sign in sign up
<<
Home , Canakinumab, Daclizumab, Dupilumab, Ixekizumab

Specialty Pipeline Update

D Drug Insights > December 2016

New drug information New indications

●● Rubraca™ (rucaparib): The U.S. Food and Drug ●● Iclusig® (ponatinib): The FDA has granted full approval Administration (FDA) granted accelerated approval to of Ariad’s Iclusig for adult patients with chronic phase, Clovis Oncology, Inc.’s Rubraca (rucaparib) for women accelerated phase, or blast phase chronic myeloid with advanced ovarian cancer who have been treated leukemia (CML) or Philadelphia chromosome-positive with two or more chemotherapies and whose tumors acute lymphoblastic leukemia (Ph+ ALL) for whom no have a specific gene mutation (deleterious BRCA) as other tyrosine kinase inhibitor (TKI) therapy is indicated; identified by an FDA-approved companion diagnostic and for the treatment of adult patients with T315I- test. The FDA approved Rubraca under its accelerated positive CML (chronic phase, accelerated phase, or blast approval program based on objective response rate and phase) or T315I positive Ph+ ALL. Iclusig was initially duration of response. Continued approval for this approved under the FDA’s accelerated approval program indication may be contingent upon verification and which allows patients access to new drugs that treat description of clinical benefit in confirmatory trials. serious conditions while the company conducts studies to prove clinical benefit.

●● Avastin® (bevacizumab): ’s Avastin has been approved in combination with chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. Prior to this approval, Avastin was approved for use in these same cancers with platinum-resistance in combination with chemotherapy; as well as other cancer diagnosis.

While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner. Specialty Pipeline > December 2016 Page 2

December news

●● “AstraZeneca’s (AZ) lung cancer medication, Tagrisso® (osimertinib), a blockbuster hopeful and important pillar in the company’s big sales ambitions, soundly beat chemotherapy in a new phase 3 trial, staving off cancer growth for more than twice as long as the older regimen. The results have AZ execs talking up their case for Tagrisso as a new standard of care in certain patients.”1

●● “’ Sandoz unit has been marketing Zarxio®, its biosimilar version of Amgen’s blockbuster drug Neupogen®, for more than a year, but the drug is still tangled in a patent fight that boils down to one central question: Should biosimilar makers have to give six months’ notice to the original drugmaker after they receive FDA approval for their copycat version? The answer will affect not only Novartis and Amgen, but any company seeking to make a biosimilar product.”2 Specialty Pipeline > December 2016 Page 3

Specialty new product approvals in the past 12 months Route of Generic name Brand name Manufacturer Indication(s) administration Date approved* bezlotoxumab Zinplava™ Merck Recurring Clostridium difficile Intravenous November 2016 infection infusion -otto Amjevita™ Amgen Several inflammatory Intravenous October 2016 diseases; biosimilar to infusion Humira® (adalimumab) eteplirsen Exondys 51™ Sarepta Therapeutics Duchenne muscular dystrophy Intravenous September (DMD) in patients who have infusion 2016 a confirmed mutation in the DMD gene that is amenable to exon 51 skipping immune globulin (human), Cuvitru™ Shire/Baxalta Primary immunodeficiency in Subcutaneous September 20% solution adults and pediatric patients infusion 2016 aged two and older -szzs Erelzi™ Sandoz Several autoimmune Subcutaneous August 2016 diseases; biosimilar to Enbrel® injection Launch delayed (etanercept) until late 2018 or beyond. sofosbuvir/velpatasvir Epclusa® Gilead Hepatitis C (all genotypes) Oral June 2016

high-yield process Zinbryta™ and AbbVie Subcutaneous May 2016 injection obeticholic acid Ocaliva™ Intercept Primary biliary cholangitis Oral May 2016

