Lung Cancer (NSCLC) Impact on Utilization and Total Cost of Care among 15 Million Commercially Insured Members Osimertinib First-Line Approval in Epidermal Growth Factor Receptor (EGFR) Mutation-Positive Metastatic Non-Small Cell J.J. Whalen,J.J. PharmD, BCOP All brand names are theproperty of theirrespective owners. [email protected] PATRICK GLEASON,800.858.0723, ext. 5190 AMCP, October 2019, National Harbor, MD, USA 2900 Ames Crossing Road, Eagan, MN55121 4085-G © Prime Therapeutics LLC 10/19 • • • • • • • • determine the real-world: integrated medical and pharmacy claims, members insured commercially 15Using million OBJECTIVE • BACKGROUND • • • • • • • • • or unacceptable toxicity. unacceptable or osimertinib (Tagrisso osimertinib erlotinib (Tarceva erlotinib EGFR inhbitor (EGFR-i) therapy mutation are treated chronic with oral NSCLCMetastatic patients an with EGFR (Gilotrif and management opportunities. management and care (TCC), well as value-based as contracting utilization trend and impact on total cost of stakeholders to understand first-line its pricing making it important for payers and indication, it maintained second-line its Although osimertinib gained afirst-line FDA-approved was Osimertinib mutation.(EGFR) Receptor Factor Growth Epidermal an having cell lung cancer (NSCLC), 10% with to 50% Most lung cancer cases (84%) are non-small cause of cancer death in the U.S. cancer for men and women and is the leading Lung cancer is the 2nd most common of form newly initiating EGFR members among rate Discontinuation (cEGFR osimertinib TCC to competitor EGFR post-initiation of EGFR Average member TCC 6-months and pre- new to EGFR members for trend utilization Osimertinib for first-lineuse. 2018,April osimertinib gained approval FDA first-linepreferred therapy for NSCLC, and in a as osimertinib include to guidelines Cancer (NCCN) changed Network their 2017, Sept In Comprehensive National gefitinib). erlotinib, than the initial first-line EGFR-is (afatinib, of $177,152,(WAC) which is 1.7-fold higher cost acquisition wholesale annual an pricing, line use in November 2015 second-line with osimertinib to cEGFR to osimertinib ‑ is). ® ), dacomitinib (Vizimpro ), dacomitinib ‑i therapy. 5, 3 2, 6 ® ), gefitinib (Iressa ‑i therapy; comparing ‑ ® is. ‑i therapy; comparing until progression ) —until 3 1, 2 ; D.J. PharmD Eckwright, 4 — for second- 1 afatinib ® ), ), ‑is ® ), or or ), • Newly Initiating EGFR-i Therapy, vs Competitor EGFR-is Osimertinib Average 6-Month Pre- Post-Total and Cost of Care (TCC) among Members • • • • vs CompetitorDiscontinuation EGFR-is Osimertinib Members, Among New Start • • TCC Assessment Population for Identification EGFR-iAnalytic Discontinuationand Assessment • • • • • • of Newly Members Proportion Initiating EGFR-i Therapy using Osimertinib claims 15 million data from commercially insured members. All analyses were conducted using integrated medical and pharmacy administrative METHODS • • • • • • • • • • • • • • • cEGFR-i therapies group. TCC broken was into the following: and averaged for members newly initiating EGFR-i by osimertinib and group the the analysis period, i.e., EGFR-i index date or pre- post- period were summed member level, the sum of all health care claims defined costs was as TCC during analyzed in this study. included Costs member and plan paid allowed. the At Pharmacy and medical claim allowed after costs, discounts, network were EGFR-i groups compared was achi-squared with test. differenceThe in discontinuationrates osimertinib between and competitive discontinuation. constitutes e.g., the cEGFR-i to osimertinib would not extend members days on therapy and discontinued all agents within the group. Therefore, switching groups, between discontinuation. cEGFR-i utilizers were only counted discontinued as if they → → → by 30 Days on therapy prior to discontinuation (30-day gap) then was evaluated March 1, 2018 ((Jan. 1, 2017 + would be declared if the member had no subsequent afatinib claims by afatinib claim