Subject: sildenafil-Revatio 1651-A SGM P2021

Drug

Revatio  (sildenafil tablets and oral suspension)

sildenafil tablets

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.

          A.  FDA-Approved Indication
               Sildenafil/Revatio is indicated for the treatment of pulmonary arterial hypertension (World
               Health Organization [WHO] Group 1) in adults to improve exercise ability and delay
               clinical worsening.

               Limitation of use: Adding sildenafil to bosentan therapy does not result in any beneficial
               effect on exercise capacity.
 
         B.  Compendial Use
              Secondary Raynaud’s phenomenon (Tablets only)

         All other indications are considered experimental/investigational and not medically necessary.

 
   II.  CRITERIA FOR INITIAL APPROVAL

         A.  Pulmonary Arterial Hypertension (PAH)
              Authorization of 12 months may be granted for treatment of PAH 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 either criterion (i) or criterion (ii) below: 
                   i.   Pretreatment right heart catheterization with all of the following results:  
                        a.  mPAP > 20 mmHg
                        b.  PCWP ≤ 15 mmHg
                        c.  PVR ≥ 3 Wood units 
                   ii.  For infants less than one year of age, PAH was confirmed by Doppler
                        echocardiogram if right heart catheterization cannot be performed.
 
        B.  Secondary Raynaud’s Phenomenon
             Authorization of 12 months may be granted for treatment of secondary Raynaud’s
             phenomenon when the member has had an inadequate response to one of the following
             medications:
             1.  Calcium channel blockers
             2.  Angiotensin receptor blockers
             3.  Selective serotonin reuptake inhibitors
             4.  Alpha blockers
             5.  Topical nitrates

 III. CONTINUATION OF THERAPY  

        Authorization of 12 months may be granted for members with an indication listed in Section II
        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.

 

 

Special Notes:

   IV.  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 tumours of the testis
                           Other tumours
                 4.2.3  Non-malignant tumours
                           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:

V. REFERENCES 

1. Revatio [package insert]. New York, NY: Pfizer Inc.; February 2020.
2. Sildenafil [package insert]. Morgantown, WV: Mylan Pharmaceuticals Inc.; February 2018.
3. Chin KM, Rubin LJ. Pulmonary arterial hypertension. J Am Coll Cardiol. 2008;51(16):1527-1538.
4. 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.
5. Badesch DB, Champion HC, Gomez-Sanchez MA, et al. Diagnosis and assessment of pulmonary arterial hypertension. J Am Coll Cardiol. 2009;54:S55-S66.
6. Simonneau G, Robbins IM, Beghetti M, et al. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2013;62:D34-S41.
7. 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.
8. 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.
9. 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.
10. Barst RJ, Ivy DD, Gaitan G, et al. A randomized, double-blind, placebo-controlled, dose-ranging study of oral sildenafil citrate in treatment-naïve children with pulmonary arterial hypertension. Circulation. 2012;125:324-334.
11. FDA Drug Safety Communication: FDA recommends against use of Revatio in children with pulmonary hypertension. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm317123.htm. Accessed April 28, 2015.
12. Abman SH, Kinsella JP, Rosenzweig EB, et al. Implications of the U.S. Food and Drug Administration warning against the use of sildenafil for the treatment of pediatric pulmonary hypertension. Am J Respir Crit Care Med. 2013;187(6):572-575.  
13. FDA Drug Safety Communication: FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm390876.htm. Accessed April 28, 2015.
14. 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.
15. Galiè N, Ghofrani HA, Torbicki A, et al. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med. 2005;353:2148-2157.
16. Rubin LJ, Badesch DB, Fleming RT, et al. Long-term treatment with sildenafil citrate in pulmonary arterial hypertension. Chest. 2011;140(5):1274-1283.
17. IBM Micromedex^® DRUGDEX^® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed April 06, 2020.
18. Hughes M, Ong VH, Anderson ME, et al. Consensus best practice pathway of the UK Scleroderma Study Group: digital vasculopathy in systemic sclerosis. Rheumatology. 2015;54:2015-2024.
19. Roustit M, Blaise S, Allanore Y, et al. Phosphodiesterase-5 inhibitors for the treatment of secondary Raynaud’s phenomenon: systematic review and meta-analysis of randomized trials. Ann Rheum Dis. 2013;72(10):1696-1699.
20. Walker KM, Pope J, et al. Treatment of systemic sclerosis complications: what to use when first-line treatment fails – a consensus of systemic sclerosis experts. Semin Arthritis Rheum. 2012;42(1):42-55.
21. 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.
22. 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.
23. 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.

September 29, 2021