CENTENE PHARMACY & THERAPEUTICS COMMITTEE THIRD QUARTER 2017 NEW DRUG ARRIVALS SUMMARY TABLE

RT Drug Name Review FDA-Approved Utilization Management Product Comparison P & T Formulary 1,2, Reason Indication(s) Recommendation Decision Pending 3,5 Strategy Development Committee Review 1 Brigatinib New Drug Alunbrig is indicated There is significant CPAC score: 58 vs. Approval of the (Alunbrig™) for the treatment of potential for inappropriate Zykadia (ceritinib) – Utilization patients with use, and utilization Equal therapeutic Management anaplastic management in the form outcomes anticipated. recommendation and lymphoma kinase of a prior authorization is prior authorization (ALK)-positive recommended. CPAC score: 57 vs policy. The final metastatic non-small Alecensa (alectinib) – formulary placement is cell lung cancer who Equal therapeutic determined by SDC have progressed on outcomes anticipated. after the product has or are intolerant to launched. crizotinib. 1 Deutetrabenazine New Drug Austedo is indicated There is significant CPAC score: 58 vs. Approval of the (Austedo™) for the treatment of potential for inappropriate Xenazine – Equal Utilization chorea associated use, and utilization therapeutic outcomes Management with Huntington’s management in the form anticipated. recommendation and disease. of a prior authorization is prior authorization

recommended. policy. The final formulary placement is determined by SDC after the product has launched. 1 Cerliponase alfa New Drug Brineura is indicated There is significant Brineura was not Approval of the (Brineura™) to slow the loss of potential for inappropriate scored because it is the Utilization ambulation in use, and utilization only FDA-approved Management symptomatic management in the form therapeutic option to recommendation and pediatric patients 3 of a prior authorization is slow the loss of prior authorization years of age and recommended. ambulation in policy. The final older with late formulary placement is

CENTENE PHARMACY & THERAPEUTICS COMMITTEE THIRD QUARTER 2017 NEW DRUG ARRIVALS SUMMARY TABLE

infantile neuronal symptomatic pediatric determined by SDC ceroid lipofuscinosis patients with CLN2. after the product has type 2 (CLN2), also launched. known as tripeptidyl peptidase 1 (TPP1) deficiency. 1 Dupilumab New Drug Dupixent is There is significant CPAC score: 59 vs. Approval of the (Dupixent®) indicated for the potential for inappropriate systemic cyclosporine Utilization treatment of adult use, and utilization (off-label) – Equal Management patients with management in the form therapeutic outcomes recommendation and moderate-to-severe of a prior authorization is anticipated. prior authorization atopic dermatitis recommended. policy. The final

whose disease is not formulary placement is adequately determined by SDC controlled with after the product has topical prescription launched. therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids. 1 Valbenazine New Drug Ingrezza is indicated There is significant CPAC score: 59 vs. Approval of the (Ingrezza™) for the treatment of potential for inappropriate Austedo – Equal Utilization adults with tardive use, and utilization therapeutic outcomes Management dyskinesia. management in the form anticipated. recommendation and of a prior authorization is prior authorization

recommended. policy. The final formulary placement is determined by SDC

CENTENE PHARMACY & THERAPEUTICS COMMITTEE THIRD QUARTER 2017 NEW DRUG ARRIVALS SUMMARY TABLE

after the product has launched. 1 Ribociclib New Drug Kisqali is indicated There is not significant CPAC score: 44 vs. Approval of the (Kisqali®) in combination with potential for inappropriate Ibrance – May be used Utilization an aromatase use. under unique Management inhibitor as initial circumstances. recommendation and endocrine-based prior authorization therapy for the policy. The final treatment of formulary placement is postmenopausal determined by SDC women with after the product has hormone receptor launched. (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative advanced or metastatic breast cancer. 1 Ocrelizumab New Drug Ocrevus is indicated There is not significant Relapsing-remitting Approval of the (Ocrevus™) for the treatment of potential for inappropriate MS (RRMS): Utilization patients with use. Management CPAC score: 69 vs. relapsing or primary recommendation and Rebif – Modest progressive forms of prior authorization benefits over current multiple sclerosis policy. The final therapies. (MS). formulary placement is CPAC score: 47 vs. determined by SDC Tecfidera – Equal after the product has therapeutic outcomes launched. anticipated.

