CurrentUnitedHealthcarePolicy CS2025D0214J

Nplate (romiplostim) — Medical Benefit Drug Policy (ITP and Lower‑Risk MDS)

Medical benefit drug policy describing clinical coverage criteria and authorization requirements for Nplate (romiplostim) for immune thrombocytopenic purpura (ITP) and lower‑risk myelodysplastic syndromes (MDS) for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyNplate (romiplostim) — Medical Benefit Drug Policy (ITP and Lower‑Risk MDS)

Policy CodePolicy CS2025D0214J

Change TypeState-specific application update

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization and document diagnosis, baseline platelet count, and prior therapies before initiating or continuing Nplate.

SourceLink

POLICY UPDATE CHANGES

Application: Added language that this Medical Benefit Drug Policy does not apply to the state of Arizona; refer to the state's Medicaid clinical policy.

12 monthsmaximum initial and continuation authorization period

<30baseline platelet count required for initial ITP therapy

≥50platelet count threshold indicating clinical response for continuation

J2802HCPCS code for romiplostim (1 mcg)

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Coverage Criteria for Nplate (romiplostim)

Initial Therapy (ITP)

Nplate is proven and medically necessary for chronic ITP when ALL of the following are met:

Initial ITP therapy: Diagnosis of chronic immune thrombocytopenic purpura (ITP);

Baseline platelet count: Documented baseline platelet count < 30 x 10^9/L;< 30 x 10^9/L

Prior therapy failure or intolerance: History of insufficient response, contraindication, or intolerance to one of the following: corticosteroids, immunoglobulins, or splenectomy;

Specialist involvement: Prescribed by or in consultation with a hematologist;

Appropriate indication: Nplate is not being used to treat thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP;

Not to normalize counts: Nplate is not being used to normalize platelet counts;

Dosing: Nplate is initiated and titrated according to U.S. Food and Drug Administration labeled dosing for ITP;

Initial authorization up to 12 months.

Continuation Therapy (ITP)

For continuation of ITP therapy, ALL of the following are required:

Prior Nplate exposure: Patient has previously received Nplate subcutaneous injection;

Clinical response: Documentation of positive clinical response to therapy as evidenced by an increase in platelet count to a level sufficient to avoid clinically important bleeding (platelet count ≥ 50 x 10^9/L as necessary to reduce the risk for bleeding);>= 50 x 10^9/L

Appropriate indication: Nplate is not being used to treat thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP;

Not to normalize counts: Nplate is not being used to normalize platelet counts;

MDS (Lower‑Risk) Therapy

Nplate is medically necessary for treatment of Myelodysplastic Syndromes (MDS) when ALL of the following are met:

Diagnosis of lower risk myelodysplastic syndrome (IPSS-R very low, low, intermediate);

Thrombocytopenia severity: Presence of severe thrombocytopenia or refractory thrombocytopenia;

Prior HMA/IST status: One of the following: disease progression after hypomethylating agent(s) (HMA) or immunosuppressive therapy (IST); no response to HMA or IST; or relapse after HMA or IST;

Initial authorization up to 12 months.

Continuation criteria: For continuation, patient does not show evidence of progressive disease while on Nplate therapy; and patient demonstrates clinically significant response defined by one of the following: increased platelet counts; decreased bleeding events; or reduced need for platelet transfusion;

Authorization up to 12 months. NCCN Category 2A support referenced.

Nplate (romiplostim) is not indicated for thrombocytopenia due to causes other than chronic immune thrombocytopenic purpura (ITP). Requests for Nplate should be limited to members with a documented diagnosis of chronic ITP or lower‑risk myelodysplastic syndrome (MDS) when applicable. Nplate must not be used to normalize platelet counts and should only be initiated and titrated according to the U.S. Food and Drug Administration labeled dosing for ITP.

Use of Nplate to achieve normalization of platelet counts is not supported by this policy. For continuation of ITP therapy, the patient must have previously received subcutaneous Nplate and demonstrate a positive clinical response, defined as an increase in platelet count sufficient to avoid clinically important bleeding (specifically platelet count ≥ 50 × 10^9/L as necessary to reduce bleeding risk). Additionally, Nplate must not be used for thrombocytopenia due to myelodysplastic syndromes or other non‑ITP causes when the MDS criteria in this policy are not met.

