What s New Medical Pharmaceutical Plicy September Updates 2017 MBP 154.0 Radicava (edaravne)- New Plicy CRITERIA FOR USE: Requires Prir Authrizatin by Medical Directr r Designee Radicava (edaravne) will be cnsidered medically necessary when ALL f the fllwing criteria are met: Prescriptin written by r in cnsultatin with a neurlgist AND Medical recrd dcumentatin f a diagnsis f ALS (amytrphic lateral sclersis) AND Medical recrd dcumentatin f baseline functinal status (as evidenced by a scring system such as ALSFRS-R, r by physician dcumentatin f subjective reprts n speech, mtr functin, pulmnary functin, etc.) AND Medical recrd dcumentatin that Radicava is being given in cmbinatin with riluzle OR intlerance r cntraindicatin t riluzle AUTHORIZATION DURATION: Initial apprval will be fr 12 mnths r less if the reviewing prvider feels it is medically apprpriate. Subsequent apprvals will be fr an additinal 12 mnths r less if the reviewing prvider feels it is medically apprpriate and will require the fllwing criteria. Medical recrd dcumentatin that member is tlerating and cmpliant with prescribed edaravne regimen AND Medical recrd dcumentatin f regular physician fllw-up Quantity Limit: Initial Cycle: 2800mL per 28 days (28 [30mg/100mL] bags per 28 days) Subsequent Cycles: 2000mL per 28 days (20 [30mg/100mL] bags per 28 days) MBP 155.0 Ocrevus (crelizumab)- New Plicy CRITERIA FOR USE: Requires Prir Authrizatin by Medical Directr r Designee Ocrevus (crelizumab) will be cnsidered medically necessary when ALL f the fllwing criteria are met: Medical recrd dcumentatin f age > 18 years AND Medical recrd dcumentatin Ocrevus is prescribed by a neurlgist AND Medical recrd dcumentatin f a diagnsis f primary prgressive MS (PPMS) OR Medical recrd dcumentatin f a diagnsis f a relapsing frm f multiple sclersis AND Fr members with a diagnsis f a relapsing frm f multiple sclersis, medical recrd dcumentatin f therapeutic failure n, intlerance t, r cntraindicatin t three frmulary alternatives. AUTHORIZATION DURATION: Initial apprval will be fr 12 mnths r less if the reviewing prvider feels it is medically apprpriate. Subsequent apprvals will be fr an additinal 12 mnths r less if the reviewing prvider feels it is medically apprpriate and will require medical recrd dcumentatin f cntinued disease imprvement r lack f disease prgressin. The medicatin will n lnger be cvered if patient experiences txicity r wrsening f disease. Quantity Limit: Initial authrizatin: 12 mnth duratin with quantity limit f 3 dses Re-authrizatin: 12 mnth duratin with quantity limit f 2 dses 1
MBP 156.0 Imfinzi (durvalumab)- New Plicy CRITERIA FOR USE: Requires Prir Authrizatin by Medical Directr r Designee Imfinzi (durvalumab) will be cnsidered medically necessary when ALL f the fllwing criteria are met: 1. Urthelial Carcinma Medical recrd dcumentatin that patient is 18 years f age AND Medical recrd dcumentatin f a diagnsis f lcally advanced r metastatic urthelial carcinma AND ne f the fllwing: Disease prgressin during r fllwing platinum-cntaining chemtherapy OR Disease prgressin within 12 mnths f neadjuvant r adjuvant treatment with platinum-cntaining chemtherapy AUTHORIZATION DURATION: Initial apprval will be fr 6 mnths r less if the reviewing prvider feels it is medically apprpriate. Subsequent apprvals will be fr an additinal 12 mnths r less if the reviewing prvider feels it is medically apprpriate and will require medical recrd dcumentatin f cntinued disease imprvement r lack f disease prgressin. The medicatin will n lnger be cvered if patient experiences txicity r wrsening f disease. MBP 57.0 Tysabri (natalizumab)- Criteria Updated Tysabri (natalizumab) will be cnsidered medically necessary when all f the fllwing criteria are met: 1. Relapsing Multiple Sclersis Tysabri is cnsidered medically necessary fr the treatment f relapsing frms f multiple sclersis relapsing multiple sclersis when the fllwing criteria are met: Medical recrd dcumentatin f member being established n and respnding t Tysabri fr at least 60 days prir t their effective date with the plan OR Medical recrd dcumentatin f a diagnsis f a relapsing frm f multiple sclersis relapsing/remitting multiple AND Medical recrd dcumentatin that the patient 18 years r lder AND Medical recrd dcumentatin that Tysabri is being prescribed by a neurlgist AND Patient