Specialty Pipeline Update

Transcription

1 Specialty Pipeline Update D Drug Insights > March New drug information Xermelo (telotristat etiprate): The U.S. Food and Drug Administration (FDA) granted approval of Lexicon s Xermelo tablets for the treatment of adults with carcinoid syndrome diarrhea that somatostatin analogues (SSA) therapy alone has inadequately controlled. Carcinoid syndrome occurs in people with carcinoid tumors which are rare. Carcinoid syndrome occurs in less than 10 percent of patients with carcinoid tumors. SSAs control carcinoid syndrome in 80 percent of patients. 2, 3 In a 12-week trial, 33 percent of patients randomized to add Xermelo on to SSA therapy experienced an average reduction of 2 bowel movements per day compared to 4 percent of patients taking SSA alone. 1 Xermelo must be taken 3 times daily with food. Kisqali (ribociclib): The FDA approved Novartis Kisqali in combination with an aromatase inhibitor as initial endocrinebased therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This will compete with Pfizer s Ibrance (palbociclib) which has the same mechanism of action and indication. Novartis anticipates Kisqali will have a percent lower aggregate cost than Ibrance due to Kisqali s flexible pricing structure. 4 Although Kisqali may cost less than Ibrance, use of Kisqali requires ECG monitoring which is not a requirement with Ibrance use. New indications Revlimid (lenalidomide): Celgene received a new indication for maintenance treatment of newly diagnosed multiple myeloma (MM) patients after receiving autologous stem cell transplant. Prior to this indication, Revlimid was approved for use in MM in combination with dexamethasone, transfusion-dependent anemia due to low- or intermediate- 1 risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities, and mantle cell lymphoma whose disease has relapsed or progressed after 2 prior therapies, one of which included bortezomib. Keytruda (pembrolizumab): Merck received a new indication for the treatment of patients with refractory classical Hodgkin lymphoma, or who have relapsed after 3 or more prior lines of therapy. This indication was approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. 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 > March Page 2 March news The FDA accepted Mylan and Biocon s Herceptin biosim application and set a regulatory decision deadline for Sept. 3,. With that news, plus a new settlement agreement, Mylan says it could reach the lucrative U.S. market before any other competitor. 5 The FDA has informed Radius Health that it will require additional time to complete its review of the company s new drug application (NDA) for abaloparatide-sc. The agency extended the Prescription Drug User Fee Act (PDUFA) action date to June 30,. In its letter, the FDA did not request any additional information from Radius. 6 Regeneron and Sanofi s Dupixent showed positive results in a one-year study in which patients receiving the drug achieved significantly improved clearance of skin lesions and reduction of overall disease severity compared with topical corticosteroids alone in adults with moderate-to-severe atopic dermatitis or eczema. 7 AstraZeneca s Lynparza honed its edge in ovarian cancer, and just in time to help preserve its lead in the marketplace. In detailed results from a test of the drug in patients who d relapsed after platinum chemo, the first-in-class PARP inhibitor held off cancer recurrence by more than two years, compared with placebo, and delivered a statistically significant improvement in the risk of tumor progression or death. Those numbers compare favorably with Tesaro s competitor niraparib, which delivered a 15.5-month survival advantage in its own maintenance-therapy trial. 9 Results from the long-awaited Fourier trial, designed to test Amgen s Repatha as a tool to cut cardiovascular risks, showed that the drug cut heart attack risks by 27% over the course of the study, which followed patients for an average of two years. It cut the risk of stroke by 21%. 10 PTC Therapeutics Inc said on Thursday it would buy Marathon Pharmaceuticals LLC s recently approved Duchenne muscular dystrophy drug, Emflaza, and promised to re-examine the hefty U.S. price tag on the treatment. Emflaza is available outside the United States as a generic to treat the devastating muscle-wasting genetic disease that mainly affects young boys. Last month, the U.S. Food and Drug Administration approved Marathon selling Emflaza in the United States. 8

