Specialty Pipeline Update

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1 CLINICAL SOLUTIONS Drug Insights > December 2015 Specialty Pipeline Update New Drug Information Alecensa (alectinib): The Food and Drug Administration (FDA) approved Genentech s orally administered ALK inhibitor for the treatment of metastatic, non small cell lung cancer in patients that are intolerant or unresponsive to Xalkori (crizotinib). Uptravi (selexipag): The FDA approved Actelion s Uptravi for the treatment of pulmonary arterial hypertension (PAH). The drug is approved in World Health Organization (WHO) Group I PAH patients to delay disease progression and reduce the risk of hospitalization. Kanuma (sebelipase alfa): Alexion received FDA approval for their enzyme replacement therapy. Kanuma is approved to treat lysosomal acid lipase deficiency. This condition can be seen shortly after birth or later in life. Ninlaro (ixazomib): The FDA approved Millennium Pharmaceuticals and Takeda s Ninlaro for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ninlaro is a proteasome inhibitor that is orally administered and will compete against Velcade. Vistogard (uridine triacetate): Wellstat Therapeutics received FDA approval for Vistogard for patients at risk of serious toxicity following an overdose of the chemotherapy agent 5-fluorouracil (5-FU) and patients exhibiting symptoms of serious toxicity within 96 hours of 5-FU administration. Wellstat submitted Vistogard as a separate new drug application from the original approval of Xuriden (uridine triacetate) for hereditary orotic aciduria. Bendeka (bendamustine): Teva received FDA approval for their intravenously administered oncology drug to treat chronic lymphocytic leukemia and indolent B-cell non-hodgkin lymphoma. Empliciti (elotuzumab): The FDA approved Bristol-Myers Squibb and AbbVie s treatment of multiple myeloma. Empliciti is to be used in combination with Revlimid and dexamethasone in patients that have received prior therapy. The drug is administered by intravenous. Portrazza (necitumumab): Lilly received approval for their intravenously administered fully human epidermal growth factor receptor (EGFR) monoclonal antibody. Portrazza is used for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer. Vonvendi [von Willebrand factor (VWF), recombinant]: The FDA approved Baxalta s recombinant VWF for the acute treatment of bleeding episodes. 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 Drug Insights > Specialty Pipeline Update Page 2 New Indications Opdivo (nivolumab): Bristol-Myers Squibb received a complete response letter from the FDA for an expanded indication in the treatment of metastatic melanoma. The FDA did not approve the drug for treating BRAF V600 mutation positive metastatic melanoma; however it was approved earlier for the treatment of BRAF V600 wild type melanoma. Keytruda (pembrolizumab): The FDA approved Merck s Keytruda as a first-line treatment for unresectable or metastatic melanoma and as a treatment for patients with ipilimumab (Yervoy )-refractory melanoma. Keytruda is also approved for advanced (metastatic) non-small cell lung cancer. December News A panel of outside advisers to the U.S. Food and Drug Administration indicated that efficacy data from BioMarin Pharmaceutical Inc on its experimental drug for treating a muscle wastage disorder [drisapersen] was not persuasive enough to warrant approval. The FDA panel did not officially vote on an approval of the drug, but 15 out of 17 members were of the opinion that the lack of statistical significance in BioMarin s late-stage study weakened the findings from two earlier studies. 1 BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) has notified the Company that they had not yet completed their review process and would be unable to take an action by the Prescription Drug User Fee Act (PDUFA) action date for Kyndrisa (drisapersen) of December 27, 2015, and anticipate taking action in early January Amgen Inc said it filed with U.S. health regulators seeking approval to sell its first biosimilar drug, which would be a less expensive alternative to AbbVie s Humira, the world s top-selling prescription medicine. Amgen said its drug, ABP 501, has demonstrated clinical equivalence and comparable safety to Humira (adalimumab) in late stage clinical trials for rheumatoid arthritis and the skin condition plaque psoriasis. 3

