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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