CENTENE PHARMACY & THERAPEUTICS COMMITTEE THIRD QUARTER 2017 NEW DRUG ARRIVALS SUMMARY TABLE

Primary-progressive MS (PPMS): Ocrevus was not scored for PPMS because it is the only FDA-approved therapeutic option. 1 House dust mite New Drug Odactra is indicated There is significant CPAC score: 57 vs. Approval of the (Dermatophagoides as immunotherapy potential for inappropriate subcutaneous Utilization farinae and for house dust mite- use, and utilization immunotherapy (SCIT) Management Dermatophagoides induced allergic management in the form (allergen extract of recommendation and pteronyssinus) rhinitis, with or of a prior authorization is Standardized Mite prior authorization allergen extract without recommended. Dermatophagoides policy. The final (Odactra™) conjunctivitis, farinae and formulary placement is confirmed by in Dermatophagoides determined by SDC vitro testing for IgE pteronyssinus) – Equal after the product has antibodies to therapeutic outcomes launched. Dermatophagoides anticipated. farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts in adults 18 years through 65 years of age. 1 Edaravone New Drug Radicava is There is significant Not applicable. Approval of the (Radicava™) indicated for the potential for inappropriate Utilization treatment of use, and utilization Management

CENTENE PHARMACY & THERAPEUTICS COMMITTEE THIRD QUARTER 2017 NEW DRUG ARRIVALS SUMMARY TABLE

amyotrophic lateral management in the form recommendation and sclerosis (ALS). of a prior authorization is prior authorization recommended. policy. The final formulary placement is determined by SDC after the product has launched. 1 Midostaurin New Drug Rydapt is indicated There is significant AML: Approval of the ® (Rydapt ) for the treatment of potential for inappropriate Rydapt was not Utilization newly diagnosed use, and utilization scored as it is the Management acute myeloid management in the form only available recommendation and leukemia (AML) of a prior authorization is therapy for FLT3 prior authorization recommended. policy. The final that is FLT3 mutation positive formulary placement is mutation positive as disease. detected by an FDA- determined by SDC approved test, in ASM: after the product has combination with CPAC score: 69 vs. launched. standard cytarabine Gleevec – Modest and daunorubicin benefits over current induction and therapies. cytarabine consolidation; and treatment of aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM- AHN), or mast cell leukemia (MCL).

CENTENE PHARMACY & THERAPEUTICS COMMITTEE THIRD QUARTER 2017 NEW DRUG ARRIVALS SUMMARY TABLE

1 Naldemedine New Drug Symproic is There is significant CPAC score: 57 vs. Approval of the (Symproic®) indicated for the potential for inappropriate Movantik – Equal Utilization treatment of opioid- use, and utilization therapeutic outcomes Management induced constipation management in the form anticipated. recommendation and in adult patients with of a prior authorization is prior authorization chronic non-cancer recommended. policy. The final pain. formulary placement is determined by SDC after the product has launched. 1 Abaloparatide New Drug Tymlos is indicated There is significant CPAC score: 52 vs. Approval of the (Tymlos®) for the treatment of potential for inappropriate Forteo – Equal Utilization postmenopausal use, and utilization therapeutic outcomes Management women with management in the form anticipated. recommendation and osteoporosis at high of a prior authorization is prior authorization risk for fracture recommended. policy. The final defined as history of formulary placement is osteoporotic determined by SDC fracture, multiple after the product has risk factors for launched. fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. 1 New Drug Xadago is indicated There is significant CPAC score: 56 vs. Approval of the (Xadago®) as adjunctive potential for inappropriate Comtan – Equal Utilization treatment to use, and utilization therapeutic outcomes Management levodopa/ management in the form anticipated. recommendation and in patients with of a prior authorization is prior authorization recommended. policy. The final

CENTENE PHARMACY & THERAPEUTICS COMMITTEE THIRD QUARTER 2017 NEW DRUG ARRIVALS SUMMARY TABLE

Parkinson’s disease CPAC score: 56 vs. formulary placement is experiencing “off” Azilect – Equal determined by SDC episodes. therapeutic outcomes after the product has anticipated. launched. 1 Telotristat ethyl New Drug Xermelo is indicated There is significant Xermelo was not Approval of the (Xermelo™) for the treatment of potential for inappropriate scored because it is the Utilization use, and utilization only FDA-approved Management diarrhea in management in the form second-line therapeutic recommendation and combination with of a prior authorization is option for carcinoid prior authorization analog recommended. syndrome diarrhea. policy. The final (SSA) therapy in formulary placement is

adults inadequately determined by SDC controlled by SSA after the product has therapy. launched. 1 Niraparib New Drug Zejula is indicated There is significant CPAC score: 68 vs. Approval of the (Zejula™) for the maintenance potential for inappropriate Rubraca – Modest Utilization treatment of adult use, and utilization benefits over current Management patients with management in the form therapies. recommendation and recurrent epithelial of a prior authorization is prior authorization ovarian, fallopian recommended. policy. The final tube, or primary formulary placement is peritoneal cancer determined by SDC who are in a after the product has complete or partial launched. response to platinum-based chemotherapy.

