Specialty Pipeline Update

Transcription

1 Specialty Pipeline Update D Drug Insights > December 2016 New drug information Rubraca (rucaparib): The U.S. Food and Drug Administration (FDA) granted accelerated approval to Clovis Oncology, Inc. s Rubraca (rucaparib) for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test. The FDA approved Rubraca under its accelerated approval program based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. New indications Iclusig (ponatinib): The FDA has granted full approval of Ariad s Iclusig for adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated; and for the treatment of adult patients with T315Ipositive CML (chronic phase, accelerated phase, or blast phase) or T315I positive Ph+ ALL. Iclusig was initially approved under the FDA s accelerated approval program which allows patients access to new drugs that treat serious conditions while the company conducts studies to prove clinical benefit. Avastin (bevacizumab): Genentech 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.

2 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 Novartis 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

3 Specialty Pipeline > December 2016 Page 3 Specialty new product approvals in the past 12 months Generic name Brand name Manufacturer Indication(s) bezlotoxumab Zinplava Merck Recurring Clostridium difficile infection adalimumab-otto Amjevita Amgen Several inflammatory diseases; biosimilar to Humira (adalimumab) eteplirsen Exondys 51 Sarepta Therapeutics Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping immune globulin (human), 20% solution Cuvitru Shire/Baxalta Primary immunodeficiency in adults and pediatric patients aged two and older etanercept-szzs Erelzi Sandoz Several autoimmune diseases; biosimilar to Enbrel (etanercept) Route of administration Subcutaneous Subcutaneous injection Date approved* November 2016 October 2016 September 2016 September 2016 August 2016 Launch delayed until late 2018 or beyond. sofosbuvir/velpatasvir Epclusa Gilead Hepatitis C (all genotypes) Oral June 2016 daclizumab high-yield process Zinbryta Biogen and AbbVie Multiple sclerosis Subcutaneous May 2016 injection obeticholic acid Ocaliva Intercept Primary biliary cholangitis Oral May 2016 recombinant Factor VIII single chain Afstyla CSL Behring Hemophilia A infliximab Remsima Celltrion/Pfizer Rheumatoid arthritis, Crohn s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis; biosimilar to Remicade emtricitabine/tenofovir alafenamide defibrotide Defitelio Jazz Hepatic veno-occlusive disease (VOD) following a hematopoietic stem cell transplant May 2016 April 2016 Descovy Gilead HIV Oral April 2016 reslizumab Cinqair Teva Severe eosinophilic asthma ixekizumab Taltz Lilly Psoriasis Subcutaneous injection emtricitabine/ Odefsey Gilead HIV Oral tenofovir alafenamide/ rilpivirine coagulation Factor IX Idelvion CSL Behring Hemophilia B octocog alfa Kovaltry Bayer Hemophilia A tofacitinib Xeljanz XR Pfizer Rheumatoid arthritis Oral February 2016 grazoprevir/elbasvir Zepatier Merck Hepatitis C (genotypes 1 and 4) Oral January 2016

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 canakinumab 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 Biopharmaceuticals Lower limb spasticity in pediatric patients aged 2 and older August 2016 ombitasvir, paritaprevir, ritonavir, dasabuvir Viekira XR AbbVie, Enanta New once-daily formulation of the direct-acting 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 July 2016 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 single injection omalizumab Xolair Roche Moderate to severe persistent asthma in children aged 6 to 11 adalimumab Humira AbbVie Non-infectious intermediate, posterior, and panuveitis alpha-1 proteinase inhibitor [human] Glassia Shire and Kamada Self-administration for alpha 1-antitrypsin deficiency in people who have symptoms of emphysema July 2016 July 2016 July 2016 June 2016 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 secukinumab Cosentyx Novartis Adult patients with active ankylosing spondylitis and active psoriatic arthritis January 2016