3 Specialty Pipeline > March Page 3 Specialty new product approvals in the past 12 months Generic name Brand name Manufacturer Indication(s) Route of administration Date approved* telotristat etiprate Xermelo Lexicon Carcinoid syndrome Oral February brodalumab Siliq Valeant Plaque psoriasis Subcutaneous February injection immune globulin Gammaplex 10% Bio Products Primary immunodeficiency/ chronic immune thrombocytopenic purpura IV February deflazacort Emflaza Marathon Pharmaceuticals Duchenne muscular dystrophy (DMD) Oral February etelcacetide Parsabiv Amgen Secondary February hyperparathyroidism nusinersen Spinraza Ionis/Biogen Spinal muscular atrophy (SMA) Intrathecal December 2016 bezlotoxumab Zinplava Merck Reduce recurrence of Clostridium difficile infection adalimumab-otto Amjevita Amgen Biosimilar to Humira (adalimumab): 7 inflammatory diseases 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 To treat adults and pediatric patients ages 2 years and older with primary immunodeficiency etanercept-szzs Erelzi Sandoz Biosimiliar to Enbrel (etanercept) all indications Subcutaneous Subcutaneous injection October 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 injection obeticholic acid Ocaliva Intercept Primary biliary cholangitis Oral recombinant factor VIII single chain Afstyla CSL Behring Hemophilia A infliximab Remsima Celltrion/Pfizer Biosimilar to Remicade April 2016 emtricitabine/tenofovir alafenamide Descovy Gilead HIV Oral April 2016

4 Specialty Pipeline > March Page 4 New indications for approved specialty products Generic name Brand name Manufacturer Indication(s) Date approved* ranibizumab Lucentis Genentech Myopic choroidal neovascularization (mcnv) February 2016 Factor VIII, recombinant, pegylated Adynovate Shire Pediatric hemophilia A patients who are 12 years old and younger, as well as for use in surgical settings for children and adults etanercept Enbrel Amgen Pediatric patients 4 years or older with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy; prior to this approval only adults aged 18 years and older were approved for this indication canakinumab Ilaris Novartis Tumor necrosis factor-receptor 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 6 years and older who are homozygous for the F508del mutation in the CFTR gene abobotulinumtoxina Dysport Ipsen Biopharmaceuticals ombitasvir, paritaprevir, ritonavir, dasabuvir To treat lower limb spasticity in pediatric patients ages 2 years and older Viekira XR AbbVie, Enanta New once-daily formulation of the directacting antiviral combination for treatment of chronic hepatitis C virus 1 in patients with or without compensated cirrhosis and is used in combination with twice-daily ribavirin for genotype 1a patients and without ribavirin for genotype 1b patients December 2016 October 2016 October 2016 August 2016 July 2016 C1 esterase inhibitor [human] Berinert CSL Bering To treat hereditary angioedema (HAE) attacks in July 2016 pediatric patients darunavir Prezista Janssen To treat HIV infection in pregnant women July 2016 evolocumab Repatha Amgen 420 mg once monthly dose administered as a single injection omalizumab Xolair Roche For the treatment of moderate-to-severe persistent asthma in children ages 6 through 11 adalimumab Humira AbbVie For patients with non-infectious intermediate, posterior, and panuveitis alpha-1 proteinase inhibitor [human] Glassia Shire and Kamada Self-administration indication (alpha 1-antitrypsin deficiency in people who have symptoms of emphysema) July 2016 July 2016 July 2016 June 2016

5 Specialty Pipeline > March Page 5 Oncology product approvals in the past twelve months Generic Name Brand Name Manufacturer Indication(s) Route of Administration Date Approved ribociclib Kisqali Novartis Breast cancer Oral March 2016 rucaparib Rubraca Clovis Ovarian cancer Oral December 2016 oloaratumab Lartruvo Lilly Soft tissue sarcoma atezolizumab Tecentriq Roche Metastatic urothelial bladder cancer cabozantinib Cabometyx Exelixis Advanced renal cell carcinoma Oral April 2016 venetoclax Venclexta AbbVie/Genentech Chronic lymphocytic leukemia (CLL) Oral April 2016 New indications for approved oncology drugs Generic name Brand name Manufacturer New Indication(s) Date approved* pembrolizumab Keytruda Merck Refractory classical Hodgkin lymphoma March lenalidomide Revlimid Celgene Maintenance treatment of newly diagnosed multiple myeloma patients after receiving autologous stem cell transplant (ASCT) nivolumab Opdivo Bristol Patients with locally advanced unresectable or metastatic urothelial carcinoma following progression on a platinum-containing therapy ibrutinib Imbruvica Janssen Marginal zone lymphoma (MZL) who require systemic therapy bevacizumab Avastin Genetech 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 daratumumab Darzalex Janssen In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy nivolumab Opdivo BMS To treat metastatic or recurrent squamous cell carcinoma of the head and neck following disease progression on or after platinum-based therapy pembrolizumab Keytruda Merck For the treatment of patients with metastatic NSCLC whose tumors express PD-L1 as determined by an FDA-approved test. This approval also expands the indication in secondline treatment of lung cancer to include all patients with PD-L1-expressing NSCLC erlotinib Tarceva Genetech For metastatic non-small cell lung cancer (NSCLC) to limit use 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 February February January December 2016 continued

