CurrentAnthemPolicy CC-0111

Nplate (romiplostim) — clinical prior authorization and medical necessity criteria

Clinical prior authorization and medical necessity criteria for use of Nplate (romiplostim) across ITP, lower-risk MDS, HS-ARS, chemotherapy-induced thrombocytopenia, and immunotherapy-related thrombocytopenia for Anthem members.

Policy Summary

PayerAnthem

PolicyNplate (romiplostim) — clinical prior authorization and medical necessity criteria

Policy CodePolicy CC-0111

Change TypeMaterial: added immunotherapy‑related thrombocytopenianon‑material: HCPCS coding update

Effective Date07/01/2025

Next Review Date

Key ActionObtain prior authorization and document diagnosis, platelet counts, and prior therapies (e.g., corticosteroids, IVIg, or splenectomy) as required for the indicated condition.

SourceLink

POLICY UPDATE CHANGES

Add immunotherapy-related thrombocytopenia indication and associated ICD-10 codes; coding reviewed and updated.

CMS coding update replaced HCPCS J2796 with J2802 effective 1/1/25.

6 monthsinitial approval duration

12 monthscontinuation approval duration

J2802HCPCS code

<30 x10^9/LITP threshold

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HS-ARS radiation threshold

Coverage and Medical Necessity Criteria

Initial Therapy — ITP

Initial requests for ITP may be approved when ALL of the following are met:

ITP initial: Individual has a diagnosis of immune (idiopathic) thrombocytopenia (ITP)

ITP platelet/bleeding: Documentation of platelet count <30 x 10^9/L OR active bleeding<30 x 10^9/L

References ASH 2011; Hicks et al., 2014

ITP prior therapy: Prior trial and insufficient response to one of: corticosteroids OR immunoglobulins (for example IVIg or anti-D) OR splenectomy

Step requirement before romiplostim

Continuation Therapy — ITP

Continuation requests for ITP may be approved when ALL of the following are met:

ITP continuation diagnosis: Individual has a diagnosis of ITP

ITP demonstrated response: Documentation of demonstrated response to therapy shown by increased platelet counts

ITP maintenance goal: Continuation is to maintain an adequate platelet count (50 - 100 x 10^9/L) to decrease the risk of bleeding50-100 x 10^9/L

Per specialty committee consensus

Initial Therapy — Lower-risk MDS

Initial requests for lower-risk MDS may be approved when ALL of the following are met:

MDS diagnosis: Documentation of lower-risk myelodysplastic syndrome (IPSS-R Very Low/Low/Intermediate; IPSS Low/Intermediate-1; WPSS Very low/low/intermediate)

NCCN 2A

MDS thrombocytopenia refractory: Severe or refractory thrombocytopenia following disease progression or no response to hypomethylating agents or immunosuppressive therapy

NCCN 2A

Continuation Therapy — MDS

Continuation requests for MDS may be approved when ANY of the following demonstrate clinically significant response:

MDS response options: Increase in platelet counts OR decrease in bleeding events OR reduction in need for platelet transfusions

NCCN 2A

HS-ARS

Requests for HS-ARS may be approved when ALL of the following are met:

HS-ARS diagnosis: Diagnosis of Hematopoietic Syndrome of Acute Radiation Syndrome (acute exposure to myelosuppressive doses of radiation)

HS-ARS exposure: Exposure or suspected exposure to radiation levels >2 Gy>2 Gy

Single administration per episode

Initial Therapy — CIT

Initial requests for chemotherapy-induced thrombocytopenia (CIT) may be approved when ALL of the following are met:

CIT diagnosis: Diagnosis of chemotherapy-induced thrombocytopenia (CIT)

NCCN 2A

CIT platelet criteria: Platelets <100 x 10^9/L for at least 3 weeks after last chemotherapy OR platelets <100 x 10^9/L with chemotherapy-related delays<100 x 10^9/L

CIT causative agent: Patient was receiving a cytotoxic chemotherapy agent known to cause thrombocytopenia

CIT treatment goal: Goal of therapy is to maintain dosing schedule and/or intensity of the chemotherapy regimen when benefits outweigh potential risks

Continuation Therapy — CIT

Continuation requests for CIT may be approved when ALL of the following are met:

CIT continuation diagnosis: Individual has a diagnosis of CIT

CIT demonstrated response: Documentation of demonstrated response to therapy shown by increased platelet counts

