ph-0089
print Print Back Back

Nplate ( romiplostim)

Policy Number: PH-0089

(Subcutaneous)

 

Last Review Date: 02/04/2020

Date of Origin: 01/01/2012

Dates Reviewed: 12/2011, 02/2013, 02/2014, 12/2014, 10/2015, 09/2016, 12/2016, 03/2017, 06/2017, 12/2017, 03/2018, 06/2018, 10/2018, 01/2019, 12/2019, 02/2020

  1. Length of Authorization

Coverage will be provided for 3 months and may be renewed.

  1. Dosing Limits

A.  Quantity Limit (max daily dose) [NDC Unit]:

  • 250 mcg injection: 20 vials per 28 days
  • 500 mcg injection: 12 vials per 28 days

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

  • 125 billable units weekly
  1. Initial Approval Criteria1

Coverage is provided in the following conditions:

Universal Criteria

  • Patient is not on any other thrombopoietin receptor agonist or mimetic (e.g., lusutrombopag, eltrombopag, avatrombopag, etc) or fostamtinib; AND
  • Must not be used in an attempt to normalize platelet counts; AND
  • Laboratory value for platelet count is current (i.e., drawn within the previous 28 days); AND

Immune (idiopathic) thrombocytopenia (ITP) †1,4,5,6,7,8,9,10

  • The patient is at increased risk for bleeding as indicated by platelet count less than 30 × 109/L (30,000/mm³); AND
    • Patient has acute ITP; AND
      • Patient is at least 18 years of age; AND
      • Patient has previously failed one of the following treatments for ITP:
        • Patient has failed previous therapy with corticosteroids; OR
        • Patient has failed previous therapy with immunoglobulins; OR
        • Patient has had a splenectomy; OR
    • Patient with chronic ITP for at least 6 months (or meets the corticosteroid requirement below); AND
      • Patient is 1 year of age or older; AND
      • Patient has previously failed one of the following treatments for ITP:
        • Patient has failed previous therapy with corticosteroids (i.e., patient had no response to at least a 3-month trial or is corticosteroid-dependent); OR
        • Patient has failed previous therapy with immunoglobulins; OR
        • Patient has had a splenectomy

Myelodysplastic Syndromes (MDS) ‡2,3

  • Patient has lower risk disease [i.e., IPSS-R (Very Low, Low, Intermediate), IPSS (Low/Intermediate-1), WPSS (Very Low, Low, Intermediate)]; AND
  • Patient has severe or refractory thrombocytopenia (i.e., platelet count <20 x 109/L or higher with a history of bleeding); AND
  • Patient progressed or had no response to hypomethylating agents (e.g., azacitadine, decitabine, etc.), immunosuppressive therapy, or clinical trial

FDA-labeled indication(s); Compendia recommended indication(s)

  1. Renewal Criteria1
  • Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: thrombotic/thromboembolic complications, risk of progression of myelodysplastic syndromes to acute myelogenous leukemia, etc.; AND

ITP

  • Disease response indicated by the achievement and maintenance of a platelet count of at least 50 × 109/L (not to exceed 400 x 109/L) as necessary to reduce the risk for bleeding; OR

MDS2,3

  • Patient has not developed acute myeloid leukemia (AML) (Note: romiplostim induces an increase in immature white blood cells and peripheral blasts which is not indicative of development of AML); AND
  • Disease response indicated by an increase in platelet count compared to pretreatment baseline (not to exceed 450 x 109/L), reduction in bleeding events, or reduction in platelet transfusion requirements
  1. 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.

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
  • Do not exceed the maximum weekly dose of 10 mcg/kg
  1. Billing Code/Availability Information

HCPCS:

  • J2796 – Injection, romiplostim, 10 micrograms; 10 mcg = 1 billable unit

NDC(s):

  • Nplate 125 mcg single-dose vial: 55513-0223-xx
  • Nplate 250 mcg single-dose vial: 55513-0221-xx
  • Nplate 500 mcg single-dose vial: 55513-0222-xx
  1. References
  1. NPlate [package insert]. Thousand Oaks, CA; Amgen Inc; October 2019. Accessed January 2020.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for romiplostim. National Comprehensive Cancer Network, 2020. 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 2020.
  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.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C93.10

Chronic myelomonocytic leukemia not having achieved remission

D46.0

Refractory anemia without ring sideroblasts, so stated

D46.1

Refractory anemia with ring sideroblasts

D46.20

Refractory anemia with excess of blasts, unspecified

D46.21

Refractory anemia with excess of blasts 1

D46.4

Refractory anemia, unspecified

D46.9

Myelodysplastic syndrome, unspecified

D46.A

Refractory cytopenia with multilineage dysplasia

D46.B

Refractory cytopenia with multilineage dysplasia and ring sideroblasts

D46.Z

Other myelodysplastic syndromes

D69.3

Immune thrombocytopenic purpura

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Articles may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/Article): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto Government Benefit Administrators, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

NPLATE™ (romiplostim) Prior Auth Criteria
Proprietary Information. Restricted Access – Do not disseminate or copy without approval.
©2020, Magellan Rx Management

White MRx.PNG