BlueCross BlueShield of Tennessee Medical Policy Manual

Treprostinil for Continuous Subcutaneous/Intravenous Infusion

NDC CODE(S)

66302-101-XX Remodulin 1 mg/mL (UNITED THERAPEUTICS)

 

66302-102-XX Remodulin 2.5 mg/mL (UNITED THERAPEUTICS)

 

66302-105-XX Remodulin 5 mg/mL (UNITED THERAPEUTICS)

 

66302-110-XX Remodulin 10 mg/mL(UNITED THERAPEUTICS)

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 infusion and oral inhalation; however this policy exclusively addresses administration by subcutaneous or intravenous infusion.

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
Remodulin (Continuous Subcutaneous/Intravenous Infusion)

1.25 ng/kg/min (or 0.625 ng/kg/min if not tolerated); dose increase based on clinical response (increments of 1.25 ng/kg/min per week for the first 4 weeks of treatment, later 2.5 ng/kg/min per week).

Continuous subcutaneous infusion is the preferred mode to prevent risk of blood stream infections (BSIs). No diluent is required for subcutaneous infusion. Treprostinil for intravenous use should be administered via a surgically placed indwelling Central Venous Catheter and diluted prior to infusion. 

Transitioning from SC/IV routes of treprostinil (Remodulin®) to oral inhalation (Orenitram®):

  • Oral total daily dose (mg) = 0.0072 X Remodulin dose (ng/kg/min) X weight (kg)

  • Decrease the dose of SC/IV while simultaneously increasing the dose of Oral Inhalation. The Remodulin dose can be reduced up to 30 ng/kg/min per day and dose of Oral Inhalation simultaneously increased up to 6 mg per day (2 mg TID) if tolerated.

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed.

Click here to view DOSAGE LIMITS

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 treprostinil for the treatment or prevention of other conditions or diseases.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2017). Advanced Therapies for Pharmacologic Treatment of Pulmonary Hypertension (5.01.09). Retrieved February 5, 2018 from BlueWeb.

Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS). (2016). 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. European Heart Journal, 37 (10), 67-119.

Lexicomp Online. (2018, February). AHFS DI. Treprostinil®. Retrieved March 30, 2018 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, February). Treprostinil. Retrieved March 30, 2018 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2014, December). Center for Drug Evaluation and Research. Remodulin® (treprostinil). Retrieved February 6, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021272s019lbl.pdf.

ORIGINAL EFFECTIVE DATE:  6/1/2002

MOST RECENT REVIEW DATE: 5/7/2018

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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

BILLABLE UNIT

MAXIMUM UNITS

Pulmonary Arterial Hypertension

1 mg = 1 billable unit

7 billable units per day