5 Specialty Pipeline > December 2016 Page 5 Oncology product approvals in the past twelve months Generic Name Brand Name Manufacturer Indication(s) rucaparib Rubraca Clovis Advanced ovarian cancer with deleterious BRCA olaratumab Lartruvo Lilly Soft tissue sarcoma atezolizumab Tecentriq Roche Metastatic urothelial bladder cancer Route of Administration Date Approved Oral December 2016 November 2016 May 2016 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 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 lenalidomide and dexamethasone, or bortezomib and dexamethasone nivolumab Opdivo BMS Metastatic or recurrent squamous cell carcinoma of November 2016 the head and neck following disease progression on, or after, platinum-based therapy pembrolizumab 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 antibody; approved for use in combination with fludarabine and cyclophosphamide pembrolizumab Keytruda Merck For head and neck cancer August 2016 continued

6 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 (rituximab) 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 ROS 1 gene mutation obinutuzumab Gazyva Genentech Follicular lymphoma; approved for use in combination with bendamustine followed by obinutuzumab alone everolimus Afinitor Novartis Inoperable, locally advanced or metastatic neuroendocrine tumors palbociclib Ibrance Pfizer Hormone receptor-positive (HR+), human 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 mutationpositive January 2016 unresectable or metastatic melanoma; approved for use in combination with Yervoy eribulin mesylate Halaven Eisai Second-line treatment of liposarcoma January 2016

7 Specialty Pipeline > December 2016 Page 7 Pipeline watch Generic Name Brand Name Manufacturer Indication(s) 177Lu-DOTA0-Tyr3-octrotate Lutathera Advanced Accelerator Applications Gastroentero-pancreatic neuroendocrine tumors (GEP NETS) Route of Administration Anticipated Approval date* Subcutaneous December 2016 baricitinib N/A Lilly and Incyte Rheumatoid arthritis Oral January 2016 SB2 Biosimilar of Remicade Samsung Bioepis and Merck Rheumatoid arthritis, Crohn s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis January 2016 brodalumab 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 Pharmaceuticals Duchenne muscular dystrophy (DMD) Oral February 2017 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 Intracerebroventricular April 2017 ribociclib N/A Novartis Breast cancer Oral April-May 2017 *Anticipated approval dates are predictions made by Prime Therapeutics based on industry information.

8 Specialty Pipeline > December 2016 Page 8 Watch list Criteria for inclusion on the watch list include: Drug is submitted to the FDA and is anticipated to have material impact to trend and/or material impact to preferred product strategies (medical or pharmacy). Brand (generic)/ manufacturer Ocrevus (ocrelizumab)/ Genentech Dupixent (dupilumab)/ Regeneron/Sanofi Radicava (edaravone)/ Mitsubishi Tanabe Pharma Proposed indication/route of administration Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Remitting Multiple Sclerosis (RRMS) (IV) Atopic Dermatitis (AD)/ subcutaneous injection Amyotrophic Lateral Sclerosis (ALS)/IV Anticipated approval (PDUFA date) Similar products (by indication) Spend* Net new impact to PMPM* pharmacy benefit Net new impact to PMPM* medical benefit March 2017 None for PPMS $$ $$$ None $$ $$$ 1st Half 2017 None $$ $$$ $$-$$$ None June 2017 Rilutek (riluzole) $$ None $$ *Notations: $ < $0.08 per member per month (PMPM), $$ = $0.08 $0.39 PMPM, $$$ = $0.40 $2.00 PMPM, $$$$ > $2.01 PMPM. References 1 tok=eyjpijoitursbfpttxpzamn4wmpkbsisinqioijgzlwva0llbvbpwunnxc81mwrsqvf2r1wvwercynf1ykvcoedwm0w2y3m3mwtszwvuvdfdclnunk02exbxn0tudwwytfh1awdtwehzd ytnsmrmtvwvcstgvthclzrlzvu2dnruddf0qmvwv3excu5fpsj tok=eyjpijoitxpvmk5ua3lzv1jowldjncisinqioijxuw84wwphcuixqtbtbufwslo2udrbcw8ynjblxc9rb3bscgh1ck5mbwfxk092rmrgagtdbff2uuzkbstnmjdnm3c1n3hnefhsunkzu 1Erd2NqZzU5TmlzaFZja0dKMXRDNmpuWWFXS0ZxQmc9In0%3D. All brand names are property of their respective owners B1 Prime Therapeutics LLC 12/16