moderate inducer of CYP3A4 as well as other enzymes and Concomitant Medications: Advise patients to speak with their physicians transporters. Because NINLARO is administered with dexamethasone, the risk about any other medication they are currently taking and before starting any for reduced efficacy of contraceptives needs to be considered. Advise women new medications. using hormonal contraceptives to also use a barrier method of contraception. 8.4 Pediatric Use: Safety and effectiveness have not been established in Please see full Prescribing Information for NINLARO at NINLARO-hcp.com. pediatric patients. All trademarks are the property of their respective owners. 8.5 Geriatric Use: Of the total number of subjects in clinical studies of ©2017 Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of NINLARO, 55% were 65 and over, while 17% were 75 and over. No overall Takeda Pharmaceutical Company Limited. All rights reserved. differences in safety or effectiveness were observed between these subjects AUG 2018 MAT-US-IXA-18-00350 and younger subjects, and other reported clinical experience has not identified

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IXAZ18CDNY6873_Shain_Advertorial_Oncologists_BS_r10.indd 2 11/15/18 12:16 PM Option 1 Option 2

MIPS Tips ADVANCING CARE QUALITY INFORMATION Information to help your practice successfully meet all MIPS measures

IMPROVEMENT ACTIVITIES COST

Option 3

QUALITY

ADVANCING CARE INFORMATION It’s Not Too Late to Ask

IMPROVEMENT for Help with 2018 MIPS ACTIVITIES

COST Data Submission

Gathering and submitting data for the Centers for Medicare & Medicaid Services’ Quality Payment Program can be overwhelming – especially to the practice that does not have the luxury of a dedicated resource handling the MIPS (Merit-based Incentive Payment System) performance measures. With the different formats for submission, and differing performance periods (Quality must be submitted for a full year, while Promoting Interoperability must be a minimum of 90 days), the process is complicated. In addition, the practice must keep a record of all data submitted to ensure it is receiving the accurate number of points and reimbursement adjustment. Also, CMS can audit a practice up to six years after a submission has been completed and recommends maintaining records for up to 10 years. As the reimbursement adjustment for Medicare Part B payments goes to +/- 9 percent by 2022, the impact to a practice could be significant. Any upward payment adjustment is better than a neutral or downward payment adjustment. Your performance will also be publicly reported on Physician Compare, so your scores may impact your practice reputation. It is not too late to get help for your 2018 data submission. The Quality Reporting Engagement Group offers a Submission Assistance option to assist your practice in collecting all available data and ensure your clinicians submit the required components to earn you the maximum number of points possible. If you are interested in speaking to one of the team members about how they can help your practice for 2018, contact [email protected].

14 | Oncologistics MIPS TIPS

Physicians Feeling Increasing Pressures on their Practices

A recent study from the Medical Group Management With the regulations and the burdens created on practices, Association (MGMA) found that physicians are increasingly physicians believe these are taking away from patient care. burdened with both financial pressures on their practices Study authors noted, “Empowering a variety of physicians and regulatory issues dealing with reimbursement. to help shape new programs and initiatives may help to With 426 medical practices responding, the majority (from improve physician satisfaction, thereby hastening the move 68% – 88%) were concerned with regulations around, in toward value.” order of the top five: The message and problem were made clear: despite the ◾◾ The Centers for Medicare & Medicaid Services’ (CMS) Administration’s “Patients over Paperwork” plan and other Quality Payment Program (MIPS/APMS) – as a point initiatives in the last year, regulatory burden on physician of reference, only 9 percent of the respondents in practices continues to increase. the study were satisfied or very satisfied with the Many smaller practices or solo practitioner practices may performance feedback in MIPS be burdened with MIPS reporting, especially without a ◾◾ Obtaining Prior Authorizations dedicated resource overseeing MIPS reporting. The Quality ◾◾ Lack of electronic health record (EHR) interoperability Reporting Engagement Group can help identify the most – as different vendors move toward their own version appropriate measures and submission methods and help of interoperability, practices feel the software is your practice maximize potential reimbursements under the becoming too costly to implement Quality Payment Program. To speak with one of the experts ◾◾ Government EHR requirements about how they can help your practice, send an email to [email protected]. ◾◾ Audits and appeals processes

Oncologistics | 15 CYRAMZA boosted efficacy results vs docetaxel alone in the REVEL ITT population— with consistent results in patients with rapidly progressing disease*1 Exploratory Subgroup Analysis: Patients With Rapidly Progressing Disease* (n=209)1 Time-to-progression ≤12 weeks OS†1 ORR1 PFS§1 (95% CI) (95% CI) (95% CI) CYRAMZA Placebo CYRAMZA Placebo CYRAMZA Placebo + docetaxel + docetaxel + docetaxel + docetaxel + docetaxel + docetaxel 9.1 vs 5.8 % vs % vs ‡ ‡ 19 9 3.6 1.6 MONTHS MONTHS ‡ ‡ (12, 28) (4, 17) MONTHS MONTHS (6.7, 10.8) (4.3, 7.5) (2.8, 4.2) (1.5, 2.6)

Unstratified HR=0.74 Unstratified HR=0.73 (95% CI: 0.54, 1.00) (95% CI: 0.55, 0.97) REVEL EXPLORATORY ANALYSIS The REVEL trial was not adequately powered, nor error-controlled, for subgroup analysis. Treatment differences observed in this subgroup cannot be regarded as statistically significant. The analysis described here was post hoc and exploratory.2 REVEL ITT Population (n=1253)3 OS||3 ORR¶3 PFS#3 Major Outcome Measure Supportive Outcome Measure Supportive Outcome Measure (95% CI) (95% CI) (95% CI) CYRAMZA Placebo CYRAMZA Placebo CYRAMZA Placebo + docetaxel + docetaxel + docetaxel + docetaxel + docetaxel + docetaxel 10.5 vs 9.1 23% vs 14% 4.5 vs 3.0 MONTHS‡ MONTHS‡ MONTHS‡ MONTHS‡ (20, 26) (11, 17) (9.5, 11.2) (8.4, 10.0) (4.2, 5.4) (2.8, 3.9) HR=0.86 (95% CI: 0.75, 0.98) P<0.001 HR=0.76 (95% CI: 0.68, 0.86) P=0.024 P<0.001 STUDY DESIGN The phase III REVEL trial evaluated the efficacy and safety of CYRAMZA plus docetaxel vs placebo plus docetaxel in patients with mNSCLC with disease progression on or after platinum-based chemotherapy. Major efficacy outcome measure was OS. Supportive efficacy outcome measures were PFS and ORR. All patients were required to have ECOG PS 0 or 1. Patients were randomized 1:1 to receive either CYRAMZA 10 mg/kg (n=628) or placebo (n=625), in combination with docetaxel at 75 mg/m2 every 21 days.3 *Rapidly progressing disease is defined by time-to-progression within 9 or 12 weeks after starting initial platinum-based treatment.4 †The percentage of deaths at the time of analysis in the CYRAMZA plus docetaxel arm was 75.7% (84 patients) and 80.6% (79 patients) in the placebo plus docetaxel arm. ‡Median. §The percentage of events at the time of analysis in the CYRAMZA plus docetaxel arm was 91% (101 patients) and 92.9% (91 patients) in the placebo plus docetaxel arm. || The percentage of deaths at the time of analysis was 68% (428 patients) and 73% (456 patients) in the CYRAMZA plus docetaxel and placebo plus docetaxel arms, respectively. ¶Disease progression and tumor response were assessed by investigators in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.5 #The percentage of events at the time of analysis was 89% (558 patients) and 93% (583 patients) in the CYRAMZA plus docetaxel and placebo plus docetaxel arms, respectively. ORR=complete + partial response; does not include stable disease. CI=confidence interval; ECOG=Eastern Cooperative Oncology Group; HR=hazard ratio; ITT=intent-to-treat; mNSCLC=metastatic non-small cell lung cancer; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; PS=performance status. INDICATION CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA. IMPORTANT SAFETY INFORMATION FOR CYRAMZA WARNING: HEMORRHAGE, GASTROINTESTINAL PERFORATION, AND IMPAIRED WOUND HEALING Hemorrhage: CYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage, including severe and sometimes fatal hemorrhagic events. Permanently discontinue CYRAMZA in patients who experience severe bleeding. Gastrointestinal Perforation: CYRAMZA can increase the risk of gastrointestinal perforation, a potentially fatal event. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation. Impaired Wound Healing: Impaired wound healing can occur with antibodies inhibiting the VEGF pathway. Discontinue CYRAMZA therapy in patients with impaired wound healing. Withhold CYRAMZA prior to surgery and discontinue CYRAMZA if a patient develops wound healing complications. IMPORTANT SAFETY INFORMATION FOR CYRAMZA (CONT’D) Embryofetal Toxicity Warnings and Precautions • Based on its mechanism of action, CYRAMZA can cause fetal harm when administered to pregnant women. Animal models link angiogenesis, VEGF, and VEGF Receptor 2 (VEGFR2) to critical Hemorrhage aspects of female reproduction, embryofetal development, and postnatal development. Advise • CYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage, including severe pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use and sometimes fatal hemorrhagic events. In study 3, which evaluated CYRAMZA plus docetaxel in effective contraception during treatment with CYRAMZA and for at least 3 months after the last metastatic non-small cell lung cancer (NSCLC), the incidence of severe bleeding was 2.4% for dose of CYRAMZA. CYRAMZA plus docetaxel and 2.3% for placebo plus docetaxel. Patients with NSCLC receiving therapeutic anticoagulation or chronic therapy with NSAIDs or other antiplatelet therapy other Most Common Adverse Reactions than once-daily aspirin or with radiographic evidence of major airway or blood vessel invasion or • The most commonly reported adverse reactions (all grades; grade 3/4) occurring in ≥5% of patients intratumor cavitation were excluded from study 3; therefore, the risk of pulmonary hemorrhage receiving CYRAMZA plus docetaxel and ≥2% higher than placebo plus docetaxel in study 3 were in these groups of patients is unknown. Permanently discontinue CYRAMZA in patients who neutropenia (55% vs 46%; 49% vs 40%), fatigue/asthenia (55% vs 50%; 14% vs 11%), stomatitis/ experience severe bleeding. mucosal inflammation (37% vs 19%; 7% vs 2%), epistaxis (19% vs 7%; <1% vs <1%), febrile neutropenia (16% vs 10%; 16% vs 10%), peripheral edema (16% vs 9%; 0% vs <1%), Arterial Thromboembolic Events (ATEs) thrombocytopenia (13% vs 5%; 3% vs <1%), lacrimation increased (13% vs 5%; <1% vs 0%), and • Serious, sometimes fatal, ATEs including myocardial infarction, cardiac arrest, cerebrovascular hypertension (11% vs 5%; 6% vs 2%). accident, and cerebral ischemia occurred in clinical trials. Permanently discontinue CYRAMZA in • The most common serious adverse events with CYRAMZA plus docetaxel in study 3 were febrile patients who experience a severe ATE. neutropenia (14%), pneumonia (6%), and neutropenia (5%). The use of granulocyte colony- Hypertension stimulating factors was 42% in CYRAMZA plus docetaxel-treated patients versus 37% in patients • An increased incidence of severe hypertension occurred in patients receiving CYRAMZA plus who received placebo plus docetaxel. docetaxel (6%) as compared to placebo plus docetaxel (2%). Control hypertension prior to initiating • In patients ≥65 years of age, there were 18 (8%) deaths on treatment or within 30 days of treatment with CYRAMZA. Monitor blood pressure every 2 weeks or more frequently as indicated discontinuation for CYRAMZA plus docetaxel and 9 (4%) deaths for placebo plus docetaxel. during treatment. Temporarily suspend CYRAMZA for severe hypertension until medically controlled. In patients <65 years of age, there were 13 (3%) deaths on treatment or within 30 days of Permanently discontinue CYRAMZA if medically significant hypertension cannot be controlled with discontinuation for CYRAMZA plus docetaxel and 26 (6%) deaths for placebo plus docetaxel. antihypertensive therapy or in patients with hypertensive crisis or hypertensive encephalopathy. • Treatment discontinuation due to adverse reactions occurred more frequently in CYRAMZA plus Infusion-Related Reactions (IRRs) docetaxel-treated patients (9%) than in placebo plus docetaxel-treated patients (5%). The most • Prior to the institution of premedication recommendations across clinical trials of CYRAMZA, IRRs common adverse events leading to treatment discontinuation of CYRAMZA were infusion-related occurred in 6 out of 37 patients (16%), including 2 severe events. The majority of IRRs across trials reaction (0.5%) and epistaxis (0.3%). occurred during or following a first or second CYRAMZA infusion. Symptoms of IRRs included rigors/ • For patients with nonsquamous histology, the overall incidence of pulmonary hemorrhage was tremors, back pain/spasms, chest pain and/or tightness, chills, flushing, dyspnea, wheezing, 7% and the incidence of grade ≥3 pulmonary hemorrhage was 1% for CYRAMZA plus docetaxel hypoxia, and paresthesia. In severe cases, symptoms included bronchospasm, supraventricular compared to 6% overall incidence and 1% for grade ≥3 pulmonary hemorrhage for placebo plus tachycardia, and hypotension. Monitor patients during the infusion for signs and symptoms of IRRs docetaxel. For patients with squamous histology, the overall incidence of pulmonary hemorrhage in a setting with available resuscitation equipment. Immediately and permanently discontinue was 10% and the incidence of grade ≥3 pulmonary hemorrhage was 2% for CYRAMZA plus docetaxel CYRAMZA for grade 3 or 4 IRRs. compared to 12% overall incidence and 2% for grade ≥3 pulmonary hemorrhage for placebo plus Gastrointestinal Perforations docetaxel. • CYRAMZA is an antiangiogenic therapy that can increase the risk of gastrointestinal perforation, a • Clinically relevant adverse reactions reported in ≥1% and <5% of CYRAMZA plus docetaxel-treated potentially fatal event. In study 3, the incidence of gastrointestinal perforation was 1% for CYRAMZA patients in study 3 were hyponatremia (4.8% CYRAMZA plus docetaxel versus 2.4% for placebo plus plus docetaxel versus 0.3% for placebo plus docetaxel. Permanently discontinue CYRAMZA in docetaxel) and proteinuria (3.3% CYRAMZA plus docetaxel versus 0.8% placebo plus docetaxel). patients who experience a gastrointestinal perforation. Drug Interactions Impaired Wound Healing • No pharmacokinetic interactions were observed between ramucirumab and docetaxel. Impaired wound healing can occur with antibodies inhibiting the VEGF pathway. CYRAMZA has not • Use in Specific Populations been studied in patients with serious or nonhealing wounds. CYRAMZA, as an antiangiogenic • Pregnancy: Based on its mechanism of action, CYRAMZA can cause fetal harm. Animal models therapy, has the potential to adversely affect wound healing. Discontinue CYRAMZA therapy in link angiogenesis, VEGF, and VEGF Receptor 2 (VEGFR2) to critical aspects of female reproduction, patients with impaired wound healing. Withhold CYRAMZA prior to surgery. Resume CYRAMZA embryofetal development, and postnatal development. There are no available data on CYRAMZA following the surgical intervention based on clinical judgment of adequate wound healing. If a use in pregnant women to inform any drug-associated risks. No animal studies have been patient develops wound healing complications during therapy, discontinue CYRAMZA until the wound conducted to evaluate the effect of ramucirumab on reproduction and fetal development. Advise is fully healed. females of reproductive potential of the potential risk for maintaining pregnancy, risk to the fetus, Clinical Deterioration in Child-Pugh B or C Cirrhosis and risk to newborn and infant development, and to use effective contraception during CYRAMZA • Clinical deterioration, manifested by new onset or worsening encephalopathy, ascites, or therapy and for at least 3 months following the last dose of CYRAMZA. hepatorenal syndrome, was reported in patients with Child-Pugh B or C cirrhosis who received • Lactation: Because of the potential risk for serious adverse reactions in nursing infants single-agent CYRAMZA. Use CYRAMZA in patients with Child-Pugh B or C cirrhosis only if the from ramucirumab, advise women that breastfeeding is not recommended during treatment potential benefits of treatment are judged to outweigh the risks of clinical deterioration. with CYRAMZA. Reversible Posterior Leukoencephalopathy Syndrome (RPLS) • Females of Reproductive Potential: Advise females of reproductive potential that based on animal • RPLS has been reported at a rate of <0.1% in clinical studies with CYRAMZA. Confirm the diagnosis data CYRAMZA may impair fertility. of RPLS with MRI and discontinue CYRAMZA in patients who develop RPLS. Symptoms may resolve or improve within days, although some patients with RPLS can experience ongoing neurologic Please see Brief Summary of Prescribing Information for CYRAMZA, including sequelae or death. Boxed Warning for hemorrhage, gastrointestinal perforation, and impaired wound Proteinuria Including Nephrotic Syndrome healing, on adjacent pages. • Monitor proteinuria by urine dipstick and/or urinary protein creatinine ratio for the development RB-L HCP ISI 17SEP2015 of worsening of proteinuria during CYRAMZA therapy. Withhold CYRAMZA for urine protein levels that are ≥2 g over 24 hours. Reinitiate CYRAMZA at a reduced dose once the urine protein level returns to <2 g over 24 hours. Permanently discontinue CYRAMZA for urine protein levels >3 g over 24 hours or in the setting of nephrotic syndrome. Thyroid Dysfunction Visit CYRAMZAhcp.com to find out more • Monitor thyroid function during treatment with CYRAMZA. References: 1. Data on file. Eli Lilly and Company. ONC20170503d. 2. Data on file. Eli Lilly and Company. ONC20170503c. 3. CYRAMZA (ramucirumab) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017. 4. Data on file. Eli Lilly and Company. ONC20170503a. 5. Garon EB, Ciuleanu T-E, Arrieta O, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014;384(9944):665-673.