CIT maintenance goal: Continuation is to maintain an adequate platelet count (100 - 150 x 10^9/L) to allow resumption of chemotherapy as appropriate100-150 x 10^9/L

Initial Therapy — Immunotherapy-related thrombocytopenia

Initial requests for immunotherapy-related thrombocytopenia may be approved when ALL of the following are met:

Immunotherapy-related diagnosis: Documentation of Grade 3 or 4 thrombocytopenia (platelet count ≤50,000/mm3) due to immune checkpoint inhibitor therapy≤50,000/mm3

NCCN 2A

Immunotherapy steroid failure: Thrombocytopenia has not responded to corticosteroid treatment after at least one week of therapy

Continuation Therapy — Immunotherapy-related thrombocytopenia

Continuation requests for immunotherapy-related thrombocytopenia may be approved when ALL of the following are met:

Immunotherapy continuation diagnosis: Individual has a diagnosis of immunotherapy-related thrombocytopenia

Immunotherapy demonstrated response: Documentation of demonstrated response to therapy shown by increased platelet counts

Per the product label and policy limitations, Nplate (romiplostim) is not indicated for thrombocytopenia due to myelodysplastic syndrome (MDS) or for any cause of thrombocytopenia other than immune (idiopathic) thrombocytopenia (ITP). The label further states romiplostim should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding, and it should not be used to normalize platelet counts.

Despite the label limitation for MDS, the NCCN provides a Category 2A recommendation supporting romiplostim for selected lower-risk MDS patients with severe or refractory thrombocytopenia after progression or lack of response to hypomethylating agents, immunosuppressive therapy, or clinical trial therapy; use in these scenarios is an exception to the general MDS label exclusion and is addressed separately in the coverage criteria.

Requests will be denied when romiplostim is used to normalize platelet counts, when requested for conditions not specified in this policy, or when used in combination with eltrombopag. Additional non-approvable scenarios include any request that does not meet the specific indication-based criteria (ITP, lower‑risk MDS per NCCN exception, HS‑ARS, chemotherapy‑induced thrombocytopenia, or immunotherapy‑related thrombocytopenia).

Approval durations differ by indication (for example, immunotherapy‑related thrombocytopenia initial approvals are for 6 months with continuation approvals for 12 months); when criteria are not met the request is not medically necessary per policy.

Billing and Diagnosis Codes

HCPCSHCPCS

J2802

Injection, romiplostim, 1 mcg [Nplate]

ICD-10 DiagnosisICD-10

D46.0-D46.9	Myelodysplastic syndromes
D69.3	Immune thrombocytopenic purpura
D69.49	Other primary thrombocytopenia
D69.59	Other secondary thrombocytopenia
T45.1X5A-T45.1X5S	Adverse effect of antineoplastic and immunosuppressive drugs
T66.XXXA--T66.XXXS	Radiation sickness, unspecified

ITP platelet threshold

ThresholdPlatelet count < 30 x 10^9/L or active bleeding

ContextUsed as the initiation threshold for romiplostim in ITP (initial requests)

Supporting guidanceReferences ASH 2011; Hicks et al., 2014 as cited in policy

HS-ARS radiation exposure threshold

ThresholdExposure or suspected exposure to radiation > 2 Gy

IndicationHematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS)

Administration

Prior Authorization, Documentation, and Operational Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for Nplate (romiplostim) for all indications referenced in this policy prior to initiation of therapy.

Applies to initial and continuation requests.
Policy Number: CC-0111
Effective Date: 07/01/2025

Documentation Required

ITP — Documentation Requirements

Initial and continuation requests for immune (idiopathic) thrombocytopenia (ITP) must include documentation that supports diagnosis, severity, prior therapies, and response to romiplostim where applicable.

Diagnosis of ITP documented in chart/problem list.
Platelet count < 30 x 10^9/L OR documentation of active bleeding (e.g., clinical notes, laboratory reports).

