Epoprostenol Sodium for the Treatment of Pulmonary Hypertension
DESCRIPTION
Epoprostenol sodium is a synthetic version of the naturally occurring prostaglandin epoprostenol (PGI2, PGX, or prostacyclin). Epoprostenol is a metabolite of arachidonic acid and has two major functions: It is a potent vasodilator and it inhibits the activity of platelets.
Examples of preparations of epoprostenol sodium are FlolanŽ and VeletriŽ.
REFER TO DECISION SUPPORT TREE
POLICY
Epoprostenol sodium for the treatment of pulmonary hypertension is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Epoprostenol sodium for the treatment of other forms of pulmonary hypertension or other conditions/diseases, including, but not limited to, the following, is considered investigational.
Pulmonary hypertension with left heart disease (WHO Group II)
Pulmonary hypertension associated with lung diseases and/or hypoxemia (WHO Group III)
Pulmonary hypertension due to chronic thromboembolic hypertension (i.e., CTEPH) (WHO Group IV)
Pulmonary hypertension with unclear multifactorial mechanisms (e.g., hematological disorders, systemic orders, metabolic disorders) (WHO Group V)
Pulmonary hypertension after cardiac surgery
Peripheral vascular disease
Raynaud's phenomenon
Aerosolized epoprostenol in children with pulmonary hypertension
Acute respiratory distress syndrome
Class IIIB or class IV congestive heart failure with decreased left ventricular ejection fraction
Policies with similar titles: Treprostinil for the Treatment of Pulmonary Hypertension
MEDICAL APPROPRIATENESS
Epoprostenol sodium for the treatment of pulmonary hypertension is considered medically appropriate if ALL of the following criteria are met:
Disease is classified as World Health Organization (WHO) Group I [i.e., pulmonary arterial hypertension (PAH)]
Individual has functional classification per the New York Heart Association (NYHA) of ANY ONE of the following:
Class III - moderate limitation of exercise tolerance
Class IV - severe limitation of exercise tolerance
Individual is ANY ONE of the following:
Inadequately responsive to conventional therapy (e.g., calcium channel blockers, nitric oxide)
Not a candidate for conventional therapy
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
No controlled studies were found in the published literature that validate the treatment of other conditions / diseases with epoprostenol sodium.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2009). Treatment of pulmonary arterial hypertension with prostacyclin analogues, endothelin receptor antagonists, or phosphodiesterase inhibitors (5.01.09). Retrieved August 17, 2009 from BlueWeb.
Lexi-Comp Online. (2009). AHFS DI. Epoprostenol. Retrieved August 17, 2009 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Epoprostenol. Retrieved August 17, 2009 from MICROMEDEX Healthcare Series.
Simonneau, G., Robbins, I. M., Beghetti, M., Channick, R. N., Delcroix, M., Denton, C. P.,et al. (2009). Updated clinical classification of pulmonary hypertension. Journal of the American College of Cardiology, 54(1 Suppl), S43-54.
U. S. Food and Drug Administration. (2008, March). Center for Drug Evaluation and Research. FlolanŽ (epoprostenol). Retrieved August 21, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020444s016lbl.pdf.
U. S. Food and Drug Administration. (2008, March). Center for Drug Evaluation and Research. FlolanŽ (epoprostenol). Retrieved August 21, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020444s016ltr.pdf.
U. S. Food and Drug Administration. (2010, August). Center for Drug Evaluation and Research. VeletriŽ (epoprostenol sodium). Retrieved February 2, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022260s002lbl.pdf.
ORIGINAL EFFECTIVE DATE: 6/1/2002
MOST RECENT REVIEW DATE: 3/17/2010
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
Pharmaceutical Decision Support Tree
Epoprostenol Sodium (FlolanŽ, VeletriŽ)
Is the requested medication being used to treat ANY ONE of the following?
Pulmonary hypertension with left heart disease (WHO Group II)
Pulmonary hypertension associated with lung diseases and/or hypoxemia (WHO Group III)
Pulmonary hypertension due to chronic thromboembolic hypertension (i.e., CTEPH) (WHO Group IV)
Pulmonary hypertension with unclear multifactorial mechanisms (e.g., hematological disorders, systemic orders, metabolic disorders) (WHO Group V)
Pulmonary hypertension after cardiac surgery
Peripheral vascular disease
Raynaud's phenomenon
Aerosolized epoprostenol in children with pulmonary hypertension
Acute respiratory distress syndrome
Class IIIB or class IV congestive heart failure with decreased left ventricular ejection fraction
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of pulmonary arterial hypertension (PAH) [i.e., World Health Organization (WHO) Group I]?
If yes, go to question #3
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the individual receiving another agent for the treatment of PAH (e.g., ambrisentan, bosentan, iloprost, sildenafil citrate, tadalafil, treprostinil sodium)?
If yes, route to Specialty Pharmacy for review
If no, go to question #4
Does the individual show evidence of ALL of the following?
Moderate to severe limitation of exercise tolerance (Class III or Class IV) functional classification per the New York Heart Association (NYHA)
Inadequate responsiveness to or not a candidate for conventional therapy (e.g., calcium channel blockers, nitric oxide)
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
|
NYHA Class |
Exercise Tolerance |
Symptoms |
|
I |
no limitation |
No symptoms during usual activity |
|
II |
mild limitation |
Comfortable with rest or with mild exertion |
|
III |
moderate limitation |
Comfortable only at rest |
|
IV |
severe limitation |
Any physical activity brings on discomfort and symptoms occur at rest |