is enrlled in a risk-minimizatin prgram, called the TOUCH Prescribing Prgram, AND Physician dcumentatin that Tysabri is being used as mntherapy is prvided. AND Medical recrd dcumentatin that the member has been tested fr anti-jcv antibdy prir t start f Tysabri therapy. If patient is anti-jcv antibdy psitive, medical recrd dcumentatin that benefits f drug utweigh the risks f prgressive multifcal leukencephalpathy (PML) and patient is aware f increased PML risk AND Medical recrd dcumentatin f therapeutic failure n, cntraindicatin t, r intlerance t tw frmulary alternatives. NOTE: Accrding t the American Academy f Neurlgy recmmendatin, Tysabri may be cnsidered as a first line therapy in individuals with relapsing remitting multiple sclersis wh exhibit particularly aggressive initial curse f disease and in whm the ptential benefit is felt t utweigh the risk. Patients with a pr prgnsis/aggressive disease include thse with a heavy T2 lesin lad, lesins in brain stem, cerebellum, and spinal crd. 2
LIMITATIONS: Cannt be used in cmbinatin with immunsuppressants (i.e. 6-mercaptpurine, azathiprine, cyclsprine, methtrexate) r inhibitrs f TNF-alpha AUTHORIZATION DURATION: Initial authrizatin and reauthrizatins fr MS will be fr a perid f ne (1) year. Fr re-authrizatin, medical recrd dcumentatin f patient adherence t medicatin and imprvement in signs and symptms f multiple sclersis while n Tysabri therapy will be required. Fr patients wh were previusly anti-jcv antibdy negative, medical recrd dcumentatin that physician has re-tested fr anti-jcv antibdy status within the last 12 mnths. Fr patients wh were anti-jcv antibdy psitive at baseline r n re-test, medical recrd dcumentatin that benefits f cntinuing drug utweigh risks. MBP 62.0 Remdulin IV (treprstinil sdium)- Criteria Updated Remdulin IV (treprstinil sdium) will be cnsidered medically necessary when all f the fllwing criteria are met: Must be prescribed by a pulmnlgist r cardilgist; and Physician prvided dcumentatin f a diagnsis f class 4 pulmnary arterial hypertensin; r Physician prvided dcumentatin f a diagnsis f class 2 r 3 pulmnary arterial hypertensin with therapeutic failure n, intlerance t r cntraindicatin t Revati and Ventavis; r Individuals wh require transitin frm Fllan, t reduce the rate f clinical deteriratin. The risks and benefits f each drug shuld be carefully cnsidered prir t transitin MBP 82.0 Jevtana (cabazitaxel)- Criteria Updated Jevtana (cabazitaxel) will be cnsidered medically necessary when all f the fllwing criteria are met: 1. Metastatic Hrmne- Resistant Prstate Cancer Physician prvided dcumentatin f a diagnsis f metastatic hrmne-refractry prstate cancer; and Physician prvided dcumentatin f abdminal, chest r pelvic MRI r CT scan t rule ut neurendcrine invlvement: and Is given in cmbinatin with ral prednisne 10mg daily thrughut treatment with Jevtana; and Physician prvided dcumentatin f neutrphil cunt greater than 1500 cells/mm 3 ; and Physician prvided dcumentatin f therapeutic failure n, intlerance t, r cntraindicatin t a dcetaxel-based regimen 3
MBP 106.0 Injectable Antipsychtic Medicatins- Criteria Updated Prir authrizatin requirement applies nly t new starts. Insured individuals wh have been n Invega Trinza, Invega Sustenna, Aristada, Abilify Maintena, Zyprexa Relprevv, r Risperdal Cnsta IM Injectin prir t cming n t the Plan will be grandfathered and can cntinue t receive therapy. The fllwing Injectable Antipsychtic Medicatins (n Invega Trinza, Invega Sustenna, Aristada, Abilify Maintena, Zyprexa Relprevv, r Risperdal Cnsta) will be cnsidered medically necessary when the fllwing criteria are met: - Medical recrd dcumentatin that the patient is 18 years f age r lder AND - Medical recrd dcumentatin f a histry f pr adherence t ral medicatins and dcumentatin that educatin t imprve adherence has been attempted AND - Medical recrd dcumentatin f use fr an FDA apprved indicatin. Abilify Maintena Schizphrenia Aristada Schizphrenia Invega Sustenna Schizphrenia r Schizaffective disrders as mntherapy and as an adjunct t md stabilizers r antidepressants Invega Trinza Schizphrenia Risperdal Cnsta Schizphrenia r Biplar I Disrder as mntherapy r as adjunctive therapy t lithium r valprate Zyprexa Relprevv Schizphrenia - In additin: The fllwing criteria shuld apply t Invega Trinza: Medical recrd dcumentatin