o Prostanoids/prostacyclin therapies (oral and inhaled) o Inhaled agents: Ventavis, Tyvaso Page 1 of 5 Revised 02/17/17

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1 Request fr Prir Authrizatin Pulmnary Arterial Hypertensin (PAH) Agents (Oral and Inhaled) Website Frm Submit request via: Fax All requests fr Pulmnary Arterial Hypertensin (PAH) agents (Oral and Inhaled) require prir authrizatin and will be screened fr medical necessity and apprpriateness using the criteria listed belw. Requests fr a nn-preferred agent will require dcumented failure r cntraindicatin f a preferred agent within the same class, unless specified therwise. PAH agents (Oral and Inhaled) Initial Prir Authrizatin Criteria Cverage will be prvided when the diagnsis is Pulmnary Arterial Hypertensin (PAH) WHO Grup I and all f the crrespnding criteria are met in sectins A, B, and C: A. Diagnsis Criteria Treatment is prescribed by, r in cnsultatin with, a cardilgist r pulmnlgist; AND Member has a diagnsis f PAH WHO Grup I (refer belw t Appendix I) cnfirmed by chart dcumentatin f right-heart catheterizatin (RHC) r echcardigraphy if the prvider indicates RHC is nt recmmended; AND Member has functinal class II, III r IV symptms (refer belw t Appendix II); AND Prceed belw t Sectin B. Treatment Criteria B. Treatment Criteria Endthelin receptr-antagnists (ERA): Letairis, Tracleer, Opsumit If the request is fr a nn-preferred ERA, must have dcumentatin f inadequate respnse, cntraindicatin r intlerance t a preferred agent within this class; AND Prceed belw t Sectin C. Planned PAH Treatment Regimen Phsphdiesterase type 5 inhibitrs (PDE-5 inhibitrs): sildenafil, Adcirca, Revati Member is nt cncurrently using nitrates (regularly r intermittently) r a guanylate cyclase stimulatr (e.g. Adempas [riciguat]); AND If the request is fr Revati tablets r Adcirca**, must have dcumentatin f inadequate respnse, cntraindicatin r intlerance t a preferred agent within this class **If Adcirca is requested with Letairis as initial cmbinatin therapy, this requirement des nt apply. OR If the request is fr Revati suspensin, must prvide clinical ratinale fr why member is unable t take a slid dsage frm (e.g. tablet) AND Prceed belw t Sectin C. Planned PAH Treatment Regimen Sluble Guanylate Cyclase Stimulatr: Adempas Member is nt cncurrently using nitrates (regularly r intermittently) r phsphdiesterase inhibitrs; AND Must have dcumentatin f inadequate respnse, cntraindicatin r intlerance t a PDE-5 inhibitr (e.g. sildenafil, Revati, Adcirca) AND Prceed belw t Sectin C. Planned PAH Treatment Regimen Prstanids/prstacyclin therapies (ral and inhaled) Inhaled agents: Ventavis, Tyvas Page 1 f 5

