Specialty Pipeline Monthly Update

Transcription

1 Specialty Pipeline Monthly Update Critical updates in an ever changing environment June 2017 New drug information Kevzara (sarilumab): Sanofi/Regeneron Pharmaceuticals received Food and Drug Administration (FDA) approval for the treatment of adult patients with moderately-to-severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying anti-rheumatic drugs (DMARDs). The wholesale acquisition cost (WAC) of Kevzara is $39,000 which is about 30% lower than the two most widely used TNF-alpha drugs. 1 Rebinyn (coagulation Factor IX (recombinant), GlycoPEGylated): Novo Nordisk received FDA approval for the on-demand treatment and control of bleeding episodes and the perioperative management of bleeding in adults and children with hemophilia B. Rebinyn is not FDA approved for routine prophylaxis in patients with hemophilia B. Novo Nordisk anticipates launching Rebinyn in the first half of New indications Keytruda (pembrolizumab): The FDA approved Merck s Keytruda for the treatment of any unresectable or metastatic solid tumors associated as microsatellite instability-high or mismatch repair deficient. Keytruda is the first treatment approved by the FDA based on a patient s specific genetic traits regardless of where in the body the disease started. Zykadia (certinib): Novartis Zykadia received FDA approval for first-line treatment of patients with ALK+ metastatic non-small cell lung cancer (NSCLC). Orencia (abatacept): Bristol-Myers Squibb received FDA approval for a new Orencia subcutaneous injection for use in patients aged 2 years with moderately to severely active polyarticular juvenile idiopathic arthritis (pjia). The prefilled syringe allows physicians, patients, and caregivers of these patients the option of treatment with Orencia administered at home. Dysport (abobotulinumtoxina): The FDA expanded approval of Ipsen s Dysport for treatment of spasticity in adults from the upper limbs only to include the lower limbs as well. Darzalex (daratumumab): Johnson & Johnson/Genmab received FDA approval for Darzalex to be used in combination with Celgene s Pomalyst (pomalidomide) and dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, with a proteasome inhibitor and an immunomodulator. 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 Update: June 2017 Page 2 June news A clinical trial from Roche combining the company s newer targeted drug for breast cancer with an older treatment resulted in a modest benefit for women with a specific type of disease, according to data. Roche has sought to shield its lucrative breast cancer franchise from cheaper copies of its drugs by showing the combination would provide a greater benefit. 3 Novartis pioneering CAR-T drug CTL019 (tisagenlecleucel) scored high in treating diffuse large B-cell lymphoma (DLBCL), spotlighting numbers that will likely allow the pharma giant to plunge head-to-head in the market against its main initial rival, Kite Pharma. But Novartis also found itself defending its manufacturing operations, as analysts zeroed in on a number of patients who couldn t be treated in the study. 4 The U.S. Supreme Court cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies. 5 An experimental extended-release version of the drug amantadine can reduce the duration of the involuntary dancing-like movements seen in people whose long-term use of levodopa has kept their Parkinson s disease under control. 6

3 Specialty Pipeline Update: June 2017 Page 3 Specialty new product approvals in the past twelve months Generic name Brand name Manufacturer Indication(s) Route of administration Month approved coagulation Factor IX Rebinyn Novo Nordisk Hemophilia B Intravenous June 2017 (recombinant), GlycoPEGylated sarilumab Kevazara Sanofi/Regeneron Rheumatoid arthritis Subcutaneous May 2017 edaravone Radicava Mitsubishi Tanabe Pharma Amyotrophic lateral sclerosis (ALS) Intravenous May 2017 abaloparatide Tymlos Radius health Osteoporosis in Subcutaneous April 2017 postmenopausal women cerliponase alfa Brineura BioMarin CLN2 disease Intracerebroventricular April 2017 infliximab-abda Renflexis (biosimilar to Remicade ) Samsung Bioepis/ Merck valbenazine Ingrezza Neurocrine Biosciences Inc Rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis Intravenous April 2017 Tardive dyskinesia Oral April 2017 deutetrabenazine Austedo Teva Chorea associated with Oral April 2017 Huntington s disease ocrelizumab Ocrevus Genetech Multiple sclerosis Intravenous March 2017 dupilumab Dupixent Sanofi/Regeneron Atopic dermatitis Subcutaneous March 2017 telotristat etiprate Xermelo Lexicon Carcinoid syndrome Oral February 2017 brodalumab Siliq Valeant Plaque psoriasis Subcutaneous February 2017 immune globulin Gammaplex Bio Products Primary immunodeficiency/ 10% chronic immune thrombocytopenic purpura deflazacort Emflaza Marathon Pharmaceuticals Duchenne muscular dystrophy (DMD) Intravenous February 2017 Oral February 2017 etelcacetide Parsabiv Amgen Secondary hyperparathyroidism Intravenous February 2017 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 immune globulin (human), 20% solution Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping Cuvitru Shire/Baxalta To treat adults and pediatric patients ages two years and older with primary immunodeficiency. etanercept-szzs Erelzi Sandoz Biosimiliar to Enbrel (etanercept)-all indications Intravenous Subcutaneous injection Intravenous Subcutaneous Subcutaneous injection October 2016 September 2016 September 2016 August 2016 launch delayed until late 2018 or beyond