CYRAMZA® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. PP-RB-US-1086 10/2017 PRINTED IN USA © Lilly USA, LLC 2017. All rights reserved. CYRAMZA® (ramucirumab) injection Reversible Posterior Leukoencephalopathy Syndrome (RPLS) BRIEF SUMMARY: For complete safety, please consult the full Prescribing Information. RPLS has been reported with a rate of <0.1% in clinical studies with CYRAMZA. Confirm the WARNING: HEMORRHAGE, GASTROINTESTINAL PERFORATION, diagnosis of RPLS with MRI and discontinue CYRAMZA in patients who develop RPLS. Symptoms AND IMPAIRED WOUND HEALING may resolve or improve within days, although some patients with RPLS can experience ongoing Hemorrhage: CYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage, neurologic sequelae or death. including severe and sometimes fatal hemorrhagic events. Permanently discontinue Proteinuria Including Nephrotic Syndrome CYRAMZA in patients who experience severe bleeding. In Study 4, severe proteinuria occurred more frequently in patients treated with CYRAMZA plus FOLFIRI compared to patients receiving placebo plus FOLFIRI. Severe proteinuria was reported in Gastrointestinal Perforation: CYRAMZA can increase the risk of gastrointestinal perforation, 3% of patients treated with CYRAMZA plus FOLFIRI (including 3 cases [0.6%] of nephrotic syndrome) a potentially fatal event. Permanently discontinue CYRAMZA in patients who experience a compared to 0.2% of patients treated with placebo plus FOLFIRI. Monitor proteinuria by urine gastrointestinal perforation. dipstick and/or urinary protein creatinine ratio for the development of worsening of proteinuria during CYRAMZA therapy. Withhold CYRAMZA for urine protein levels that are 2 or more grams over Impaired Wound Healing: Impaired wound healing can occur with antibodies inhibiting the 24 hours. Reinitiate CYRAMZA at a reduced dose once the urine protein level returns to less than VEGF pathway. Discontinue CYRAMZA therapy in patients with impaired wound healing. 2 grams over 24 hours. Permanently discontinue CYRAMZA for urine protein levels greater than Withold CYRAMZA prior to surgery and discontinue CYRAMZA if a patient develops wound 3 grams over 24 hours or in the setting of nephrotic syndrome. healing complications. Thyroid Dysfunction Monitor thyroid function during treatment with CYRAMZA. In Study 4, the incidence of hypothyroidism reported as an adverse event was 2.6% in the CYRAMZA plus FOLFIRI treated patients and 0.9% in INDICATIONS AND USAGE the placebo plus FOLFIRI treated patients. Non-Small Cell Lung Cancer: Embryofetal Toxicity CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic Based on its mechanism of action, CYRAMZA can cause fetal harm when administered to pregnant non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. women. Animal models link angiogenesis, VEGF and VEGF Receptor 2 (VEGFR2) to critical aspects of Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved female reproduction, embryofetal development, and postnatal development. Advise pregnant women therapy for these aberrations prior to receiving CYRAMZA. of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with CYRAMZA and for at least 3 months after the last dose of CYRAMZA. CONTRAINDICATIONS None. ADVERSE REACTIONS Clinical Trials Experience WARNINGS AND PRECAUTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates Hemorrhage observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of CYRAMZA increased the risk of hemorrhage and gastrointestinal hemorrhage, including severe and another drug and may not reflect the rates observed in practice. sometimes fatal hemorrhagic events. In Study 1, the incidence of severe bleeding was 3.4% for CYRAMZA Administered in Combination with Docetaxel CYRAMZA and 2.6% for placebo. In Study 2, the incidence of severe bleeding was 4.3% for CYRAMZA Study 3 was a multinational, randomized, double-blind study conducted in patients with NSCLC plus paclitaxel and 2.4% for placebo plus paclitaxel. Patients with gastric cancer receiving nonsteroid with disease progression on or after one platinum-based therapy for locally advanced or metastatic anti-inflammatory drugs (NSAIDs) were excluded from enrollment in Studies 1 and 2; therefore, the risk disease. Patients received either CYRAMZA 10 mg/kg intravenously plus docetaxel 75 mg/m2 of gastric hemorrhage in CYRAMZA-treated patients with gastric tumors receiving NSAIDs is unknown. intravenously every 3 weeks or placebo plus docetaxel 75 mg/m2 intravenously every 3 weeks. In Study 3, the incidence of severe bleeding was 2.4% for CYRAMZA plus docetaxel and 2.3% for placebo plus docetaxel. Patients with NSCLC receiving therapeutic anticoagulation or chronic therapy Due to an increased incidence of neutropenia and febrile neutropenia in patients enrolled in East Asian sites, Study 3 was amended and 24 patients (11 CYRAMZA plus docetaxel, 13 placebo plus with NSAIDS or other antiplatelet therapy other than once daily aspirin or with radiographic evidence of 2 major airway or blood vessel invasion or intratumor cavitation were excluded from Study 3; therefore docetaxel) at East Asian sites received a starting dose of docetaxel at 60 mg/m every 3 weeks. the risk of pulmonary hemorrhage in these groups of patients is unknown. In Study 4, the incidence of Study 3 excluded patients with an ECOG PS of 2 or greater, bilirubin greater than the upper limit of severe bleeding was 2.5% for CYRAMZA plus FOLFIRI and 1.7% for placebo plus FOLFIRI. Permanently normal (ULN), uncontrolled hypertension, major surgery within 28 days, radiographic evidence of discontinue CYRAMZA in patients who experience severe bleeding. major airway or blood vessel invasion by cancer, radiographic evidence of intra-tumor cavitation, or Arterial Thromboembolic Events gross hemoptysis within the preceding 2 months, and patients receiving therapeutic anticoagulation Serious, sometimes fatal, arterial thromboembolic events (ATEs) including myocardial infarction, or chronic anti-platelet therapy other than once daily aspirin. The study also excluded patients whose cardiac arrest, cerebrovascular accident, and cerebral ischemia occurred in clinical trials including 1.7% only prior treatment for advanced NSCLC was a tyrosine kinase (epidermal growth factor receptor of 236 patients who received CYRAMZA as a single agent for gastric cancer in Study 1. Permanently [EGFR] or anaplastic lymphoma kinase [ALK]) inhibitor. The data described below reflect exposure to discontinue CYRAMZA in patients who experience a severe ATE. CYRAMZA plus docetaxel in 627 patients in Study 3. Demographics and baseline characteristics were Hypertension similar between treatment arms. Median age was 62 years; 67% of patients were men; 84% were An increased incidence of severe hypertension occurred in patients receiving CYRAMZA as a single White and 12% were Asian; 33% had ECOG PS 0; 74% had non-squamous histology and 25% had agent (8%) as compared to placebo (3%) and in patients receiving CYRAMZA plus paclitaxel (15%) squamous histology. Patients received a median of 4.5 doses of CYRAMZA; the median duration of as compared to placebo plus paclitaxel (3%), in patients receiving CYRAMZA plus docetaxel (6%) as exposure was 3.5 months, and 195 (31% of 627) patients received CYRAMZA for at least six months. compared to placebo plus docetaxel (2%), and in patients receiving CYRAMZA plus FOLFIRI (11%) In Study 3, the most common adverse reactions (all grades) observed in CYRAMZA plus docetaxel- as compared to placebo plus FOLFIRI (3%). Control hypertension prior to initiating treatment with treated patients at a rate of ≥30% and ≥2% higher than placebo plus docetaxel were neutropenia, CYRAMZA. Monitor blood pressure every two weeks or more frequently as indicated during treatment. fatigue/asthenia, and stomatitis/mucosal inflammation. Treatment discontinuation due to adverse Temporarily suspend CYRAMZA for severe hypertension until medically controlled. Permanently reactions occurred more frequently in CYRAMZA plus docetaxel-treated patients (9%) than in placebo discontinue CYRAMZA if medically significant hypertension cannot be controlled with antihypertensive plus docetaxel-treated patients (5%). The most common adverse events leading to treatment therapy or in patients with hypertensive crisis or hypertensive encephalopathy. discontinuation of CYRAMZA were infusion-related reaction (0.5%) and epistaxis (0.3%). For patients Infusion-Related Reactions with non-squamous histology, the overall incidence of pulmonary hemorrhage was 7% and the Prior to the institution of premedication recommendations across clinical trials of CYRAMZA, incidence of ≥Grade 3 pulmonary hemorrhage was 1% for CYRAMZA plus docetaxel compared to infusion-related reactions (IRRs) occurred in 6 out of 37 patients (16%), including two severe 6% overall incidence and 1% for ≥Grade 3 pulmonary hemorrhage for placebo plus docetaxel. For events. The majority of IRRs across trials occurred during or following a first or second CYRAMZA patients with squamous histology, the overall incidence of pulmonary hemorrhage was 10% and the infusion. Symptoms of IRRs included rigors/tremors, back pain/spasms, chest pain and/or tightness, incidence of ≥Grade 3 pulmonary hemorrhage was 2% for CYRAMZA plus docetaxel compared to chills, flushing, dyspnea, wheezing, hypoxia, and paresthesia. In severe cases, symptoms included 12% overall incidence and 2% for ≥Grade 3 pulmonary hemorrhage for placebo plus docetaxel. The bronchospasm, supraventricular tachycardia, and hypotension. Monitor patients during the infusion most common serious adverse events with CYRAMZA plus docetaxel were febrile neutropenia (14%), for signs and symptoms of IRRs in a setting with available resuscitation equipment. Immediately and pneumonia (6%), and neutropenia (5%). The use of granulocyte colony-stimulating factors was permanently discontinue CYRAMZA for Grade 3 or 4 IRRs. 42% in CYRAMZA plus docetaxel-treated patients versus 37% in patients who received placebo Gastrointestinal Perforations plus docetaxel. In patients ≥65 years, there were 18 (8%) deaths on treatment or within 30 days CYRAMZA is an antiangiogenic therapy that can increase the risk of gastrointestinal perforation, a of discontinuation for CYRAMZA plus docetaxel and 9 (4%) deaths for placebo plus docetaxel. In potentially fatal event. Four of 570 patients (0.7%) who received CYRAMZA as a single agent in clinical patients <65 years, there were 13 (3%) deaths on treatment or within 30 days of discontinuation trials experienced gastrointestinal perforation. In Study 2, the incidence of gastrointestinal perforations for CYRAMZA plus docetaxel and 26 (6%) deaths for placebo plus docetaxel. Table 4 provides the was also increased in patients that received CYRAMZA plus paclitaxel (1.2%) as compared to patients frequency and severity of adverse reactions in Study 3. receiving placebo plus paclitaxel (0.3%). In Study 3, the incidence of gastrointestinal perforation was 1% for CYRAMZA plus docetaxel and 0.3% for placebo plus docetaxel. In Study 4, the incidence of Table 4: Adverse Reactions Occurring at Incidence Rate ≥5% and a ≥2% Difference Between gastrointestinal perforation was 1.7% for CYRAMZA plus FOLFIRI and 0.6% for placebo plus FOLFIRI. Arms in Patients Receiving CYRAMZA in Study 3 Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation. Impaired Wound Healing CYRAMZA plus docetaxel Placebo plus docetaxel Impaired wound healing can occur with antibodies inhibiting the VEGF pathway. CYRAMZA has not been Adverse Reactions (N=627) (N=618) studied in patients with serious or non-healing wounds. CYRAMZA, as an antiangiogenic therapy, has (MedDRA) the potential to adversely affect wound healing. Withhold CYRAMZA prior to surgery. Resume following System Organ Class All Grades Grade 3-4 All Grades Grade 3-4 the surgical intervention based on clinical judgment of adequate wound healing. If a patient develops (Frequency %) (Frequency %) (Frequency %) (Frequency %) wound healing complications during therapy, discontinue CYRAMZA until the wound is fully healed. Blood and Lymphatic System Disorders Clinical Deterioration in Patients with Child-Pugh B or C Cirrhosis Clinical deterioration, manifested by new onset or worsening encephalopathy, ascites, or hepatorenal Febrile neutropenia 16 16 10 10 syndrome was reported in patients with Child-Pugh B or C cirrhosis who received single-agent Neutropenia 55 49 46 40 CYRAMZA. Use CYRAMZA in patients with Child-Pugh B or C cirrhosis only if the potential benefits of treatment are judged to outweigh the risks of clinical deterioration. Thrombocytopenia 13 3 5 <1 CYRAMZA® (ramucirumab) injection RB-L HCP BS 27MAR2017 CYRAMZA® (ramucirumab) injection RB-L HCP BS 27MAR2017

