CurrentCommunity-CarePolicy N/A

Nplate (romiplostim) — Medical Benefit Medication Utilization Policy

Defines medical benefit coverage criteria, quantity limits, authorization periods, and applicable codes for romiplostim (Nplate) for immune thrombocytopenia and hematopoietic syndrome of acute radiation syndrome for the payer's membership.

Policy Summary

PayerCommunity-Care

PolicyNplate (romiplostim) — Medical Benefit Medication Utilization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, hematologist involvement, prior therapies, current platelet count, and patient weight.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2indications covered

10 mcg/kg/wkmax dose (ITP)

1 yrauth period (ITP)

1 moauth period (radiation)

Coverage Criteria for Romiplostim (Nplate)

Initial Therapy — Hematopoietic syndrome of acute radiation syndrome

Covered when ALL of the following are met

Hematopoietic radiation syndrome diagnosis: Diagnosis of hematopoietic syndrome of acute radiation syndrome

Required for approval

Initial Therapy — Immune thrombocytopenia

Covered when ALL of the following are met

Prescriber specialty: Prescribed by, or in consultation with, a hematologist

Required

Diagnosis of immune thrombocytopenia

Required

Policy Summary

PayerCommunity-Care

PolicyNplate (romiplostim) — Medical Benefit Medication Utilization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, hematologist involvement, prior therapies, current platelet count, and patient weight.

SourceLink

On This Page

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This policy establishes that romiplostim (Nplate) is a covered medication when the documented clinical criteria are met for the approved indications. For hematopoietic syndrome of acute radiation syndrome, coverage is available when the diagnosis is documented. For immune thrombocytopenia (ITP), coverage for initial therapy requires that the medication be prescribed by or in consultation with a hematologist, the diagnosis of ITP is documented, a trial of one of the following — corticosteroids, immunoglobulins, or splenectomy — was ineffective, contraindicated, or not tolerated, and the member’s platelet count is < 30,000/µl. Continuation of therapy for ITP requires documentation that the member is being monitored and has had a meaningful improvement in platelet count such that continued treatment with romiplostim is appropriate.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for romiplostim (Nplate). Approval is granted only when the specified clinical criteria are met and required documentation is submitted.

Prior authorization required prior to dispensing/administering romiplostim
Approval limited to when medical necessity criteria (Initial or Continuation) are satisfied

Step Therapy

Step Therapy Prior to Romiplostim

For immune thrombocytopenia (ITP), a step-therapy requirement applies before romiplostim will be approved. The prescriber must document that one of the following was ineffective, contraindicated, or not tolerated:

Corticosteroids
Immunoglobulins (e.g., IVIG)
Prior splenectomy

Documentation Required

Required Documentation

Documentation must be provided with the prior authorization request to support the diagnosis and clinical need for romiplostim. Required documentation includes:

Confirmed diagnosis (e.g., immune thrombocytopenia) with relevant clinical notes
Platelet counts, including baseline and recent values (for ITP: platelet count < 30,000/µl for initial approval when applicable)
Weight (required for dosing authorization up to 10 mcg/kg/week)
Evidence of hematologist involvement: prescription by or consultation with a hematologist
Documentation of prior therapies tried and the reason they were ineffective, contraindicated, or not tolerated (for ITP step therapy)
Monitoring plan and documentation of meaningful platelet response for continuation requests

Denial Risk

Triggers for Denial

Applications may be denied if required information is missing or if clinical criteria are not met. Common triggers for denial include:

Absence of documentation that a hematologist prescribed the medication or was consulted
Lack of evidence of diagnosis consistent with the approved indications (e.g., no documentation of ITP or hematopoietic syndrome of acute radiation syndrome)
Missing platelet counts or other laboratory data demonstrating need (for ITP: no platelet count < 30,000/µl when required for initial approval)
No documentation of prior trial(s) of corticosteroids, immunoglobulins, or splenectomy when step therapy is applicable
Missing patient weight when dosing/quantity limits are weight-based
Insufficient documentation of clinical benefit or monitoring for continuation requests

Key Definitions

inv-13: Immune thrombocytopenia (ITP) — definition/label as documented by prescriber

DefinitionImmune thrombocytopenia (ITP): Diagnosis of immune thrombocytopenia documented by the prescriber as the indication for romiplostim

Prescriber requirementPrescribed by, or in consultation with, a hematologist for initial approval

Prior therapiesTrial of corticosteroids, immunoglobulins, or splenectomy must be ineffective, contraindicated, or not tolerated

inv-14: Hematopoietic syndrome of acute radiation syndrome — definition/approved indication under medical benefit

Approved indicationHematopoietic syndrome of acute radiation syndrome: diagnosis documented as an approved indication for romiplostim under the medical benefit

Initial approval criterionDiagnosis of hematopoietic syndrome of acute radiation syndrome is required for approval

Authorization periodIf approved, coverage is allowed for one month (subject to benefit changes)

Background

Romiplostim (Nplate) is a thrombopoietin receptor agonist used to increase platelet counts and is listed in this policy for two indications: immune thrombocytopenia (ITP) and hematopoietic syndrome of acute radiation syndrome. For ITP, use is managed by or in consultation with a hematologist and generally follows failure, intolerance, or contraindication to first‑line therapies (corticosteroids, immunoglobulins, or splenectomy). Dosing guidance in the policy authorizes up to 10 mcg/kg per week when approved (a patient weight is required for dosing), and the authorization periods are defined as up to one year for ITP and up to one month for hematopoietic radiation syndrome.

OpenPayer

Nplate (romiplostim) — Medical Benefit Medication Utilization Policy

Coverage Criteria for Romiplostim (Nplate)

Applicable Codes and Clinical Thresholds

Prior Authorization, Documentation, and Denial Triggers

Key Definitions

Background