BlueCross BlueShield of Tennessee Medical Policy Manual

Epoprostenol

NDC CODE(S)

00703-1985-XX - Epoprostenol Sodium 0.5 MG SOLR (TEVA PARENTERAL MEDICINES)

 

00703-1995-XX - Epoprostenol Sodium 1.5 MG SOLR (TEVA PARENTERAL MEDICINES )

 

00173-0517-XX - Flolan 0.5 MG SOLR (GLAXO SMITH KLINE)

 

00173-0519-XX - Flolan 1.5 MG SOLR (GLAXO SMITH KLINE)

DESCRIPTION

Epoprostenol 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.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

 

Inadequate Clinical Response Criteria

 

Inadequate clinical response for patients who were initially in WHO Functional Class II or III:

  Resulting clinical status defined as ANY ONE of the following:
 
  • Stable and not satisfactory

 
  • Unstable and deteriorating

 

Inadequate clinical response for patients who were initially in WHO Functional Class IV:

 
  • No rapid improvement to WHO Functional Class III or better
 
  • Resulting clinical status defined as stable and not satisfactory

 

WHO Classification of Pulmonary Hypertension (PH)

Group 1 PAH

Pulmonary arterial hypertension (PAH)

Group 2 PH

Pulmonary hypertension owing to left heart disease

Group 3 PH

Pulmonary hypertension owing to lung diseases and/or hypoxia

Group 4 PH

Chronic thromboembolic pulmonary hypertension (CTEPH)

Group 5 PH

Pulmonary hypertension with unclear multifactorial mechanisms

 

 

New York Heart Association (NYHA) Functional Classification

Class I

No symptoms with ordinary physical activity.

Class II Symptoms with ordinary activity. Slight limitation of activity.
Class III

Symptoms with less than ordinary activity. Marked limitation of activity.

Class IV

Symptoms with any activity or even at rest.

 

 

World Health Organization (WHO) Functional Assessment Classification

Class I

Patients with PH but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.

Class II Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.
Class III

Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope

Class IV

Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.

 

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Flolan®/Veletri® (continuous intravenous infusion)

Increase in increments of 2 ng/kg/min every 15 minutes or longer until dose-limiting pharmacologic effects are elicited or until a tolerance limit to the drug is established.

Epoprostenol must be infused via a central venous catheter

LENGTH OF AUTHORIZATION

Coverage is provided for six months and will be eligible for renewal.

Refer to DOSAGE LIMITS below

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

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 chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of Epoprostenol for the treatment or prevention of other conditions or diseases.

SOURCES 

BlueCross BlueShield Association. Medical Policy Reference Manual. (10: 2017). Treatment of pulmonary arterial hypertension with prostacyclin analogues, endothelin receptor antagonists, or phosphodiesterase inhibitors (5.01.09). Retrieved March 28 2018 from BlueWeb.

Galie N, Humbert M, Vachiery JL, et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS) Eur Heart J 2016; 37: 67–119.  doi:10.1093/eurheartj/ehv317.

Lexi-Comp Online. (2018). AHFS DI. Epoprostenol. Retrieved March 28, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, January). Epoprostenol. Retrieved March 28, 2018 from MICROMEDEX Healthcare Series.   

U. S. Food and Drug Administration. (2015, April). Center for Drug Evaluation and Research. Flolan® (epoprostenol sodium) for injection. Retrieved March 28, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020444s018lbl.pdf.

U. S. Food and Drug Administration. (2012, June). Center for Drug Evaluation and Research. Veletri®  (epoprostenol) for injection. Retrieved March 28, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022260s005lbl.pdf.  

ORIGINAL EFFECTIVE DATE:  5/7/2018

MOST RECENT REVIEW DATE: 5/7/2018

ID_MRx

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.

This document has been classified as public information.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

DIAGNOSIS

MAXIMUM UNITS

Pulmonary Arterial Hypertension

Flolan/Veletri -  6 billable units per day