BlueCross BlueShield of Tennessee Medical Policy Manual

Romiplostim (Nplate®)

NDC CODE(S)

55513-0221-XX NPLATE 250MCG Solution Reconstituted (AMGEN)

55513-0222-XX NPLATE 500MCG Solution Reconstituted (AMGEN)

55513-0223-XX NPLATE 125MCG Solution Reconstituted (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.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL CRITERIA

Universal Criteria

Immune (idiopathic) thrombocytopenia (ITP)

Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS)

Myelodysplastic Syndromes (MDS)

RENEWAL CRITERIA

ITP

HS-ARS

MDS

DOSAGE/ADMINISTRATION

INDICATION

DOSE

ITP

ADULT/PEDIATRIC

Initial: 1 mcg/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.

Hematopoietic Syndrome of Acute Radiation Syndrome

ADULT/PEDIATRIC

·  10 mcg/kg subcutaneously x 1 dose administered as soon as possible after suspected or confirmed exposure to radiation

MDS

Initial: 750 mcg weekly

·   Adjust dose in 250 mcg increments (from 250 mcg every other week up to 1000 mcg weekly) based on platelet counts

  • If platelet count is <50 x 109/L for 3 consecutive weeks, then increase to the next highest dose level

  • Withhold the dose if platelet count >450 x 109/L

  • Reinitiate at a reduced dose when platelet count is <200 x 109/L

LENGTH OF AUTHORIZATION

Coverage will be provided for 3 months and may be renewed, unless otherwise specified.

DOSING LIMITS

Max Units (per dose and over time) [HCPCS Unit]:

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).

SOURCES

1.     Nplate [package insert]. Thousand Oaks, CA; Amgen Inc; January  2021. Accessed January 2021.

2.     Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for romiplostim. National Comprehensive Cancer Network, 20201. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to www.nccn.org/. Accessed January 2021.

3.     Giagounidis A, Mufti GJ, Fenaux P, et al. Results of a randomized, double-blind study of romiplostim versus placebo in patients with low/intermediate-1-risk myelodysplastic syndrome and thrombocytopenia. Cancer. 2014 Jun 15;120(12):1838-46.

4.     Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017. 129:2829-2835. doi:10.1182/blood-2017-03-754119.

5.     Neunert C, Terrell DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019 Dec 10;3(23):3829-3866.

6.     Newland A, Godeau B, Priego V, et al. Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study. Br J Haematol. 2016 Jan;172(2):262-73. doi: 10.1111/bjh.13827.

7.     Bussel JB, Buchanan GR, Nugent DJ, et al, “A Randomized, Double-Blind Study of Romiplostim to Determine Its Safety and Efficacy in Children With Immune Thrombocytopenia,” Blood, 2011, 118(1):28-36.

8.     Bussel JB, Kuter DJ, Pullarkat V, et al, “Safety and Efficacy of Long-Term Treatment With Romiplostim in Thrombocytopenic Patients With Chronic ITP,” Blood, 2009, 113(10):2161-71.

9.     Kuter DJ, Bussel JB, Lyons RM, et al, “Efficacy of Romiplostim in Patients With Chronic Immune Thrombocytopenic Purpura: A Double-Blind Randomised Controlled Trial,” Lancet, 2008, 371(9610):395-403.

10.  Kuter DJ, Rummel M, Boccia R, et al, “Romiplostim or Standard of Care in Patients With Immune Thrombocytopenia,” N Engl J Med, 2010, 363(20):1889-99.

11.  Kuter DJ, Bussel JB, Newland A, et al. Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy. Br J Haematol. 2013 May;161(3):411-23. doi: 10.1111/bjh.12260.

12.  Tarantino MD, Bussel JB, Blanchette VS, et al. Romiplostim in children with immune thrombocytopenia: a phase 3, randomised, double-blind, placebo-controlled study. Lancet. 2016 Jul 2;388(10039):45-54. doi: 10.1016/S0140-6736(16)00279-8.

13.  Kantarjian H, Fenaux P, Sekeres MA, et al. Safety and efficacy of romiplostim in patients with lower-risk myelodysplastic syndrome and thrombocytopenia. J Clin Oncol. 2010 Jan 20;28(3):437-44.

14.  Kantarjian HM, Giles FJ, Greenberg PL, et al. Phase 2 study of romiplostim in patients with low- or intermediate-risk myelodysplastic syndrome receiving azacitidine therapy. Blood. 2010 Oct 28;116(17):3163-70

15.  Lexi-Comp Online. (2021). AHFS Dl. Romiplostim. Retrieved February 11, 2021 from Lexi­ Comp Online with AHFS.

16.  MICROMEDEX Healthcare Series. Drugdex Evaluations. (2021, February). Romiplostim. Retrieved February 11, 2021 from MICROMEDEX Healthcare Series.

ORIGINAL EFFECTIVE DATE: 12/1/2016

MOST RECENT REVIEW DATE:    6/2/2021

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