4 Specialty Pipeline Update: June 2017 Page 4 New indications for approved specialty products Generic name Brand name Manufacturer New indication(s) Date approved tocilizumab Actemra Roche Giant cell arteritis May 2017 ivacaftor Kalydeco Vertex To treat additional mutations in cystic fibrosis, May 2017 bringing the number of treatable CFTR gene mutations to 33 ranibizumab Lucentis Genetech (Roche) The anti-vascular endothelial growth factor A April 2017 (VEGF-A) monoclonal antibody for treatment of diabetic retinopathy in patients without diabetic macular edema (DME) ledipasvir/sofosbuvir Harvoni Gilead Hepatitis C in children April 2017 sofosbuvir Sovaldi Gilead Hepatitis C in children April 2017 ranibizumab Lucentis Genentech Myopic choroidal neovascularization (mcnv) February 2017 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 abobotulinumtoxina Dysport Ipsen Biopharmaceuticals ombitasvir, paritaprevir, ritonavir, dasabuvir Treatment of cystic fibrosis in patients 6 years and older who are homozygous for the F508del mutation in the CFTR gene To treat lower limb spasticity in pediatric patients ages 2 years and older Viekira XR AbbVie, Enanta Once-daily formulation for treatment of chronic hepatitis C virus 1 in patients with or without compensated cirrhosis December 2016 October 2016 October 2016 August 2016 July 2016 C1 esterase inhibitor [human] Berinert CSL Bering To treat Hereditary Angioedema (HAE) attacks July 2016 in 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 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 Update: June 2017 Page 5 Oncology product approvals in the past twelve months Generic name Brand name Manufacturer Indication(s) Route of administration Date approved ribociclib/letrozole Kisqali and Novartis Breast cancer Oral May 2017 Femara CoPack brigatinib Alunbrig ARIAD Pharmaceuticals ALK + NSCLC resistant to Xalkori Oral April 2017 durvalumab Imfinzi AstraZeneca Bladder cancer IV April 2017 midostaurin Rydapt Novartis FLT3-mutated AML or systemic Oral April 2017 mastocytosis niraparib Zejula Tesaro Ovarian, fallopian tube, or Oral March 2017 primary peritoneal cancer avelumab Bavencio Merck KgaA/Pfizer Metastatic Merkel cell IV March 2017 carcinoma ribociclib Kisqali Novartis Breast cancer Oral March 2017 rucaparib Rubraca Clovis Ovarian cancer Oral December 2016 oloaratumab Lartruvo Lilly Soft tissue sarcoma Intravenous

6 Specialty Pipeline Update: June 2017 Page 6 New indications for approved oncology drugs Generic name Brand name Manufacturer Indication(s) Date approved certinib Zykadia Novartis ALK inhibitor for first-line treatment of patients with ALK + NSCLC June 2017 pembrolizumab Keytruda Merck Unresectable or metastatic solid tumor associated with the genetic June 2017 abnormality microsatellite instability pembrolizumab Keytruda Merck Bladder cancer May 2017 pembrolizumab Keytruda Merck Metastatic non-squamous non-small lung cancer May 2017 avelumab Bavencio Merck/Pfizer Bladder cancer May 2017 regorafenib Stivarga Bayer Hepatocellular carcinoma who were previously treated with Nexavar May 2017 atezolizumab Tecentriq Genetech Bladder cancer April 2017 pembrolizumab Keytruda Merck Refractory classical Hodgkin lymphoma March 2017 lenalidomide Revlimid Celgene Maintenance treatment of newly diagnosed multiple myeloma patients February 2017 after receiving autologous stem cell transplant (ASCT) nivolumab Opdivo Bristol Patients with locally advanced unresectable or metastatic urothelial February 2017 carcinoma following progression on a platinum-containing therapy ibrutinib Imbruvica Janssen Marginal zone lymphoma (MZL) who require systemic therapy January 2017 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 second-line 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 atezolizumab Tecentriq Roche Treatment of patients with metastatic non-small cell lung cancer (NSCLC) patients who have progressed during or following platinum-containing chemotherapy blinatumomab Blincyto Amgen For the treatment of pediatric and adolescent 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 use in combination with fludarabine and cyclophosphamide for treatment of patients with relapsed chronic lymphocytic leukemia (CLL) December 2016 October 2016 August 2016 August 2016 pembrolizumab Keytruda Merck For head and neck cancer August 2016