6 Specialty Pipeline > March Page 6 Generic name Brand name Manufacturer New Indication(s) Date approved* atezolizumab Tecentriq Roche Treatment of patients with metastatic non-small October 2016 cell lung cancer (NSCLC) who have progressed during or following platinum-containing chemotherapy blinatumomab Blincyto Amgen For the treatment of pediatric and adolescent August 2016 patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) ofatumumab Arzerra Novartis, Genmab For the anti-cd20 monoclonal antibody for August 2016 use in combination with fludarabine and cyclophosphamide for treatment of patients with relapsed chronic lymphocytic leukemia (CLL) pembrolizumab Keytruda Merck For head and neck cancer August 2016 nivolumab Opdivo Bristol-Myers Squibb For treatment of classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and posttransplantation brentuximab vedotin (Adcetris) lenvatinib Lenvima Eisai For patients with advanced renal cell carcinoma who were previously treated with an antiangiogenic therapy ibrutinib Imbruvica AbbVie and Johnson & Johnson For use in combination with bendamustine and Rituxan (rituximab) for treatment of relapsed or refractory chronic lymphocytic leukemia and small lymphocytic leukemia afatinib Gilotrif Boehringer Ingelheim For patients with advanced squamous cell carcinoma of the lung with progression after firstline chemotherapy April 2016

7 Specialty Pipeline > March Page 7 Pipeline watch Generic Name Brand Name Manufacturer Indication(s) Route of Administration Anticipated Approval date* HIV vaccine Remune Immune Response HIV Intramuscular February SB2 Biosimilar of Remicade Samsung Bioepis and Merck Rheumatoid arthritis, Crohn s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis April 2016 baricitinib Olumiant Lilly and Incyte Rheumatoid arthritis Oral April brigatinib N/A Ariad Pharmaceuticals Non-small cell lung cancer Oral April valbenazine Ingrezza Neurocrine Biosciences Tardive dyskinesia Oral April deutetrabenazine N/A Teva Chorea associated with Oral April Huntington disease cerliponase alfa Brineura BioMarin Batten disease Intracerebroventricular April midostaurin N/A Novartis AML Oral May binimetinib N/A Array BioPharma Melanoma Oral June niraparib N/A Tesaro Recurrent ovarian/fallopian Oral June tube/primary peritoneal cancer nonacog beta pegol (Factor IX, N/A Novo Nordisk Hemophilia B May recombinant glyco-pegylated) C1-estrase inhibitor N/A CSL Bering Hereditary angioedema Subcutaneous June rituximab N/A Genetech/Roche NHL/CLL Subcutaneous June-July filgrastim Grastofil Apotex Neutropenia Subcutaneous June peg-filgrastim Lapelga Apotex Neutropenia Subcutaneous June peg-filgrastim N/A Coherus BioSciences Neutropenia Subcutaneous June sarilumab Kevzara Sanofi/Regeneron Rheumatoid arthritis Subcutaneous 2Q neratinib Puma Biotech/ Pfizer Breast cancer Oral July Pfizer enasidenib N/A Celegene/Agios R/R AML Oral August sofosbuvir, velpatasvir and N/A Gilead Hepatitis C Oral August voxilaprevir glecaprevir/pibrentasvir N/A AbbVie Hepatitis C Oral August sirukumab N/A GSK/Janssen Biotech Rheumatoid arthritis Subcutaneous eptacog beta, activated (Factor VIIa) N/A revo Biologics/LFB Hemophilia A or B with inhibitors adalimumab N/A Boehringer Ingelheim Arthritis, plaque psoriasis, ankylosing spondylitis, Crohn s disease, and ulcerative colitis trastuzumab N/A Mylan/Biocon HER2-positive breast and gastric cancers bevacizumab N/A Amgen NSCLC, colon cancer *Anticipated approval dates are predictions made by Prime Therapeutics based on industry information.