CYRAMZA RB-L HCP BS 27MAR2017 - 7 x 10 PRINTER VERSION 1 OF 2 Table 4: Adverse Reactions Occurring at Incidence Rate ≥5% and a ≥2% Difference Between Geriatric Use Arms in Patients Receiving CYRAMZA in Study 3 (Cont.) Of the 563 CYRAMZA-treated patients in two randomized gastric cancer clinical studies, 36% were 65 and over, while 7% were 75 and over. No overall differences in safety or effectiveness were CYRAMZA plus docetaxel Placebo plus docetaxel observed between these subjects and younger subjects. Of the 1253 patients in Study 3, 455 (36%) Adverse Reactions (N=627) (N=618) were 65 and over and 84 (7%) were 75 and over. Of the 627 patients who received CYRAMZA plus (MedDRA) docetaxel in Study 3, 237 (38%) were 65 and over, while 45 (7%) were 75 and over. In an exploratory System Organ Class All Grades Grade 3-4 All Grades Grade 3-4 subgroup analysis of Study 3, the hazard ratio for overall survival in patients less than 65 years old (Frequency %) (Frequency %) (Frequency %) (Frequency %) was 0.74 (95% CI: 0.62, 0.87) and in patients 65 years or older was 1.10 (95% CI: 0.89, 1.36). Gastrointestinal Disorders Renal Impairment No dose adjustment is recommended for patients with renal impairment based on population Stomatitis/Mucosal 37 7 19 2 pharmacokinetic analysis. inflammation Hepatic Impairment Eye Disorders No dose adjustment is recommended for patients with mild (total bilirubin within upper limit of normal Lacrimation increased 13 <1 5 0 [ULN] and aspartate aminotransferase [AST] >ULN, or total bilirubin >1.0-1.5 times ULN and any AST) or moderate (total bilirubin >1.5-3.0 times ULN and any AST) hepatic impairment based on population General Disorders and Administration Site Disorders pharmacokinetic analysis. Clinical deterioration was reported in patients with Child-Pugh B or C Fatigue/Asthenia 55 14 50 11 cirrhosis who received single-agent CYRAMZA. Peripheral edema 16 0 9 <1 DOSAGE AND ADMINISTRATION Respiratory, Thoracic, and Mediastinal Disorders Do not administer CYRAMZA as an intravenous push or bolus. Epistaxis 19 <1 7 <1 Vascular Disorders Recommended Dose and Schedule Hypertension 11 6 5 2 The recommended dose of CYRAMZA is 10 mg/kg administered by intravenous infusion over 60 minutes on day 1 of a 21-day cycle prior to docetaxel infusion. Continue CYRAMZA until disease progression or unacceptable toxicity. Clinically relevant adverse drug reactions reported in ≥1% and <5% of the CYRAMZA plus docetaxel- Premedication treated patients in Study 3 were hyponatremia (4.8% CYRAMZA plus docetaxel versus 2.4% for placebo Prior to each CYRAMZA infusion, premedicate all patients with an intravenous histamine H1 antagonist plus docetaxel) and proteinuria (3.3% CYRAMZA plus docetaxel versus 0.8% placebo plus docetaxel). (e.g., diphenhydramine hydrochloride). For patients who have experienced a Grade 1 or 2 infusion reaction, Immunogenicity also premedicate with dexamethasone (or equivalent) and acetaminophen prior to each CYRAMZA infusion. As with all therapeutic proteins, there is the potential for immunogenicity. In 23 clinical trials, Dose Modifications 86/2890 (3.0%) of CYRAMZA-treated patients tested positive for treatment-emergent anti-ramucirumab Infusion-Related Reactions (IRR) antibodies by an enzyme-linked immunosorbent assay (ELISA). Neutralizing antibodies were detected in • Reduce the infusion rate of CYRAMZA by 50% for Grade 1 or 2 IRRs. 14 of the 86 patients who tested positive for treatment-emergent anti-ramucirumab antibodies. • Permanently discontinue CYRAMZA for Grade 3 or 4 IRRs. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Hypertension Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an • Interrupt CYRAMZA for severe hypertension until controlled with medical management. assay may be influenced by several factors including assay methodology, sample handling, timing of • Permanently discontinue CYRAMZA for severe hypertension that cannot be controlled with sample collection, concomitant medications, and underlying disease. For these reasons, comparison antihypertensive therapy. of incidence of antibodies to CYRAMZA with the incidences of antibodies to other products may Proteinuria be misleading. • Interrupt CYRAMZA for urine protein levels ≥2 g/24 hours. Reinitiate treatment at a reduced dose of 8 mg/kg every 3 weeks once the urine protein level returns to <2 g/24 hours. If the protein level DRUG INTERACTIONS ≥2 g/24 hours reoccurs, interrupt CYRAMZA and reduce the dose to 6 mg/kg every 3 weeks once No pharmacokinetic (PK) interactions were observed between ramucirumab and docetaxel. the urine protein level returns to <2 g/24 hours. • Permanently discontinue CYRAMZA for urine protein level >3 g/24 hours or in the setting of USE IN SPECIFIC POPULATIONS nephrotic syndrome. Pregnancy Wound Healing Complications Risk Summary • Interrupt CYRAMZA prior to scheduled surgery until the wound is fully healed. Based on its mechanism of action, CYRAMZA can cause fetal harm. Animal models link angiogenesis, Arterial Thromboembolic Events, Gastrointestinal Perforation, or Grade 3 or 4 Bleeding VEGF and VEGF Receptor 2 (VEGFR2) to critical aspects of female reproduction, embryofetal development, • Permanently discontinue CYRAMZA. and postnatal development. There are no available data on CYRAMZA in pregnant women to inform any drug-associated risks. No animal studies have been conducted to evaluate the effect of ramucirumab For toxicities related to docetaxel, refer to the current respective prescribing information. on reproduction and fetal development. The background risk of major birth defects and miscarriage for the indicated populations are unknown. In the U.S. general population the estimated background PATIENT COUNSELING INFORMATION risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, • Hemorrhage: respectively. Advise pregnant women of the potential risk to a fetus. Advise patients that CYRAMZA can cause severe bleeding. Advise patients to contact their health care Animal Data provider for bleeding or symptoms of bleeding including lightheadedness. No animal studies have been specifically conducted to evaluate the effect of ramucirumab on • Arterial thromboembolic events: reproduction and fetal development. In mice, loss of the VEGFR2 gene resulted in embryofetal death and Advise patients of an increased risk of an arterial thromboembolic event. these fetuses lacked organized blood vessels and blood islands in the yolk sac. In other models, VEGFR2 • Hypertension: signaling was associated with development and maintenance of endometrial and placental vascular Advise patients to undergo routine blood pressure monitoring and to contact their health care provider function, successful blastocyst implantation, maternal and feto-placental vascular differentiation, and if blood pressure is elevated or if symptoms from hypertension occur including severe headache, development during early pregnancy in rodents and non-human primates. Disruption of VEGF signaling lightheadedness, or neurologic symptoms. has also been associated with developmental anomalies including poor development of the cranial • Gastrointestinal perforations: region, forelimbs, forebrain, heart, and blood vessels. Advise patients to notify their health care provider for severe diarrhea, vomiting, or severe abdominal pain. Lactation • Impaired wound healing: Risk Summary Advise patients that CYRAMZA has the potential to impair wound healing. Instruct patients not to undergo There is no information on the presence of ramucirumab in human milk, the effects on the breast-fed surgery without first discussing this potential risk with their health care provider. infant, or the effects on milk production. Human IgG is present in human milk, but published data suggest • Pregnancy and fetal harm: that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Advise females of reproductive potential of the potential risk for maintaining pregnancy, risk to the fetus, Because of the potential risk for serious adverse reactions in nursing infants from ramucirumab, advise and risk to postnatal newborn and infant development and to use effective contraception during CYRAMZA women that breastfeeding is not recommended during treatment with CYRAMZA. therapy and for at least 3 months following the last dose of CYRAMZA. Females and Males of Reproductive Potential • Lactation: Contraception Advise patients not to breastfeed during CYRAMZA treatment. Females • Infertility: Based on its mechanism of action, CYRAMZA can cause fetal harm. Advise females of reproductive Advise females of reproductive potential regarding potential infertility effects of CYRAMZA. potential to use effective contraception while receiving CYRAMZA and for at least 3 months after the last dose of CYRAMZA. Additional information can be found at www.CYRAMZAhcp.com. Infertility Females Advise females of reproductive potential that based on animal data CYRAMZA may impair fertility. Pediatric Use The safety and effectiveness of CYRAMZA in pediatric patients have not been established. In animal Eli Lilly and Company, Indianapolis, IN 46285, USA studies, effects on epiphyseal growth plates were identified. In cynomolgus monkeys, anatomical Copyright © 2017, Eli Lilly and Company. All rights reserved. pathology revealed adverse effects on the epiphyseal growth plate (thickening and osteochondropathy) at all doses tested (5-50 mg/kg). Ramucirumab exposure at the lowest weekly dose tested in the RB-L HCP BS 27MAR2017 cynomolgus monkey was 0.2 times the exposure in humans at the recommended dose of ramucirumab as a single agent. PP-RB-US-0984 CYRAMZA® (ramucirumab) injection RB-L HCP BS 27MAR2017 CYRAMZA® (ramucirumab) injection RB-L HCP BS 27MAR2017

CYRAMZA RB-L HCP BS 27MAR2017 - 7 x 10 PRINTER VERSION 2 OF 2 What’s News at ION

Making the Case for Medically Integrated Dispensing

An article written by Barry Fortner, Ph.D., Senior Vice President and President of Specialty Physician Services at AmerisourceBergen, was published in November 2018 to Oncology Live’s website. “Making the Case for Medically Integrated Dispensing” showcases the potential of medically integrated dispensing within practices and the challenges physicians currently face with implementation. Barry walks readers through best practices and recommendations for implementing an in-office dispensing program – from leveraging data and hiring a technician to getting involved in advocacy efforts on Capitol Hill. Practices interested in learning more about how in-office dispensing can maximize your practice’s revenue and enhance patient care should contact [email protected].

AmerisourceBergen, ION Solutions Join Groups Opposing New Part B Demo

In December 2018, AmerisourceBergen and ION Solutions joined 337 other patient, provider and caregiver organizations in a letter to congressional leadership asking them to help stop the U.S. Department of Health and Human Services’ (HHS) recently announced advance notice of the International Pricing Index Model for Medicare Part B Drugs (IPI). As proposed, the IPI model could be implemented in 2020 and would institute a mandatory demonstration project for 50 percent of the U.S. that would replace Medicare’s existing Part B drug reimbursement mechanism with a new benchmark based on foreign drug prices. It would change provider reimbursement to a flat add-on fee and restructure the current buy and bill model so that a new vendor system would be implemented whereby the medicines would be purchased and delivered to the physician by a vendor that would then be reimbursed by Medicare, a revised version of the failed 2006 Competitive Acquisition Program (CAP). The letter articulates myriad concerns with the proposal, including potential disruptions to beneficiary access to needed medications, provider reimbursement cuts and dampening medical innovation. AmerisourceBergen will continue to collaborate with aligned stakeholders to ensure these concerns are heard by congressional and administration policymakers heading into 2019.

APP Programs are Essential to Ensure Access to Quality Cancer Care

Successfully managing clinical workloads and maximizing both the quality of care delivered and staff productivity are synonymous with your practice’s operational health. As the demand for oncology services increases, practices need to find a way to improve access to care, engage patients and offer services such as patient education and advance care planning. One of the most successful strategies is the addition of an Advanced Practice Provider (APP) program. Integrating an APP program can have complexities that benefit from an outside view. ION Solutions’ Clinical Quality Consultants can help navigate those issues after a 360˚ practice assessment. The consultant provides an on-site assessment to either start or strengthen a current APP program and reviews the current roles within the practice to provide guidance on potentially implementing the program or finding other opportunities for improvement. The consultant will use an ROI tool to guide decision making for implementing a program, as well as identifying those services that would best help the practice. Evaluating the need for additional provider-based services in the clinical workflow will also be discussed.

20 | Oncologistics What’s News

Following an APP 360˚ practice assessment, the practice can engage the consultant for implementation services that will provide support, resources and tools to aid in the onboarding and orientation of an APP, as well as develop, implement and/or optimize a standardized APP practice model. The focus will also be on revenue enhancing services such as patient education, same day visit schedules and survivorship. “Given the increasing number of patients with and survivors of cancer, APPs are important to ensure access to quality cancer care now and in the future.1” If you are interested in learning more about how an APP program can help balance the demands for your physicians’ time while providing patient-centered care, contact [email protected]

1. http://ascopubs.org/doi/abs/10.1200/JOP.18.00181

MHP Joins ION Solutions GPO Network and Selects Oncology Supply as Exclusive Specialty Distributor

Michigan Healthcare Professionals (MHP) has selected ION Solutions for GPO contracting and Oncology Supply for exclusive specialty distribution. This marks a six-year strategic relationship focused on supporting patient outcomes and driving economic competitiveness. With more than 400 physicians, MHP is a large-specialty group spanning numerous specialties. MHP’s community The strongest differentiator for oncology practice consists of 24 physicians, including ION Solutions and Oncology radiation oncologists and surgeons, staffing 11 different sites of care that span the entire metro-Detroit area. As Supply is the VIP level of service an Oncology Care Model practice, MHP provides high- quality, efficient, coordinated, appropriate and cost-effective that we receive.” healthcare. MHP has two retail pharmacies and offers, fast, safe and free delivery anywhere in Michigan within 24 hours. - Dr. Jeffrey Margolis, President of MHP participates in TACO, the Medicare Shared Savings Michigan Healthcare Professionals Program Accountable Care Organization. “As the largest physician service organization and GPO specializing in the support of independent oncology practices, we pride ourselves in the strength and caliber of our membership, and MHP certainly adds to both,” said Barry Fortner, Ph.D., Senior Vice President & President of Specialty Physician Services at AmerisourceBergen. “We look forward to leveraging the full power of our ION GPO and AmerisourceBergen’s integrated service and technology offerings to support MHP as the practice builds on the exceptional work they’re already doing to create efficiencies, deliver positive clinical outcomes and enhance the patient experience.” Through this new agreement, MHP will have a dedicated account team that acts as an extension of the practice and actively consults on contract performance, purchasing activities and creating operational efficiencies. MHP will have access to Oncology Supply’s robust inventory of specialty and full-line oral, infusible and injectable products. “The strongest differentiator for ION Solutions and Oncology Supply is the VIP level of service that we receive,” said Dr. Jeffrey Margolis, President of Michigan Healthcare Professionals. “Justin Doyle, John Johns and the team from ION Solutions and Oncology Supply is incredibly hands on and they anticipate our needs before we even ask. When we implement a new technology or solution, the team sees it through to the very end to ensure a seamless execution. It’s clear that we are more than a transaction or sales volume to them. It’s a real relationship.”

Oncologistics | 21 Educational Programs

2019 Meeting Schedule

Meeting Date Meeting Name Location Venue

January 25 Multiple Myeloma Orlando, FL Renaissance Sea World

January 25-26 ASH Review Orlando, FL Renaissance Sea World

March 8-9 Oral Therapies Plano, TX Renaissance Plano

May 16-17 Smart ID Charlotte, NC Westin Charlotte

National Healthcare May 17-18 Charlotte, NC Westin Charlotte Practitioners

*Meeting Dates Subject to Change* Registration will be available approximately 60 days prior to each event. To register, visit www.iononline.com.

