CurrentEmblemHealthPolicy N/A

Nplate (romiplostim) — coverage criteria for thrombocytopenia

Defines accepted indications, dosing guidance, contraindications, exclusions, coding, and prior authorization expectations for Nplate (romiplostim) for members across specified lines of business; applies to providers submitting medication requests to Evolent/EmblemHealth.

Policy Summary

PayerEmblemHealth

PolicyNplate (romiplostim) — coverage criteria for thrombocytopenia

Policy CodePolicy N/A

Change TypeAdded new indication (CIT)template conversion/replacement

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with supporting FDA labeling or CMS-recognized compendia and documentation showing eligibility (e.g., CIT or chronic ITP criteria) to Evolent.

SourceLink

POLICY UPDATE CHANGES

Added new indication for chemotherapy-induced thrombocytopenia (CIT).

Converted to new Evolent guideline template and replaced prior UM ONC_1243 guideline.

2Indications covered

J2802HCPCS code

≤10 mcg/kgMax single-dose

Commercial/Exchange/MedicaidApplicable lines

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Chemotherapy-Induced Thrombocytopenia (CIT)

Covered when ALL of the following are met

CIT coverage criteria

Requested therapy follows the recommended romiplostim dosing guidelines (start 2 mcg/kg, increase by 1 mcg/kg/week for up to 3 weeks) until platelet count ≥ 100 x 10^9/L is achieved.

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Chronic Immune Thrombocytopenic Purpura (ITP)

Covered when ALL of the following are met

Chronic ITP coverage criteria

Requested therapy follows the recommended romiplostim dosing guidelines (start 1 mcg/kg with subsequent increments of 1 mcg/kg/week if platelet count remains < 50 x 10^9/L).

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Coverage excludes concurrent use of Nplate (romiplostim) with other thrombopoietin (TPO) receptor agonists, specifically including Promacta (eltrombopag) and Doptelet (avatrombopag).

Requests will also be excluded when proposed dosing exceeds a single dose of 10 mcg/kg for romiplostim.

Investigational or off‑label uses that lack sufficient evidence or are not generally accepted by the medical community are excluded. Adequate evidence must be supported by CMS‑recognized compendia or acceptable peer‑reviewed literature and should address whether the patient and regimen are represented in the evidence, whether outcomes are clinically meaningful (for example ASCO‑recommended thresholds), and whether study design is appropriate. Case reports and meeting abstracts without full peer‑reviewed publication generally do not provide adequate support.

Off‑label indications for romiplostim are considered investigational or not generally accepted when there is insufficient supporting evidence in CMS‑recognized compendia or acceptable peer‑reviewed literature. The policy specifies that adequacy of evidence is judged by whether the clinical characteristics of the patient and cancer, the administered oncologic regimen, and the reported study outcomes are adequately represented in the published literature.

The guideline outlines additional evidence standards including expectations for clinically meaningful outcomes (for example, ASCO‑recommended effect sizes), appropriate experimental design for the question at hand, and that non‑randomized trials with substantial subject numbers may provide supportive evidence. Conversely, single case reports and abstracts without full peer‑reviewed articles are generally inadequate to establish an off‑label use as accepted.

Dosing guidance summary (CIT)

Starting dose2 mcg/kg (initial dose for CIT)

Titration scheduleIncrease by 1 mcg/kg weekly for up to 3 weeks until platelet ≥100 x 10^9/L

Target platelet rangeAim for platelet count ≥100 x 10^9/L for CIT to allow chemotherapy continuation

Single-dose capDo not exceed a single dose of 10 mcg/kg

Regimen	Dosing / Titration	Notes
Romiplostim (Nplate)	Start 2 mcg/kg subcutaneously once weekly; increase by 1 mcg/kg weekly with monitoring of platelet count until target achieved; do not exceed a single dose of 10 mcg/kg.	Used to support continuation/initiation of chemotherapy when thrombocytopenia meets CIT definition; concurrent use with other TPO receptor agonists is excluded; clinical evidence and prescribing information should be referenced.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Requests for Nplate (romiplostim) must obtain prior authorization unless they meet the continuity/continuation exemption criteria below.