3 Drug Insights > Specialty Pipeline Update Page 3 Specialty New Product Approvals in the Past Twelve Months Generic Name Brand Name Manufacturer Indication(s) Route of Administration Date Approved selexipag Uptravi Actelion Pulmonary arterial hypertension Oral December 2015 von Willebrand factor, Vonvendi Baxalta Von Willebrand disease Intravenous December 2015 recombinant sebelipase alfa Kanuma Alexion/Synageva Enzyme replacement therapy Intravenous December 2015 asfotase alfa Strensiq Alexion Enzyme replacement therapy Subcutaneous November 2015 Factor VIII, recombinant, pegylated Adynovate Baxalta Hemophilia A Intravenous November 2015 mepolizumab Nucala GlaxoSmithKline Severe eosinophilic asthma Subcutaneous November 2015 elvitegravir/cobicistat/ Genvoya Gilead HIV Oral November 2015 emtricitabine/tenofovir alafenamide Factor X concentrate Coagadex BioProducts Laboratory Factor X deficiency Intravenous October 2015 uridine triacetate Xuriden Wellstat Therapeutics Hereditary orotic aciduria Oral October 2015 Factor VIII, recombinant Nuwiq Octapharma Hemophilia A Intravenous September 2015 uridine triacetate Xuriden Wellstat Therapeutics Hereditary orotic aciduria Oral September 2015 dichlorphenamide Keveyis Taro Primary hyperkalemic and Oral August 2015 hypokalemic periodic paralysis evolocumab Repatha Amgen High cholesterol Subcutaneous August 2015 daclatasvir Daklinza BMS Hepatitis C (genotype 3) Oral July 2015 ombitasvir, paritaprevir, Technivie AbbVie Hepatitis C (genotype 4) Oral July 2015 ritonavir with ribavirin alirocumab Praluent Sanofi-Genzyme High cholesterol Subcutaneous July 2015 lumacaftor/ivacaftor Orkambi Vertex Cystic fibrosis Oral July 2015 coagulation factor IX (recombinant) Ixinity Emergent BioSolutions Hemophilia B Intravenous May 2015 glatiramer Glatopa Sandoz Multiple sclerosis Subcutaneous April 2015 deferasirox Jadenu Novartis Chronic iron overload Oral April 2015 raltegravir/lamivudine Dutrebis Merck HIV Oral March 2015 cholic acid Cholbam Asklepion Pharmaceuticals Bile acid synthesis disorders Oral March 2015 filgrastim-sndz (biosimilar to Neupogen ) Zarxio Sandoz Neutropenia Intravenous March 2015 darunavir/cobicistat Prezcobix Janssen HIV Oral February 2015 atazanavir/cobicistat Evotaz BMS HIV Oral February 2015 ferric pyrophosphate citrate Triferic Rockwell Medical Iron replacement Intravenous January 2015 recombinant human Natpara NPS Pharmaceuticals Hypoparathyroidism Intravenous January 2015 parathyroid hormone secukinumab Cosentyx Novartis Plaque psoriasis Subcutaneous January 2015

4 Drug Insights > Specialty Pipeline Update Page 4 New Indications for Approved Specialty Products Generic Name Brand Name Manufacturer New Indication(s) Date Approved ambrisentan Letairis Gilead Treatment of pulmonary arterial hypertension, October 2015 in combination with tadalafil adalimumab Humira AbbVie Treatment of moderate to severe hidradenitis September 2015 suppurativa cysteamine Procysbi Raptor Pediatric nephropathic cystinosis in patients August 2015 Pharmaceuticals ages 2 6 years old abobotulinumtoxina Dysport Ipsen Treatment of upper limb spasticity in adults July 2015 sirolimus Rapamune Pfizer Treatment of lymphangioleiomyomatosis May 2015 aflibercept Eylea Regeneron Diabetic retinopathy April 2015 onabotulinumtoxina Botox Allergan Treatment of upper limb spasticity in adults April 2015 ivacaftor Kalydeco Vertex For use in children 2 5 years old who have March 2015 one of 10 mutations in the cystic fibrosis transmembrane conductance regulator gene ranibizumab Lucentis Roche Treatment of diabetic retinopathy in patients February 2015 with diabetic macular edema ivacaftor Kalydeco Vertex For patients with mutation R117H January 2015

5 Drug Insights > Specialty Pipeline Update Page 5 Oncology Product Approvals in the Past Twelve Months Route of Generic Name Brand Name Manufacturer Indication(s) Administration Date Approved alectinib Alecensa Genentech Non-small cell lung cancer Oral December 2015 elotuzumab Empliciti Bristol-Myers Squibb/ AbbVie Multiple myeloma bendamustine Bendeka Teva Chronic lymphocytic leukemia and indolent B-cell non-hodgkin lymphoma Intravenous Intravenous December 2015 December 2015 necitumumab Portrazza Lilly Non-small cell lung cancer Intravenous November 2015 ixazomib Ninlaro Millennium Multiple myeloma Oral November 2015 Pharmaceuticals/ Takeda daratumumab Darzalex Janssen Multiple myeloma Intravenous November 2015 osimertinib Tagrisso AstraZeneca Non-small cell lung cancer Oral November 2015 irinotecan liposome Onivyde Merrimack Pharmaceuticals Pancreatic cancer Intravenous November 2015 trabectedin Yondelis Janssen Soft tissue sarcoma Intravenous November 2015 cobimetinib Cotellic Genentech Metastatic melanoma Oral November 2015 talimogene Imlygic Amgen Metastatic melanoma Injection October 2015 laherparepvec trifluridine/tipiracil Lonsurf Otsuka Colorectal cancer Orals September 2015 gefitinib Iressa AstraZeneca Non-small cell lung cancer Oral July 2015 sonidegib Odomzo Novartis Basal cell carcinoma Oral July 2015 dinutuximab Unituxin United Therapeutics Neuroblastoma Intravenous March 2015 panobinostat Farydak Novartis Multiple myeloma Oral February 2015 palbociclib Ibrance Pfizer Breast cancer Oral February 2015 lenvatinib Lenvima Eisai Thyroid cancer Oral February 2015