7 Specialty Pipeline Update: June 2017 Page 7 Pipeline watch Anticipated Generic name Brand name Manufacturer Indication(s) approval date* Rituxan (rituximab)/hyaluronidase N/A Genetech/Roche NHL/CLL June-July 2017 filgrastim Grastofil Apotex Neutropenia June 2017 [Biosimilar to Neupogen ] peg-filgrastim Lapelga Apotex Neutropenia June 2017 [Biosimilar to Neulasta ] peg-filgrastim N/A Coherus BioSciences Neutropenia June 2017 [Biosimilar to Neulasta ] epoetin alfa Retacrit Pfizer Anemia June 2017 [Biosimilar to Procrit /Epogen ] neratinib N/A Puma Biotech/Pfizer Breast cancer July 2017 romosozumab N/A Amgen/UCB Osteoporosis July 2017 enasidenib N/A Celegene/Agios R/R AML August 2017 sofosbuvir, velpatasvir and N/A Gilead Hepatitis C August 2017 voxilaprevir glecaprevir/pibrentasvir N/A AbbVie Hepatitis C August 2017 sirukumab N/A GSK/Janssen Biotech Rheumatoid arthritis September 2017 eptacog beta, activated (Factor VIIa) adalimumab, BI [Biosimilar to Humira ] trastuzumab [Biosimilar to Herceptin ] bevacizumab [Biosimilar to Avastin ] N/A revo Biologic/LFB Hemophilia A or B with inhibitors September 2017 N/A Boehringer Ingelheim Arthritis, plaque psoriasis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis September 2017 N/A Mylan/Biocon HER2-positive breast and September 2017 gastric cancers N/A Amgen NSCLC, colon cancer September 2017 guselkumab N/A J&J/Janssen Plaque psoriasis November 2017 benralizumab N/A AstraZeneca Asthma December 2017 *Anticipated approval dates are predictions made by Prime Therapeutics based on industry information.

8 Specialty Pipeline Update: June 2017 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 Endari [pharmaceutical grade L-glutamine (PGLG)]/ Emmaus Life Science Translarna (ataluren)/ PTC Therapeutics tisagenlecleucel-t (CTL019)/Novartis axicabtagene ciloleucel (KTEC19)/ Kite Pharma, Inc voretigene neparvovec/ Sparks Therapeutics plasminogen (human plasma-derived purified)/prometic Life Sciences, Inc Proposed indication/ route of administration Anticipated approval (PDUFA date) Similar productions (by indication) Sickle cell disease/oral July 2017 L-glutamine OTC/Hydrea [NutreStore off-label] Nonsense mutation Duchenne muscular dystrophy (nmdmd)/ oral R/R pediatric & young adult B-cell ALL/ IV CAR T-cell therapy R/R B-cell NHL/ IV CAR T-cell therapy Inherited retinal disease (IRD) caused by mutations in the RPE65 gene/intravitreal injection Congenital plasminogen deficiency/iv Net new impact Net new impact Spend* to PMPM* pharmacy benefit to PMPM* medical benefit $ $$ $ $$ None October 2017 None $$ $$$ $$ $$$ None 9/29/2017 or earlier None $ $$ None $ $$ 11/29/2017 None $$$ None $$$ 4Q2017 None $ $$ None $ $$ 4Q2017 None $ $$ None $ $$ Drugs to be evaluated for Watch List fostamatinib/rigel Chronic and persistent immune thrombocytopenia/oral TBD CS, IVIG, Nplate, Promacta, Rituxan, anti-d TBD TBD None ibalizumab/ TaiMed Biologics and Theratechnologies Multidrug resistant HIV 1 infection/iv January 2018 Treatment depends on resistance testing TBD None TBD Orphan drugs, evaluated for Watch List, do not meet criteria Haegarda [CSL830 (C1-estrase inhibitor)]/ CSL Bering amantadine XR/ Adamas sirolimus (DE-109) References Prevention of hereditary angioedema attacks/sc Levodopa-induced dyskinesia (LID)/oral Non-infectious uveitis, posterior segment (NIU PS)/intravitreal June 2017 Berinert Cinryze Ruconest August 2017 None by indication [amantadine IR, off-label] Switch therapy: spend may shift from medical to pharmacy due to SC dosing Switch therapy: assume patients will switch from amantadine IR 4. e3b8680cb8e7f61759ff65a72948d6d0&utm_source=endpoints%20 s&utm_term=novartis%20posts%20landmark%20car-t%20data%20as%20head-to-head%20rivalry%20with%20kite%20pharma%20looms All brand names are property of their respective owners B1 Prime Therapeutics LLC 06/17 None None Switch therapy: December 2017 Humira Triesence Ozurdex not net new trend *Notations: $ < $0.08 per member per month (PMPM), $$ = $0.08 $0.39 PMPM, $$$ = $0.40 $2.00 PMPM, $$$$ > $2.01 PMPM