22 | Oncologistics B:8.75” T:7.875” S:7”

Along the MBC journey*— explore Verzenio1

Verzenio is indicated for the treatment of hormone receptor−positive (HR+), human epidermal growth factor receptor 2−negative (HER2−) advanced or metastatic breast cancer (MBC):  In combination with fulvestrant for women with disease progression following endocrine therapy  In combination with an aromatase inhibitor (AI) for postmenopausal women as initial endocrine-based therapy  As a single agent for adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting * Patients who received prior therapy with a CDK4 & 6 inhibitor were excluded from the MONARCH trials.2-4 There are currently no data regarding the use of Verzenio following use of another CDK4 & 6 inhibitor. B:11.25” T:10.5” S:10”

For patients with HR+, HER2− MBC, including those with concerning clinical characteristics1-14†

† Disease characteristics that typically confer a less favorable prognosis. Visceral disease and progression on ET and prior chemotherapy in the metastatic setting were concerning clinical characteristics in MONARCH 1. Primary resistance and visceral disease were concerning clinical characteristics in MONARCH 2. Liver metastases and treatment-free interval <36 months were concerning clinical characteristics in MONARCH 3. Exploratory subgroup analyses of PFS were performed for patients with liver metastases and for patients with a treatment-free interval <36 months.2-14 CDK4 & 6=cyclin-dependent kinases 4 and 6; ET=endocrine therapy; PFS=progression-free survival.

Select Important Safety Information Diarrhea occurred in 81% of patients receiving Verzenio plus an aromatase Grades 2 and 3 were 9 days and 6 days, respectively. In MONARCH 3, inhibitor in MONARCH 3, 86% of patients receiving Verzenio plus fulvestrant 19% of patients with diarrhea required a dose omission and 13% required in MONARCH 2 and 90% of patients receiving Verzenio alone in MONARCH 1. a dose reduction. In MONARCH 2, 22% of patients with diarrhea required Grade 3 diarrhea occurred in 9% of patients receiving Verzenio plus an a dose omission and 22% required a dose reduction. The time to onset aromatase inhibitor in MONARCH 3, 13% of patients receiving Verzenio and resolution for diarrhea were similar across MONARCH 3, MONARCH plus fulvestrant in MONARCH 2 and in 20% of patients receiving Verzenio 2, and MONARCH 1. alone in MONARCH 1. Episodes of diarrhea have been associated with Instruct patients that at the fi rst sign of loose stools, they should start dehydration and infection. antidiarrheal therapy such as loperamide, increase oral fl uids, and notify Diarrhea incidence was greatest during the fi rst month of Verzenio dosing. In their healthcare provider for further instructions and appropriate follow-up. MONARCH 3, the median time to onset of the first diarrhea event was For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, 8 days, and the median duration of diarrhea for Grades 2 and 3 were discontinue Verzenio until toxicity resolves to ≤Grade 1, and then 11 and 8 days, respectively. In MONARCH 2, the median time to onset of the resume Verzenio at the next lower dose. fi rst diarrhea event was 6 days, and the median duration of diarrhea for

Please see additional Important Safety Information and Brief Summary of full Prescribing Information for Verzenio on the following pages.

Oncologistics | 23

200 FIFTH AVENUE NEW YORK, NY 10010

THIS ADVERTISEMENT PREPARED BY TOWNHOUSE JOB #: ELIAHU-Q80204_BASE_Pg1_REV2 PROOF: 2 CLIENT: ELI LILLY & COMPANY SIZE, SPACE: 7.875” x 10.5”, Journal Ad CLIENT: ELI LILLY & COMPANY OP: CV, JS PRODUCT: ABEMACICLIB US HCP PUBS: NCCN Journal Ad SPACE/SIZE: B: 8.75” x 11.25” T: 7.875” x 10.5” S: 7” x 10” LEGAL RELEASE STATUS JOB#: ELIAHU-Q80204_BASE_Pg1_REV2 ISSUE: 2018 AD APPROVAL ART DIRECTOR: J. Goody COPYWRITER: None DATE: Release has been obtained Legal Coord: Acct Mgmt: Print Prod: Art Director: Proofreader: Copywriter: Studio: B:17.25” T:15.75” S:14.75”

Verzenio + AI Verzenio + fulvestrant

For women with HR+, HER2− MBC For women with HR+, HER2− MBC Verzenio + AI as fi rst-line endocrine-based therapy1,3 Verzenio + fulvestrant in patients who recurred >28-month median PFS as initial endocrine-based therapy1 ORR in patients with measurable disease1,3*†‡ or progressed on or after ET1 100 1,2 1 >16-month median PFS in women who recurred or ORR in patients with measurable disease *† ITT 1 progressed on or after ET 100 80 55.4% (95% CI: 23.5-NR) vs 14.8 months ORR ITT1 28.2 with AI alone (95% CI: 11.2-19.2) 80 60 48.1% months HR=0.540 (95% CI: 0.418-0.698) (95% Cl: 49.5-61.4) (95% CI: 14.4-19.3) vs 9.3 months 3.4% CR 40.2% ORR ORR mPFS 1 with fulvestrant alone (95% CI: 7.4-12.7) P<.0001 (n=9) 16.4 (95% Cl: 31.8-48.5) 60

PATIENTS (%) PATIENTS 40 months HR=0.553 (95% CI: 0.449-0.681) mPFS P<.00011 (95% Cl: 42.6-53.6) 3.5% CR  The percentage of events at the time of analysis was 52.1% PR (%) PATIENTS 40 (n=11) 20 (n=139) 40.2% PR 42.1% (n=138) and 65.5% (n=108) in the Verzenio + AI and 21.3% ORR (n=53) (95% Cl: 15.1-27.6) AI alone arms, respectively1  The percentage of events at the time of analysis was 49.8% 20 44.7% PR  At the time of the PFS analysis, 19% of patients had 0 (n=222) and 70.4% (n=157) in the Verzenio + fulvestrant and (n=142) 1 1 died, and overall survival data were immature VERZENIO + Al PLACEBO + Al fulvestrant alone arms, respectively 21.3% PR (N=267) (N=132)  At the time of the primary analysis of PFS, overall survival (n=35) 0 1 data were not mature (20% of patients had died) VERZENIO + FULVESTRANT PLACEBO + FULVESTRANT  ORR was defi ned as the proportion of patients with CR + PR and (N=318) (N=164) does not include stable disease1  ORR was defi ned as the proportion of patients with CR + PR, and *In patients with measurable disease; N=267 for the Verzenio + AI arm, N=132 for the AI alone arm.1 1,15 †Based upon confi rmed responses.1 does not include stable disease † ‡PR defi ned as ≥30% reduction in target lesion size per RECIST 1.1.3,15 *N=318 for the Verzenio + fulvestrant arm; N=164 for the fulvestrant alone arm.1 †PR defi ned as ≥30% reduction in target lesion size per RECIST 1.1.2,15 Exploratory subgroup analyses PFS results in women with concerning clinical characteristics PFS results in women with concerning clinical characteristics 1,2,5-8‡ 1,3,9-14§ were consistent with the ITT population B:11.25”

were consistent with the ITT population T:10.5” S:10” ‡Disease characteristics that typically confer a less favorable prognosis. Primary resistance and visceral disease were concerning §Disease characteristics that typically confer a less favorable prognosis. Liver metastases and treatment-free interval <36 months were concerning clinical characteristics in MONARCH 2. clinical characteristics in MONARCH 3. Primary resistance16 Visceral disease16 Liver metastases13 Treatment-free interval <36 months14 (95% Cl: 12.4-24.1) (n=111) vs 7.9 months (95% Cl: 13.0-17.4) (n=245) vs 6.5 months (95% CI: 7.4-23.7) (n=47) vs (95% CI: 11.6-NR) (n=44) vs 15.3 14.7 15.0 29.5 with fulvestrant alone (95% Cl: 5.7-11.4) (n=58) with fulvestrant alone (95% Cl: 5.6-8.7) (n=128) 7.2 months median PFS with 9.0 months median PFS with months months months months (95% CI: 0.306-0.674) (95% CI: 0.369-0.627) AI alone (95% CI: 2.1-14.0) (n=31) AI alone (95% CI: 3.7-14.2) (n=32) HR=0.454 HR=0.481 HR=0.477 (95% CI: 0.272-0.837) HR=0.441 (95% CI: 0.241-0.805)  Primary resistance is defi ned as relapse while on the fi rst 2  Visceral disease was defi ned as at least 1 lesion on an internal years of adjuvant endocrine therapy, or progressive disease organ or in the third space and could have included lung, liver,  Exploratory subgroup analyses of PFS were performed for the subgroups of patients with liver metastases or with treatment-free interval within the fi rst 6 months of fi rst-line endocrine therapy for pleural, or peritoneal metastatic involvement17 <36 months after completion of adjuvant ET. Estimated HRs and CIs for the within group analyses that were adjusted for treatment metastatic breast cancer1 interaction are shown. The analyses were not adjusted for multiplicity and the study was not powered to test the eff ect of  Preplanned subgroup analyses of PFS were performed for stratifi cation factors of disease site, including visceral disease, and endocrine Verzenio + AI among subgroups.13,14 resistance, including primary resistance. The analyses were not adjusted for multiplicity and the study was not powered to test the eff ect of Verzenio + fulvestrant among subgroups16 MONARCH 3 was a multicenter trial that enrolled 493 patients with HR+, HER2− locoregionally recurrent or MBC in combination with a MONARCH 2 was a phase III, randomized, double-blind, placebo-controlled trial that enrolled 669 patients with HR+, HER2− MBC who nonsteroidal AI as initial endocrine-based therapy. The median patient age was 63 years (range, 32 to 88 years). Forty-seven percent of progressed on ET. Patients were randomized 2:1 to Verzenio + fulvestrant or placebo + fulvestrant. Verzenio was dosed on a continuous dosing patients had received prior ET and 39% of patients had received chemotherapy in the adjuvant setting. Patients were randomized 2:1 to schedule until disease progression or unacceptable toxicity. The primary endpoint was PFS. Key secondary endpoints were ORR, overall Verzenio + AI or placebo + AI. Patients received either letrozole (80%) or anastrozole (20%). Verzenio was dosed continuously until disease survival, and DoR.1,2 progression or unacceptable toxicity. The primary endpoint was PFS. Key secondary endpoints were ORR and DoR.1,3

CI=confi dence interval; CR=complete response; DoR=duration of response; HR=hazard ratio; ITT=intent-to-treat; NR=not reached; ORR=objective response rate; PR=partial response; Select Important Safety Information (cont’d) RECIST 1.1= Response Evaluation Criteria in Solid Tumors version 1.1. In MONARCH 3, for patients receiving Verzenio plus an aromatase Venous thromboembolic events were reported in 5% of patients Select Important Safety Information (cont’d) inhibitor with Grade ≥3 increases in ALT or AST, median time to onset treated with Verzenio plus an aromatase inhibitor as compared to 0.6% of was 61 and 71 days, respectively, and median time to resolution to patients treated with an aromatase inhibitor plus placebo in MONARCH Neutropenia occurred in 41% of patients receiving Verzenio plus an and as clinically indicated. Dose interruption, dose reduction, or delay Grade <3 was 14 and 15 days, respectively. In MONARCH 2, for patients 3. Venous thromboembolic events were reported in 5% of patients aromatase inhibitor in MONARCH 3, 46% of patients receiving Verzenio in starting treatment cycles is recommended for patients who develop receiving Verzenio plus fulvestrant with Grade ≥3 increases in ALT treated with Verzenio plus fulvestrant in MONARCH 2 as compared plus fulvestrant in MONARCH 2 and 37% of patients receiving Verzenio Grade 3 or 4 neutropenia. or AST, median time to onset was 57 and 185 days, respectively, and to 0.9% of patients treated with fulvestrant plus placebo. Venous alone in MONARCH 1. A Grade ≥3 decrease in neutrophil count (based on Febrile neutropenia has been reported in <1% of patients exposed to median time to resolution to Grade <3 was 14 and 13 days, respectively. thromboembolic events included deep vein thrombosis, pulmonary laboratory fi ndings) occurred in 22% of patients receiving Verzenio plus Verzenio in the MONARCH studies. Two deaths due to neutropenic For assessment of potential hepatotoxicity, monitor liver function tests embolism, pelvic venous thrombosis, an aromatase inhibitor in MONARCH 3, 32% of patients receiving Verzenio sepsis were observed in MONARCH 2. Inform patients to promptly cerebral venous sinus thrombosis, plus fulvestrant in MONARCH 2 and in 27% of patients receiving Verzenio (LFTs) prior to the start of Verzenio therapy, every 2 weeks for the fi rst report any episodes of fever to their healthcare provider. 2 months, monthly for the next 2 months, and as clinically indicated. subclavian and axillary vein thrombosis, alone in MONARCH 1. In MONARCH 3, the median time to fi rst episode of and inferior vena cava thrombosis. Across Grade ≥3 neutropenia was 33 days, and in MONARCH 2 and MONARCH 1, Grade ≥3 increases in alanine aminotransferase (ALT) (6% versus 2%) Dose interruption, dose reduction, dose discontinuation, or delay in and aspartate aminotransferase (AST) (3% versus 1%) were reported in starting treatment cycles is recommended for patients who develop the clinical development program, deaths was 29 days. In MONARCH 3, median duration of Grade ≥3 neutropenia due to venous thromboembolism have was 11 days, and for MONARCH 2 and MONARCH 1 was 15 days. the Verzenio and placebo arms, respectively, in MONARCH 3. Grade ≥3 persistent or recurrent Grade 2, or Grade 3 or 4, hepatic transaminase increases in ALT (4% versus 2%) and AST (2% versus 3%) were reported elevation. been reported. Monitor complete blood counts prior to the start of Verzenio therapy, in the Verzenio and placebo arms respectively, in MONARCH 2. every 2 weeks for the fi rst 2 months, monthly for the next 2 months, Please see additional Important Safety Information and Brief Summary of full Prescribing Information for Verzenio on the following pages. 24 | Oncologistics

Pg 2 Pg 3

200 FIFTH AVENUE NEW YORK, NY 10010

THIS ADVERTISEMENT PREPARED BY TOWNHOUSE JOB #: ELIAHU-Q80204_Spread_1_REV2 PROOF: 2 CLIENT: ELI LILLY & COMPANY SIZE, SPACE: 15.75” x 10.5”, 4C CLIENT: ELI LILLY & COMPANY OP: CV PRODUCT: ABEMACICLIB US DTC PUBS: MAGAZINE SPACE/SIZE: B: 17.25” x 11.25” T: 15.75” x 10.5” S: 14.75” x 10” LEGAL RELEASE STATUS JOB#: ELIAHU-Q80204_Spread_1_REV2 ISSUE: 2018 AD APPROVAL ART DIRECTOR: J. Goody COPYWRITER: None DATE: Release has been obtained Legal Coord: Acct Mgmt: Print Prod: Art Director: Proofreader: Copywriter: Studio: B:17.25” T:15.75” S:14.75”

Verzenio + AI Verzenio + fulvestrant

Pg 2 Pg 3

200 FIFTH AVENUE NEW YORK, NY 10010

Single agent

For heavily pretreated women with HR+, HER2− MBC The only CDK4 & 6 inhibitor approved as a single agent1 Abemaciclib (Verzenio®): recommended by the National Comprehensive Cancer Network®(NCCN®)19 ORR1 Median duration of response (mDoR)1†

Abemaciclib (Verzenio): the only CDK4 & 6 inhibitor recommended by (95% CI: 13.3-27.5) NCCN in combination with fulvestrant or an AI and as a single agent19 per investigator assessment1 8.6 19.7% ORR was deﬁ ned as the proportion months of patients with CR + PR, and does (95% CI: ORR 5.8-10.2) ‡ not include stable disease1,15* CATEGORY 1* CATEGORY 2A Investigator assessment

