CurrentEmblemHealthPolicy N/A

Nplate (romiplostim) coverage

Defines accepted indications, continuation, exclusion criteria, and authorization/approval authority for Nplate (romiplostim) medication requests for members served by the payer (EmblemHealth). Applies to network ordering providers submitting requests to Evolent for benefit determination.

Policy Summary

PayerEmblemHealth

PolicyNplate (romiplostim) coverage

Policy CodePolicy N/A

Change TypeAdministrative (no material clinical changes)

Effective DateJun 28, 2024

Next Review DateN/A

Key ActionObtain Evolent prior authorization and document support with FDA labeling, CMS compendia, NCCN/ASCO guidance, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥1 yrminimum member age

<30platelet threshold

10 mcg/kgsingle-dose max

1 mcg/kg/wktitration step

06/28/24effective

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inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Chronic ITP initial request: Member is adult or pediatric ≥1 year with relapsed/refractory chronic ITP and initial request is for platelet count <30 x 10^9/Lplatelets <30 x 10^9/L

from policy chunk 4

Prior corticosteroid failure/intolerance: Member has experienced therapeutic failure of, or has intolerance/contraindication to, corticosteroids

from policy chunk 4

Dosing guidance: Recommended dosing guidelines for Nplate (romiplostim) are followed (start dose per labeling with subsequent increments of 1 mcg/kg/week if platelet count remains below 50 x 10^9/L)increment 1 mcg/kg/week

from policy chunk 4

Concurrent administration of Nplate (romiplostim) with other thrombopoietin (TPO) receptor agonists is excluded. Specifically, combined use with Promacta (eltrombopag) or Doptelet (avatrombopag) is not allowed. Additionally, requests will be excluded if the prescribed dosing exceeds the policy’s single‑dose maximum of 10 mcg/kg.

Use of Nplate for investigational or off‑label indications that lack sufficient supporting evidence is excluded. The policy requires that indications be supported by CMS‑recognized compendia or acceptable peer‑reviewed literature; case reports, abstracts without full peer‑reviewed publication, and other anecdotal evidence are generally insufficient. Evidence should adequately represent the patient population, the treatment regimen, and demonstrate clinically meaningful outcomes per accepted standards.

Clinical Thresholds and Coding-Related Limits

inv-04: Platelet count — clinical threshold for initial requests

Clinical thresholdInitial requests for chronic ITP require a platelet count < 30 x 10^9/L

Applies toAdult and pediatric patients age ≥1 year

Associated requirementMember must have relapsed/refractory chronic ITP

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

inv-05: Single dose maximum — maximum allowed single dose before exclusion

Single‑dose maximumMaximum allowed single dose of Nplate (romiplostim) is 10 mcg/kg — doses exceeding this are excluded

Exclusion consequenceRequests with dosing that exceed the single‑dose limit are excluded from coverage

Related exclusionConcurrent use with other TPO receptor agonists is also excluded

Initial Therapy for Chronic ITP

inv-12: Initial Therapy for Chronic ITP — initial therapy covered when criteria met

Initial therapy covered when criteria met

Age and diagnosis: Member is adult or pediatric ≥1 year with relapsed/refractory chronic ITPage ≥1 year

chunk 4

Platelet threshold: Initial request is for platelet count <30 x 10^9/L<30 x 10^9/L

chunk 4

Prior corticosteroid failure/intolerance: Therapeutic failure of or intolerance/contraindication to corticosteroids

chunk 4

Provider Requirements, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Evolent is responsible for processing all medication requests from network ordering providers. Medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable. Final authorization is granted by the Utilization Management Committee per approval authority.

Evolent processes prior authorization requests for Nplate (romiplostim).
Final approval authority: Utilization Management Committee.

Documentation Required

Support by Accepted Evidence Required

Requests must be supported by recognized evidence. The use of Nplate should be documented with one or more of the following: FDA-approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature that meets CMS standards.

Acceptable sources: FDA labeling; CMS compendia; NCCN; ASCO; peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.
Insufficient evidence examples: case reports, abstracts without full peer‑reviewed articles, or literature that does not adequately represent patient/therapy characteristics or clinically meaningful outcomes.

Denial Risk

Corticosteroid Failure/Intolerance Required for Chronic ITP

For chronic ITP (age ≥ 1 year) initial requests for Nplate require documented therapeutic failure of, intolerance to, or contraindication to corticosteroids prior to approval. The request should also indicate an initial platelet count < 30 x 10^9/L and follow recommended dosing/titration guidelines (e.g., start dose mcg/kg with weekly increments of 1 mcg/kg if platelets remain < 50 x 10^9/L).

Adult or pediatric (≥ 1 year) with relapsed/refractory chronic ITP and platelet count < 30 x 10^9/L required for initial approval.
Document corticosteroid failure, intolerance, or contraindication prior to Nplate initiation.
Dosing must follow recommended titration: start dose per labeling and increase by 1 mcg/kg/week if platelets remain < 50 x 10^9/L.

Documentation Required

Evidence Documentation and Continuation Exemptions

Continuation requests for medications deemed not approvable under this policy may be exempt when specific continuity criteria are met. Additionally, investigational or off‑label uses lacking sufficient accepted evidence may be excluded from approval/reimbursement.

Continuation exemption applies if the medication was used within the last year, the member has not experienced disease progression or intolerance, and no additional medications are being added to the continuation request.
Off‑label or investigational uses without adequate supporting evidence (per CMS compendia or acceptable peer‑reviewed literature) may be denied or deemed not reimbursable.

Continuation and Reauthorization Criteria

inv-13: Continuation Requests Exemption — conditions under which previously non-approvable medications may be exempt

Continuation requests for previously used not-approvable medications may be exempt if ALL of the following are met:

Continuation exemption: Requested medication was used within the last yearwithin last year

from policy chunk 3

No progression or intolerance: Member has not experienced disease progression and has not experienced intolerance to the requested medication

from policy chunk 3

No additional medications: No additional medication(s) are being added to the continuation request

from policy chunk 3

Step	Requirement
1	Member has experienced therapeutic failure of, or has intolerance/contraindication to, corticosteroids before initiation of Nplate (romiplostim).

Key Definitions

inv-11: Chronic ITP definition — relapsed/refractory chronic immune thrombocytopenic purpura in patients ≥1 year with platelet count threshold

DefinitionRelapsed/refractory chronic immune thrombocytopenic purpura (chronic ITP) in patients ≥1 year of age

Platelet threshold for initial Nplate requestsPlatelet count < 30 x 10^9/L

Prior treatment requirementTherapeutic failure of, or intolerance/contraindication to, corticosteroids is required before Nplate

Dosing guidance noteRecommended dosing must be followed (start dose specified in policy; subsequent increments by 1 mcg/kg/week if platelets remain <50 x 10^9/L)

Policy Summary

PayerEmblemHealth

PolicyNplate (romiplostim) coverage

Policy CodePolicy N/A

Change TypeAdministrative (no material clinical changes)

Effective DateJun 28, 2024

Next Review DateN/A

Key ActionObtain Evolent prior authorization and document support with FDA labeling, CMS compendia, NCCN/ASCO guidance, or acceptable peer-reviewed literature.

SourceLink

On This Page

OpenPayer

Nplate (romiplostim) coverage

Coverage Criteria for Nplate (romiplostim)

Clinical Thresholds and Coding-Related Limits

Initial Therapy for Chronic ITP

Provider Requirements, Documentation, and Authorization

Continuation and Reauthorization Criteria

Step Therapy Requirements

Key Definitions

Background on Nplate (romiplostim)