CENTENE PHARMACY & THERAPEUTICS COMMITTEE THIRD QUARTER 2017 NEW DRUG ARRIVALS SUMMARY TABLE

2 Ledipasvir- New Harvoni is indicated There is significant Not applicable. Approval of the sofosbuvir Indication for the treatment of potential for inappropriate Utilization (Harvoni®) pediatric patients 12 use, and utilization Management years of age and management in the form recommendation and older or weighing at of a prior authorization is prior authorization least 35 kg with recommended. policy. The final genotype 1, 4, 5, or formulary placement is 6 without cirrhosis determined by SDC or with compensated after the product has cirrhosis. launched. 2 Palbociclib New “Letrozole as initial There is not significant Not applicable. Approval of the (Ibrance®) Indication endocrine-based potential for inappropriate Utilization therapy in use. Management postmenopausal recommendation and women” was revised prior authorization to “An aromatase policy. The final inhibitor as initial formulary placement is endocrine-based determined by SDC therapy in after the product has postmenopausal launched. women.” 2 Ranibizumab New Lucentis is There is significant Not applicable. Approval of the (Lucentis®) Indication indicated for the potential for Utilization treatment of patients inappropriate use, and Management with diabetic utilization management recommendation and retinopathy. in the form of a prior prior authorization authorization is policy. The final recommended. formulary placement is determined by SDC after the product has launched.

CENTENE PHARMACY & THERAPEUTICS COMMITTEE THIRD QUARTER 2017 NEW DRUG ARRIVALS SUMMARY TABLE

2 Desmopressin New Noctiva is indicated There is significant It would not be Approval of the acetate nasal spray Indication for the treatment of potential for clinically appropriate to Utilization (Noctiva™) nocturia due to inappropriate use, and require a trial of any Management nocturnal polyuria in utilization management other desmopressin recommendation and adults who awaken in the form of a prior formulation prior to prior authorization at least 2 times per authorization is Noctiva. policy. The final night to void. recommended. formulary placement is It would not be determined by SDC clinically appropriate to after the product has require a trial of launched. Noctiva prior to any other desmopressin formulation as the strengths of these products differ. 2 Infliximab-abda New Renflexis is There is not significant Equal therapeutic Approval of the (Renflexis™) Indication indicated for all of potential for inappropriate outcomes are Utilization (New the same uses as use relative to Remicade. anticipated for Management Biosimilar) Remicade except for Renflexis and recommendation and pediatric ulcerative Remicade; therefore it prior authorization colitis. would be appropriate to policy. The final provide equal access to formulary placement is both or to require a trial determined by SDC of one before the other. after the product has launched. 2 Lenalidomide New Revlimid is There is significant It would not be Approval of the (Revlimid®) Indication indicated for the potential for inappropriate clinically appropriate to Utilization treatment of patients use, and utilization require a trial of Management with multiple management in the form Velcade (NCCN recommendation and myeloma as of a prior authorization is category 2A prior authorization maintenance recommended. recommendation) prior policy. The final following to initiation of formulary placement is

CENTENE PHARMACY & THERAPEUTICS COMMITTEE THIRD QUARTER 2017 NEW DRUG ARRIVALS SUMMARY TABLE

autologous Revlimid (NCCN determined by SDC hematopoietic stem category 1 after the product has cell transplantation recommendation) for launched. (auto-HSCT). maintenance therapy following auto-HSCT. 2 Sofosbuvir New Sovaldi is indicated There is significant Not applicable. Approval of the (Sovaldi®) Indication for the treatment of potential for inappropriate Utilization chronic hepatitis C use, and utilization Management virus (HCV) in management in the form recommendation and pediatric patients 12 of a prior authorization is prior authorization years of age and recommended. policy. The final older or weighing at formulary placement is least 35 kg with determined by SDC genotype 2 or 3 after the product has chronic HCV launched. infection without cirrhosis or with compensated cirrhosis in combination with ribavirin. 2 Regorafenib New Stivarga is indicated There is significant Not applicable. It is the Approval of the (Stivarga®) Indication for the treatment of potential for inappropriate only available second Utilization patients with use, and utilization line therapy for HCC. Management hepatocellular management in the form recommendation and carcinoma (HCC) of a prior authorization is prior authorization who have been recommended. policy. The final previously treated formulary placement is with sorafenib. determined by SDC after the product has launched.