recombinant Factor VIII single Afstyla™ CSL Behring Hemophilia A Intravenous May 2016 chain infusion Remsima™ Celltrion/Pfizer , Crohn’s Intravenous April 2016 disease, ulcerative colitis, infusion ankylosing spondylitis, and ; biosimilar to Remicade® emtricitabine/tenofovir Descovy® Gilead HIV Oral April 2016 alafenamide defibrotide Defitelio® Jazz Hepatic veno-occlusive Intravenous March 2016 disease (VOD) following infusion a hematopoietic stem cell transplant Cinqair™ Teva Severe eosinophilic Intravenous March 2016 infusion Taltz® Lilly Psoriasis Subcutaneous March 2016 injection emtricitabine/ Odefsey® Gilead HIV Oral March 2016 tenofovir alafenamide/ rilpivirine coagulation Factor IX Idelvion® CSL Behring Hemophilia B Intravenous March 2016 infusion octocog alfa Kovaltry™ Bayer Hemophilia A Intravenous March 2016 infusion Xeljanz® XR Pfizer Rheumatoid arthritis Oral February 2016

grazoprevir/elbasvir Zepatier™ Merck Hepatitis C (genotypes 1 Oral January 2016 and 4) Specialty Pipeline > December 2016 Page 4

New indications for approved specialty products

Generic name Brand name Manufacturer Indication(s) Date approved* etanercept Enbrel® Amgen For pediatric patients aged 4 or older with November 2016 chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy; prior approval was only for adults aged 18 and older Ilaris® Novartis Tumor Necrosis Factor-Receptor October 2016 Associated Periodic Syndrome (TRAPSS), Hyperimmunoglobulin D Syndrome (HIDS)/ Mevalonate Kinase Deficiency (MKD), and Familial Mediterranean Fever (FMF) lumacaftor/ivacaftor Orkambi® Vertex Pharmaceuticals Treatment of cystic fibrosis in patients aged 6 October 2016 and older who are homozygous for the F508del mutation in the CFTR gene abobotulinumtoxinA Dysport® Ipsen Lower limb spasticity in pediatric patients aged 2 August 2016 Biopharmaceuticals and older ombitasvir, paritaprevir, Viekira XR™ AbbVie, Enanta New once-daily formulation of the direct-acting July 2016 ritonavir, dasabuvir antiviral combination for treatment of chronic hepatitis C virus 1 in patients with or without compensated cirrhosis; used in combination with twice-daily ribavirin for genotype 1a patients and without ribavirin for genotype 1b patients C1 esterase inhibitor [human] Berinert® CSL Bering Hereditary angioedema (HAE) in pediatric July 2016 patients darunavir Prezista® Janssen HIV infection in pregnant women July 2016

evolocumab Repatha® Amgen Once monthly dose (420 mg) administered as a July 2016 single injection Xolair® Roche Moderate to severe persistent asthma in children July 2016 aged 6 to 11 adalimumab Humira® AbbVie Non-infectious intermediate, posterior, and July 2016 panuveitis alpha-1 proteinase inhibitor Glassia™ Shire and Kamada Self-administration for alpha 1-antitrypsin June 2016 [human] deficiency in people who have symptoms of emphysema ledipasvir/sofosbuvir Harvoni® Gilead Liver transplant recipients with genotype 1 or 4 February 2016 infection without cirrhosis or with compensated cirrhosis, and for genotype 1-infected patients with decompensated cirrhosis daclatasvir Daklinza™ Bristol-Myers Squibb Chronic hepatitis C virus (HCV) in patients February 2016 co-infected with HIV, and for HCV patients with advanced cirrhosis, including decompensated cirrhosis and patients with post-liver transplant recurrence of HCV genotype 1 infection; approved for use in combination with Sovaldi® (sofosbuvir) onabotulinumtoxinA Botox® Allergan Adults with lower limb spasticity January 2016

Cosentyx® Novartis Adult patients with active ankylosing spondylitis January 2016 and active psoriatic arthritis Specialty Pipeline > December 2016 Page 5

Oncology product approvals in the past twelve months Route of Generic Name Brand Name Manufacturer Indication(s) Administration Date Approved rucaparib Rubraca™ Clovis Advanced ovarian cancer with Oral December 2016 deleterious BRCA olaratumab Lartruvo™ Lilly Soft tissue sarcoma Intravenous November 2016 infusion Tecentriq™ Roche Metastatic urothelial bladder Intravenous May 2016 cancer infusion cabozantinib Cabometyx® Exelixis Advanced renal cell carcinoma Oral April 2016

venetoclax Venclexta™ AbbVie/Genentech Chronic lymphocytic leukemia Oral April 2016

captisol-enabled melphalan Evomela™ Spectrum Multiple myeloma Intravenous March 2016 infusion