occurred on Jan. 1, 2018 a30 with of their initial EGFR Discontinuation defined was as a 30 discontinuation. evaluate to Members identifiedas new to therapy EGFR-i thein previous analysis wereused members by drug isnew start reported. continuous enrollment pre/post periods. Prevalence of lung cancer diagnosis by code beginning in any of five positions C34.xx with on a medical claim during the evaluated for presence of at least one claim lung with cancer diagnosis, ICD-10 initiating EGFR-i therapy osimertinib with or a cEGFR-i had their medical claims NSCLC Diagnosis: All members meeting continuous enrollment criteria newly discontinuation and TCC analyses. and six months(post-index) after their initial EGFR-i claim were included for the were identified andthose continuously enrolled monthssix (pre-index) before EGFR-i members duringNew start January 2017 to December 2018 (2 years) cEGFR-is January 2017 from to June 2019. Note: No dacomitinib claims were found. EGFR-i utilizers were trended by of proportion osimertinib quarterly compared to claims in the pre-period. Members were required to be newly initiating EGFR-i therapy definedas no EGFR-i date. index their period) Members were required to be continuously enrolled six months before (pre- definedtheiras index date and index drug. A member’s first EGFR-i claimfound during January 2017 to June 2019 was 21534030000320). and cEGFR-is (215340061003xx, 215340251003xx, 215340190003xx and using Generic Identifier Product (GPI) codesfor osimertinib (215340652003xx) Pharmacy claims were queried January 2017 from to June 2019 for EGFR-i claims study. this in included were osimertinib, and gefitinib, erlotinib, dacomitinib, afatinib, indication, FDA-approved NSCLC with EGFR-is discontinue EGFR-i, during the post-period. diagnosis and limited to members who remained EGFR-i persistent, i.e., did not EGFR-i TCC sub-analyses limited were performed to members aNSCLC with 1 → → → EGFR-i costs. All pharmacy benefitexcluding costs, EGFR-i costs. costs. benefit medical All ; J.P. Burke, PhD, MPH ‑ day for osimertinib intervals and cEGFR ‑i claim plus days supply For example, among an new starts. 30 1 ; P.P. Gleason, PharmD ‑ day supply) ‑ day or greater in gap therapy afterthe end – ‑is to understand timing of 1 + ‑ day supply. Discontinuation 30 ‑ day gap). 1, 2 .
1 Prime Therapeutics United Eagan, MN, LLC, States; • of Newly Members Proportion Initiating EGFR-i Therapy (Figures using 2) 1 and Osimertinib RESULTS • • • • • 1) vs CompetitorDiscontinuation EGFR-is Osimertinib Members, Among New Start (Table • vs Competitor EGFR-isOsimertinib 3) 1, Figure (Figure Average 6-Month Pre- Post-TCC and Newly Among Members Initiating EGFR-i Therapy, • • • • • • • • • • • → → → → → → → → → → → → → → → → new starts to EGFR-i therapy. EGFR-i to starts new continuously enrolled six months prior to their first EGFR-i claim and 492 (48.2%) were identifiedas 1,020 members aclaim with for an EGFR-i were identified. 768 (75.3%) of 1,020 members were Among 15 million commercially insured members, during January 2017 through June 2019, subsets, the osimertinib costs were: post-period group TTC therapy cost accounting for 49.3% in the cEGFR-i and group 71.7% in osimertinib group. Among the Osimertinib mean group post-period TCC $37,934 was higher versus cEGFR-i group, the with EGFR-i were: costs osimertinib osimertinib group, for a109.8% higher average cost in the osimertinib. Among the subsets, Post-period EGFR-i only costs averaged $42,286 for the cEGFR-i and group $88,706 for the respectively. compared to 7.5% and 2.6% of total costs in the post-period for cEGFR-i and osimertinib groups, Non-EGFR-i pharmacy costs account for 3% of total costs for both cEGFR-i and osimertinib groups, a 112.4% increase. Osimertinib 33.9% (58 of 171) of cEGFR-i p users, 18.6% (24 of 129) discontinued of osimertinib new starts therapy in the post-period compared to enrolled in the and pre- post-period and 300 (57.4%) members were new starts. From January 2017 to December 2018, 523 members an with EGFR-i claim were continuously cEGFR-i 171 mean users TCC $71,520 pre-period was and $85,745 post-period, a19.9% increase. compared to 14 (8.2%) of 171 cEGFR-i switched users to osimertinib, p 4 (3.1%) of 129 switched of osimertinib to another new starts EGFR-i therapy in the post-index period → → → → → → → → → → → → → → → → − − $44,529 higher in persistent and NSCLC comparison. $45,054 higher in persistent only comparison. $37,334 higher in NSCLC only comparison. 