Regimens and Guideline-based Uses

Regimen	Indication	Coverage status
Romiplostim per NCCN 2A recommendation	Lower-risk myelodysplastic syndrome (MDS) with severe or refractory thrombocytopenia after progression or no response to hypomethylating agents or immunosuppressive therapy	Covered

Regimen	Indication	Coverage status
Romiplostim per NCCN 2A recommendation	Chemotherapy‑induced thrombocytopenia (CIT) to allow maintenance or resumption of chemotherapy when benefits outweigh risks; criteria include platelets <100 x 10^9/L for ≥3 weeks after last chemotherapy or <100 x 10^9/L with chemotherapy‑related delays, and use of a cytotoxic agent known to cause thrombocytopenia	Covered

Salvage and Line of Therapy Notes

salvage

Salvage for MDS: Use in lower-risk MDS after progression or no response to hypomethylating agents, immunosuppressive therapy, or clinical trial

NCCN 2A

Clinical Background

Romiplostim is a thrombopoietin receptor agonist that increases platelet production and is FDA‑approved for patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, intravenous immunoglobulin, or splenectomy. It is used to raise platelet counts and reduce bleeding risk. In addition to its labeled ITP indication, guideline (NCCN) recommendations support romiplostim in selected situations such as lower‑risk MDS with severe or refractory thrombocytopenia after other therapies fail, and for chemotherapy‑induced thrombocytopenia when the goal is to allow resumption of chemotherapy and the benefits outweigh risks.

Definitions and Abbreviations

Aplastic anemia

DefinitionAplastic anemia: A condition in which the body stops producing enough new blood cells.

Clinical relevanceMay be referenced in differential diagnosis of thrombocytopenia and bone marrow failure contexts

Document sourceDefinitions and Measures section of policy

Immune thrombocytopenia (ITP)

DefinitionImmune thrombocytopenia (ITP): A bleeding disorder caused by low platelet counts due to autoantibodies against platelets resulting in impaired clotting.

Initiation criteriaDiagnosis of ITP plus platelet count <30 x 10^9/L or active bleeding required for initial romiplostim approval

Document History and Changes

05/16/2025annual_reviewLatest

Added immunotherapy-related thrombocytopenia indication and updated ICD-10-CM coding (added T45.1X5A-T45.1X5S and T66.XXXD/T66.XXXS; removed D69.41 and D69.42).

11/25/2024coding_update

CMS coding update recorded: HCPCS J2802 added effective 01/01/2025 and J2796 deleted.

05/17/2024annual_review

Policy Summary

PayerAnthem

PolicyNplate (romiplostim) — clinical prior authorization and medical necessity criteria

Policy CodePolicy CC-0111

Change TypeMaterial: added immunotherapy‑related thrombocytopenianon‑material: HCPCS coding update

Effective Date07/01/2025

Next Review Date

Key ActionObtain prior authorization and document diagnosis, platelet counts, and prior therapies (e.g., corticosteroids, IVIg, or splenectomy) as required for the indicated condition.

SourceLink

On This Page

Single administration per episode as specified for HS-ARS

CIT platelet thresholds

Initial platelet criteriaPlatelets < 100 x 10^9/L for ≥3 weeks after last chemotherapy OR platelets < 100 x 10^9/L with chemotherapy-related delays

Causation requirementPatient was receiving a cytotoxic chemotherapy agent known to cause thrombocytopenia

Continuation maintenance goalMaintain platelet count 100 - 150 x 10^9/L to allow resumption of chemotherapy

Immunotherapy-related thrombocytopenia grade

Grade definitionGrade 3 or 4 thrombocytopenia: platelet count ≤ 50,000/mm^3 (≤50,000/mm3)

AttributionThrombocytopenia must be due to immune checkpoint inhibitor therapy

Steroid failure requirementFailure to respond to ≥1 week of corticosteroid treatment prior to romiplostim

ITP/MDS maintenance platelet goals

ITP maintenance goalMaintain platelet count 50 - 100 x 10^9/L to decrease bleeding risk

MDS continuation responseContinuation for lower-risk MDS requires demonstration of clinically significant response (increase in platelet counts, fewer bleeding events, or reduced platelet transfusions)

PurposeGoals intended to reduce bleeding risk or allow continuation/resumption of therapy as appropriate

Documentation of prior trial and insufficient response to one of: corticosteroids, immunoglobulins (IVIg or anti-D), or splenectomy.

For continuation requests: documentation of therapeutic response (increased platelet counts) and goal to maintain adequate platelet count (50–100 x 10^9/L).

Include relevant lab reports with dates and treating clinician progress notes showing platelet trend.

Documentation Required

MDS — Documentation Requirements

Requests for romiplostim to treat lower-risk myelodysplastic syndrome (MDS) must include disease risk classification and evidence of refractory or severe thrombocytopenia despite prior disease-directed therapy.