Indication	Regimen / Dosing	Supporting Rationale	Coverage Status
Lower‑risk MDS with severe or refractory thrombocytopenia after progression or no response to HMA/IST (IPSS‑R Very Low, Low, Intermediate)
Romiplostim (Nplate) administered per FDA‑labeled dosing (initiate and titrate according to product labeling)
NCCN Drugs & Biologics Compendium: Category 2A recommendation for romiplostim in lower‑risk MDS with severe or refractory thrombocytopenia following progression or lack of response to hypomethylating agents or immunosuppressive therapy; policy requires diagnosis of lower‑risk MDS and presence of severe or refractory thrombocytopenia.
covered

Billing and Diagnosis Codes

Covered HCPCS CodesHCPCS

J2802

Injection, romiplostim, 1 mcg

Relevant ICD-10 CodesICD-10

D69.3	Immune thrombocytopenic purpura
D46.Z	Other myelodysplastic syndromes
D46.9	Myelodysplastic syndrome, unspecified

Platelet count thresholds — baseline and response

Baseline platelet count for initial ITP therapyDocumented baseline platelet count < 30 x 10^9/L

Continuation therapy response thresholdPlatelet count ≥ 50 x 10^9/L (increase sufficient to avoid clinically important bleeding)

Maximum authorization periodInitial and continuation authorizations are granted for no more than 12 months

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial and continuation authorizations are each granted for no more than 12 months.

Initial authorization duration: ≤ 12 months
Continuation authorization duration: ≤ 12 months

Documentation Required

Documentation Requirements

For chronic immune thrombocytopenic purpura (ITP), the provider must document the diagnosis of chronic ITP and a baseline platelet count. Documentation should include baseline platelet count, prior therapies and their outcomes, and evidence of positive clinical response for continuation requests.

Documented diagnosis: chronic ITP
Baseline platelet count (e.g., < 30 × 10^9/L for initial therapy)

Salvage and Line of Therapy Considerations

salvage

Use in the post‑HMA/IST (salvage) setting is considered when ALL of the following are met:

Line of therapy - Post‑HMA/IST setting: Use considered after disease progression, lack of response, or relapse following hypomethylating agents or immunosuppressive therapy in lower‑risk MDS with severe or refractory thrombocytopenia;

NCCN Drugs and Biologics Compendium Category 2A referenced for this salvage setting.

Covered Regimens and Dosing

Regimen	Clinical Criteria	Authorization Notes
Romiplostim (Nplate) per FDA dosing and NCCN compendium support
Diagnosis of lower‑risk MDS (IPSS‑R very low, low, or intermediate) AND presence of severe thrombocytopenia or refractory thrombocytopenia; one of the following: disease progression after HMA/IST, no response to HMA/IST, or relapse after HMA/IST.
Prior authorization required; initial authorization up to 12 months. Continuation considered if clinically significant response (increased platelets, decreased bleeding, or reduced transfusion requirement) and no progressive disease while on therapy. NCCN Category 2A support referenced.

Definitions and Risk Stratification

Lower‑risk MDS — definition and context

Definition of lower‑risk MDS (IPSS‑R)IPSS‑R Very Low, Low, or Intermediate

NCCN contextNCCN supports romiplostim for lower‑risk MDS with severe or refractory thrombocytopenia after progression or no response to HMA/IST

Use case for therapy considerationConsider romiplostim after disease progression, lack of response, or relapse following hypomethylating agents or immunosuppressive therapy

Background

Immune thrombocytopenic purpura (ITP) is an autoimmune disorder characterized by low platelet counts and mucocutaneous bleeding; in adults, ITP is frequently chronic. Thrombopoietin receptor agonists such as romiplostim (Nplate) act by stimulating megakaryocytes to increase platelet production. In the context of myelodysplastic syndromes (MDS), patients with lower‑risk disease (IPSS‑R Very Low, Low, or Intermediate) may develop severe or refractory thrombocytopenia and can be considered for romiplostim in selected circumstances after inadequate response to treatments such as hypomethylating agents or immunosuppressive therapy.

Revision History

2025-10-01state-specific application note addedLatest

Application: added language that this Medical Benefit Drug Policy does not apply to the state of Arizona; refer to the state's Medicaid clinical policy; archived previous policy version CS2025D0214I.