BlueCross BlueShield of Tennessee Medical Policy Manual

Romiplostim

NDC CODE(S)

Nplate 250mcg: 55513-0221-xx (Amgen)

 

Nplate 500mcg: 55513-0222-xx (Amgen)

DESCRIPTION

Romiplostim is an Fc-peptide fusion protein of the TPO mimetic class and is considered a thrombopoietin receptor agonist.  It is produced by recombinant DNA technology in Escherichia coli (E. coli).  Through binding and activation of the TPO receptor, romiplostim increases platelet production in the same way that endogenous TPO functions in the body.  Increases in platelet counts are romiplostim dose-dependent.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
All indications

Initial dose: 1mcg/kg subcutaneously weekly

Adjust dose weekly by increments of 1 mcg/kg to achieve and maintain platelet count of ≥ 50 × 109/L (50,000/mm³) as necessary to reduce the risk for bleeding

Do not exceed the maximum weekly dose of 10 mcg/kg

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 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 romiplostim for the treatment of conditions or diseases.

SOURCES

Lexi-Comp Online. (2016, March). AHFS Dl. Romiplostim. Retrieved June 28, 2016 from Lexi­ Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, June). Romiplostim. Retrieved June 28, 2016 from MICROMEDEX Healthcare Series.

U.S. Food and Drug Administration.  (2016, April). Center for Drug Evaluation and Research. Nplate® (romiplostim) for injection. Retrieved June 28, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125268s155s156lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  2/27/2018

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.

Pharmaceutical Decision Support Tree

Romiplostim (Nplate®)

  1. Is this the initial request for the agent for this individual?

If yes, go to question #2

If no, go to question #6

  1. Does the individual have a diagnosis of chronic immune/idiopathic thrombocytopenia with increased risk for bleeding due to degree of thrombocytopenia (e.g., platelet count within the previous 28 days of less than 30 × 109/L [30,000/mm³]) and clinical condition but the agent is NOT being requested in an attempt to normalize the platelet count?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual show evidence of inadequate response to ANY ONE of the following?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Are 125 billable units (1 billable unit = 10 mcg) or less requested weekly for up to three months?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the requested dosing for an initial dose of 1mcg/kg subcutaneously weekly which may be increased to a max of 10mcg/kg weekly based on patient response to maintain a platelet count of ≥50 × 109/L (50,000/mm³) as necessary to reduce the risk for bleeding for an authorization of three months or less?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual show disease response is indicated by the achievement and maintenance of a platelet count within the previous 28 days of at least 50 × 109/L (not to exceed 400 x 109/L) as necessary to reduce the risk for bleeding?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Was there absence of unacceptable toxicity and/or adverse reactions, e.g., arthralgia, dizziness, insomnia, myalgia, pain in extremity, abdominal pain, shoulder pain, dyspepsia, paresthesia, progression of MDS to AML, thrombotic/thromboembolic complications?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Are 125 billable units (1 billable unit = 10 mcg) or less requested weekly with the requested dosing based on the previous dosage with a max of 10mcg/kg weekly based on patient response to maintain a platelet count within the previous 28 days of ≥50 × 109/L (50,000/mm³) for an authorization of three months or less?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.