94.6% higher in persistent and NSCLC comparison. 90.8% higher in persistent only comparison. 105.5% higher in NSCLC only comparison. $131,355 post-period, a99.9% increase. A subset of 94 osimertinib persistent NSCLC with users had aTCC of $65,697 pre-period and post-period, a112.8% increase. A subset of 102 osimertinib persistent had users aTCC of $60,589 pre-period and $128,931 post-period, a103.9% increase. A subset of 117 osimertinib NSCLC with users had aTCC of $62,283 pre-period and $126,966 $86,826 post-period, a26.0% increase. A subset of cEGFR-i 90 persistent NSCLC with users had aTCC of $68,893 pre-period and post A subset of 104 cEGFR-i persistent had users aTCC of $63,481 pre-period and $83,877 post A subset of 144 cEGFR-i NSCLC with users had aTCC of $76,367 pre-period and $89,632 criteria: enrollment 261 (87.0%) members of alung with 300 new start cancer diagnosis meeting continuous 129 (43.0%) and 171 (57.0%) initiated osimertinib and cEGFR-is, respectively. a ten first quarter of 2017as compared to 71.1% (32 of 45) thein second quarter of 2019, amongOsimertinib accounted all new starts EGFR-is new starts for 6.9% (4 of 58) in the therapy. EGFR-i to During the 2.5 years assessed, per quarter an average of 49 members (range 37 to 61) were new − − › › › cEGFR-is Osimertinib › › › ‑period, a32.1% increase. ‑period, a17.4% increase. ‑fold increase. Gefitinib: 7 (100.0%) of 7 members. Erlotinib: 69 (75.8%) of 91 members. Afatinib: (93.2%) 68 of 73 members. — 129 mean users TCC $58,221 pre-period was and $123,679 post-period, — 144 (84.2%) of 171 members: — 117 (90.1%) of 129 members. 2 University of Minnesota College of Pharmacy, Minneapolis, United MN, States. < 0.001. members Three switched within cEGFR-i group. = 0.086.
newly initiating EGFR-i therapy were defined as having no previous EGFR-i claim in the 6-month period prior to their identified EGFR-i claim. No dacomitinib (Vizimpro®)claim. Notheirto prior claims dacomitinib claim EGFR-i period identified 6-month were the in during identified EGFR-i oftime as initiating were definedno having previous therapy analysis. newly EGFR-i 2017January from Junethrough 2019. claim for as an EGFR-i wereMembers identified a having pharmacy Memberswere required to continuousclaim. have enrollment Members theirmonthsEGFR-i 6 to prior first EGFR-I EGFR-i previous EGFR-i claimclaim. in to the 6months their prior EGFR-i EGFR-i first previous claimsusing were identifiedclaims EGFR-i for approximately pharmacy 15 million commercially 2017January from insured June through members 2019. no aswerehaving therapy defined Membersto EGFR-i new Competitor EGFR-is % • • • • LIMITATIONS Lives Insured Proportion of Members New to EGFR-i Therapy: Osimertinib vs Competitor EGFR-is among Quarterly 15 Million Commercially FIGURE 2 Identification of Members Newly StartingTherapy EGFR-i FIGURE 1 % % % % % % % % % • • • • % members’ actual drug use and diagnoses. potential to be miscoded and include assumptions of Administrative pharmacy and medical claims have the controlled for in this study. radiation, non-EGFR-i drugs) were not evaluated or therapy; other methods of therapy (e.g., surgery, Members were only confirmed to be new to EGFR-i progression, progression free survival, or overall survival. survival. overall or survival, free progression progression, disease outcomes: treatment or status, performance Members of wereillness, not by severity stratified 30 supply30-day or less, which our strengthens use of a differentresults. Our data showed of 99% claims a had discontinuation rates and other methods would generate This analysisexist. to gap used a30-day describe discontinuation determining for methods different Several = = Epidermal Growth Factor Receptor Factor inhibitor.Epidermal Growth Q (N Receptor Factor inhibitor.Epidermal Growth TCC Members oncompetitor EGFR: 266 New Start Utilization Trend Utilization Start New ‑ day gap. gap. day Members onosimertinib: 226 New to EGFR-i Therapy =