2 Must have dcumentatin f inadequate respnse, cntraindicatin r intlerance t at least ne ral therapy frm ne f the fllwing three therapeutic classes: a PDE-5 inhibitr (e.g. sildenafil, Adcirca r Revati), an ERA (e.g. Letairis, Opsumit, Tracleer), r a guanylate cyclase stimulatr (e.g. Adempas) OR dcumentatin the member has previusly received an infused prstacyclin therapy (e.g. epprstenl, Fllan, Veletri, Remdulin); AND If the request is fr a nn-preferred inhaled agent, must have dcumentatin f inadequate respnse, cntraindicatin r intlerance t a preferred agent within this class; AND Prceed belw t Sectin C. Planned PAH Treatment Regimen Oral agents: Uptravi, Orenitram ER Fr Uptravi: Must have dcumentatin f inadequate respnse, cntraindicatin r intlerance t at least ne ral therapy frm ne f the fllwing three therapeutic classes: a PDE-5 inhibitr (e.g. sildenafil, Adcirca, Revati), an ERA (e.g. Letairis, Opsumit, Tracleer), r a guanylate cyclase stimulatr (e.g. Adempas); AND Member is nt taking Uptravi in cmbinatin with a prstanid/prstacyclin therapy (e.g. epprstenl, ilprst, treprstinil); AND Prceed belw t Sectin C. Planned PAH Treatment Regimen Fr Orenitram ER: Must have dcumentatin f inadequate respnse, cntraindicatin r intlerance t at least ne ral therapy frm ne f the fllwing three therapeutic classes: a PDE-5 inhibitr (e.g. sildenafil, Adcirca, Revati), an ERA (e.g. Letairis, Opsumit, Tracleer), r a guanylate cyclase stimulatr (e.g. Adempas); AND Member is nt taking Orenitram ER in cmbinatin with a prstanid/prstacyclin therapy (e.g. epprstenl, ilprst, treprstinil); AND Prceed belw t Sectin C. Planned PAH Treatment Regimen C. Planned PAH Treatment Regimen The requested drug will be used as mntherapy; OR Letairis and Adcirca are requested as initial cmbinatin therapy; OR If the requested drug will be used fr add-n therapy t existing mntherapy r dual therapy, then bth f the fllwing requirements must be met: i. Medicatins are frm different therapeutic classes; AND ii. Member has unrespnsive r prgressive disease despite established PAH-specific therapies Cverage will be prvided when the diagnsis is Chrnic Thrmbemblic Pulmnary Hypertensin (CTEPH) (WHO Grup 4) and all f the fllwing criteria are met: Fr Adempas: Treatment is prescribed by, r in cnsultatin with, a cardilgist r pulmnlgist; AND Member has a cnfirmed diagnsis f persistent/recurrent CTEPH after surgical treatment (i.e. pulmnary endarterectmy) r inperable CTEPH; AND Member is nt cncurrently using nitrates (regularly r intermittently) r phsphdiesterase inhibitrs If member is new t the plan and requests a cntinuatin f therapy, all f the fllwing criteria must be met: Chart dcumentatin indicates member is currently n requested therapy; AND Dcumentatin frm prescriber substantiates a diagnsis f PAH WHO Grup I r CTEPH (depending n agent requested); AND Treatment is prescribed by, r in cnsultatin with, a cardilgist r pulmnlgist Page 2 f 5

3 The requested dse is within FDA-apprved dsing recmmendatins. If a requested dse is abve these recmmendatins, medical ratinale must be submitted. Initial apprval duratin will be fr 3 mnths. Reauthrizatin Criteria Must prvide dcumentatin that demnstrates member is tlerating and receiving clinical benefit frm treatment Fr Revati Suspensin: must indicate that member remains unable t take a slid dsage frm (e.g. tablet) Reauthrizatin duratin will be fr 12 mnths Cverage may be prvided fr any nn-fda labeled indicatin if it is determined that the use is a medically accepted indicatin supprted by natinally recgnized pharmacy cmpendia r peer-reviewed medical literature fr treatment f the diagnsis(es) fr which it is prescribed. These requests will be reviewed n a case by case basis t determine medical necessity. Appendix 1: Wrld Health Organizatin (WHO) Clinical Classificatin f Pulmnary Hypertensin (PH) Grup 1 Pulmnary Arterial Hypertensin (PAH) Idipathic Heritable Drug/txin-induced Assciated with: Cnnective tissue disease HIV infectin Prtal hypertensin Cngenital heart disease Schistsmiasis Grup 1 Pulmnary ven-cclusive disease (PVOD) and/r pulmnary capillary hemangimatsis (PCH) Grup 1 Persistent pulmnary hypertensin f the newbrn (PPHN) Grup 2 PH due t left heart disease Grup 3 PH due t lung diseases and/r hypxia Grup 4 Chrnic thrmbemblic PH (CTEPH)and ther pulmnary artery bstructins Grup 5 PH with unclear and/r multifactrial mechanisms Appendix 2: Wrld Health Organizatin (WHO) Functinal Classificatin f Members with PH Classificatin Physical Activity Symptms (Dyspnea, fatigue, chest pain, syncpe) Class I N limitatin Nne upn rdinary physical activity Class II Slight limitatin Symptms appear upn rdinary physical activity Class III Marked limitatin Symptms appear upn less than rdinary activity Class IV Severe limitatin Symptms appear upn any physical activity r may even be present at rest; signs f right heart failure present References 1.) Taichman DB, Ornelas J, Chung L, et al. Pharmaclgic therapy fr pulmnary arterial hypertensin in adults: CHEST guideline and expert panel reprt. Chest. 2014; 146(2): Available at: Accessed March 29, Page 3 f 5

