Injectable Agents for the Treatment of Pulmonary Arterial Hypertension (PAH)
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1 Texas Prior Authorization Program Clinical Edit Criteria Drug/Drug Class Injectable Agents for the Treatment of Pulmonary Arterial Hypertension (PAH) Clinical Edit Information Included in this Document Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical edit Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical edit criteria rules Logic diagram: a visual depiction of the clinical edit criteria logic Supporting tables: a collection of information associated with the steps within the criteria (diagnosis codes, procedure codes, and therapy codes) References: clinical publications and sources relevant to this clinical edit Note: Click the hyperlink to navigate directly to that section. Revision Notes Added GCNs for riociguat and macitentan to clinical edit supporting tables, step 3. November 24, 2014 Copyright 2014 Health Information Designs, LLC 1
2 Injectable Agents for the Treatment of PAH Drugs Requiring Prior Authorization Label Name GCN FLOLAN 0.5MG VIAL FLOLAN 1.5MG VIAL REMODULIN 10MG/ML VIAL REMODULIN 1MG/ML VIAL REMODULIN 2.5MG/ML VIAL REMODULIN 5MG/ML VIAL VELETRI 0.5MG VIAL VELETRI 1.5MG VIAL November 24, 2014 Copyright 2014 Health Information Designs, LLC 2
3 Injectable Agents for the Treatment of PAH Clinical Edit Criteria Logic 1. Does the client have a diagnosis of pulmonary arterial hypertension in the last 730 days? [] Yes Go to #2 [] No Deny 2. Has the diagnosis been confirmed by or does the client have a contraindication to right heart catheterization? [manual] [] Yes Go to #3 [] No Deny 3. Has the client tried other available PAH therapies in the last 180 days? [] Yes Approve (365 days) [] No Go to #4 4. Does the client have a contraindication to other available PAH therapies? [manual] [] Yes Approve (365 days) [] No - Deny November 24, 2014 Copyright 2014 Health Information Designs, LLC 3
4 Injectable Agents for the Treatment of PAH Clinical Edit Criteria Logic Diagram (See Diagram Next Page) November 24, 2014 Copyright 2014 Health Information Designs, LLC 4
![[manual] No Deny Request Yes Step 3 Has the client tried other available PAH therapies in the last 180 days?](/docs-images/80/82334932/images/5-1.jpg "Yes Approve Request (365 days) No Step 4 Does the client have a contraindication to other available PAH therapies?")
5 Step 1 Does the client have a diagnosis of pulmonary arterial hypertension in the last 730 days? No Deny Request Yes Step 2 Has the diagnosis been confirmed by or does the client have a contraindication to right heart catheterization? [manual] No Deny Request Yes Step 3 Has the client tried other available PAH therapies in the last 180 days? Yes Approve Request (365 days) No Step 4 Does the client have a contraindication to other available PAH therapies? [manual] No Deny Request Yes Approve Request (365 days) November 24, 2014 Copyright 2014 Health Information Designs, LLC 5