that the patient has been adequately treated with Invega Sustenna fr at least 4 mnths. GRANDFATHER PROVISION Geisinger Health Plan will grandfather prescriptins fr nn-frmulary medicatins r thse frmulary medicatins requiring prir authrizatin within quantity limits when there is an n-line prescriptin drug claim histry shwing 30 days use f the requested medicatin within the previus 90 days. If there is n n-line claim, the prescribing prvider shuld request a prir authrizatin. Medical recrd dcumentatin shwing the member receiving the requested medicatin fr at least 30 days within the previus 90 days must be prvided. LIMITATIONS: The fllwing quantity limits shuld apply (please enter claims payment nte, when entering authrizatin) - Abilify Maintena One syringe r vial per 28 days - Aristada One syringe per 28 days (441mg/1.6ml, 662mg/2.4ml, 882mg/3.2ml strength), ne syringe per 56 days (1064mg/3.9ml strength) - Invega Sustenna tw syringes per 1 week, then ne syringe per 28 days thereafter Enter claims payment nte as fllws t accunt fr lading dse in the first week: - Rx Cunt f 1 apprved by GPID fr 234 mg, quantity limit 1 - Rx Cunt f 1 apprved by GPID fr 156 mg, quantity limit 1 - Open-ended authrizatin fr quantity limit 1 syringe per mnth, request t be apprved by GPID fr the prescribed strength. - Invega Trinza One syringe per 84 days (3 mnths) - Risperdal Cnsta Tw vials per 28 days - Zyprexa Relprevv Tw vials per 28 days 4
MBP 119.0 Keytruda (pembrlizumab) - Criteria Updated Keytruda (pembrlizumab) will be cnsidered medically necessary when all f the fllwing criteria are met: 1. Unresectable r Metastatic Melanma Medical recrd dcumentatin that patient is 18 years f age AND Medical recrd dcumentatin f a diagnsis f unresectable r metastatic melanma AND Medical recrd dcumentatin that Keytruda is nt being used in cmbinatin with any ther agents fr the treatment f unresectable r metastatic melanma. 2. Metastatic Nn-Small Cell Lung Cancer Medical recrd dcumentatin that patient is 18 years f age AND Medical recrd dcumentatin f a diagnsis f metastatic NSCLC meeting ne f the fllwing situatins: Medical recrd dcumentatin that Keytruda is being given as mntherapy AND Medical recrd dcumentatin that tumrs have high PD-L1 expressin (Tumr Prprtin Scre (TPS) 50% as determined by an FDA-apprved test AND Medical recrd dcumentatin that tumrs d nt have EGFR r ALK genmic tumr aberratins OR Medical recrd dcumentatin that Keytruda is being given as mntherapy AND Medical recrd dcumentatin that tumrs express PD-L1 (TPS) 1% as determined by an FDA-apprved test AND Medical recrd dcumentatin f disease prgressin n r after platinum-cntaining chemtherapy AND Fr patients with EGFR r ALK genmic tumr aberratins: medical recrd dcumentatin f disease prgressin n FDA-apprved therapy fr these aberratins prir t receiving Keytruda. OR Medical recrd dcumentatin f metastatic nnsquamus NSCLC AND Medical recrd dcumentatin that Keytruda will be given in cmbinatin with pemetrexed AND carbplatin 3. Head and Neck Squamus Cell Carcinma Medical recrd dcumentatin that patient is 18 years f age AND Medical recrd dcumentatin f a diagnsis f Head and Neck Squamus Cell Carcinma that is recurrent r metastatic and had disease prgressin n r after platinum-cntaining chemtherapy 4. Classical Hdgkin Lymphma Medical recrd dcumentatin f Classical Hdgkin Lymphma AND One f the fllwing: a. Medical recrd dcumentatin f a diagnsis f refractry Classical Hdgkin Lymphma OR b. Medical recrd dcumentatin f relapse fllwing three (3) r mre prir lines f therapy 5. Micrsatellite Instability-High Cancer 5
Medical recrd dcumentatin f unresectable r metastatic micrsatellite instability-high (MSI-H) r mismatch repair deficient (dmmr) slid tumrs OR clrectal cancer AND Fr slid tumrs: Medical recrd dcumentatin f prgressin fllwing prir treatment(s) AND Medical recrd dcumentatin f n satisfactry alternative treatment ptins Fr clrectal cancer: Medical recrd dcumentatin f prgressin fllwing treatment with flurpyrimidine, xaliplatin, and irintecan 6. Urthelial Carcinma Medical recrd dcumentatin that patient is 18 years f age AND Medical recrd dcumentatin f lcally advanced r metastatic urthelial carcinma AND Medical recrd dcumentatin f ne f the fllwing: Disease prgressin during r fllwing platinum-cntaining chemtherapy OR Disease prgressin within 12 mnths f