Download Sildenafil Citrate Powder - Federal Employee Program

Federal Employee Program®
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Washington, D.C. 20005
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Fax 202.942.1125
5.06.15
Section:
Effective Date:
January 1, 2016
Subsection: Central Nervous System Drugs
Original Policy Date:
December 6, 2013
Subject:
Page:
1 of 6
Prescription Drugs
Sildenafil Citrate Powder
Last Review Date:
December 3, 2015
Sildenafil Citrate Powder
Description
Sildenafil citrate powder
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). Sildenafil citrate is
indicated for oral treatment of pulmonary arterial hypertension (PAH) which is classified by
WHO as Group 1 (2). Oral sildenafil citrate is used to treat pulmonary arterial hypertension
(PAH, high blood pressure in the lungs) to improve the exercise ability (2). Sildenafil citrate, at
different dosages, is currently also marketed as Viagra for the treatment of erectile dysfunction
(2).
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: (4,5)
• 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
5.06.15
Section:
Prescription Drugs
Effective Date:
January 1, 2016
Subsection: Central Nervous System Drugs Original Policy Date:
December 6, 2013
Subject:
2 of 6
Sildenafil Citrate Powder
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Pulmonary veno-occlusive disease (PVOD)
Pulmonary capillary hemangiomatosis (PCH)
The American College of Chest Physicians (ACCP) has published an updated clinical practice
guideline for treating PAH (6). 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. Sildenafil citrate is indicated for patients with NYHA
Functional Class II, III, or IV (2).
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.
(7,8)(3-4)
These guidelines recommend that oral therapy with Sildenafil citrate be used as first-line
therapy for Class II and III patients (6). Sildenafil citrate should not be used alone or as a firstline 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 (6). Sildenafil citrate is the same therapeutic class as Adcirca (tadalafil) and has the
same indication for PAH (WHO group 1) (6).
Regulatory Status
FDA-approved indication: Sildenafil citrate powder is a phosphodiesterase 5 (PDE5) inhibitor
indicated for the oral 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).
5.06.15
Section:
Prescription Drugs
Effective Date:
January 1, 2016
Subsection: Central Nervous System Drugs Original Policy Date:
December 6, 2013
Subject:
3 of 6
Sildenafil Citrate Powder
Page:
The oral use of sildenafil citrate is contraindicated in patients who are using any form of organic
nitrate, either regularly or intermittently. Sildenafil citrate potentiates the hypotensive effect of
nitrates. This potentiation is thought to result from the combined effects of nitrates and sildenafil
citrate on the nitric oxide/cGMP pathway (2).
The efficacy of oral sildenafil citrate has not been adequately evaluated in patients taking
bosentan concurrently. Sildenafil citrate is not recommended for patients younger than 18 years
of age (2).
The use of sildenafil for the treatment of erectile dysfunction (ED) remains a plan exclusion.
Off-label (non-FDA approved) compounded topical preparations of sildenafil citrate have been
used off-label for erectile or sexual dysfunction.
Related policies
Policy
This policy statement applies to clinical review performed for pre-service (Prior Approval,
Precertification, Advanced Benefit Determination, etc.) and/or post-service claims.
Sildenafil citrate powder may be considered medically necessary for the oral treatment of
patients with pulmonary arterial hypertension, WHO Group I and NYHA functional classification
of physical activity II, III, or IV who are not receiving organic nitrate medications, no concurrent
(dual) therapy with PDE-5 inhibitors, the requested oral dose does not exceed 20mg / unit, the
requested strength is not commercially available and the requested dosage form is not being
used topically.
Sildenafil citrate powder may be considered investigational for patients with other diagnoses,
or who are being treated with nitrates, and for topical use.
The use for the treatment of erectile or sexual dysfunction is not a covered benefit.
Prior-Approval Requirements
Diagnoses
5.06.15
Section:
Prescription Drugs
Effective Date:
January 1, 2016
Subsection: Central Nervous System Drugs Original Policy Date:
December 6, 2013
Subject:
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Sildenafil Citrate Powder
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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 ALL of the following:
1. NO concurrent use with nitrate medication
2. NO concurrent (dual) therapy with PDE-5 inhibitors
3. The requested oral dose does not exceed 20mg / unit
4. The requested strength is NOT commercially available
5. The requested dosage form is NOT being used topically
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
AND ALL of the following:
1.
2.
3.
4.
5.
NO concurrent use with nitrate medication
NO concurrent (dual) therapy with PDE-5 inhibitors
The requested oral dose does not exceed 20mg / unit
The requested strength is NOT commercially available
The requested dosage form is NOT being used topically
Policy Guidelines
Pre - PA Allowance
None
Prior - Approval Limits
Duration
12 months
5.06.15
Section:
Prescription Drugs
Effective Date:
January 1, 2016
Subsection: Central Nervous System Drugs Original Policy Date:
December 6, 2013
Subject:
5 of 6
Sildenafil Citrate Powder
Page:
Prior – Approval Renewal Limits
Duration
12 months
Rationale
Summary
Sildenafil citrate powder is a phosphodiesterase 5 (PDE5) inhibitor indicated for the oral
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. The use of Sildenafil
citrate is contraindicated in patients who are using any form of organic nitrate, either regularly or
intermittently. Sildenafil citrate is not recommended for patients younger than 18 years of age.
The use of sildenafil for the treatment of erectile dysfunction (ED) remains a plan exclusion (18).
Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of
Sildenafil citrate powder 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 [package insert]. New York, NY. Pfizer Inc. March 2014.
3. Farber HW, Loscalzo J. Pulmonary arterial hypertension. N Engl J Med. 2004; 351:165565.
4. Simonneau G, Robbins IM, Beghetti M, et al. Updated clinical classification of pulmonary
hypertension. J Am Coll Cardiol. 2009; 54(suppl 1):S43-S54.
5. 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: 5s12s.
6. Badesch DB, Abman SH, Simonneau G, Rubin LJ, McLaughlin VV. Medical therapy for
pulmonary arterial hypertension: updated ACCP evidence-based clinical practice guidelines.
Chest. 2007; 131:1917-1928.
7. Trenton D. Nauser, M.D., Steven Stites, M.D. Am Fam Physician. 2001 May 1; 63(9):17891799.
8. 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.
5.06.15
Section:
Prescription Drugs
Effective Date:
January 1, 2016
Subsection: Central Nervous System Drugs Original Policy Date:
December 6, 2013
Subject:
6 of 6
Sildenafil Citrate Powder
Page:
Policy History
Date
Action
December 2013
New addition to PA
December 2013
Annual editorial review
December 2014
Annual editorial review and reference update
Addition of no concurrent (dual) therapy with PDE-5 inhibitors
December 2015
Annual review
Keywords
This policy was approved by the FEP® Pharmacy and Medical Policy Committee on
December 3, 2015 and is effective January 1, 2016.
Deborah M. Smith, MD, MPH