6 Injectable Agents for the Treatment of PAH Clinical Edit Criteria Supporting Tables Step 1 (diagnosis of Pulmonary Hypertension) Required quantity: 1 Look back timeframe: 730 days ICD-9 Code Description PRIMARY PULMONARY HYPERTENSION ICD-10 Code Description I27.0 PRIMARY PULMONARY HYPERTENSION Step 3 (alternate therapy) Required quantity: 1 Look back timeframe: 180 days GCN Description DILTIAZEM 90MG CAPSULE SA DILTIAZEM 120MG CAPSULE SA DILTIAZEM 60MG CAPSULE SA DILTIAZEM CD 180MG CAPSULE DILTIAZEM CD 240MG CAPSULE DILTIAZEM CD 300MG CAPSULE DILTIAZEM CD 120MG CAPSULE DILTIAZEM 360MG CAPSULE SA DILTIAZEM ER 180MG CAPSULE DILTIAZEM ER 120MG CAPSULE DILTIAZEM ER 240MG CAPSULE DILTIAZEM 300MG CAPSULE SA DILTIAZEM 30MG TABLET DILTIAZEM 60MG TABLET DILTIAZEM 90MG TABLET DILTIAZEM 120MG CAPLET DILTIAZEM CD 360MG CAPSULE DILTIAZEM ER 180MG CAPSULE DILTIAZEM ER 240MG CAPSULE November 24, 2014 Copyright 2014 Health Information Designs, LLC 6
7 Step 3 (alternate therapy) Required quantity: 1 Look back timeframe: 180 days GCN Description DILTIAZEM ER 120MG CAPSULE DILTIAZEM ER 180MG TABLET DILTIAZEM ER 240MG TABLET DILTIAZEM ER 300MG TABLET DILTIAZEM ER 360MG TABLET DILTIAZEM ER 420MG TABLET DILTIAZEM ER 420MG CAPSULE CARDIZEM LA 120MG TABLET NICARDIPINE 20MG CAPSULE NICARDIPINE 30MG CAPSULE CARDENE SR 30MG CAPSULE CARDENE SR 45MG CAPSULE CARDENE SR 60MG CAPSULE VERAPAMIL 120MG CAPSULE PELLET VERAPAMIL 120MG TABLET VERAPAMIL 120MG TABLET SA VERAPAMIL 180MG CAPSULE PELLET VERAPAMIL 180MG TABLET SA VERAPAMIL 240MG CAPSULE PELLET VERAPAMIL 240MG TABLET SA VERAPAMIL 360MG CAPSULE PELLET VERAPAMIL 40MG TABLET VERAPAMIL 80MG TABLET VERAPAMIL ER 120MG CAPSULE VERAPAMIL ER PM 100MG CAPSULE VERAPAMIL ER PM 200MG CAPSULE VERAPAMIL ER 300MG CAPSULE COVERA-HS 180MG TABLET COVERA-HS 240MG TABLET ISRADIPINE 2.5MG CAPSULE ISRADIPINE 5MG CAPSULE DYNACIRC CR 10MG TABLET DYNACIRC CR 5MG TABLET NIFEDIPINE 10MG CAPSULE NIFEDIPINE 20MG CAPSULE NIFEDIPINE ER 90MG TABLET NIFEDIPINE ER 30MG TABLET November 24, 2014 Copyright 2014 Health Information Designs, LLC 7
8 Step 3 (alternate therapy) Required quantity: 1 Look back timeframe: 180 days GCN Description NIFEDIPINE ER 30MG TABLET NIFEDIPINE ER 60MG TABLET NIFEDIPINE ER 60MG TABLET NIFEDIPINE ER 90MG TABLET NIMODIPINE 30MG CAPSULE NYMALIZE 60MG/20ML SOLUTION NYMALIZE 60MG/20ML SOLUTION AMLODIPINE 10MG TABLET AMLODIPINE 2.5MG TABLET AMLODIPINE 5MG TABLET FELODIPINE ER 10MG TABLET FELODIPINE ER 2.5MG TABLET FELODIPINE ER 5MG TABLET NISOLDIPINE ER 17MG TABLET NISOLDIPINE ER 20MG TABLET NISOLDIPINE ER 25.5MG TABLET NISOLDIPINE ER 30MG TABLET NISOLDIPINE ER 34MG TABET NISOLDIPINE ER 40MG TABLET NISOLDIPINE ER 8.5MG TABLET SULAR 10MG TABLET LETAIRIS 10MG TABLET LETAIRIS 5MG TABLET TRACLEER 125MG TABLET TRACLEER 62.5MG TABLET VENTAVIS 10MCG/1ML SOLUTION VENTAVIS 20MCG/1ML SOLUTION VENTAVIS 20MCG/2ML SOLUTION SILDENAFIL 20MG TABLET ADCIRCA 20MG TABLET ADEMPAS 2.5MG TABLET ADEMPAS 1MG TABLET ADEMPAS 2MG TABLET ADEMPAS 2.5MG TABLET ADEMPAS 0.5MG TABLET ADEMPAS 1.5MG TABLET OPSUMIT 10MG TABLET November 24, 2014 Copyright 2014 Health Information Designs, LLC 8
9 Injectable Agents for the Treatment of PAH Clinical Edit Criteria References 1. Clinical Pharmacology [online database]. Tampa, FL: Elsevier / Gold Standard, Inc Available at Accessed on March 26, ICD-9-CM Diagnosis Codes, Volume Available at Accessed on March 26, ICD-10-CM Diagnosis Codes, Volume Available at Accessed on March 26, Flolan Prescribing Information. GlaxoSmithKline. Research Triangle Park, NC. March Veletri Prescribing Information. Actelion Pharmaceuticals US, Inc. South San Francisco, CA. June Remodulin Prescribing Information. United Therapeutics Corp. Research Triangle Park, NC. October McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 Expert Consensus Document on Pulmonary Hypertension: A Report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association: Developed in Collaboration with the American College of Chest Physicians, American Thoracic Society, Inc., and the Pulmonary Hypertension Association. Circulation. 