= erlotinib (Iressa®), and (Tarceva®), afatinib dacomitinib (Gilotrif®). geftinib No claims were identified during (Vizimpro®) time of analysis. Q (N ) Analysis 1: Analysis
= Q (N )
= Q (N ) = Total Care. of Cost
= Q (N )
= Q (N ) 6-month prior to first EGFR-i claim 6-month after first EGFR-i claim (Jan. 2017through June 2019) (Jan. Members with ≥ 15,000,000 commercially Continuous enrollment Continuous enrollment
= insured members Q (N ) Members: 1,020 Members: 523 Members: 768
= Q (N 1 EGFR-i claim • • • ) • • • differing cost markups. cost differing facility, professional or pharmacy) which can contribute to Claim costs were not adjusted for site of care (e.g., findings remained. remained. findings and the substantiallyperformed higher osimertinib TCC subset analysis including only persistent members was osimertinib had users significantly higher persistence.A limited to the lung cancer diagnosed subset. In addition, TCC comparisons may be most appropriately compared other cancers besides NSCLC. Therefore, osimertinib Two of the cEGFR-is had FDA-approved indications to treat or Medicaid populations. Medicaid or Medicare to generalizable not are results and population dataThe used in this limited was study to acommercial
= Q (N )
= Q (N )
=
) Members oncompetitor EGFR: 171 (Jan. 2017through Dec. 2018) (Jan. TCC Discontinuation and Members onosimertinib: 129 New to EGFR-i Therapy Osimertinib Osimertinib designation byFDA approval Network (NCCN) Comprehensive Cancer designation byNational Analysis 2and 3: (erlotinib (Tarceva Competitor EGFR-i osimertinib (Tagrisso getinib (Iressa afatinib (Gilotrif st st -line -line ® ® ), and )) ® ),
® ) Competitor EGFR-is EGFR-i previous EGFR-i use in the previous 6 months. Discontinuation was defined as a≥ defined 6months. Discontinuation in was the use previous EGFR-i previous 2017no January from December as wereclaim 2018.defined through pharmacy Continuousby aEGFR-i wereMembers identified enrollment thestarts required claim. was monthsinitial 6 to New prior and months 6 after EGFR-i Using Chi-Squared test, discontinuation was significantly lower with osimertinib vs competitor EGFR-is (p Usingosimertinib vs competitor EGFR-is with Chi-Squared lower discontinuation significantly test, was Total line the is top each of 95% indicated bar. care of above the cost extended by interval dacomitinibNo claims were identified during (Vizimpro®) time of analysis.TCC both member are of medicaland inclusive andcosts plan months. 6 Pharmacy paidamounts. use in allowed the previous EGFR-i no as previous defined was therapy to EGFR-i starts claim. New EGFR-i members’ first EGFR-i Compared to Competitor EGFR-is Competitor to Compared • • CONCLUSIONS Post-Period 6-month the in Therapy Initiating EGFR-i Newly Members for Discontinuation 1 TABLE Average Total Cost of Care for Members Newly Initiating EGFR-i 6Months Therapy and Post-initial Pre- EGFR-i Claim: Osimertinib (Tagrisso FIGURE 3 4. 3. 2. 1. REFERENCES 31 to 60 61 to 90 1 to 30 91 to 120 Days on Therapy Prior to Discontinuation Total Discontinued Members 121 to 152 • • Total Cost of Care mutation-positive metastatic non-small cell lung cancer. AstraZeneca Nov, 2015. Tagrisso™ (AZD9291)approved by theUS FDA for patients with EGFR T790M nscl.pdf last accessed Sept 16,2019. Lung Cancer Version 7.2019.https://www.nccn.org/professionals/physician_gls/pdf/ NCCN Clinical Practice Guidelines inOncology (NCCN Guidelines ®)Non-Small Cell last accessedfigures-2019.pdf) onAugust 26,2019. cancer-facts-and-statistics/annual-cancer-facts-and-figures/2019/cancer-facts-and- Cancer Society, 2019.