Treprostinil Sodium for the Treatment of Pulmonary Hypertension
DESCRIPTION
Treprostinil is a stable synthetic analog of prostacyclin, a powerful vasodilator and inhibitor of platelet aggregation. Its exact mechanism of vasodilation activity is not known, but prostacyclin synthase expression is decreased in the lungs of individuals with pulmonary arterial hypertension (PAH).
Treprostinil is commercially available for use in three routes of administration: subcutaneous or intravenous injection (treprostinil sodium) and oral inhalation (treprostinil).
An example of a preparation of treprostinil sodium in injection form is Remodulin®.
An example of a preparation of treprostinil in oral inhalation form is Tyvaso®.
REFER TO DECISION SUPPORT TREE
POLICY
Treprostinil sodium for injection (e.g., Remodulin®) for the treatment of pulmonary hypertension is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Treprostinil for oral inhalation (e.g., Tyvaso®) for the treatment of pulmonary hypertension is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Treprostinil for the treatment of other conditions/diseases, including, but not limited to, the following is considered investigational.
Pulmonary hypertension with left heart disease (WHO Group 2)
Pulmonary hypertension associated with lung diseases and/or hypoxemia (WHO Group 3)
Pulmonary hypertension due to chronic thrombotic and/or embolic disease (WHO Group 4)
Pulmonary hypertension with unclear multifactorial mechanisms (e.g., hematological disorders, systemic orders, metabolic disorders) (WHO Group 5)
Policies with similar titles:
Epoprostenol Sodium for the Treatment of Pulmonary Hypertension
Sildenafil Citrate for the Treatment of Pulmonary Hypertension
MEDICAL APPROPRIATENESS
Treprostinil sodium for injection (e.g., Remodulin®) 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 1 [i.e., pulmonary arterial hypertension (PAH)]
Individual has a functional classification per the New York Heart Association (NYHA) of ANY ONE of the following:
Class II - mild limitation of exercise tolerance
Class III - moderate limitation of exercise tolerance
Class IV - severe limitation of exercise tolerance
Treprostinil for oral inhalation (e.g., Tyvaso®) 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 1 [i.e., pulmonary arterial hypertension (PAH)]
Class III (moderate limitation of exercise tolerance) functional classification per the New York Heart Association (NYHA)
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.
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 use of treprostinil sodium for the treatment of any other conditions/diseases.
SOURCES
Lexi-Comp Online. (2009). AHFS DI. Treprostinil Sodium. Retrieved September 29, 2009 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Treprostinil. Retrieved September 29, 2009 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2008, March). Center for Drug Evaluation and Research. Remodulin® (treprostinil sodium) injection. Retrieved September 29, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021272s008lbl.pdf.
U. S. Food and Drug Administration. (2008, March). Center for Drug Evaluation and Research. Remodulin® (treprostinil sodium) injection approval letter. Retrieved September 29, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021272s008ltr.pdf.
U. S. Food and Drug Administration. (2009, July). Center for Drug Evaluation and Research. Tyvaso® (treprostinil sodium) inhalation solution. Retrieved September 29, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022387LBL.pdf.
U. S. Food and Drug Administration. (2009, July). Center for Drug Evaluation and Research. Tyvaso® (treprostinil sodium) inhalation solution approval letter. Retrieved September 29, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022387s000ltr.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
Treprostinil Sodium (Remodulin®, Tyvaso®)
Is the requested medication being used to treat ANY ONE of the following?
Pulmonary hypertension with left heart disease (WHO Group 2)
Pulmonary hypertension associated with lung diseases and/or hypoxemia (WHO Group 3)
Pulmonary hypertension due to chronic thrombotic and/or embolic disease (WHO Group 4)
Pulmonary hypertension with unclear multifactorial mechanisms (e.g., hematological disorders, systemic orders, metabolic disorders) (WHO Group 5)
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 1]?
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, epoprostenol sodium, iloprost, sildenafil citrate, tadalafil)?
If yes, route to Specialty Pharmacy for review
If no, go to question #4
Does the individual have a Class III (moderate limitation of exercise tolerance) functional classification per the New York Heart Association (NYHA)?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #5
Does the individual have a functional classification per the New York Heart Association (NYHA) of ANY ONE of the following?
Class II – mild limitation of exercise tolerance
Class IV – severe limitation of exercise tolerance
If yes, go to question #6
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the agent requested the injection form of treprostinil sodium (e.g., Remodulin®)?
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 |