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Federal Employee Program® 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.06.06 Section: Effective Date: April 1, 2014 Subsection: Central Nervous System Drugs Original Policy Date: November 1, 2009 Subject: Page: 1 of 6 Prescription Drugs Revatio Last Review Date: March 13, 2014 Revatio Description Revatio (sildenafil) Background Pulmonary arterial hypertension is a rare disorder of the pulmonary arteries in which the pulmonary arterial pressure rises above normal levels in the absence of left ventricular failure. This condition can progress to cause right-sided heart failure and death (1). Revatio received approval on May 26, 2009 for treatment of pulmonary arterial hypertension (PAH) which is classified by WHO as Group 1 (2). Revatio is used to treat pulmonary arterial hypertension (PAH, high blood pressure in the lungs) to improve the exercise ability (2). Sildenafil, at different dosages, is currently also marketed as Viagra for the treatment of erectile dysfunction. The World Health Organization (WHO) has classified pulmonary hypertension into five different groups:(3) Pulmonary arterial hypertension (PAH) makes up the first group, referred to as WHO Group I, and includes: (11,12) Idiopathic (IPAH) Familial (FPAH) Association with other diseases (APAH) such as: o Collagen vascular disease, scleroderma, congenital shunts between the systemic and pulmonary circulation, portal hypertension, HIV infection, drugs, and toxins. o Thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, and splenectomy. o Associated with significant venous or capillary involvement o Pulmonary veno-occlusive disease (PVOD) o Pulmonary capillary hemangiomatosis (PCH) 5.06.06 Section: Effective Date: April 1, 2014 Subsection: Central Nervous System Drugs Original Policy Date: November 1, 2009 Subject: Page: 2 of 6 Prescription Drugs Revatio The American College of Chest Physicians (ACCP) has published an updated clinical practice guidelines for treating PAH (3). These guidelines use the New York Heart Association (NYHA) functional classification of physical activity scale to classify PAH patients in classes I-IV based on the severity of their symptoms (3). Class I Class II Class III Class IV Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope. Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Patients with pulmonary hypertension resulting in marked limitation of physical activity. These patients are comfortable at rest, but less than ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Patients with pulmonary hypertension resulting in inability to perform any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present at rest, and discomfort is increased by any physical activity. (9,10) These guidelines recommend that oral therapy with Revatio be used as first-line therapy for Class II and III patients (4). Revatio should not be used alone or as a first-line therapy for Class IV patients unless the patient refuses to use or is believed not to be capable of managing the complex delivery systems for intravenous, subcutaneous, or inhaled medications (4). Revatio (sildenafil) is the same therapeutic class as Adcirca (tadalafil) and has the same indication for PAH (WHO group 1). Regulatory Status FDA-approved indication: Revatio is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (primary) pulmonary hypertension (71%) or pulmonary hypertension associated with connective tissue disease (25%) (2). The use of Revatio is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. Revatio potentiates the hypotensive effect of nitrates. This potentiation is thought to result from the combined effects of nitrates and Revatio on the nitric oxide/cGMP pathway (2). The efficacy of Revatio has not been adequately evaluated in patients taking bosentan concurrently. Revatio is not recommended for patients younger than 18 years of age (2). 5.06.06 Section: Effective Date: April 1, 2014 Subsection: Central Nervous System Drugs Original Policy Date: November 1, 2009 Subject: Page: 3 of 6 Prescription Drugs Revatio Related policies Adcirca Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Revatio may be considered medically necessary for the treatment of patients with pulmonary arterial hypertension, WHO Group I and NYHA functional class II, III, or IV who are not receiving organic nitrate medications. Revatio may be considered investigational for patients with other diagnoses, or who are being treated with nitrates Prior-Approval Requirements Diagnoses Patient must have BOTH of the following 1. Pulmonary Arterial Hypertension - WHO Group I 2. NYHA functional classification of physical activity - Class II, III, or IV AND NOT on the following: Nitrate medication (examples: isosorbide dinitrate [Isordil], isosorbide mononitrate [Imdur, Ismo]. Nitroglycerin tablets, capsules, patches [ex. Nitro-Dur], isosorbide dinitrate/hydralazine [BiDil]) Prior – Approval Renewal Requirements Same as above OR PAH WHO Group I and NYHA Class I, who was previously NYHA Class II and has improved due to previous therapy. 