Prior authorization required for new starts and non-continuation requests.
Continuation exemption: member has not had disease progression on the requested medication; the medication was used within the last year without a lapse >30 days of an active authorization; and no additional medications are being added to the continuation request.

Prior Authorization

Chronic ITP — Prior Therapy and Dosing Requirements

For chronic immune thrombocytopenic purpura (ITP), documentation must show the member is age ≥1 year with relapsed/refractory chronic ITP, the initial request is for platelet count < 30 x 10^9/L, and the member has experienced therapeutic failure of, or intolerance/contraindication to, corticosteroids. Dosing must follow recommended titration (start 1 mcg/kg with weekly 1 mcg/kg increments if platelet count remains < 50 x 10^9/L).

Applicable to adult and pediatric members ≥1 year.
Initial platelet count requirement: < 30 x 10^9/L.
Must have failed or be intolerant/contraindicated to corticosteroids.
Follow recommended dosing and titration (start 1 mcg/kg; increase by 1 mcg/kg/week as indicated).

Documentation Required

Evidence and Documentation Requirements

Requests must be supported by one of the following sources: FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS standards. Supply supporting documentation with the request (relevant prescribing information, compendia citations, guideline excerpts, or peer-reviewed articles).

Acceptable evidence: FDA-approved product labeling (Nplate prescribing information).
CMS-recognized compendia and NCCN/ASCO guidelines.
Peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards (e.g., full articles, not abstracts or anecdotal case reports).
Cite specific references included with request as applicable.

Denial Risk

Exclusion Conditions and Denial Risks

Requests meeting any exclusion criteria are at high risk for denial. Do not request concurrent use with other TPO receptor agonists, exceed the single-dose limit, or request investigational/off-label uses without sufficient evidence.

Exclusion — concurrent use with other TPO receptor agonists (eltrombopag, avatrombopag) is not allowed.
Exclusion — dosing exceeding single-dose limit of 10 mcg/kg will be denied.
Exclusion — investigational or off‑label indications lacking sufficient evidence (insufficient representation of patient/therapy in published evidence, uncontrolled case reports, abstracts without full articles, or otherwise not supported by CMS compendia or acceptable peer‑reviewed literature).

Definitions

Definition: Chemotherapy-Induced Thrombocytopenia (CIT)

DefinitionChemotherapy-Induced Thrombocytopenia (CIT): platelets < 100 x 10^9/L for ≥ 3 to 4 weeks following last chemotherapy administration and/or following delays in chemotherapy initiation related to thrombocytopenia

PopulationAdults receiving chemotherapy

Dosing implicationEligible when recommended romiplostim dosing is followed (start 2 mcg/kg, increase by 1 mcg/kg/week up to 3 weeks until platelet ≥100 x 10^9/L)

Definition: Chronic ITP (relapsed/refractory)

DefinitionChronic ITP: relapsed/refractory chronic idiopathic thrombocytopenic purpura in adults or pediatric patients ≥1 year of age

Platelet requirementInitial request must be for platelet count < 30 x 10^9/L

Prior therapy requirementMember has experienced therapeutic failure of, or has intolerance/contraindications to corticosteroids

Dosing guidanceStart 1 mcg/kg and increase by 1 mcg/kg/week if platelet count remains <50 x 10^9/L on the prior dose

Background

Romiplostim (Nplate) is a thrombopoietin receptor agonist used to increase platelet counts. Within this guideline it is addressed for immune thrombocytopenia and newly for chemotherapy‑induced thrombocytopenia, with dosing recommendations and safety limits to achieve platelet targets while avoiding excessive dosing.

The policy emphasizes appropriate use parameters and evidence standards when romiplostim is proposed for off‑label indications — including representation of the patient population and regimen in the published evidence and demonstration of clinically meaningful outcomes — to ensure romiplostim’s clinical role is supported by adequate literature before coverage is approved.

OpenPayer

Nplate (romiplostim) — coverage criteria for thrombocytopenia

Coverage Criteria for Nplate (romiplostim)

Regimens and Dosing

Coding and Platelet Thresholds

Provider Actions and Authorization Requirements

Line of Therapy / Salvage Use

Definitions

Background