Subject: treprostinil-Remodulin 1644-A SGM P2024

Drug

REMODULIN  (treprostinil injection)

treprostinil injection

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 Indications
          A.  Treatment of pulmonary arterial hypertension (PAH; World Health Organization [WHO]
               Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness
               included patients with New York Heart Association (NYHA) Functional Class II-IV symptoms
               and etiologies of idiopathic or heritable PAH, PAH associated with congenital systemic-to-
               pulmonary shunts, or PAH associated with connective tissue diseases.
          B.  In patients with PAH requiring transition from epoprostenol, to diminish the rate of clinical
               deterioration. Consider the risks and benefits of each drug prior to transition.

          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)
          Indefinite authorization 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 members or
                           pulmonary vascular resistance index (PVRI) ≥ 3 Wood units x m² in pediatric
                           members
               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

          Indefinite authorization 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 (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

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Remodulin [package insert]. Research Triangle Park, NC: United Therapeutics Corp.; October 2023.
2. Treprostinil [package insert]. Princeton, NJ: Sandoz Inc.; April 2023.
3. 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.
4. Badesch DB, Champion HC, Gomez-Sanchez MA, et al. Diagnosis and assessment of pulmonary arterial hypertension. J Am Coll Cardiol. 2009;54:S55-S66.
5. Taichman DB, Ornelas J, Chung L, et al. Pharmacologic therapy for pulmonary arterial hypertension in adults: CHEST guideline and expert panel report. Chest. 2014;146(2):449-475.
6. 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.
7. Klinger JR, Elliott CG, Levine DJ, et al. Therapy for pulmonary arterial hypertension in adults: update of the CHEST guideline and expert panel report. Chest. 2019;155(3):565-586.
8. 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
9. Simonneau G, Montani D, Celermajer DS, et al. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019;53(1):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.

October 30, 2024