19† 19† 1  17.4% ORR (95% CI: 11.4-25.0), per independent review 02 4 6 810 Abemaciclib (Verzenio) + fulvestrant Abemaciclib (Verzenio) as a single agent MONTHS Recommended option for the treatment of postmenopausal women Recommended option for the treatment of postmenopausal women with HR+, HER2− MBC after disease progression on prior ET with HR+, HER2− MBC after disease progression on prior ET and prior chemotherapy in the metastatic setting MONARCH 1 was a single-arm, open-label, multicenter study in 132  3.7-month median time to response (range: 1.1-14.2 months)4,18 Abemaciclib (Verzenio) + an AI19† women with measurable HR+, HER2− MBC whose disease progressed  7.2-month mDoR (95% CI: 5.6-NR), per independent review1 during or after ET, had received a taxane in any setting, and who Recommended option for the treatment of postmenopausal women received 1 or 2 prior chemotherapy regimens in the metastatic setting. with HR+, HER2− MBC as initial endocrine-based therapy Patients had an Eastern Cooperative Oncology Group Performance *PR deﬁ ned as ≥30% reduction in target lesion size per RECIST 1.1.4,15 1 Status of 0 (55% of patients) or 1 (45% of patients). Patients took 200 mg †Among 26 patients (investigator assessed) and 23 patients (independent review) who had a PR. of Verzenio orally twice daily on a continuous schedule unless disease *Category 1: Based upon high-level evidence,nce, there is uniform NCCN conconsensennsussusus ththathat the ininterventiontervention is appropriate.appropriate.19 †If there is disease progression while on CDK4K4 & 6 inhibitor therapy,therarapypy, tththereere areare no data to support an additiadditionalonal llineine of therapy with anotheranother CDK4 & 6–conta6–containiiningng regimen. progression or unacceptable toxicity occurred. The primary endpoint 19 1,4 ‡Category 2A: Based upon lower-level evidence,ce, there is uuniformniform NCCN coconnsensussensus that the intervention isis appropriate. was ORR. A key secondary endpoint was DoR. NCCN makes no warranties of any kind whatsoeverever regardingregagardding their content, use, or application and disclaidisclaimsms any responsibilityresponsibility for their applicatioapplicationn or use in any way. B:11.25” T:10.5” S:10”

Select Important Safety Information (cont’d) Select Important Safety Information (cont’d) Monitor patients for signs and symptoms of venous thrombosis and placebo plus fulvestrant vs placebo plus fulvestrant were diarrhea (86% Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 3 in ≥10% is predictedpredicted to increase the AUCAUC of abemaciclibabemaciclib by upu to 16-fold.16-fold. In pulmonary embolism and treat as medically appropriate. vs 25%), neutropenia (46% vs 4%), fatigue (46% vs 32%), nausea (45% for Verzenio plus anastrozole or letrozole and ≥2% higher than placebobo patientspatients with recommendedrecommended startingstarting dosesdoses ofof2f 200200 mg twicetwicee dailydaily or Verzenio can cause fetal harm when administered to a pregnant woman vs 23%), infections (43% vs 25%), abdominal pain (35% vs 16%), anemia plus anastrozole or letrozole vs placebo plus anastrozole or letrozolee 150 mg twice daily,daily, reducereduce the VerzenioVerzenio dosedosse to 100 mgg twicetwice daily withwith based on fi ndings from animal studies and the mechanism of action. In (29% vs 4%), leukopenia (28% vs 2%), decreased appetite (27% vs 12%), were increased serum creatinine (98% vs 84%; 2% vs 0%), decreased concomitantconcomitant use of other ststrongrong CYP3ACYP3P3A inhibitors.inhibitors. IInnpn patientspatients who havehave animal reproduction studies, administration of abemaciclib to pregnant vomiting (26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 3%), white blood cells (82% vs 27%; 13% vs <1%), anemia (82% vs 28%; 2% vs had a dose reductionreduction to 100 mg twicetwice dailydailyy duedue toto adverseadverse reactions,reactions, rats during the period of organogenesis caused teratogenicity and thrombocytopenia (16% vs 3%), alopecia (16% vs 2%), stomatitis (15% vs 0%), decreased neutrophil count (80% vs 21%; 22% vs 3%), decreased furtherrther reducereduce the VerzenioVerzenio dosedose to 50 mg twice dailydaily withwith concomitconcomitantantnt decreased fetal weight at maternal exposures that were similar to the 10%), ALT increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%), lymphocyte count (53% vs 26%; 8% vs 2%), decreased platelet count (36% use of other strongstrong CYP3ACYP3P3A inhibitors.inhibititorors. If a patientpatient takingtaking VerzenioVerzeenion human clinical exposure based on area under the curve (AUC) at the dizziness (12% vs 6%), AST increased (12% vs 7%), peripheral edema (12% vs 12%; 2% vs <1%), increased ALT (48% vs 25%; 7% vs 2%), and increased discontinuesntinues a strongstrong CYP3ACYP3A inhibitor,inhibitor, increaseincrease the VerzenioVerzenio dosedose (after maximum recommended human dose. Advise pregnant women of the vs 7%), creatinine increased (12% vs <1%), rash (11% vs 4%), pyrexia (11% vs AST (37% vs 23%; 4% vs <1%). 3 to 5 half-livesalf-lives of thehe inhibitor)inhibitor) tot the dose that waswas usedused beforebefore startirtingng potential risk to a fetus. Advise females of reproductive potential to use 6%), and weight decreased (10% vs 2%). Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 2 in ≥10% for the strongg inhibitor.inhibittoor. PatientsPatients shouldshould avoidavoid grapefruitgrapefruit producproductsctsts.. eff ective contraception during treatment with Verzenio and for at least 3 The most common adverse reactions (all grades, ≥10%) observed in Verzenio plus fulvestrant and ≥2% higher than placebo plus fulvestrant Avoid concomitantomitant usese of strongstrong CYP3ACYP3A inducersinducers andand considerconsider weeks after the last dose. There are no data on the presence of Verzenio MONARCH 1 with Verzenio were diarrhea (90%), fatigue (65%), nausea vs placebo plus fulvestrant were increased serum creatinine (98% vs alternative agentsents. CCoadministrationooadministration of VeVerzeniorzenio wiwiththh rrifamprifampin,in, a strong in human milk or its eff ects on the breastfed child or on milk production. (64%), decreased appetite (45%), abdominal pain (39%), neutropenia 74%; 1% vs 0%), decreased white blood cells (90% vs 33%; 23% vs 1%), CYP3A inducer, decreaseddeecreased thethe plasmaplasma concentrationsconcentraationsti of abemaciabebemacciclclibib Advise lactating women not to breastfeed during Verzenio treatment (37%), vomiting (35%), infections (31%), anemia (25%), thrombocytopenia decreased neutrophil count (87% vs 30%; 33% vs 4%), anemia (84% vs plus its active metabolitesabolites andand maymay leadlead toto rreducededuuceced activity.activt ityy. and for at least 3 weeks after the last dose because of the potential (20%), headache (20%), cough (19%), leukopenia (17%), constipation (17%), 33%; 3% vs <1%), decreased lymphocyte count (63% vs 32%; 12% vs 2%), With severe hepaticc impairmentimpairment (Child-Pugh(Child-PuPughg ClaClassss C), reduce tthehe for serious adverse reactions in breastfed infants. Based on fi ndings in arthralgia (15%), dry mouth (14%), weight decreased (14%), stomatitis (14%), decreased platelet count (53% vs 15%; 2% vs 0%), increased ALT (41% vs Verzenio dosing frequencyuency ttoo ooncence dadaily.ily. TThehe phapharmacokineticsrmacokinetics ooff animals, Verzenio may impair fertility in males of reproductive potential. creatinine increased (13%), alopecia (12%), dysgeusia (12%), pyrexia (11%), 32%; 5% vs 1%), and increased AST (37% vs 25%; 4% vs 4%). Verzenio in patients withh severesevere renalrenall imimpairmentpairment (CL(CLcrcr <30 mL/mimL/min),n), The most common adverse reactions (all grades, ≥10%) observed dizziness (11%), and dehydration (10%). Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 1 with end stage renal disease, or in patientspatientss ono didialysisalysis is unknown.unknown. No dodosagesage in MONARCH 3 for Verzenio plus anastrozole or letrozole and ≥2% The most frequently reported ≥5% Grade 3 or 4 adverse reactions that Verzenio were increased serum creatinine (98%; <1%), decreased white adjustments are necessary in ppatientsatiatieents wwithith mimildld or modmoderateerate hephepaticatic higher than placebo plus anastrozole or letrozole vs placebo plus occurred in the Verzenio arm vs the placebo arm of MONARCH 3 were blood cells (91%; 28%), decreased neutrophil count (88%; 27%), anemia (Child-Pugh A or B) and/or renalall impairmentimpi airment (CLcr(CLcr ≥30-30-8989 mL/mL/min).min). anastrozole or letrozole were diarrhea (81% vs 30%), neutropenia (41% vs neutropenia (22% vs 2%), diarrhea (9% vs 1%), leukopenia (8% vs <1%), (68%; 0%), decreased lymphocyte count (42%; 14%), decreased platelet 2%), fatigue (40% vs 32%), infections (39% vs 29%), nausea (39% vs 20%), ALT increased (7% vs 2%), and anemia (6% vs 1%). count (41%; 2%), increased ALT (31%; 3%), and increased AST (30%; 4%). AL HCP ISI 26FEB2018 abdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs The most frequently reported ≥5% Grade 3 or 4 adverse reactions that Strong CYP3A inhibitors increased the exposure of abemaciclib plus 5%), alopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia occurred in the Verzenio arm vs the placebo arm of MONARCH 2 were its active metabolites to a clinically meaningful extent and may lead to (21% vs 2%), creatinine increased (19% vs 4%), constipation (16% vs 12%), neutropenia (27% vs 2%), diarrhea (13% vs <1%), leukopenia (9% vs 0%), increased toxicity. Avoid concomitant use of ketoconazole. Ketoconazole ALT increased (16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), anemia (7% vs 1%), and infections (6% vs 3%). pruritus (13% vs 9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight decreased (10% vs 3%), infl uenza-like illness (10% vs The most frequently reported ≥5% Grade 3 or 4 adverse reactions 8%), and thrombocytopenia (10% vs 2%). from MONARCH 1 with Verzenio were neutropenia (24%), diarrhea (20%), Please see Brief Summary of full Prescribing Information for Verzenionio fatigue (13%), infections (7%), leukopenia (6%), anemia (5%), and nausea on the following pages. The most common adverse reactions (all grades, ≥10%) observed (5%). in MONARCH 2 for Verzenio plus fulvestrant and ≥2% higher than

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THIS ADVERTISEMENT PREPARED BY TOWNHOUSE JOB #: ELIAHU-Q80204_Spread_2_REV2 PROOF: 2 CLIENT: ELI LILLY & COMPANY SIZE, SPACE: 15.75” x 10.5”, 4C CLIENT: ELI LILLY & COMPANY OP: CV, JS PRODUCT: ABEMACICLIB US DTC PUBS: MAGAZINE SPACE/SIZE: B: 17.25” x 11.25” T: 15.75” x 10.5” S: 14.75” x 10” LEGAL RELEASE STATUS JOB#: ELIAHU-Q80204_Spread_2_REV2 ISSUE: 2018 AD APPROVAL ART DIRECTOR: J. Goody COPYWRITER: None DATE: Release has been obtained Legal Coord: Acct Mgmt: Print Prod: Art Director: Proofreader: Copywriter: Studio: B:17.25” T:15.75” S:14.75”

Single agent

19† 19† 1  17.4% ORR (95% CI: 11.4-25.0), per independent review 02 4 6 810 Abemaciclib (Verzenio) + fulvestrant Abemaciclib (Verzenio) as a single agent MONTHS Recommended option for the treatment of postmenopausal women Recommended option for the treatment of postmenopausal women with HR+, HER2− MBC after disease progression on prior ET with HR+, HER2− MBC after disease progression on prior ET and prior chemotherapy in the metastatic setting MONARCH 1 was a single-arm, open-label, multicenter study in 132  3.7-month median time to response (range: 1.1-14.2 months)4,18 Abemaciclib (Verzenio) + an AI19† women with measurable HR+, HER2− MBC whose disease progressed  7.2-month mDoR (95% CI: 5.6-NR), per independent review1 during or after ET, had received a taxane in any setting, and who Recommended option for the treatment of postmenopausal women received 1 or 2 prior chemotherapy regimens in the metastatic setting. with HR+, HER2− MBC as initial endocrine-based therapy Patients had an Eastern Cooperative Oncology Group Performance *PR deﬁ ned as ≥30% reduction in target lesion size per RECIST 1.1.4,15 1 Status of 0 (55% of patients) or 1 (45% of patients). Patients took 200 mg †Among 26 patients (investigator assessed) and 23 patients (independent review) who had a PR. of Verzenio orally twice daily on a continuous schedule unless disease *Category 1: Based upon high-level evidence,nce, there is uniform NCCN conconsensennsussusus ththathat the ininterventiontervention is apprappropriate.opriate.19 †If there is disease progression while on CDK4K4 & 6 inhibitor therapy,therarapypy, tththereere areare no data to support an additiadditionalonal llineine of therapy with anotheranother CDK4 & 6–conta6–containiiningng regimen. progression or unacceptable toxicity occurred. The primary endpoint 19 1,4 ‡Category 2A: Based upon lower-level evidence,ce, there is uuniformniform NCCN coconnsensussensus that the intervention isis appropriate. was ORR. A key secondary endpoint was DoR. NCCN makes no warranties of any kind whatsoeverever reregardinggagardding their content, use, or application and disclaidisclaimsms any responsibilityresponsibility for their applicatioapplicationn or use in any way. B:11.25” T:10.5” S:10”