neadjuvant r adjuvant treatment with platinum-cntaining chemtherapy OR Patient is nt eligible cisplatin-cntaining chemtherapy* *Nte: In clinical trials, patients wh were nt cnsidered cisplatin-eligible had the fllwing characteristics: baseline creatinine clearance f <60 ml/min, ECOG perfrmance status f 2, ECOG 2 and baseline creatinine clearance f <60 ml/min, ther reasns (Class III heart failure, Grade 2 r greater peripheral neurpathy, and Grade 2 r greater hearing lss). AUTHORIZATION DURATION: Initial apprval will be fr 6 mnths r less if the reviewing prvider feels it is medically apprpriate. Subsequent apprvals will be fr an additinal 12 mnths r less if the reviewing prvider feels it is medically apprpriate and will require medical recrd dcumentatin f cntinued disease imprvement r lack f disease prgressin. The medicatin will n lnger be cvered if patient experiences txicity r wrsening f disease. MBP 126.0 Opdiv (nivlumab)- Criteria Updated Opdiv (nivlumab) will be cnsidered medically necessary when all f the fllwing criteria are met: 1. Melanma Medical recrd dcumentatin that patient is > 18 years f age AND Medical recrd dcumentatin f a diagnsis f unresectable r metastatic melanma AND Medical recrd dcumentatin that Opdiv is nt being used in cmbinatin with any ther agents fr the treatment f unresectable r metastatic melanma (with the exceptin f ipilimumab). 2. Nn-Small Cell Lung Cancer (NSCLC) Medical recrd dcumentatin that patient is > 18 years f age AND Medical recrd dcumentatin f a diagnsis f metastatic nn-small cell lung cancer (NSCLC) with disease prgressin while n r after platinum-based chemtherapy AND Medical recrd dcumentatin that Opdiv is nt being used in cmbinatin with any ther agents fr the treatment f metastatic nn-small cell lung cancer (NSCLC) 3. Renal Cell Carcinma Medical recrd dcumentatin f use as a single agent fr relapse r fr surgically unresectable advanced r metastatic renal cell carcinma AND 6
Medical recrd dcumentatin f a therapeutic failure n r intlerance t prir anti-angigenic therapy, including, but nt limited t, Sutent (sunitinib), Vtrient (pazpanib), Inlyta (axitinib), Nexavar (srafenib), Avastin (bevacizumab), Afinitr (everlimus), r Trisel (temsirlimus). 4. Classical Hdgkin Lymphma (CHL) Medical recrd dcumentatin that patient is > 18 years f age AND Medical recrd dcumentatin f a diagnsis f classical Hdgkin lymphma (CHL) that has relapsed r prgressed after: Autlgus hematpietic stem cell transplantatin and pst-transplantatin brentuximab vedtin (Adcetris). OR Three (3) r mre lines f systemic therapy that includes autlgus HSCT 5. Squamus Cell Carcinma f the Head and Neck (SCCHN) Medical recrd dcumentatin that patient is 18 years f age AND Medical recrd dcumentatin f a diagnsis f recurrent r metastatic squamus cell carcinma f the head and neck AND Medical recrd dcumentatin f disease prgressin while n r after receiving a platinumbased therapy 6. Urthelial Carcinma Medical recrd dcumentatin that patient > 18 years f age AND Medical recrd dcumentatin f a diagnsis f lcally advanced r metastatic urthelial carcinma AND ne f the fllwing: Disease prgressin during r fllwing platinum-cntaining chemtherapy OR Disease prgressin within 12 mnths f neadjuvant r adjuvant treatment with platinum-cntaining chemtherapy AND Medical recrd dcumentatin that Opdiv is NOT being used in cmbinatin with any ther agent AUTHORIZATION DURATION: Initial apprval will be fr 6 mnths r less if the reviewing prvider feels it is medically apprpriate. Subsequent apprvals will be fr an additinal 6 12 mnths r less if the reviewing prvider feels it is medically apprpriate and will require medical recrd dcumentatin f cntinued disease imprvement r lack f disease prgressin. The medicatin will n lnger be cvered if patient experiences txicity r wrsening f disease. The fllwing plicies were reviewed with n changes: MBP 2.0 Synagis (palivizumab) MBP 15.0 Zevalin (Ibritummab) MBP 36.0 Abraxane (paclitaxel prtein bund particles) MBP 40.0 Orencia IV (abatacept) MBP 48.0 Rituxan (rituximab) MBP 53.0 Eraxis (anidulafungin) MBP 68.0 Nplate (rmiplstim) MBP 74.0 Cimzia (certlizumab pegl) 7
MBP 76.0 Actemra IV (tcilizumab) MBP 112.0 Simpni Aria (glimumab) MBP 125.0 Lemtrada (alemtuzumab) MBP 134.0 Cresemba IV (isavucnaznium sulfate) MBP 135.0 Unituxin (dinutuximab) MBP 145.0 Cinqair (reslizumab) 8