5.06.06 Section: Effective Date: April 1, 2014 Subsection: Central Nervous System Drugs Original Policy Date: November 1, 2009 Subject: Page: 4 of 6 Prescription Drugs Revatio Policy Guidelines Pre - PA Allowance None Prior - Approval Limits Duration 12 months Prior - Approval Renewal Limits Duration 12 months Rationale Summary Pulmonary arterial hypertension is a rare disorder of the pulmonary arteries in which the pulmonary arterial pressure rises above normal levels in the absence of left ventricular failure. This condition can progress to cause right-sided heart failure and death. Revatio is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and delay clinical worsening. Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Revatio while maintaining optimal therapeutic outcomes. References 1. Lee AJ, Chiao TB, Tsang MP. Sildenafil for pulmonary hypertension. Ann Pharmacother. 2005 May;39(5):869-84. 2. Revatio. Product Information. Pfizer Inc. August 2012. 3. Farber HW, Loscalzo J. Pulmonary arterial hypertension. N Engl J Med. 2004 Oct 14;351(16):1655-65. Review. 4. Badesch DB, Abman SH, Simonneau G, Rubin LJ, McLaughlin VV; American College of Chest Physicians. Medical therapy for pulmonary arterial hypertension: Updated ACCP evidence-based clinical practice guidelines. Chest. 2007;131;1917-1928. 5. Ravipati G, McClung JA, Aronow WS, et al. Type 5 Phosphodiesterase Inhibitors in the Treatment of Erectile Dysfunction and Cardiovascular Disease. Cardiology in Review 2007; 15(2) 76-86. 6. Minai OA and Arroliga AC. Long-term Results After Addition of Sildenafil in Idiopathic PAH Patients on Bosentan. Southern Medical Journal 2006; 99(8): 880-883. 5.06.06 Section: Effective Date: April 1, 2014 Subsection: Central Nervous System Drugs Original Policy Date: November 1, 2009 Subject: Page: 5 of 6 Prescription Drugs Revatio 7. Sastry BKS. Pharmacologic treatment for pulmonary arterial hypertension. Curr Opin Cardiol 2006; 21: 561-568. 8. Archer SL and Michelakis ED. Phosphodiesterase Type 5 Inhibitors for Pulmonary Arterial Hypertension 9. Trenton D. Nauser, M.D., Steven Stites, M.D. Am Fam Physician. 2001 May 1;63(9):17891799. HTTP://WWW.AAFP.ORG/AFP/2001/0501/P1789.HTML 10. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256. 11. Simonneau G, Robbins IM, Beghetti M, et al. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2009;54(suppl 1):S43-S54. 12. The Venice 2003 revised Classification system; Simonneau G, Galiè N, Rubin LJ et al. Clinical classification of pulmonary hypertension. J Am Coll Cardiol 2004; 43: Suppl S: 5sa 12s Policy History Date Action November 2009 The FDA has approved Revatio (sildenafil, from Pfizer) injection, an intravenous phosphodiesterase-5 (PDE-5) inhibitor, for the treatment of adults with pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and delay clinical worsening. Revatio injection is for the continued treatment of patients with PAH who are currently prescribed Revatio tablets but who are temporarily unable to take oral medication. Revatio injection will be available in a single-use vial. Revatio tablets are already available in 20mg dosage strength. December 2009 Both PDE5 inhibitors are indicated for the treatment of PAH WHO group 1, NYHA class II, III, or IV. Patients taking tadalafil or sildenafil may see an improvement in NYHA class that could prevent them from qualifying for prior approval renewal. Studies show evidence of improvements in functional class (NYHA class), usually one class jump only; such as from class II to class I. If the PDE5 is discontinued, the patient’s functional class may return to its baseline state or worsen. (5,6,7,8) Renewal requirements have been modified to allow continuation of therapy for patients who were previously NYHA Class II for tadalafil or sildenafil, but whose condition has improved on therapy to NYHA Class I. September 2012 The U.S. Food and Drug Administration (FDA) recommends that Revatio (sildenafil) not be prescribed to children (ages 1 through 17) for pulmonary arterial hypertension (PAH; high pressure in the blood vessels leading to the 5.06.06 Section: Effective Date: April 1, 2014 Subsection: Central Nervous System Drugs Original Policy Date: November 1, 2009 Subject: Page: 6 of 6 Prescription Drugs Revatio lungs). PA criteria modified to require minimum age of 18. March 2013 Annual editorial review and reference update March 2014 Annual review September 2014 Line addition of Revatio oral recon suspension Keywords This policy was approved by the FEP® Pharmacy and Medical Policy Committee on March 13, 2014 and is effective April 1, 2014. Signature on File Deborah M. Smith, MD, MPH