New indications for approved oncology drugs

Generic name Brand name Manufacturer New Indication(s) Date approved* bevacizumab Avastin® Genentech Platinum-sensitive recurrent epithelial December 2016 ovarian, fallopian tube or primary peritoneal cancer; approved for use in combination with chemotherapy, followed by Avastin alone daratumumab Darzalex® Janssen Treatment of patients with multiple myeloma November 2016 who have received at least one prior therapy; approved for use in combination with and dexamethasone, or bortezomib and dexamethasone Opdivo® BMS Metastatic or recurrent squamous cell carcinoma of November 2016 the head and neck following disease progression on, or after, platinum-based therapy Keytruda® Merck Metastatic NSCLC in which tumors express PD-L1 November 2016 as determined by an FDA-approved test; approval also expands the indication in second-line treatment of lung cancer to include all patients with PD-L1-expressing NSCLC erlotinib Tarceva® Genentech Metastatic non-small cell lung cancer (NSCLC); November 2016 limited to patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by a FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least 1 prior chemotherapy regimen atezolizumab Tecentriq® Roche Metastatic non-small cell lung cancer (NSCLC) October 2016 patients who have progressed during or following platinum-containing chemotherapy blinatumomab Blincyto® Amgen Pediatric and adolescent patients with Philadelphia August 2016 chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia ofatumumab Arzerra® Novartis, Genmab Relapsed chronic lymphocytic leukemia for August 2016 the anti-CD20 monoclonal ; approved for use in combination with fludarabine and cyclophosphamide pembrolizumab Keytruda® Merck For head and neck cancer August 2016

continued Specialty Pipeline > December 2016 Page 6

Generic name Brand name Manufacturer New Indication(s) Date approved* nivolumab Opdivo® Bristol-Myers Squibb Hodgkin Lymphoma that has relapsed or May 2016 progressed after autologous hematopoietic stem cell transplantation (HSCT) and posttransplantation brentuximab vedotin (Adcetris) lenvatinib Lenvima® Eisai Advanced renal cell carcinoma in patients May 2016 previously treated with an anti-angiogenic therapy ibrutinib Imbruvica® AbbVie and Relapsed or refractory chronic lymphocytic May 2016 Johnson & Johnson leukemia and small lymphocytic leukemia; approved for use in combination with bendamustine and Rituxan® () afatinib Gilotrif ™ Boehringer Ingelheim Advanced squamous cell carcinoma of the lung April 2016 with progression after first-line chemotherapy crizotinib Xalkori® Pfizer Non-small cell lung cancer in patients with the March 2016 ROS‑1 gene mutation Gazyva® Genentech Follicular lymphoma; approved for use in March 2016 combination with bendamustine followed by obinutuzumab alone Afinitor® Novartis Inoperable, locally advanced or metastatic March 2016 neuroendocrine tumors palbociclib Ibrance® Pfizer Hormone receptor-positive (HR+), human March 2016 epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer; approved for use in combination with fulvestrant nivolumab Opdivo® Bristol-Myers Squibb BRAF V600 wild-type and BRAF V600 mutation- January 2016 positive unresectable or metastatic melanoma; approved for use in combination with Yervoy® eribulin mesylate Halaven® Eisai Second-line treatment of liposarcoma January 2016 Specialty Pipeline > December 2016 Page 7

Pipeline watch Route of Anticipated Generic Name Brand Name Manufacturer Indication(s) Administration Approval date* 177Lu-DOTA0-Tyr3-octrotate Lutathera™ Advanced Accelerator Gastroentero-pancreatic Subcutaneous December 2016 Applications neuroendocrine tumors (GEP‑NETS) N/A Lilly and Incyte Rheumatoid arthritis Oral January 2016