2009;119: Taichman DB, Ornelas J, Chung L, et al. Pharmacological Therapy for Pulmonary Arterial Hypertension in Adults: CHEST Guideline. Chest. 2014;145(5): Galie N, Hoeper MM, Humbert M, et al. Guidelines for the diagnosis and treatment of pulmonary hypertension. The Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), endorsed by the International Society of Heart and Lung Transplantation (ISHLT). European Heart Journal (2009) 30, November 24, 2014 Copyright 2014 Health Information Designs, LLC 9
10 Publication History The Publication History records the publication iterations and revisions to this document. Notes for the most current revision are also provided in the Revision Notes on the first page of this document. Publication Date Notes 11/24/2014 Added GCNs for riociguat and macitentan to clinical edit supporting tables, step 3. November 24, 2014 Copyright 2014 Health Information Designs, LLC 10
Pulmonary Arterial Hypertension Drug Prior Authorization Protocol
Pulmonary Arterial Hypertension Drug Prior Authorization Protocol Line of Business: Medicaid P&T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed through review
Drug Class Monograph. Policy/Criteria:
Drug Class Monograph Class: Pulmonary Arterial Hypertension Agents Drugs: Adcirca (tadalafil), Adempas (riociguat), Flolan (epoprostenol), Letairis (ambrisentan), Opsumit (macitentan), Orenitram (treprostinil),
Clinical Policy: Treprostinil (Orenitram, Remodulin, Tyvaso) Reference Number: ERX.SPA.36 Effective Date:
Clinical Policy: (Orenitram, Remodulin, Tyvaso) Reference Number: ERX.SPA.36 Effective Date: 07.01.16 Last Review Date: 02.18 Revision Log See Important Reminder at the end of this policy for important
HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES
Generic Brand HICL GCN Exception/Other SELEXIPAG UPTRAVI 42922 TREPROSTINIL ORENITRAM ER 40827 If the caller wishes to initiate a request then a MRF must be completed. This drug requires a written request
Clinical Policy: Treprostinil (Orenitram, Remodulin, Tyvaso) Reference Number: ERX.SPA.36 Effective Date:
Clinical Policy: (Orenitram, Remodulin, Tyvaso) Reference Number: ERX.SPA.36 Effective Date: 07.01.16 Last Review Date: 02.19 Revision Log See Important Reminder at the end of this policy for important
Clinical Policy: Macitentan (Opsumit) Reference Number: ERX.SPMN.88
Clinical Policy: (Opsumit) Reference Number: ERX.SPMN.88 Effective Date: 07/16 Last Review Date: 06/16 Coding Implications Revision Log See Important Reminder at the end of this policy for important regulatory
PULMONARY ARTERIAL HYPERTENSION AGENTS
Approvable Criteria: PULMONARY ARTERIAL HYPERTENSION AGENTS Brand Name Generic Name Length of Authorization Adcirca tadalafil Calendar Year Adempas riociguat Calendar Year Flolan epoprostenol sodium Calendar
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Flolan, Veletri) Reference Number: CP.PHAR.192 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, Medicaid Coding Implications Revision Log See Important Reminder
Amitiza (Lubiprostone)
Texas Prior Authorization Program Clinical Edit Criteria Drug/Drug Class Clinical Edit Information Included in this Document Drugs requiring prior authorization: the list of drugs requiring prior authorization