(https://www.cancer.org/content/dam/cancer-org/research/ American Cancer Society: Cancer Facts and Figures 2019.Atlanta, Ga: American lung-cancer/about/key-statistics.html) last accessed on Sept 16,2019. Society, 2019.Revised Jan8,2019(https://www.cancer.org/cancer/non-small-cell- American Cancer Society: Key Statistics for Lung Cancer. Atlanta, Ga: American Cancer 129 osimertinib treated members. $37,934, equating to over $4 million in additional costs for findings confirm higher versuscosts competitor at EGFR-is Our real-world total cost of care (TCC) 6-month post initiation cost is more than $70,000 higher than competitor EGFR-is. concerning to payers the as annual wholesale acquisition dramaticThe increase in osimertinib first-line use EGFR-i is recommendation. guideline NCCN ten-fold increase since osimertinib received aNSCLC first-line a osimertinib, 70% over is osimertinib) or gefitinib, erlotinib, EGFR-imembers, therapy (i.e., new start afatinib, dacomitinib, In this real-world analysis of 15 million commercially insured = = Epidermal Growth Factor Receptor Factor inhibitor.Epidermal Growth Epidermal Growth Factor Receptor Factor 2017 inhibitor.January from Decemberclaim Epidermal2018. Growth through pharmacy Continuousby aEGFR-i were Members identified enrollment requiredwas months 6 to, prior and months 6 after (Member plus Plan Paid Amoutns) , , , , , , , = erlotinib (Iressa®), and (Tarceva®), afatinib dacomitinib (Gilotrif®). geftinib No claims were identified during (Vizimpro®) time of analysis. months , , Pre-TCC Competitor EGFR-i (N
=
) = Total Care. of Cost 30-day gap in therapy after the end their of initial claim in after therapy supply. plus days gap EGFR-i 30-day 11 12 13 13 N 9 months 58 of 171 , , , Post-TCC , Competitor EGFR-i N =171 6.4% 7.0% 7.6% 7.6% 5.3% < 0.001). % 6. 5. • • •
7.6% Cumulative % • • • nsclc-most-common-egfr-mutations last accessed onAugust 26,2019. information-approved-drugs/fda-approves-osimertinib-first-line-treatment-metastatic- FDA Drug Approvals and Databases. https://www.fda.gov/drugs/resources- cell-lung-cancer-10092017.html. us-fda-for-the-1st-line-treatment-of-patients-with-egfr-mutation-positive-non-small- releases/2017/tagrisso-osimertinib-granted-breakthrough-therapy-designation-by- cancer. AstraZeneca 2017https://www.astrazeneca-us.com/media/press- Oct, the 1st-line treatment of patients with EFGR-mutation positive non-small cell lung Tagrisso® (osimertinib) granted Breakthrough Therapy Designation by US FDA for metastatic-non-small-cell-lung-cancer-13112015.html#. AZD9291-approved-by-the-US-FDA-for-patients-with-EGFR-T790M-mutation-positive- https://www.astrazeneca.com/media-centre/press-releases/2015/TAGRISSO- based contracting and pharmacy management opportunities. management pharmacy and contracting based osimertinib discontinuation and total cost of care for value- of understanding foundational provide findings These to recoup the drug cost waste associated therapy with failure. the 6 monthsthe first forneed value-based warrants contacting coupled the with findingthat 1 in 6 discontinuetherapy during $177,152 Osimertinib cost acquisition wholesale annual utilizers. osimertinib among higher were compared, the TCC 6-month difference $45,054was when only persistent osimertinib and competitor EGFR-i utilizers compared to members utilizing competitor EGFR-is. However, tobe the attributed 15-percentage point higher persistence Some of the higher osimertinib treated members’ TCC could 33.9% 21.1% 14.6% 28.7% 33.9% months , , Pre-TCC No externalNo funding provided for this research Osimertinib (Tagrisso (N N
6 5 6 4 3 =
) 24 of 129 Osimertinib (Tagrisso , months ® , , Post-TCC , ) N =129 4.7% 3.9% 4.7% 3.1% 2.3% % ® ) Pharmacy (non-EGFR) Medical (Tagrisso osimertinib (erlotinib (Tarceva Competitor EFGR-i gefitinib (Iressa afatinib (Gilotrif 4.7% 9.3% Cumulative % 18.6% 13.2% 16.3% 18.6%
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