CENTENE PHARMACY & THERAPEUTICS COMMITTEE THIRD QUARTER 2017 NEW DRUG ARRIVALS SUMMARY TABLE

2 Ombitasvir- New Technivie is There is significant Based on the AASLD- Approval of the paritaprevir-ritonavir Indication indicated in potential for inappropriate IDSA guidelines, it Utilization (Technivie™) combination with use, and utilization would be clinically Management ribavirin for the management in the form appropriate to provide recommendation and treatment of patients of a prior authorization is equal access to any of prior authorization with genotype 4 recommended. the following four FDA policy. The final chronic hepatitis C labeled drugs or to formulary placement is virus (HCV) prefer any one drug determined by SDC infection with over another: after the product has compensated Technivie, Epclusa, launched. cirrhosis. Zepatier, and Harvoni.

The AASLD-IDSA guidelines recommend against using the FDA labeled drugs Sovaldi and Olysio. 5 Avelumab Intravenous Bavencio is There is significant Not applicable. Approval of the (Bavencio®) Chemo- indicated for the potential for inappropriate Utilization therapy treatment of patients use, and utilization Management with locally management in the form recommendation and advanced or of a prior authorization is prior authorization metastatic urothelial recommended. policy. The final carcinoma who have formulary placement is disease progression determined by SDC during or following after the product has platinum-containing launched. chemotherapy, or who have disease progression within 12 months of neoadjuvant or

CENTENE PHARMACY & THERAPEUTICS COMMITTEE THIRD QUARTER 2017 NEW DRUG ARRIVALS SUMMARY TABLE

adjuvant treatment with platinum- containing chemotherapy. 5 Durvalumab Intravenous Imfinzi is indicated There is significant Not applicable. Approval of the (Imfinzi™) Chemo- for the treatment of potential for inappropriate Utilization therapy patients with locally use, and utilization Management advanced or management in the form recommendation and metastatic urothelial of a prior authorization is prior authorization carcinoma who have recommended. policy. The final disease progression formulary placement is during or following determined by SDC platinum-containing after the product has chemotherapy, or launched. who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum- containing chemotherapy. 5 Pembrolizumab Intravenous Keytruda is There is significant Not applicable. Approval of the (Keytruda®) Chemo- indicated: potential for inappropriate Utilization therapy • In combination use, and utilization Management with pemetrexed and management in the form recommendation and carboplatin for the of a prior authorization is prior authorization first-line treatment recommended. policy. The final of patients with formulary placement is metastatic non- determined by SDC squamous non-small after the product has cell lung cancer; launched.

CENTENE PHARMACY & THERAPEUTICS COMMITTEE THIRD QUARTER 2017 NEW DRUG ARRIVALS SUMMARY TABLE

• For the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum- containing chemotherapy; • For the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior

CENTENE PHARMACY & THERAPEUTICS COMMITTEE THIRD QUARTER 2017 NEW DRUG ARRIVALS SUMMARY TABLE

treatment and who have no satisfactory alternative treatment options, or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 5 Atezolizumab Intravenous Tecentriq is There is not significant It would not be Approval of the (Tecentriq®) Chemo- indicated for the potential for inappropriate clinically appropriate to Utilization therapy treatment of patients use. require a trial of Management with locally platinum-based recommendation and advanced or chemotherapy prior to prior authorization metastatic urothelial initiation of Tecentriq policy. The final carcinoma who are for patients with locally formulary placement is not eligible for advanced or metastatic determined by SDC cisplatin-containing urothelial carcinoma after the product has chemotherapy. who are cisplatin- launched. ineligible. It would be clinically appropriate to require a trial of platinum-based chemotherapy for patients with locally advanced or metastatic urothelial carcinoma who are cisplatin- eligible.

CENTENE PHARMACY & THERAPEUTICS COMMITTEE THIRD QUARTER 2017 NEW DRUG ARRIVALS SUMMARY TABLE

Review Type (RT) Descriptions 1, 2, 3, or 5

Review type 1 (RT1): New Drug Review Full review of new chemical or biologic agents

Review type 2 (RT2): New Indication Review Abbreviated review of new dosage forms of existing agents that are approved for a new indication or use

Review type 3 (RT3): Expedited CMS Protected Class Drug Review Expedited abbreviated review of Centers for Medicare & Medicaid Services protected class drugs (anticonvulsants, antidepressants, antineoplastic, antipsychotics, antiretrovirals, and immunosuppressants)

Review type 5 (RT5): Abbreviated Reviews for Intravenous Chemotherapy Agents Abbreviated review for intravenous chemotherapy agents which are usually covered under the medical benefit

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