2017 UnitedHealthcare Services, Inc.
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2020-10 Program Prior Authorization/Medical Necessity PAH Agents Medication Adcirca (tadalafil), Adempas (riociguat), Letairis
Coding Implications Revision Log. See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Ventavis) Reference Number: CP.PHAR.193 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, Health Insurance Marketplace, Medicaid Coding Implications Revision
1. Phosphodiesterase Type 5 Enzyme Inhibitors: Sildenafil (Revatio), Tadalafil (Adcirca)
This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutic
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Orenitram, Remodulin, Tyvaso) Reference Number: CP.PHAR.199 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, Health Insurance Marketplace, Medicaid Coding Implications
Coding Implications Revision Log. See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Orenitram, Remodulin, Tyvaso) Reference Number: CP.PHAR.199 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, HIM*, Medicaid Description (Orenitram, Remodulin,
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Orenitram, Remodulin, Tyvaso) Reference Number: CP.PHAR.199 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, HIM*, Medicaid Coding Implications Revision Log
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Treprostinil (Orenitram, Remodulin, Tyvaso) Reference Number: CP.PHAR.199 Effective Date: 07.01.18 Last Review Date: 01.12.18 Line of Business: Oregon Health Plan Coding Implications Revision
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Letairis) Reference Number: CP.PHAR.190 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Health Insurance Marketplace, Medicaid Revision Log See Important Reminder at the
TREPROSTINIL Generic Brand HICL GCN Exception/Other TREPROSTINIL REMODULIN 23650
Generic Brand HICL GCN Exception/Other TREPROSTINIL REMODULIN 23650 SODIUM TREPROSTINIL TYVASO 36537 36539 36541 TREPROSTINIL ORENITRAM 40827 **Please use the criteria for the specific drug requested**
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Tracleer) Reference Number: CP.PHAR.191 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, HIM, Medicaid Revision Log See Important Reminder at the end of this
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Revatio) Reference Number: CP.PHAR.197 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, Health Insurance Marketplace, Medicaid Revision Log See Important Reminder
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Ambrisentan (Letairis) Reference Number: CP.PHAR.190 Effective Date: 07.01.18 Last Review Date: 01.12.18 Line of Business: Oregon Health Plan Revision Log See Important Reminder at the
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Letairis) Reference Number: CP.PHAR.190 Effective Date: 03.16 Last Review Date: 02.19 Line of Business: Commercial, HIM, Medicaid Revision Log See Important Reminder at the end of this
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Adcirca) Reference Number: CP.PHAR.198 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, Health Insurance Marketplace, Medicaid Revision Log See Important Reminder
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Revatio) Reference Number: CP.PHAR.197 Effective Date: 03.16 Last Review Date: 02.19 Line of Business: Commercial, HIM*, Medicaid Revision Log See Important Reminder at the end of this
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Tracleer) Reference Number: CP.PHAR.191 Effective Date: 03.16 Last Review Date: 02.19 Line of Business: Commercial, HIM, Medicaid Revision Log See Important Reminder at the end of this
See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Opsumit) Reference Number: CP.PHAR.194 Effective Date: 03.16 Last Review Date: 02.18 Line of Business: Commercial, Health Insurance Marketplace, Medicaid Revision Log See Important Reminder
Clinical Policy: Ambrisentan (Letairis) Reference Number: ERX.SPMN.84 Effective Date: 07/16
Clinical Policy: (Letairis) Reference Number: ERX.SPMN.84 Effective Date: 07/16 Last Review Date: 06/16 Revision Log See Important Reminder at the end of this policy for important regulatory and legal
Pharmacy Management Drug Policy
SUBJECT: Pulmonary Arterial Hypertension (PAH) POLICY NUMBER: Pharmacy-42 Clinical criteria used to make utilization review decisions are based on credible scientific evidence published in peer reviewed
Methylnaltrexone Bromide (Relistor)
Texas Prior Authorization Program Clinical Edit Criteria Drug/Drug Class Clinical Edit Information Included in this Document Drugs requiring prior authorization: the list of drugs requiring prior authorization
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Texas Prior Authorization Program Clinical Edit Criteria Drug/Drug Class Clinical Edit Information Included in this Document Drugs requiring prior authorization: the list of drugs requiring prior authorization
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Clinical Policy: (Adcirca) Reference Number: HIM.PA.SP23 Effective Date: 05/17 Last Review Date: Line of Business: Health Insurance Marketplace Coding Implications Revision Log See Important Reminder at
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Clinical Policy: Treprostinil (Orenitram, Remodulin, Tyvasco) Reference Number: CP.PHAR.199
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Clinical Policy: Bosentan (Tracleer) Reference Number: CP.PHAR.191
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Clinical Policy: Tadalafil (Adcirca) Reference Number: CP.PHAR.198
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