Select Important Safety Information (cont’d) Select Important Safety Information (cont’d) Monitor patients for signs and symptoms of venous thrombosis and placebo plus fulvestrant vs placebo plus fulvestrant were diarrhea (86% Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 3 in ≥10% is predictedpredicted to increase the AUCAUC of abemaciclibabemaciclib by upu to 16-fold.16-fold. In pulmonary embolism and treat as medically appropriate. vs 25%), neutropenia (46% vs 4%), fatigue (46% vs 32%), nausea (45% for Verzenio plus anastrozole or letrozole and ≥2% higher than placebobo patientspatients with recommendedrecommended startingstarting dosesdoses ofof2f 200200 mg twicetwicee dailydaily or Verzenio can cause fetal harm when administered to a pregnant woman vs 23%), infections (43% vs 25%), abdominal pain (35% vs 16%), anemia plus anastrozole or letrozole vs placebo plus anastrozole or letrozolee 150 mg twice daily,daily, reducereduce the VerzenioVerzenio dosedosse to 100 mgg twicetwice daily withwith based on fi ndings from animal studies and the mechanism of action. In (29% vs 4%), leukopenia (28% vs 2%), decreased appetite (27% vs 12%), were increased serum creatinine (98% vs 84%; 2% vs 0%), decreased concomitantconcomitant use of other ststrongrong CYP3ACYP3P3A inhibitors.inhibitors. IInnpn patientspatients who havehave animal reproduction studies, administration of abemaciclib to pregnant vomiting (26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 3%), white blood cells (82% vs 27%; 13% vs <1%), anemia (82% vs 28%; 2% vs had a dose reductionreduction to 100 mg twicetwice dailydailyy duedue toto adverseadverse reactions,reactions, rats during the period of organogenesis caused teratogenicity and thrombocytopenia (16% vs 3%), alopecia (16% vs 2%), stomatitis (15% vs 0%), decreased neutrophil count (80% vs 21%; 22% vs 3%), decreased furtherrther reducereduce the VerzenioVerzenio dosedose to 50 mg twice dailydaily withwith concomitconcomitantantnt decreased fetal weight at maternal exposures that were similar to the 10%), ALT increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%), lymphocyte count (53% vs 26%; 8% vs 2%), decreased platelet count (36% use of other strongstrong CYP3ACYP3P3A inhibitors.inhibititorors. If a patientpatient takingtaking VerzenioVerzeenion human clinical exposure based on area under the curve (AUC) at the dizziness (12% vs 6%), AST increased (12% vs 7%), peripheral edema (12% vs 12%; 2% vs <1%), increased ALT (48% vs 25%; 7% vs 2%), and increased discontinuesntinues a strongstrong CYP3ACYP3A inhibitor,inhibitor, increaseincrease the VerzenioVerzenio dosedose (after maximum recommended human dose. Advise pregnant women of the vs 7%), creatinine increased (12% vs <1%), rash (11% vs 4%), pyrexia (11% vs AST (37% vs 23%; 4% vs <1%). 3 to 5 half-livesalf-lives of thehe ininhibitor)hibitor) tot the dose that waswas usedused beforebefore startirtingng potential risk to a fetus. Advise females of reproductive potential to use 6%), and weight decreased (10% vs 2%). Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 2 in ≥10% for the strongg inhibitor.inhibittoor. PatientsPatients shouldshould avoidavoid grapefruitgrapefruit producproductsctsts.. eff ective contraception during treatment with Verzenio and for at least 3 The most common adverse reactions (all grades, ≥10%) observed in Verzenio plus fulvestrant and ≥2% higher than placebo plus fulvestrant Avoid concomitantomitant usese of strongstrong CYP3ACYP3A inducersinducers andand considerconsider weeks after the last dose. There are no data on the presence of Verzenio MONARCH 1 with Verzenio were diarrhea (90%), fatigue (65%), nausea vs placebo plus fulvestrant were increased serum creatinine (98% vs alternative agentsents. CCoadministrationooadministration of VeVerzeniorzenio wiwiththh rrifamprifampin,in, a strong in human milk or its eff ects on the breastfed child or on milk production. (64%), decreased appetite (45%), abdominal pain (39%), neutropenia 74%; 1% vs 0%), decreased white blood cells (90% vs 33%; 23% vs 1%), CYP3A inducer, decreaseddeecreased thethe plasmaplasma concentrationsconcentraationsti of abemaciabebemacciclclibib Advise lactating women not to breastfeed during Verzenio treatment (37%), vomiting (35%), infections (31%), anemia (25%), thrombocytopenia decreased neutrophil count (87% vs 30%; 33% vs 4%), anemia (84% vs plus its active metabolitesabolites andand maymay leadlead toto rreducededuuceced activity.activt ityy. and for at least 3 weeks after the last dose because of the potential (20%), headache (20%), cough (19%), leukopenia (17%), constipation (17%), 33%; 3% vs <1%), decreased lymphocyte count (63% vs 32%; 12% vs 2%), With severe hepaticc impairmentimpairment (Child-Pugh(Child-PuPughg ClaClassss C), reduce tthehe for serious adverse reactions in breastfed infants. Based on fi ndings in arthralgia (15%), dry mouth (14%), weight decreased (14%), stomatitis (14%), decreased platelet count (53% vs 15%; 2% vs 0%), increased ALT (41% vs Verzenio dosing frequencyuency ttoo ooncence dadaily.ily. TThehe phapharmacokineticsrmacokinetics ooff animals, Verzenio may impair fertility in males of reproductive potential. creatinine increased (13%), alopecia (12%), dysgeusia (12%), pyrexia (11%), 32%; 5% vs 1%), and increased AST (37% vs 25%; 4% vs 4%). Verzenio in patients withh severesevere renalrenall imimpairmentpairment (CL(CLcrcr <30 mL/mimL/min),n), The most common adverse reactions (all grades, ≥10%) observed dizziness (11%), and dehydration (10%). Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 1 with end stage renal disease, or in patientspatientss ono didialysisalysis is unknown.unknown. No dodosagesage in MONARCH 3 for Verzenio plus anastrozole or letrozole and ≥2% The most frequently reported ≥5% Grade 3 or 4 adverse reactions that Verzenio were increased serum creatinine (98%; <1%), decreased white adjustments are necessary in ppatientsatiatieents wwithith mimildld or modmoderateerate hephepaticatic higher than placebo plus anastrozole or letrozole vs placebo plus occurred in the Verzenio arm vs the placebo arm of MONARCH 3 were blood cells (91%; 28%), decreased neutrophil count (88%; 27%), anemia (Child-Pugh A or B) and/or renalall impairmentimpi airment (CLcr(CLcr ≥30-30-8989 mL/mL/min).min). anastrozole or letrozole were diarrhea (81% vs 30%), neutropenia (41% vs neutropenia (22% vs 2%), diarrhea (9% vs 1%), leukopenia (8% vs <1%), (68%; 0%), decreased lymphocyte count (42%; 14%), decreased platelet 2%), fatigue (40% vs 32%), infections (39% vs 29%), nausea (39% vs 20%), ALT increased (7% vs 2%), and anemia (6% vs 1%). count (41%; 2%), increased ALT (31%; 3%), and increased AST (30%; 4%). AL HCP ISI 26FEB2018 abdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs The most frequently reported ≥5% Grade 3 or 4 adverse reactions that Strong CYP3A inhibitors increased the exposure of abemaciclib plus 5%), alopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia occurred in the Verzenio arm vs the placebo arm of MONARCH 2 were its active metabolites to a clinically meaningful extent and may lead to (21% vs 2%), creatinine increased (19% vs 4%), constipation (16% vs 12%), neutropenia (27% vs 2%), diarrhea (13% vs <1%), leukopenia (9% vs 0%), increased toxicity. Avoid concomitant use of ketoconazole. Ketoconazole ALT increased (16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), anemia (7% vs 1%), and infections (6% vs 3%). pruritus (13% vs 9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight decreased (10% vs 3%), infl uenza-like illness (10% vs The most frequently reported ≥5% Grade 3 or 4 adverse reactions 8%), and thrombocytopenia (10% vs 2%). from MONARCH 1 with Verzenio were neutropenia (24%), diarrhea (20%), Please see Brief Summary of full Prescribing Information for Verzenionio fatigue (13%), infections (7%), leukopenia (6%), anemia (5%), and nausea on the following pages. The most common adverse reactions (all grades, ≥10%) observed (5%). in MONARCH 2 for Verzenio plus fulvestrant and ≥2% higher than

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DISCOVER MORE DATA AT verzenio.com/hcp B:11.25” T:10.5” S:10”

Please see Brief Summary of full Prescribing Information for Verzenio on the following pages.

References: 1. Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2018. 2. Sledge GW Jr, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2− advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35:2875-2884. 3. Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35:3638-3646. 4. Dickler MN, Tolaney SM, Rugo HS, et al. MONARCH 1, a phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast cancer. Clin Cancer Res. 2017;23:5218- 5224. 5. Imkampe A, Bendall S, Bates T. The signifi cance of the site of recurrence to subsequent breast cancer survival. Eur J Surg Oncol. 2007;33:420-423. 6. Largillier R, Ferrero JM, Doyen J, et al. Prognostic factors in 1038 women with metastatic breast cancer. Ann Oncol. 2008;19:2012-2019 7. Solomayer EF, Diel IJ, Meyberg GC, Gollan C, Bastert G. Metastatic breast cancer: clinical course, prognosis and therapy related to the fi rst site of metastasis. Breast Cancer Res Treat. 2000;59:271-278. 8. Cardoso F, Costa A, Senkus E, et al. 3rd ESO–ESMO international consensus guidelines for advanced breast cancer (ABC 3). Breast. 2017;31:244-259. 9. Gerratana L, Fanotto V, Bonotto M, et al. Pattern of metastasis and outcome in patients with breast cancer. Clin Exp Metastasis. 2015;32:125-133. 10. Vogel CL, Azevedo S, Hilsenbeck S, East DR, Ayub J. Survival after fi rst recurrence of breast cancer: the Miami experience. Cancer. 1992;70:129-135. 11. Chang J, Clark GM, Allred DC, Mohsin S, Chamness G, Elledge RM. Survival of patients with metastatic breast carcinoma: importance of prognostic markers of the primary tumor. Cancer. 2003;97:545-553. 12. Yamamoto N, Watanabe T, Katsumata N, et al. Construction and validation of a practical prognostic index for patients with metastatic breast cancer. J Clin Oncol. 1998;16:2401-2408. 13. Data on fi le. Lilly USA, LLC. ONC20180108a. 14. Data on fi le. Lilly USA, LLC. ONC20180328a. 15. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45:228-247. 16. Data on fi le. Lilly USA, LLC. ONC20180103a. 17. Data on fi le. Lilly USA, LLC. ONC20171128a. 18. Data on fi le. Lilly USA, LLC. ONC20171201a. 19. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.1.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed March 22, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org.

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THIS ADVERTISEMENT PREPARED BY TOWNHOUSE JOB #: ELIAHU-Q80204_BASE_Pg6_REV2 PROOF: 1 CLIENT: ELI LILLY & COMPANY SIZE, SPACE: 7.875” x 10.5”, Journal Ad CLIENT: ELI LILLY & COMPANY OP: CV, JS PRODUCT: ABEMACICLIB US HCP PUBS: NCCN Journal Ad SPACE/SIZE: B: 8.75” x 11.25” T: 7.875” x 10.5” S: 7” x 10” LEGAL RELEASE STATUS JOB#: ELIAHU-Q80204_BASE_Pg6_REV2 ISSUE: 2018 AD APPROVAL ART DIRECTOR: J. Goody COPYWRITER: None DATE: Release has been obtained Legal Coord: Acct Mgmt: Print Prod: Art Director: Proofreader: Copywriter: Studio: T:7”

VERZENIO™ (abemaciclib) tablets, for oral use *O.0/"3$) GPSQBUJFOUTSFDFJWJOH7&3;&/*0QMVTBOBSPNBUBTFJOIJCJUPSXJUI Initial U.S. Approval: 2017 (SBEFøö"-5JODSFBTFE NFEJBOUJNFUPPOTFUXBTEBZT BOENFEJBOUJNFUPSFTPMVUJPO BRIEF SUMMARY: Consult the package insert for complete prescribing information. UP(SBEFøXBTEBZT*O.0/"3$) GPSQBUJFOUTSFDFJWJOH7&3;&/*0QMVTGVMWFTUSBOU XJUI(SBEFö"-5JODSFBTFE NFEJBOUJNFUPPOTFUXBTEBZT BOENFEJBOUJNFUP

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BSPNBUBTFJOIJCJUPS"EWFSTFSFBDUJPOTMFBEJOHUPQFSNBOFOUEJTDPOUJOVBUJPOGPSQBUJFOUT *O.0/"3$) (SBEFöJODSFBTFTJO"-5 WFSTVT BOE"45 WFSTVT SFDFJWJOH7&3;&/*0QMVTBOBSPNBUBTFJOIJCJUPSXFSFEJBSSIFB "-5JODSFBTFE XFSFSFQPSUFEJOUIF7&3;&/*0BOEQMBDFCPBSNT SFTQFDUJWFMZ*O.0/"3$) (SBEFö JOGFDUJPO WFOPVTUISPNCPFNCPMJDFWFOUT 75& OFVUSPQFOJB SFOBM JODSFBTFTJO"-5 WFSTVT BOE"45 WFSTVT XFSFSFQPSUFEJOUIF7&3;&/*0 JNQBJSNFOU "45JODSFBTFE EZTQOFB QVMNPOBSZýCSPTJT BOE BOEQMBDFCPBSNT SFTQFDUJWFMZ BOFNJB SBTI XFJHIUEFDSFBTFEBOEUISPNCPDZUPQFOJB FBDI VERZENIO™ (abemaciclib) tablets, for oral use AL HCP BS 26FEB2018 VERZENIO™ (abemaciclib) tablets, for oral use AL HCP BS 26FEB2018 Oncologistics | 29

Verzenio, AL HCP BS 26FEB2018 - 7 x 10 PRINTER200 FIFTH VERSION AVENUE NEW YORK, 1 NY OF 10010 5 THIS ADVERTISEMENT PREPARED BY TOWNHOUSE JOB #: ELIAHU-Q80146_Base PROOF: 1 CLIENT: Eli Lilly & Co SIZE, SPACE: 7” x 10”, BW CLIENT: Eli Lilly & Co OP: ND PRODUCT: Abemaciclib PUBS: magazine SPACE/SIZE: B: None T: 7” x 10” S: None LEGAL RELEASE STATUS JOB#: ELIAHU-Q80146_Base ISSUE: 2018 AD APPROVAL ART DIRECTOR: J. Goody COPYWRITER: J. Wood DATE: Release has been obtained Legal Coord: Acct Mgmt: Print Prod: Art Director: Proofreader: Copywriter: Studio: T:7”

