55513-0221-XX Nplate 250 MCG SOLR (AMGEN)
55513-0222-XX Nplate 500 MCG SOLR (AMGEN)
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.
Romiplostim for the treatment of thrombocytopenia is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Romiplostim for the treatment of other conditions/diseases is considered investigational.
Romiplostim is considered medically appropriate if ALL of the following criteria are met:
Diagnosis of chronic immune/idiopathic thrombocytopenia
Individual is 1 year of age or older
Individual does NOT have a diagnosis of myelodysplastic syndrome (MDS)
Increased risk for bleeding due to degree of thrombocytopenia (e.g., platelet count within the previous 28 days less than 30 × 109/L [30,000/mm³]) and clinical condition
Individual is not on any other thrombopoietin receptor agonist or mimetic (e.g., lusutrombopag, eltrombopag, avatrombopag, etc.)
Is not to be used in an attempt to normalize platelet counts
Inadequate response to prior therapy with ANY ONE of the following:
Romiplostim is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
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
Absence of unacceptable toxicity, e.g., thrombotic/thromboembolic complications, severe hypersensitivity, risk of progression of myelodysplastic syndromes to acute myelogenous leukemia, etc.
|INDICATION(S)||DOSAGE & ADMINISTRATION|
ADULT / PEDIATRIC:
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
Adjust the dose as follows for all patients:
· If the platelet count is < 50 × 109/L, increase the dose by 1 mcg/kg.
· If platelet count is > 200 × 109/L and ≤ 400 × 109/L for 2 consecutive weeks, reduce the dose by 1 mcg/kg.
If platelet count is > 400 × 109/L, do not dose. Continue to assess the platelet count weekly. After the platelet count has fallen to < 200 × 109/L, resume Nplate at a dose reduced by 1 mcg/kg.
LENGTH OF AUTHORIZATION
Coverage will be provided for 3 months and may be renewed
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.
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.
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).
Lexi-Comp Online. (2019). AHFS Dl. Romiplostim. Retrieved February 7, 2019 from Lexi Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, January). Romiplostim. Retrieved February 7, 2019 from MICROMEDEX Healthcare Series.
U.S. Food and Drug Administration. (2018, December). Center for Drug Evaluation and Research. Nplate® (romiplostim) for injection. Retrieved February 7, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125268s163lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 5/31/2019
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.
Maximum billable units per dose and over time by indication as a Medical Benefit