6 Drug Insights > Specialty Pipeline Update Page 6 New Indications for Approved Oncology Drugs Generic Name Brand Name Manufacturer New Indication Date Approved pembrolizumab Keytruda Merck First-line treatment for unresectable or metastatic December 2015 melanoma and as a treatment for patients with ipilimumab (Yervoy )-refractory melanoma nivolumab Opdivo Bristol-Myers Squibb Treatment of BRAF V600 wild-type melanoma. December 2015 ledipasvir/sofosbuvir Harvoni Gilead For use in patients with genotype 4, 5 and 6 chronic November 2015 hepatitis C virus (HCV) infection and in patients co infected with HIV ipilimumab Yervoy Bristol-Myers Squibb Adjuvant therapy for patients with stage III melanoma November 2015 nivolumab Opdivo Bristol-Myers Squibb To be used in combination with Yervoy (ipilimumab) October 2015 for the treatment of patients with unresectable or metastatic melanoma and for the treatment of patients with metastatic nonsquamous, non-small-cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemotherapy brentuximab vedotin Adcetris Seattle Genetics To treat patients at high risk of relapse immediately August 2015 after an autologous hematopoietic stem cell transplant (HSCT) to help prevent progression of the disease carfilzomib Kyprolis Onyx/Amgen To be used in combination with lenalidomide and July 2015 dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. ramucirumab Cyramza Eli Lilly For use as a second-line treatment option for April 2015 metastatic colorectal cancer nivolumab Opdivo Bristol-Myers Squibb Advanced non-small cell lung cancer (NSCLC) March 2015 ibrutinib Imbruvica Johnson & Johnson Waldenström's macroglobulinemia February 2015 lenalidomide Revlimid Celgene First-line treatment for multiple myeloma February 2015

7 Drug Insights > Specialty Pipeline Update Page 7 Pipeline Watch Route of Administration Zinbryta Biogen/AbbVie Multiple sclerosis Subcutaneous N/A CSL Behring Hemophilia B Intravenous Generic Name Brand Name Manufacturer Indication(s) daclizumab high-yield process albutrepenonacog alfa [coagulation Factor IX] Anticipated Approval Date* December 2015 December 2015 Recombinant Factor VIII Kovaltry Bayer Hemophilia A Intravenous December 2015 drisapersen Kyndrisa BioMarin Duchenne muscular dystrophy Subcutaneous January 2016 grazoprevir/elbasvir NA Merck Hepatitis C Oral January 2016 (genotypes 1, 4 and 6) ixekizumab N/A Lilly Plaque psoriasis Subcutaneous January 2016 deutetrabenazine N/A Teva Huntington s disease Oral February 2016 eteplirsen N/A Sarepta Therapeutics Duchenne muscular dystrophy Intravenous February 2016 emtricitabine/ N/A Gilead HIV Oral March 2016 tenofovir alafenamide/ rilpivirine reslizumab Cinquil Teva Severe eosinophilic asthma Subcutaneous 1Q2016 / intravenous defibrotide N/A Jazz Pharmaceuticals Hepatic veno-occlusive disease Intravenous March 2016 emtricitabine/ N/A Gilead HIV Oral April 2016 tenofovir alafenamide octreotide Mycapssa Chiasma Acromegaly Oral April 2016 * Anticipated approval dates are predictions made by Prime Therapeutics based on industry information.

8 Drug Insights > Specialty Pipeline Update Page 8 Specialty Watch List Criteria for inclusion on the Watch List include: Drug is submitted to the FDA and is anticipated to have $1 billion or more in annual global sales. Other considerations include the potential to impact a preferred product strategy (medical or pharmacy benefit) or the potential to shift trend from one benefit to the other (medical or pharmacy). Brand (generic)/ Manufacturer Uptravi (selexipag)/ Actelion drisapersen/biomarin eteplirsen/ Sarepta Therapeutics Obeticholic acid Proposed Indication/ Route of Administration Pulmonary arterial hypertension (PAH)/ Oral Duchenne s muscular dystrophy (SC) Duchenne s muscular dystrophy (IV) Primary biliary cirrhosis (PBC); off-label use for non-alcoholic steatohepatitis (NASH) Anticipated Approval (PDUFA date) Approved 12/22/2015 Similar Products (by indication) Orenitram PDE-5 inhibitors and ERAs Spend* Net new impact to PMPM* Pharmacy benefit Net new impact to PMPM* Medical benefit $ $$ $ $$ None January 2016 None $ $$ $ $$ None 2/26/2016 None $ 5/29/2016 ursodiol $ $$ (PBC); $$$$ (NASH) $ $$ (PBC); $$$$ (NASH) None * Notations: $ < $0.08 per member per month (PMPM), $$ = $0.08 $0.39 PMPM, $$$ = $0.40 $0.79 PMPM, $$$$ > $0.80 PMPM References B1 Prime Therapeutics LLC 12/15