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5ISPNCPDZUPQFOJB 10 2 2 0 General Disorders and Administration Site Conditions .0/"3$)7&3;&/*0JO$PNCJOBUJPOXJUI'VMWFTUSBOU Women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease 20 32 00progression on or after prior adjuvant or metastatic endocrine therapy 'BUJHVF *OþVFO[BMJLFJMMOFTT 10 00 8 00 Skin and Subcutaneous Tissue Disorders 5IFTBGFUZPG7&3;&/*0 øNHUXJDFEBJMZ QMVTGVMWFTUSBOU øNH WFSTVTQMBDFCPQMVT 27001100GVMWFTUSBOUXBTFWBMVBUFEJO.0/"3$)5IFEBUBEFTDSJCFECFMPXSFþFDUFYQPTVSFUP "MPQFDJB 7&3;&/*0JOQBUJFOUTXJUI)3QPTJUJWF )&3OFHBUJWFBEWBODFECSFBTUDBODFSXIP 0500 3BTI SFDFJWFEBUMFBTUPOFEPTFPG7&3;&/*0QMVTGVMWFTUSBOUJO.0/"3$) 1SVSJUVT 1300 9 00 Metabolism and Nutrition Disorders .FEJBOEVSBUJPOPGUSFBUNFOUXBTNPOUITGPSQBUJFOUTSFDFJWJOH7&3;&/*0QMVT GVMWFTUSBOUBOENPOUITGPSQBUJFOUTSFDFJWJOHQMBDFCPQMVTGVMWFTUSBOU %FDSFBTFEBQQFUJUF 10 9 0 Investigations %PTFSFEVDUJPOTEVFUPBOBEWFSTFSFBDUJPOPDDVSSFEJOPGQBUJFOUTSFDFJWJOH Blood creatinine 19 2 0 007&3;&/*0QMVTGVMWFTUSBOU"EWFSTFSFBDUJPOTMFBEJOHUPEPTFSFEVDUJPOTJOöPGQBUJFOUT increased XFSFEJBSSIFBBOEOFVUSPQFOJB7&3;&/*0EPTFSFEVDUJPOTEVFUPEJBSSIFBPGBOZHSBEF PDDVSSFEJOPGQBUJFOUTSFDFJWJOH7&3;&/*0QMVTGVMWFTUSBOUDPNQBSFEUPPG Alanine 16 6 7 20 QBUJFOUTSFDFJWJOHQMBDFCPBOEGVMWFTUSBOU7&3;&/*0EPTFSFEVDUJPOTEVFUPOFVUSPQFOJBPG BNJOPUSBOTGFSBTF increased BOZHSBEFPDDVSSFEJOPGQBUJFOUTSFDFJWJOH7&3;&/*0QMVTGVMWFTUSBOUDPNQBSFEUPOP QBUJFOUTSFDFJWJOHQMBDFCPQMVTGVMWFTUSBOU "TQBSUBUF 1530 7 10 BNJOPUSBOTGFSBTF increased 1FSNBOFOUTUVEZUSFBUNFOUEJTDPOUJOVBUJPOEVFUPBOBEWFSTFFWFOUXBTSFQPSUFEJO PGQBUJFOUTSFDFJWJOH7&3;&/*0QMVTGVMWFTUSBOUBOEJOPGQBUJFOUTSFDFJWJOHQMBDFCP 8FJHIUEFDSFBTFE 10 03 0 QMVTGVMWFTUSBOU"EWFSTFSFBDUJPOTMFBEJOHUPQFSNBOFOUEJTDPOUJOVBUJPOGPSQBUJFOUT Respiratory, Thoracic, and Mediastinal Disorders SFDFJWJOH7&3;&/*0QMVTGVMWFTUSBOUXFSFJOGFDUJPO EJBSSIFB IFQBUPUPYJDJUZ GBUJHVF OBVTFB BCEPNJOBMQBJO BDVUFLJEOFZJOKVSZ BOE $PVHI 1300 9 00 DFSFCSBMJOGBSDUJPO %ZTQOFB 12 6 0 Nervous System Disorders %FBUITEVSJOHUSFBUNFOUPSEVSJOHUIFEBZGPMMPXVQ SFHBSEMFTTPGDBVTBMJUZ XFSF Dizziness 11 0900SFQPSUFEJODBTFT PG7&3;&/*0QMVTGVMWFTUSBOUUSFBUFEQBUJFOUTWFSTVTDBTFT PGQMBDFCPQMVTGVMWFTUSBOUUSFBUFEQBUJFOUT$BVTFTPGEFBUIGPSQBUJFOUTSFDFJWJOH a *ODMVEFTBMMSFQPSUFEQSFGFSSFEUFSNTUIBUBSFQBSUPGUIF*OGFDUJPOTBOE*OGFTUBUJPOT 7&3;&/*0QMVTGVMWFTUSBOUJODMVEFE QBUJFOUEFBUITEVFUPVOEFSMZJOHEJTFBTF TZTUFNPSHBODMBTT.PTUDPNNPOJOGFDUJPOT JODMVEFVQQFSSFTQJSBUPSZUSBDU ø EVFUPTFQTJT EVFUPQOFVNPOJUJT EVFUPIFQBUPUPYJDJUZ JOGFDUJPO MVOHJOGFDUJPO BOEQIBSZOHJUJT BOEPOF EVFUPDFSFCSBMJOGBSDUJPO VERZENIO™ (abemaciclib) tablets, for oral use AL HCP BS 26FEB2018 VERZENIO™ (abemaciclib) tablets, for oral use AL HCP BS 26FEB2018 30 | Oncologistics

Verzenio, AL HCP BS 26FEB2018 - 7 x 10 PRINTER200 FIFTH VERSION AVENUE NEW YORK, 2 NY OF 10010 5 THIS ADVERTISEMENT PREPARED BY TOWNHOUSE JOB #: ELIAHU-Q80146_Base PROOF: 1 CLIENT: Eli Lilly & Co SIZE, SPACE: 7” x 10”, BW CLIENT: Eli Lilly & Co OP: ND PRODUCT: Abemaciclib PUBS: magazine SPACE/SIZE: B: None T: 7” x 10” S: None LEGAL RELEASE STATUS JOB#: ELIAHU-Q80146_Base ISSUE: 2018 AD APPROVAL ART DIRECTOR: J. Goody COPYWRITER: J. Wood DATE: Release has been obtained Legal Coord: Acct Mgmt: Print Prod: Art Director: Proofreader: Copywriter: Studio: T:7”

5IFNPTUDPNNPOBEWFSTFSFBDUJPOTSFQPSUFE ö JOUIF7&3;&/*0BSNXFSFEJBSSIFB Table 9: Laboratory Abnormalities ≥10% in Patients Receiving VERZENIO GBUJHVF OFVUSPQFOJB OBVTFB JOGFDUJPOT BCEPNJOBMQBJO BOFNJB MFVLPQFOJB EFDSFBTFE Plus Fulvestrant and ≥2% Higher Than Placebo Plus Fulvestrant in MONARCH 2 BQQFUJUF WPNJUJOH BOEIFBEBDIF 5BCMF 5IFNPTUGSFRVFOUMZSFQPSUFE ö (SBEFPS VERZENIO plus Fulvestrant Placebo plus Fulvestrant BEWFSTFSFBDUJPOTXFSFOFVUSPQFOJB EJBSSIFB MFVLPQFOJB BOFNJB BOEJOGFDUJPOT N=441 N=223

Table 8: Adverse Reactions ≥10% in Patients Receiving VERZENIO All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4 Plus Fulvestrant and ≥2% Higher Than Placebo Plus Fulvestrant in MONARCH 2 % % % % % % VERZENIO plus Fulvestrant Placebo plus Fulvestrant Creatinine increased 98 1 0 00 N=441 N=223 8IJUFCMPPEDFMM 90 23 33 0 All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4 decreased % % % % % % /FVUSPQIJMDPVOU 87 29 30 Gastrointestinal Disorders decreased %JBSSIFB 86 13 0 25 0 Anemia 30 33 0 /BVTFB 30 23 10 63 12 32 2 0 Abdominal Paina 35201610 -ZNQIPDZUFDPVOU decreased 7PNJUJOH 26 010 20 1MBUFMFUDPVOUEFDSFBTFE 53 115 00 Stomatitis 15 010 00 Infections and Infestations Alanine 32 1 0 b BNJOPUSBOTGFSBTF *OGFDUJPOT 5 25 3 increased Blood and Lymphatic System Disorders 37 025 c "TQBSUBUF /FVUSPQFOJB 3 1 BNJOPUSBOTGFSBTF Anemiad 29 7 10 increased e -FVLPQFOJB 28 9 2 00 Creatinine Increased 5ISPNCPDZUPQFOJBG 162130 General Disorders and Administration Site Conditions "CFNBDJDMJCIBTCFFOTIPXOUPJODSFBTFTFSVNDSFBUJOJOFEVFUPJOIJCJUJPOPGSFOBMUVCVMBS H 30 32 0 TFDSFUJPOUSBOTQPSUFST XJUIPVUBGGFDUJOHHMPNFSVMBSGVODUJPO*ODMJOJDBMTUVEJFT JODSFBTFT 'BUJHVF JOTFSVNDSFBUJOJOF NFBOJODSFBTF øNHE- PDDVSSFEXJUIJOUIFýSTUEBZDZDMFPG &EFNBQFSJQIFSBM 1200 7 007&3;&/*0EPTJOH SFNBJOFEFMFWBUFECVUTUBCMFUISPVHIUIFUSFBUNFOUQFSJPE BOEXFSF 1ZSFYJB 11 6 0 SFWFSTJCMFVQPOUSFBUNFOUEJTDPOUJOVBUJPO"MUFSOBUJWFNBSLFSTTVDIBT#6/ DZTUBUJO$ Metabolism and Nutrition Disorders PSDBMDVMBUFEHMPNFSVMBSýMUSBUJPOSBUF ('3 XIJDIBSFOPUCBTFEPODSFBUJOJOF NBZCF DPOTJEFSFEUPEFUFSNJOFXIFUIFSSFOBMGVODUJPOJTJNQBJSFE %FDSFBTFEBQQFUJUF 27 1 0 12 0 Respiratory, Thoracic and Mediastinal Disorders 7&3;&/*0"ENJOJTUFSFEBTB.POPUIFSBQZJO.FUBTUBUJD#SFBTU$BODFS .0/"3$) Patients with HR-positive, HER2-negative breast cancer who received prior endocrine 13001100

$PVHI therapy and 1-2 chemotherapy regimens in the metastatic setting T:10”

Skin and Subcutaneous Tissue Disorders "MPQFDJB 1600 2 004BGFUZEBUBCFMPXBSFCBTFEPO.0/"3$) BTJOHMFBSN PQFOMBCFM NVMUJDFOUFS 13 00 6 00TUVEZJOøXPNFOXJUINFBTVSBCMF)3 )&3NFUBTUBUJDCSFBTUDBODFS1BUJFOUT 1SVSJUVT SFDFJWFEøNH7&3;&/*0PSBMMZUXJDFEBJMZVOUJMEFWFMPQNFOUPGQSPHSFTTJWFEJTFBTFPS 11 1 0 00 3BTI VONBOBHFBCMFUPYJDJUZ.FEJBOEVSBUJPOPGUSFBUNFOUXBTNPOUIT Nervous System Disorders 20 1 0 15 0 5FOQBUJFOUT EJTDPOUJOVFETUVEZUSFBUNFOUGSPNBEWFSTFSFBDUJPOTEVFUP QBUJFOU )FBEBDIF FBDI BCEPNJOBMQBJO BSUFSJBMUISPNCPTJT BTQBSUBUFBNJOPUSBOTGFSBTF "45 JODSFBTFE %ZTHFVTJB 1800 3 00CMPPEDSFBUJOJOFJODSFBTFE DISPOJDLJEOFZEJTFBTF EJBSSIFB &$(25QSPMPOHFE GBUJHVF Dizziness 12 1 0 6 0 0 IJQGSBDUVSF BOEMZNQIPQFOJB'PSUZOJOFQFSDFOUPGQBUJFOUTIBEEPTFSFEVDUJPOTEVFUP Investigations BOBEWFSTFSFBDUJPO5IFNPTUGSFRVFOUBEWFSTFSFBDUJPOTUIBUMFEUPEPTFSFEVDUJPOTXFSF EJBSSIFB OFVUSPQFOJB BOEGBUJHVF Alanine 13 5 20 BNJOPUSBOTGFSBTF %FBUITEVSJOHUSFBUNFOUPSEVSJOHUIFEBZGPMMPXVQXFSFSFQPSUFEJOPGQBUJFOUT increased $BVTFPGEFBUIJOUIFTFQBUJFOUTXBTEVFUPJOGFDUJPO "TQBSUBUF 1220 7 30 BNJOPUSBOTGFSBTF 5IFNPTUDPNNPOSFQPSUFEBEWFSTFSFBDUJPOT ö XFSFEJBSSIFB GBUJHVF OBVTFB increased EFDSFBTFEBQQFUJUF BCEPNJOBMQBJO OFVUSPQFOJB WPNJUJOH JOGFDUJPOT BOFNJB IFBEBDIF Creatinine increased 12 0 00BOEUISPNCPDZUPQFOJB 5BCMF 4FWFSF (SBEFBOE OFVUSPQFOJBXBTPCTFSWFEJO QBUJFOUTSFDFJWJOHBCFNBDJDMJC 8FJHIUEFDSFBTFE 10 02 0 a *ODMVEFTBCEPNJOBMQBJO BCEPNJOBMQBJOVQQFS BCEPNJOBMQBJOMPXFS BCEPNJOBM Table 10: Adverse Reactions (≥10% of Patients) in MONARCH 1 EJTDPNGPSU BCEPNJOBMUFOEFSOFTT VERZENIO b *ODMVEFTVQQFSSFTQJSBUPSZUSBDUJOGFDUJPO VSJOBSZUSBDUJOGFDUJPO MVOHJOGFDUJPO N=132 QIBSZOHJUJT DPOKVODUJWJUJT TJOVTJUJT WBHJOBMJOGFDUJPO TFQTJT All Grades Grade 3 Grade 4 c *ODMVEFTOFVUSPQFOJB OFVUSPQIJMDPVOUEFDSFBTFE % % % d *ODMVEFTBOFNJB IFNBUPDSJUEFDSFBTFE IFNPHMPCJOEFDSFBTFE SFECMPPEDFMMDPVOU Gastrointestinal Disorders decreased. e %JBSSIFB 90 20 0 *ODMVEFTMFVLPQFOJB XIJUFCMPPEDFMMDPVOUEFDSFBTFE 50 G *ODMVEFTQMBUFMFUDPVOUEFDSFBTFE UISPNCPDZUPQFOJB /BVTFB H *ODMVEFTBTUIFOJB GBUJHVF "CEPNJOBMQBJO 39 2 0

7PNJUJOH 35 2 0 "EEJUJPOBMBEWFSTFSFBDUJPOTJO.0/"3$)JODMVEFWFOPVTUISPNCPFNCPMJDFWFOUT EFFQ $POTUJQBUJPO 17 0 WFJOUISPNCPTJT QVMNPOBSZFNCPMJTN DFSFCSBMWFOPVTTJOVTUISPNCPTJT TVCDMBWJBOWFJO UISPNCPTJT BYJMMBSZWFJOUISPNCPTJT BOE%75JOGFSJPSWFOBDBWB XIJDIXFSFSFQPSUFEJO %SZNPVUI 00 PGQBUJFOUTUSFBUFEXJUI7&3;&/*0QMVTGVMWFTUSBOUBTDPNQBSFEUPPGQBUJFOUT Stomatitis 00 USFBUFEXJUIGVMWFTUSBOUQMVTQMBDFCP VERZENIO™ (abemaciclib) tablets, for oral use AL HCP BS 26FEB2018 VERZENIO™ (abemaciclib) tablets, for oral use AL HCP BS 26FEB2018 Oncologistics | 31

Verzenio, AL HCP BS 26FEB2018 - 7 x 10 PRINTER200 FIFTH VERSION AVENUE NEW YORK, 3 NY OF 10010 5 THIS ADVERTISEMENT PREPARED BY TOWNHOUSE JOB #: ELIAHU-Q80146_Base PROOF: 1 CLIENT: Eli Lilly & Co SIZE, SPACE: 7” x 10”, BW CLIENT: Eli Lilly & Co OP: ND PRODUCT: Abemaciclib PUBS: magazine SPACE/SIZE: B: None T: 7” x 10” S: None LEGAL RELEASE STATUS JOB#: ELIAHU-Q80146_Base ISSUE: 2018 AD APPROVAL ART DIRECTOR: J. Goody COPYWRITER: J. Wood DATE: Release has been obtained Legal Coord: Acct Mgmt: Print Prod: Art Director: Proofreader: Copywriter: Studio: T:7”

Table 10: Adverse Reactions (≥10% of Patients) in MONARCH 1 (Cont.) DRUG INTERACTIONS