4 2.) Galie N, Humbert M, Vachiery JL, et al ESC/ERS Guidelines fr the diagnsis and treatment f pulmnary hypertensin. The Jint Task Frce fr the Diagnsis and Treatment f Pulmnary Hypertensin f the Eurpean Sciety f Cardilgy (ESC) and the Eurpean Respiratry Sciety (ERS). Eur Heart J. 2016:37(1): Available at: Accessed March 29, ) Uptravi [package insert]. Suth San Francisc, CA: Actelin Pharmaceuticals US, Inc.; Dec ) Sitbn O, Channick R, Chin KM, et al. Selexipag fr the treatment f pulmnary arterial hypertensin. N Engl J Med. 2015;373(26): ) Letairis [package insert]. Fster City, CA: Gilead Sciences, Inc.; Oct ) Tracleer [package insert]. Suth San Francisc, CA: Actelin Pharmaceuticals US, Inc.; Dec ) Opsumit [package insert]. Suth San Francisc, CA: Actelin Pharmaceuticals US, Inc.; Feb ) Revati [package insert]. New Yrk, NY: Pfizer Labs; May ) Adcirca [package insert]. Indianaplis, IN: Eli Lilly and Cmpany; Apr ) Ventavis [package insert]. Actelin Pharmaceuticals US, Inc.; Nv ) Tyvas [package insert]. Research Triangle Park, NC: United Therapeutics Crp.; Aug ) Orenitram ER [package insert]. Research Triangle Park, NC: United Therapeutics Crp.; Jan ) Sildenafil citrate. In: Micrmedex Slutins. US, Canada, UK: Truven Health Analytics Inc. Accessed 4/6/16. Page 4 f 5

5 Pulmnary Arterial Hypertensin (PAH) Agents (Oral and Inhaled) PRIOR AUTHORIZATION FORM Please cmplete and fax all requested infrmatin belw including any prgress ntes, labratry test results, r chart dcumentatin as applicable t Health Optins Pharmacy Services. FAX: If needed, yu may call t speak t a Pharmacy Services Representative. PHONE: Requesting Physician: Physician Specialty: Office Address: Patient Name: Health Optins ID: PROVIDER INFORMATION NPI: Office Cntact: Office Phne: Office Fax: MEMBER INFORMATION DOB: DRUG INFORMATION Medicatin: Strength: Frequency: Duratin: Is the member currently receiving requested medicatin? Yes N Date Medicatin Initiated: MEDICAL HISTORY Diagnsis: Has chart dcumentatin f right-heart catheterizatin r echcardigraphy been prvided cnfirming the diagnsis f pulmnary arterial hypertensin? Yes N Please select the Wrld Health Organizatin (WHO) Classificatin f Pulmnary Hypertensin: Grup 1 Grup 2 Grup 3 Grup 4 Grup 5 Please indicate WHO functinal class symptms: Class I Class II Class III Class IV Is the member currently taking a nitrate prduct? Yes N Will the requested medicatin be used as mntherapy r cmbinatin therapy? If cmbinatin therapy, please list ther drug(s): Mntherapy Cmbinatin Drug Name Strength & Frequency Ratinale fr additinal therapy If the request is fr Adempas (riciguat) fr a diagnsis f Chrnic Thrmbemblic Pulmnary Hypertensin (CTEPH) (WHO Grup 4), please answer the fllwing questins: Has the member previusly failed surgical treatment (such as pulmnary endarterectmy)? Yes N Des the member have inperable CTEPH? Yes N PREVIOUS THERAPY Status (Discntinued & Drug Name Strength/Frequency Dates f Therapy Why r Current) REAUTHORIZATION Has the member tlerated and received clinical benefit frm treatment? Yes N Please explain: ADDITIONAL SUPPORTING INFORMATION r CLINICAL RATIONALE Prescribing Physician Signature Date Page 5 f 5