8 Specialty Pipeline > March 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 Proposed indication/route of administration Primary progressive multiple sclerosis (PPMS) and relapsing remitting multiple sclerosis (RRMS) (IV) Atopic dermatitis (AD)/ subcutaneous injection Anticipated approval (PDUFA date) Similar products (by indication) Spend* Net new impact to PMPM* pharmacy benefit March None for PPMS $$ None $$ Net new impact to PMPM* medical benefit March None $$ $$$ $$ $$$ None Ingrezza (valbenazine) Tardive dyskinesia (TD)/oral April Xenazine [0ff-label] $ $$ $ $$ None Radicava (edaravone)/ Mitsubishi Tanabe Pharma niraparib/tesaro Pharmaceutical grade L-glutamine (PGLG)/ Emmaus Life Science Translarna (ataluren)/ PTC Therapeutics Amyotrophic lateral sclerosis (ALS)/IV Recurrent ovarian/fallopian tube/primary peritoneal cancer/oral June Rilutek (riluzole) $$ None $$ June None $$ $$ None Sickle cell disease/oral July L-glutamine OTC/ Hydrea $ $$ $ $$ None Nonsense mutation Duchenne muscular dystrophy (nmdmd)/ oral October None $$ $$$ $$ $$$ None Orphan Drugs, evaluated for Watch List, do not meet criteria deutetrabenazine (SD-809)/Teva Brineura (cerliponase alfa) CSL830 (C1-estrase inhibitor)/csl Bering amantadine XR/Adamas Chorea associated with Huntington disease (HD)/oral CLN2 Disease, a form of Batten disease/ intracerebro-ventricular Prevention of hereditary angioedema attacks/sc Levodopa-induced dyskinesia (LID)/oral April Xenazine Switch therapy: Assume patients will switch from Xenazine to deutetrabenazine None April None $ None $ June Berinert, Cinryze, Ruconest August None by indication [amantadine IR, offlabel] Switch therapy: Spend may shift from medical to pharmacy due to SC dosing Switch therapy: Assume patients will switch from amantadine IR *Notations: $ < $0.08 per member per month (PMPM), $$ = $0.08 $0.39 PMPM, $$$ = $0.40 $2.00 PMPM, $$$$ > $2.01 PMPM. None

9 Specialty Pipeline > March Page 9 References Modlin IM, Kidd M, Latich I, Zikusoka MN, Shapiro MD. Current status of gastrointestinal carcinoids. Gastroenterology 2005 May; 128(6): Kvols LK, Moertel CG, O Connell MJ, et al. Treatment of the malignant carcinoid syndrome. Evaluation of a long-acting somatostatin analogue. NEJM 1986; 315 (11): tok=eyjpijoitw1rmu9xvmlavgd6wwpsacisinqioijkrjj3z282vvzvzctlwwpsexdrrtfsmgfjays5cwtidstjd1jwu0dkwwnlmgfrsu5xogrrwdirt1vvr3lrbuxsk094cfwvsxn3cghss0zdr2lwbkrqtxrvsmxgm3rco FhMZ0FhbHIydzZta2FxeEZnUjY2RTJvNG1aSXhiOGk3anIifQ%3D%3D&mrkid= &utm_medium=nl&utm_source=internal NcL3Q0MDJaYkxiVDluZWl5UmNIVE1lbGtNSVB5cysySlVKbVpoTGpsRFAycXdHRVltRzhhdTJQTlZGbk1sNThoZ0RpMGRrZk9uR3NZY01cL0RubXp4d09ib3kydytZMEJYWElHaTEwbHVPIn0%3D&mrkid= &utm_ medium=nl&utm_source=internal kpnqmxjwvfgne8wzvuxcnr0rg1vy0v2u05xofh2rkrsy3llc1llnfzsrfmwnmdfrjdqavjfaknwdfhungdutultedlwqlbgrlvyqzkzzfjivtfqvfzgdgptdtc2ogx0thndxc8ifq%3d%3d&mrkid= &utm_medium=nl&utm_ source=internal. All brand names are property of their respective owners B1 Prime Therapeutics LLC 03/17