Infections and Infestations Effect of Other Drugs on VERZENIO

31 5 2 *OGFDUJPOT 4USPOH$:1"*OIJCJUPST General Disorders and Administration Site Conditions 4USPOH$:1"JOIJCJUPSTJODSFBTFEUIFFYQPTVSFPGBCFNBDJDMJCQMVTJUTBDUJWFNFUBCPMJUFTUP a BDMJOJDBMMZNFBOJOHGVMFYUFOUBOENBZMFBEUPJODSFBTFEUPYJDJUZ 'BUJHVF 65 13 0 Ketoconazole 1ZSFYJB 11 0 0 Blood and Lymphatic System Disorders "WPJEDPODPNJUBOUVTFPGLFUPDPOB[PMF,FUPDPOB[PMFJTQSFEJDUFEUPJODSFBTFUIF"6$PG BCFNBDJDMJCCZVQUPGPME b /FVUSPQFOJB 37 19 5 Other Strong CYP3A Inhibitors Anemiac 25 5 0 d *OQBUJFOUTXJUISFDPNNFOEFETUBSUJOHEPTFTPGøNHUXJDFEBJMZPSøNHUXJDFEBJMZ 5ISPNCPDZUPQFOJB 20 0 SFEVDFUIF7&3;&/*0EPTFUPøNHUXJDFEBJMZXJUIDPODPNJUBOUVTFPGPUIFSTUSPOH e -FVLPQFOJB 17 5 $:1"JOIJCJUPST*OQBUJFOUTXIPIBWFIBEBEPTFSFEVDUJPOUPøNHUXJDFEBJMZEVFUP BEWFSTFSFBDUJPOT GVSUIFSSFEVDFUIF7&3;&/*0EPTFUPøNHUXJDFEBJMZXJUIDPODPNJUBOU Metabolism and Nutrition Disorders VTFPGPUIFSTUSPOH$:1"JOIJCJUPST*GBQBUJFOUUBLJOH7&3;&/*0EJTDPOUJOVFTBTUSPOH $:1"JOIJCJUPS JODSFBTFUIF7&3;&/*0EPTF BGUFSIBMGMJWFTPGUIFJOIJCJUPS UPUIFEPTF %FDSFBTFEBQQFUJUF 30 UIBUXBTVTFECFGPSFTUBSUJOHUIFTUSPOHJOIJCJUPS1BUJFOUTTIPVMEBWPJEHSBQFGSVJUQSPEVDUT

%FIZESBUJPO 10 2 0 4USPOH$:1"*OEVDFST Respiratory, Thoracic and Mediastinal Disorders $PBENJOJTUSBUJPOPG7&3;&/*0XJUISJGBNQJO BTUSPOH$:1"JOEVDFS EFDSFBTFEUIFQMBTNB $PVHI 19 0 0 DPODFOUSBUJPOTPGBCFNBDJDMJCQMVTJUTBDUJWFNFUBCPMJUFTBOENBZMFBEUPSFEVDFEBDUJWJUZ

Musculoskeletal and Connective Tissue Disorders "WPJEDPODPNJUBOUVTFPGTUSPOH$:1"JOEVDFSTBOEDPOTJEFSBMU FSOBUJWFBHFOUT

USE IN SPECIFIC POPULATIONS "SUISBMHJB 15 0 0

Nervous System Disorders Pregnancy

20 0 0 )FBEBDIF 3JTL4VNNBSZ %ZTHFVTJB 12 0 0 #BTFEPOýOEJOHTJOBOJNBMTBOEJUTNFDIBOJTNPGBDUJPO 7&3;&/*0DBODBVTFGFUBMIBSN Dizziness 11 0 0 XIFOBENJOJTUFSFEUPBQSFHOBOUXPNBO5IFSFBSFOPBWBJMBCMFIVNBOEBUBJOGPSNJOH UIFESVHBTTPDJBUFESJTL"EWJTFQSFHOBOUXPNFOPGUIFQPUFOUJBMSJTLUPBGFUVT*OBOJNBM Skin and Subcutaneous Tissue Disorders SFQSPEVDUJPOTUVEJFT BENJOJTUSBUJPOPGBCFNBDJDMJCEVSJOHPSHBOPHFOFTJTXBTUFSBUPHFOJD 12 0 0 BOEDBVTFEEFDSFBTFEGFUBMXFJHIUBUNBUFSOBMFYQPTVSFTUIBUXFSFTJNJMBSUPIVNBO "MPQFDJB DMJOJDBMFYQPTVSFCBTFEPO"6$BUUIFNBYJNVNSFDPNNFOEFEIVNBOEPTF see Data). Investigations "EWJTFQSFHOBOUXPNFOPGUIFQPUFOUJBMSJTLUPBGFUVT

Creatinine increased 13 0 5IFCBDLHSPVOESJTLPGNBKPSCJSUIEFGFDUTBOENJTDBSSJBHFGPSUIFJOEJDBUFEQPQVMBUJPOJT T:10” 8FJHIUEFDSFBTFE 00VOLOPXO)PXFWFS UIFCBDLHSPVOESJTLJOUIF64HFOFSBMQPQVMBUJPOPGNBKPSCJSUIEFGFDUT a JTUPBOEPGNJTDBSSJBHFJTUPPGDMJOJDBMMZSFDPHOJ[FEQSFHOBODJFT *ODMVEFTBTUIFOJB GBUJHVF b Data *ODMVEFTOFVUSPQFOJB OFVUSPQIJMDPVOUEFDSFBTFE c Animal Data *ODMVEFTBOFNJB IFNBUPDSJUEFDSFBTFE IFNPHMPCJOEFDSFBTFE SFECMPPEDFMM DPVOUøEFDSFBTFE *OBOFNCSZPGFUBMEFWFMPQNFOUTUVEZ QSFHOBOUSBUTSFDFJWFEPSBMEPTFTPGBCFNBDJDMJC d *ODMVEFTQMBUFMFUDPVOUEFDSFBTFE UISPNCPDZUPQFOJB VQUPøNHLHEBZEVSJOHUIFQFSJPEPGPSHBOPHFOFTJT%PTFTöøNHLHEBZDBVTFE e EFDSFBTFEGFUBMCPEZXFJHIUTBOEJODSFBTFEJODJEFODFPGDBSEJPWBTDVMBSBOETLFMFUBM *ODMVEFTMFVLPQFOJB XIJUFCMPPEDFMMDPVOUEFDSFBTFE NBMGPSNBUJPOTBOEWBSJBUJPOT5IFTFýOEJOHTJODMVEFEBCTFOUJOOPNJOBUFBSUFSZBOE BPSUJDBSDI NBMQPTJUJPOFETVCDMBWJBOBSUFSZ VOPTTJýFETUFSOFCSB CJQBSUJUFPTTJýDBUJPOPG Table 11: Laboratory Abnormalities for Patients Receiving VERZENIO in MONARCH 1 UIPSBDJDDFOUSVN BOESVEJNFOUBSZPSOPEVMBUFESJCT"UøNHLHEBZJOSBUT UIFNBUFSOBM TZTUFNJDFYQPTVSFTXFSFBQQSPYJNBUFMZFRVBMUPUIFIVNBOFYQPTVSF "6$ BUUIF VERZENIO recommended dose.

N=132 Lactation All Grades Grade 3 Grade 4 % % % 3JTL4VNNBSZ 5IFSFBSFOPEBUBPOUIFQSFTFODFPGBCFNBDJDMJCJOIVNBONJML PSJUTFGGFDUTPOUIF Creatinine increased 98 0 CSFBTUGFEDIJMEPSPONJMLQSPEVDUJPO#FDBVTFPGUIFQPUFOUJBMGPSTFSJPVTBEWFSTFSFBDUJPOT 8IJUFCMPPEDFMMEFDSFBTFE 91 28 0 JOCSFBTUGFEJOGBOUTGSPN7&3;&/*0 BEWJTFMBDUBUJOHXPNFOOPUUPCSFBTUGFFEEVSJOH 7&3;&/*0USFBUNFOUBOEGPSBUMFBTUXFFLTBGUFSUIFMBTUEPTF /FVUSPQIJMDPVOUEFDSFBTFE 88 22 5 Females and Males of Reproductive Potential Anemia 68 0 0 -ZNQIPDZUFDPVOUEFDSFBTFE 13 1SFHOBODZ5FTUJOH 1MBUFMFUDPVOUEFDSFBTFE 20#BTFEPOBOJNBMTUVEJFT 7&3;&/*0DBODBVTFGFUBMIBSNXIFOBENJOJTUFSFEUPBQSFHOBOU XPNBO1SFHOBODZUFTUJOHJTSFDPNNFOEFEGPSGFNBMFTPGSFQSPEVDUJWFQPUFOUJBMQSJPSUP ALT increased 31 3 0 JOJUJBUJOHUSFBUNFOUXJUI7&3;&/*0

AST increased 30 0 $POUSBDFQUJPO Females Creatinine Increased

7&3;&/*0DBODBVTFGFUBMIBSNXIFOBENJOJTUFSFEUPBQSFHOBOUXPNBO"EWJTFGFNBMFTPG "CFNBDJDMJCIBTCFFOTIPXOUPJODSFBTFTFSVNDSFBUJOJOFEVFUPJOIJCJUJPOPGSFOBMUVCVMBS SFQSPEVDUJWFQPUFOUJBMUPVTFFGGFDUJWFDPOUSBDFQUJPOEVSJOH7&3;&/*0USFBUNFOUBOEGPSBU TFDSFUJPOUSBOTQPSUFST XJUIPVUBGGFDUJOHHMPNFSVMBSGVODUJPO*ODMJOJDBMTUVEJFT JODSFBTFT MFBTUøXFFLTBGUFSUIFMBTUEPTF JOTFSVNDSFBUJOJOF NFBOJODSFBTF øNHE- PDDVSSFEXJUIJOUIFýSTUEBZDZDMFPG 7&3;&/*0EPTJOH SFNBJOFEFMFWBUFECVUTUBCMFUISPVHIUIFUSFBUNFOUQFSJPE BOEXFSF *OGFSUJMJUZ SFWFSTJCMFVQPOUSFBUNFOUEJTDPOUJOVBUJPO"MUFSOBUJWFNBSLFSTTVDIBT#6/ DZTUBUJO$ PS Males DBMDVMBUFE('3 XIJDIBSFOPUCBTFEPODSFBUJOJOF NBZCFDPOTJEFSFEUPEFUFSNJOFXIFUIFS SFOBMGVODUJPOJTJNQBJSFE #BTFEPOýOEJOHTJOBOJNBMT 7&3;&/*0NBZJNQBJSGFSUJMJUZJONBMFTPGSFQSPEVDUJWFøQPUFOUJBM VERZENIO™ (abemaciclib) tablets, for oral use AL HCP BS 26FEB2018 VERZENIO™ (abemaciclib) tablets, for oral use AL HCP BS 26FEB2018 32 | Oncologistics

200 FIFTH AVENUE NEW YORK, NY 10010 7FS[FOJP "-)$1#4'&#Y 13*/5&37&34*0/0' THIS ADVERTISEMENT PREPARED BY TOWNHOUSE JOB #: ELIAHU-Q80146_Base PROOF: 1 CLIENT: Eli Lilly & Co SIZE, SPACE: 7” x 10”, BW CLIENT: Eli Lilly & Co OP: ND PRODUCT: Abemaciclib PUBS: magazine SPACE/SIZE: B: None T: 7” x 10” S: None LEGAL RELEASE STATUS JOB#: ELIAHU-Q80146_Base ISSUE: 2018 AD APPROVAL ART DIRECTOR: J. Goody COPYWRITER: J. Wood DATE: Release has been obtained Legal Coord: Acct Mgmt: Print Prod: Art Director: Proofreader: Copywriter: Studio: T:7”

Pediatric Use

5IFTBGFUZBOEFGGFDUJWFOFTTPG7&3;&/*0IBWFOPUCFFOFTUBCMJTIFEJOQFEJBUSJDQBUJFOUT

Geriatric Use

0GUIFQBUJFOUTXIPSFDFJWFE7&3;&/*0JO.0/"3$) .0/"3$) BOE.0/"3$)ø XFSFZFBSTPGBHFPSPMEFSBOEXFSFZFBSTPGBHFPSPMEFS5IFNPTU DPNNPOBEWFSTFSFBDUJPOT ö (SBEFPSJOQBUJFOUTöZFBSTPGBHFBDSPTT .0/"3$) BOEXFSFOFVUSPQFOJB EJBSSIFB GBUJHVF OBVTFB EFIZESBUJPO MFVLPQFOJB BOFNJB JOGFDUJPOT BOE"-5JODSFBTFE/PPWFSBMMEJGGFSFODFTJOTBGFUZPSFGGFDUJWFOFTTPG 7&3;&/*0XFSFPCTFSWFECFUXFFOUIFTFQBUJFOUTBOEZPVOHFSQBUJFOUT

Renal Impairment

/PEPTBHFBEKVTUNFOUJTSFRVJSFEGPSQBUJFOUTXJUINJMEPSNPEFSBUFSFOBMJNQBJSNFOU $-DSöøN-NJO FTUJNBUFECZ$PDLDSPGU(BVMU<$(> 5IFQIBSNBDPLJOFUJDTPG BCFNBDJDMJCJOQBUJFOUTXJUITFWFSFSFOBMJNQBJSNFOU $-DSøN-NJO $( FOETUBHF SFOBMEJTFBTF PSJOQBUJFOUTPOEJBMZTJTJTVOLOPXO

Hepatic Impairment

/PEPTBHFBEKVTUNFOUTBSFOFDFTTBSZJOQBUJFOUTXJUINJMEPSNPEFSBUFIFQBUJDJNQBJSNFOU $IJME1VHI"PS# 3FEVDFUIFEPTJOHGSFRVFODZXIFOBENJOJTUFSJOH7&3;&/*0UPQBUJFOUT

XJUITFWFSFIFQBUJDJNQBJSNFOU $IJME1VHI$

OVERDOSAGE 5IFSFJTOPLOPXOBOUJEPUFGPS7&3;&/*05IFUSFBUNFOUPGPWFSEPTFPG7&3;&/*0TIPVME DPOTJTUPGHFOFSBMTVQQPSUJWFNFBTVSFT

3YPOMZ

"EEJUJPOBMJOGPSNBUJPODBOCFGPVOEBUXXXWFS[FOJPDPN T:10”

Eli Lilly and Company, Indianapolis, IN 46285, USA

$PQZSJHIUª &MJ-JMMZBOE$PNQBOZ"MMSJHIUTSFTFSWFE AL HCP BS 26FEB2018

11"-64 7&3;&/*0 BCFNBDJDMJC UBCMFUT GPSPSBMVTF "-)$1#4'&# Oncologistics | 33

Verzenio, AL HCP BS 26FEB2018 - 7 x 10 PRINTER200 FIFTH VERSION AVENUE NEW YORK, 5 NY OF 10010 5 THIS ADVERTISEMENT PREPARED BY TOWNHOUSE JOB #: ELIAHU-Q80146_Base PROOF: 1 CLIENT: Eli Lilly & Co SIZE, SPACE: 7” x 10”, BW CLIENT: Eli Lilly & Co OP: ND PRODUCT: Abemaciclib PUBS: magazine SPACE/SIZE: B: None T: 7” x 10” S: None LEGAL RELEASE STATUS JOB#: ELIAHU-Q80146_Base ISSUE: 2018 AD APPROVAL ART DIRECTOR: J. Goody COPYWRITER: J. Wood DATE: Release has been obtained Legal Coord: Acct Mgmt: Print Prod: Art Director: Proofreader: Copywriter: Studio: The True Purpose of your GPO

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As the pioneers of performance-based contracting, we have always been focused on the future of community oncology. That long-standing commitment remains as the healthcare landscape evolves due to changing regulations and industry standards.

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As patient needs evolve, so do the tools and resources you depend upon to meet those needs. We do our part by investing in technology, research and other resources to help you elevate the quality of patient care.

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