SB2 Biosimilar of Samsung Bioepis and Rheumatoid arthritis, Crohn’s Intravenous January 2016 Remicade® Merck disease, ulcerative colitis, infusion ankylosing spondylitis, psoriatic arthritis and psoriasis Siliq™ Valeant Plaque psoriasis Subcutaneous February 2017

telotristat N/A Lexicon Carcinoid syndrome Oral February 2017

HIV vaccine Remune™ Immune Response HIV Intramuscular February 2017

deflazacort N/A Marathon Duchenne muscular dystrophy Oral February 2017 Pharmaceuticals (DMD) brigatinib N/A Ariad Pharmaceuticals Non-small cell lung cancer Oral April 2017

valbenazine Ingrezza™ Neurocrine Biosciences Tardive dyskinesia Oral April 2017

deutetrabenazine N/A Teva Chorea associated with Oral April 2017 Huntington disease cerliponase alfa Brineura™ BioMarin Batten disease Intracerebro- April 2017 ventricular infusion ribociclib N/A Novartis Breast cancer Oral April-May 2017

*Anticipated approval dates are predictions made by Prime Therapeutics based on industry information. and/or material impact to preferred product strategies (medical or pharmacy). or (medical strategies product preferred to and/or impact material 2992-B1 owners. respective their of property are names brand All 2 1 References include list watch the on inclusion for Criteria list Watch Pipeline Specialty

Regeneron/ Mitsubishi Tanabe Pharma Mitsubishi Genentech *Notations: $ *Notations: Dupixent Ocrevus manufacturer (generic)/ Brand Radicava http://www.fiercepharma.com/pharma/supreme-court-urged-to-weigh-six-month-biosimilar-delays?utm_medium=nl&utm_source=internal&mrkid=36641180&mkt_ 1Erd2NqZzU5TmlzaFZja0dKMXRDNmpuWWFXS0ZxQmc9In0%3D. tok=eyJpIjoiTXpVMk5Ua3lZV1JoWldJNCIsInQiOiJxUW84WWphcUIxQTBtbUFWSlo2UDRBcW8yNjBLXC9Rb3BScGh1ck5mbWFXK092RmRGaGtDbFF2UUZkbStnMjdNM3c1N3hneFhsUnkzU ytNSmRMTVwvcStGVThcLzRLZVU2dnRudDF0QmVWV3ExcU5FPSJ9. tok=eyJpIjoiTURSbFptTXpZamN4WmpKbSIsInQiOiJGZlwva0lLbVBpWUNnXC81MWRSQVF2R1wvWERCYnF1YkVCOEdwM0w2Y3M3MWtsZWVuVDFDclNuNk02eXBxN0tUdWwyTFh1aWdTWEhZd http://www.fiercepharma.com/pharma/astrazeneca-touts-tagrisso-phase-3-data-3b-lung-cancer-push?utm_medium=nl&utm_source=internal&mrkid=36641180&mkt_ 12/16 LLC Therapeutics © Prime ™ ® ™ ()/ ()/ (edaravone)/

<

$0.08 per member per month (PMPM), $$ (PMPM), month per member per $0.08 >

December 2016 subcutaneous injection subcutaneous Atopic (AD)/ (ALS)/IV Sclerosis Lateral Amyotrophic Sclerosis (RRMS) (IV) (IV) (RRMS) Sclerosis Multiple Remitting Relapsing and (PPMS) Sclerosis Multiple Progressive Primary of administration Proposed indication/route

FDA and is anticipated to have material impact to trend to trend to and is have anticipated impact material FDA to the is submitted : Drug

=

$0.08 1st Half 2017 Half 1st June 2017 March 2017 March (PDUFA date) (PDUFA approval Anticipated

–

$0.39 PMPM, $$$ PMPM, $0.39 None Rilutek None for PPMS for None (by indication)(by products Similar

=

$0.40 ® (riluzole)

–

$2.00 PMPM, $$$$ PMPM, $2.00 $$ $$ $$ $$ $$ Spend*

– –

$ $

>

$2.01 PMPM. $2.01 $$-$$$ None None benefit pharmacy PMPM* to impact new Net $$ $$ None $$ benefit medical PMPM* to impact new Net

–

$ Page 8

03003184