RXMP-13 Nplate (romiplotism) Form

Nplate (romiplostim)

Updated on: 10/25/2025

Page 1 of 3 Policy Number RXMP-13 Line of Business Medicaid & Medicare Effective Date 5/26/2023 Revision Date 10/25/2025

Products: Nplate (romiplostim)

Override(s)
Approval Duration
Prior Authorization
• Initial: All indications except for HS-ARS: 6 months; Renewal: 12 months • HS-ARS: 1 single administration per episode

HCPCS Description Medical Benefit: Authorization Required J2796 Injection, romiplostim, 10 mcg [Nplate]

Medicare Criteria Medicare Part B Coverage Criteria
Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. • No LCD/NCD/LCA found as of 10/25/2025. Review using NPlate criteria below Medicare Part B 90-Day Transition Period For new Medicare members, a 90-day transition period applies. During this time, if a member is currently on an active course of the requested treatment, including when furnished by an out-of-network provider, Coverage and Step Therapy do not apply. After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage. Medicare Part B Step Therapy Criteria • For new starts, Medicare Part B Step Therapy Criteria must be met in addition to Coverage Criteria before a request may be approved.
• No step therapy

Approval Criteria Products Nplate (romiplostim) Line of Business Medicare and Medicaid Approval Length • Initial: All indications except for HS-ARS: 6 months; Renewal: 12 months • HS-ARS: 1 single administration per episode Override Type PA, QL Initial Criteria

1. Prescribed by or in consultation with a hematologist/oncologist
   AND
2. Diagnosis of hematopoietic syndrome of acute radiation syndrome (HS-ARS) AND the member is acutely exposed to myelosuppressive doses of radiation levels greater than 2 gray (Gy). OR
3. Immune thrombocytopenia (ITP) OR Relapsed/refractory ITP AND all of the following: a. Baseline platelet count is less than 30,000/mcL
   b. Inadequate response or intolerance to prior therapy with one of the following:
   1) Corticosteroids (e.g., dexamethasone, prednisone); or
   2) Immune globulins (e.g., Gammaplex, Gammagard S/D); or
   3) Splenectomy
   OR
4. Chemotherapy-induced Thrombocytopenia (CIT) AND all of the following (a, b or c): a. One of the following (1 or 2):

Nplate (romiplostim)

Updated on: 10/25/2025

Page 2 of 3 1) The platelet count is less than 100 x 109/L for at least 3 to 4 weeks following the last chemotherapy administration; OR 2) The platelets less than 100 x 10 9/L and there are delays in chemotherapy related to thrombocytopenia; AND b. The member was using a cytotoxic chemotherapy agent that is known to cause thrombocytopenia.
AND c. The goal of therapy is to maintain the dosing schedule and/or intensity of the chemotherapy regimen when such benefit outweighs the potential risks.
OR

5. Diagnosis of Myelodysplastic Syndromes AND both of the following: a. Documentation is provided that individual has a diagnosis of lower risk myelodysplastic syndrome (MDS) [Lower risk defined as IPSS-R (Very Low, Low, Intermediate), IPSS (Low/Intermediate-1), WPSS (Very low, low, intermediate)]; AND b. Individual has severe or refractory thrombocytopenia following disease progression or no response to hypomethylating agents or immunosuppressive therapy. Renewal Criteria
6. Documentation is provided that individual has demonstrated a response to therapy as confirmed by increased platelet counts; AND

7. One of the following diagnosis: a. Myelodysplastic Syndromes; or b. Diagnosis of Immune Thrombocytopenia (ITP) AND continuation of treatment is to maintain an adequate platelet count (50 – 100 X 10 9/L)* to decrease the risk of bleeding; or
   c. Chemotherapy-induced Thrombocytopenia (CIT) AND Continuation of treatment is to maintain an adequate platelet count (100 - 150 X 10 9/L) to allow for the resumption of chemotherapy regimen as appropriate.

   Exclusion Nplate (romiplostim) may not be approved for any of the following:

8. Normalizing platelet counts;
9. The treatment of low platelet count caused by any condition other than those conditions listed above; or

10. When the above criteria are not met and for all other indications.

    FDA Indications & Dosing Indication Dosing/Administration Hematopoietic subsyndrome of acute radiation syndrome 10 mcg/kg subQ single injection administered as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy). Administer regardless of whether a CBC can be obtained. Estimate the whole-body absorbed dose based on information from public health authorities, biodosimetry if available, or clinical findings (eg, time to onset of vomiting or lymphocyte depletion kinetics) Immune thrombocytopenia, In patients with insufficient response to corticosteroids, immunoglobulins, or splenectomy Initial dosage, 1 mcg/kg (actual body weight) subQ once weekly. Adjust weekly in increments of 1 mcg/kg to achieve platelet counts of 50 x 10(9)/L or greater. MAX weekly dose 10 mcg/kg; median dose was 2 to 3 mcg/kg in studies. If the platelet count is not adequate to control bleeding after 4 weeks at the MAX dose, discontinue use

    References

11. OptumRx, PA criteria, accessed May 2023.
12. CodeSource, accessed May 2023.

13. Micromedix, accessed May 2023.

    Review History

Nplate (romiplostim)

Updated on: 10/25/2025

Page 3 of 3

1. Nplate (romiplostim), supersedes prior version, 5/26/23 HB.
2. Added Continuity of Care requirement, 4/3/25 AP.