Documentation of lower-risk MDS (IPSS-R Very Low/Low/Intermediate; or IPSS Low/Intermediate-1; or WPSS Very low/Low/Intermediate).
Evidence of severe or refractory thrombocytopenia after progression or lack of response to hypomethylating agents or immunosuppressive therapy.
For continuation requests: documentation of clinically significant response (increased platelet counts, fewer bleeding events, or reduced platelet transfusion needs).
Include pertinent pathology reports, hematology consult notes, and serial platelet counts with dates.

Documentation Required

HS-ARS and CIT — Documentation Requirements

Requests for romiplostim for Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS) and for chemotherapy-induced thrombocytopenia (CIT) must include specific exposure or treatment-related documentation and platelet trends supporting use.

HS-ARS: documentation of acute exposure to myelosuppressive radiation and exposure level >2 Gy (radiation exposure report, public health authority notes, or treating facility documentation).
HS-ARS approval is for a single administration per episode — include intent and episode date.
CIT: diagnosis of chemotherapy-induced thrombocytopenia with platelets <100 x 10^9/L persisting ≥3 weeks after last chemotherapy OR platelets <100 x 10^9/L with chemotherapy delays due to thrombocytopenia.
CIT: documentation that cytotoxic chemotherapy known to cause thrombocytopenia was used and that goal is to maintain chemotherapy dosing schedule/intensity when benefit outweighs risks.
For CIT continuation: documentation of response (platelet increase) and intent to maintain platelet count (100–150 x 10^9/L) to resume/continue chemotherapy.
Include chemo administration records, oncology treatment intent notes, platelet labs with dates, and hematology/oncology progress notes.

Documentation Required

Immunotherapy-related Thrombocytopenia — Documentation Requirements

For immunotherapy-related thrombocytopenia, include clear documentation that thrombocytopenia is immune checkpoint inhibitor–related, severity grading, prior steroid therapy, and response to romiplostim when requesting continuation.

Diagnosis of immunotherapy-related Grade 3 or Grade 4 thrombocytopenia (platelet count ≤ 50,000/mm^3) with attribution to immune checkpoint inhibitor therapy.
Documentation that thrombocytopenia did not respond to corticosteroids after at least 1 week of therapy (steroid dosing, start/end dates, and response).
For continuation requests: documentation of clinical response (increased platelet counts) attributable to romiplostim.
Include oncology/immunotherapy treatment records, steroid treatment notes, serial platelet counts, and specialist consultation notes.

Denial Risk

Non-approvable Scenarios / Denial Risk

Non-approvable scenarios — requests lacking required documentation or not meeting clinical criteria are at high risk for denial.

No documentation of diagnosis or missing serial platelet counts supporting severity.
Platelet counts not meeting thresholds specified for the indication (e.g., ITP without <30 x 10^9/L or active bleeding).
No evidence of prior required therapies for ITP (corticosteroids, IVIg/anti‑D, or splenectomy) when indicated.
MDS requests without documentation of lower-risk classification or lack of prior disease-directed therapy.
CIT requests without evidence of chemotherapy known to cause thrombocytopenia or without platelet trends/duration supporting persistent thrombocytopenia or chemo delay.
Immunotherapy-related thrombocytopenia without documentation of steroid trial of at least one week or without attribution to immune checkpoint inhibitors.
Requests that exceed the approved administration limits for HS-ARS (more than one administration per episode).
Missing treating clinician progress notes, hematology/oncology consultation, or supporting lab reports.

Prior therapy requirementPrior trial and insufficient response to corticosteroids, immunoglobulins (e.g., IVIg or anti-D), or splenectomy required before romiplostim

IPSS / IPSS-R / WPSS

PurposeIPSS / IPSS-R / WPSS: Prognostic scoring systems used to define lower-risk myelodysplastic syndrome (MDS) categories for treatment decisions.

Lower-risk definitionsLower-risk defined as IPSS-R (Very Low, Low, Intermediate), IPSS (Low/Intermediate-1), WPSS (Very low, low, intermediate)

Use in policyRequired documentation of lower-risk MDS per these scoring systems for romiplostim consideration (NCCN 2A)

Annual review with wording/format updates and coding reviewed (added ICD-10-CM T66.XXXA and D69.59).

05/21/2021annual_review

Updated approval durations for ITP and MDS, added continuation parameters for MDS, added HS-ARS indication per label, and added NCCN recommendation for CIT; coding reviewed (no changes).

05/15/2020annual_review

Removed requirement for 'chronic' ITP per FDA label update and updated non-approvable criteria for consistency; coding reviewed (no changes).