Sotatercept-csrk (WinrevairI™)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
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
Winrevair is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events.
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review for initial requests: Chart notes, medical record documentation, or claims history supporting current pulmonary arterial hypertension (PAH) therapy.
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a pulmonologist or cardiologist.
IV. CRITERIA FOR INITIAL APPROVAL
Pulmonary arterial hypertension (PAH)
Authorization of 12 months may be granted for treatment of PAH in members 18 years of age and older when ALL of the following criteria are met:
1. Member has PAH defined as WHO Group 1 class of pulmonary hypertension (refer to Appendix).
2. PAH was confirmed by 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) ≥ 5 Wood units while member is stable on at least two PAH medications
3. The requested medication will be used as add-on therapy.
4. Member is currently receiving PAH therapy with medications from at least two of the following drug classes:
i. Endothelin receptor antagonist (e.g., Letairis, Opsumit, Tracleer)
ii. Phosphodiesterase-5 inhibitor (e.g., Adcirca, Revatio)
iii. Soluble guanylate cyclase stimulator (e.g., Adempas)
iv. Prostacyclin analog (e.g., Flolan, Orenitram, Remodulin, Tyvaso, Veletri, Ventavis)
v. Prostacyclin receptor agonist (e.g., Uptravi)
V. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for members with an indication listed in Section IV 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.
VI. APPENDIX
WHO Classification of Pulmonary Hypertension (PH)
1 Pulmonary arterial hypertension (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 disease
1.4.2 Human immunodeficiency virus (HIV) infection
1.4.3 Portal hypertension
1.4.4 Congenital heart disease
1.4.5 Schistosomiasis
1.5 PAH long-term responders to calcium channel blockers
1.6 PAH with overt features of venous/capillaries (pulmonary veno-occlusive disease [PVOD]/pulmonary capillary hemangiomatosis [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 left ventricular ejection fraction
(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 obstructions
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
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Winrevair [package insert]. Rahway, NJ: Merck Sharp & Dohme LLC; March 2024.
2. Hoeper MM, Badesch DB, Ghofrani HA, et al. Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. N Engl J Med. 2023;388(16):1478-1490. doi: 10.1056/NEJMoa2213558
3. Hoeper MM, Badesch DB, Ghofrani HA, et al. Phase 3 trial of sotatercept for treatment of pulmonary arterial hypertension. Supplementary appendix. N Engl J Med. 2023;Suppl Appendix.
4. Galie N, McLaughlin VV, Rubin LJ, Simonneau G. An overview of the 6th World Symposium on Pulmonary Hypertension. Eur Respir J. 2019;53(1):1802148. doi: 10.1183/13993003.02148-2018
5. Simonneau G, Montani D, Celermajer DS, et al. Hemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019;53(1):1801913. doi:10.1183/13993003.01913-2018
6. Acceleron Pharma, Inc. A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [4/25/2024]. Available from: https://clinicaltrials.gov/study/NCT04576988. NLM Identifier: NCT04576988.
ORIGINAL EFFECTIVE DATE: 8/30/2024
MOST RECENT REVIEW DATE: 8/30/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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