Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: bosentan-Tracleer 1649-A SGM P2023
Drug
TRACLEER(bosentan)
bosentan®
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indication Indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group 1): A. In adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH, PAH associated with connective tissue diseases, and PAH associated with congenital heart disease with left-to-right shunts. B. In pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.
All other indications are considered experimental/investigational and not medically necessary.
II. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a pulmonologist or cardiologist.
III. CRITERIA FOR INITIAL APPROVAL
Pulmonary Arterial Hypertension (PAH) Authorization of 12 months may be granted for treatment of PAH when ALL of the following criteria are met: A. Member has PAH defined as WHO Group 1 class of pulmonary hypertension (refer to Appendix). B. PAH was confirmed by either criterion (1) or criterion (2) below: 1. Pretreatment right heart catheterization with all of the following results: i. Mean pulmonary arterial pressure (mPAP) > 20 mmHg ii. Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg iii. Pulmonary vascular resistance (PVR) ≥ 3 Wood units in adult patients or pulmonary vascular resistance index (PVRI) ≥ 3 Wood units x m2 in pediatric patients 2. For infants less than one year of age, PAH was confirmed by Doppler echocardiogram if right heart catheterization cannot be performed.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for members with an indication listed in Section III who are currently receiving the requested medication through a paid pharmacy or medical benefit, and who are experiencing benefit from therapy as evidenced by disease stability or disease improvement.
V. APPENDIX
WHO Classification of Pulmonary Hypertension 1 PAH 1.1 Idiopathic (PAH) 1.2 Heritable PAH 1.3 Drug- and toxin-induced PAH 1.4. PAH associated with: 1.4.1 Connective tissue diseases 1.4.2 HIV infection 1.4.3 Portal hypertension 1.4.4 Congenital heart diseases 1.4.5 Schistosomiasis 1.5 PAH long-term responders to calcium channel blockers 1.6 PAH with overt features of venous/capillaries (PVOD/PCH) involvement 1.7 Persistent PH of the newborn syndrome
2 PH due to left heart disease 2.1 PH due to heart failure with preserved LVEF 2.2 PH due to heart failure with reduced LVEF 2.3 Valvular heart disease 2.4 Congenital/acquired cardiovascular conditions leading to post-capillary PH
3 PH due to lung diseases and/or hypoxia 3.1 Obstructive lung disease 3.2 Restrictive lung disease 3.3 Other lung disease with mixed restrictive/obstructive pattern 3.4 Hypoxia without lung disease 3.5 Developmental lung disorders
4 PH due to pulmonary artery obstruction 4.1 Chronic thromboembolic PH 4.2 Other pulmonary artery obstructions 4.2.1 Sarcoma (high or intermediate grade) or angiosarcoma 4.2.2 Other malignant tumors Renal carcinoma Uterine carcinoma Germ cell tumors of the testis Other tumors 4.2.3 Non-malignant tumors Uterine leiomyoma 4.2.4 Arteritis without connective tissue disease 4.2.5 Congenital pulmonary artery stenosis 4.2.6 Parasites Hydatidosis
5 PH with unclear and/or multifactorial mechanisms 5.1 Hematologic disorders: Chronic hemolytic anemia, myeloproliferative disorders 5.2 Systemic and metabolic disorders: Pulmonary Langerhans cell histiocytosis, Gaucher disease, glycogen storage disease, neurofibromatosis, sarcoidosis 5.3 Others: chronic renal failure with or without hemodialysis, fibrosing mediastinitis 5.4 Complex congenital heart disease
Place of Service:
Outpatient
The above policy is based on the following references:
Bosentan [package insert]. Baltimore, MD: Lupin Pharmaceuticals, Inc; January 2023.
Chin KM, Rubin LJ. Pulmonary arterial hypertension. J Am Coll Cardiol. 2008;51(16):1527-1538.
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. J Am Coll Cardiol. 2009;53(17):1573-1619.
Badesch DB, Champion HC, Gomez-Sanchez MA, et al. Diagnosis and assessment of pulmonary arterial hypertension. J Am Coll Cardiol. 2009;54:S55-S66.
Rubin LJ. American College of Chest Physicians. Diagnosis and management of pulmonary arterial hypertension: ACCP evidence-based clinical practice guidelines. Chest. 2004;126(1 Suppl):7S-10S.
Barst RJ, Gibbs SR, Ghofrani HA, et al. Updated evidence-based treatment algorithm in pulmonary arterial hypertension. J Am Coll Cardiol. 2009;54:S78-S84.
Taichman DB, Ornelas J, Chung L, et al. Pharmacologic therapy for pulmonary arterial hypertension in adults. CHEST guideline and expert panel report. Chest. 2014;46(2):449-475.
Abman SH, Hansmann G, Archer SL, et al. Pediatric pulmonary hypertension: guidelines from the American Heart Association and American Thoracic Society. Circulation. 2015;132(21):2037-99.
Klinger JR, Elliott CG, Levine DJ, et al. Therapy for Pulmonary Arterial Hypertension in Adults: Update of the CHEST Guidelines and Expert Panel Report. Chest. 2019:155(3): 565-586.
Galie N, McLaughlin VV, Rubin LJ, Simonneau G. An overview of the 6th World Symposium on Pulmonary Hypertension. Eur Respir J. 2019; 53: 1802148; DOI: 10.1183/13993003.02148-2018. Published 24 January 2019.
Simonneau G, Montani D, Celermajer DS, et al. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019;53:1801913; doi:10.1183/13993003.01913-2018.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
