ModifiedCignaPolicy IP0155

Thrombocytopenia - Nplate (romiplostim)

Cigna coverage policy for romiplostim (Nplate) defining prior authorization, clinical criteria, dosing, approval durations, documentation requirements, supported indications (FDA and other uses), exclusions, and billing codes.

Policy Summary

PayerCigna

PolicyThrombocytopenia - Nplate (romiplostim)

Policy CodePolicy IP0155

Change TypeAnnual and selected revisions (coding, criteria, new indication, documentation)

Effective Date

Next Review Date

Key ActionPrior Authorization is required for Nplate; obtain required documentation and follow the specified approval durations and dosing limits per indication.

SourceLink

POLICY UPDATE CHANGES

Thrombocytopenia, Chemotherapy-Induced criteria updated to require thrombocytopenia at least 3 weeks after most recent chemo; reauthorization duration updated from 1 year to 6 months.

Added 'Patient is Currently Receiving Nplate' as an approvable condition for all covered uses except Hematopoietic Syndrome of Acute Radiation Syndrome.

Updated HCPCS coding: added J2802 (effective 1/1/2025) and J2796 (effective until 12/31/2024).

Thrombocytopenia due to Immune Checkpoint Inhibitor Therapy condition and criteria were added to the policy.

Added documentation requirements throughout the policy.

5Covered Indications (listed)

1Not covered category

2HCPCS codes referenced

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Coverage Summary & Scope

Payer: Cigna. Drug: Nplate (romiplostim). Coverage stance: covered_with_criteria requiring prior authorization. Supported indications include FDA‑approved uses: Hematopoietic syndrome of acute radiation syndrome (approve for one dose; dosing up to 10 mcg/kg once) and Immune Thrombocytopenia (ITP) in adults and pediatric patients ≥ 1 year with chronic ITP (initial approvals for 3 months; ongoing users may be approved for 1 year when meeting response criteria). Other supported, evidence‑based uses listed with criteria are: chemotherapy‑induced thrombocytopenia (initial approvals for 3 months; reauthorization or current users up to 6 months), thrombocytopenia in myelodysplastic syndrome (MDS) (initial approvals for 3 months; current users up to 1 year), and thrombocytopenia due to immune checkpoint inhibitor therapy (approvals commonly for 6 months). The policy specifies specialist prescribing/consultation, documentation requirements (e.g., platelet thresholds and prior therapies), dosing limits, and HCPCS coding guidance.

Key thresholds and definition

ITP — severe thrombocytopenia thresholdPlatelet count < 30 x 10^9/L (< 30,000/mcL)

ITP — increased bleeding risk thresholdPlatelet count < 50 x 10^9/L (< 50,000/mcL)

Chemotherapy-induced thrombocytopenia thresholdPlatelet count < 100 x 10^9/L (< 100,000/mcL)

Chemotherapy timing requirementFor initial therapy, thrombocytopenia must be at least 3 weeks after the most recent dose of chemotherapy (or delay in chemotherapy related to thrombocytopenia)

Approval durations (examples)ITP initial therapy: approve for 3 months; ITP current Nplate: approve for 1 year; Chemotherapy-induced initial therapy: approve for 3 months; Chemotherapy-induced current Nplate: approve for 6 months

Definition — Beneficial clinical responseIncludes increased platelet counts, maintenance of platelet counts, and/or decreased frequency of bleeding episodes (documentation required)

FDA-Approved Indications - Authorization Criteria

FDA-Approved Indications

Prior Authorization required. Approve when criteria below are met for each indication.

Other Uses with Supportive Evidence - Authorization Criteria

Other Uses with Supportive Evidence

Approve when criteria below are met; prior authorization required. Dosing specified per condition.

ANY of the following

A) Initial Therapy
- i: Patient is ≥ 18 years of age
- ii: Patient has a platelet count < 100 x 10^9/L (< 100,000/mcL)< 100 x 10^9/L
  Documentation required
- iii. Timing related to chemotherapy

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Prior Authorization is required for benefit coverage of Nplate (codes J2796, J2802). Approvals are provided for the durations specified per indication and may be extended if criteria continue to be met.

HCPCS: J2796, J2802

Documentation Required

Documentation requirements

Documentation is required where noted and may include chart notes, laboratory tests, and claims records. Examples of required documentation include platelet counts, prior therapies or splenectomy, prescriber consultation with a hematologist/oncologist, and evidence of a beneficial clinical response.

Platelet counts (thresholds specified per indication)
Prior therapies or history of splenectomy
Prescriber consultation with hematologist or oncologist

Applicable Codes

HCPCS - Romiplostim injection codesHCPCS

J2796	Injection, romiplostim, 10 mcg (Code effective until 12/31/2024)
J2802	Injection, romiplostim, 1 microgram (Code effective 1/1/2025)

Clinical Evidence & Guidance

Guideline and evidence support: Nplate is included in NCCN and ASH guidance for relevant thrombocytopenia conditions (NCCN hematopoietic growth factors and immunotherapy‑toxicity guidance, and ASH ITP guidance), and the prescribing information is cited (Amgen Nplate PI, March 2025). The policy notes supportive data and guideline recommendations for non‑FDA uses including chemotherapy‑induced thrombocytopenia (NCCN category 2A consideration), use in lower‑risk MDS (NCCN and multiple trials/meta‑analyses reporting platelet response and reduced bleeding), and management of checkpoint inhibitor–related thrombocytopenia per NCCN immunotherapy‑toxicity guidance.

Background & Drug Information

Nplate (romiplostim) is a thrombopoietin receptor agonist indicated to increase platelet production. FDA‑approved indications listed in the policy include treatment of hematopoietic syndrome of acute radiation syndrome (to increase survival after myelosuppressive radiation exposure) and immune thrombocytopenia (ITP) in adults and pediatric patients ≥ 1 year with chronic ITP who had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The policy also references other conditions with supportive evidence or guideline mention—chemotherapy‑induced thrombocytopenia, myelodysplastic syndrome (MDS), and checkpoint inhibitor–related thrombocytopenia—and requires specialist consultation, defined platelet thresholds, and dosing limits for these uses.

Revision History

08/01/2024material_revision

Annual Review dated 08/01/2024: Thrombocytopenia, Chemotherapy-Induced criteria updated to require thrombocytopenia at least 3 weeks after most recent chemotherapy; reauthorization duration changed from 1 year to 6 months. Added 'Patient is Currently Receiving Nplate' as an approvable condition for all covered uses except Hematopoietic Syndrome of Acute Radiation Syndrome.

12/01/2024material_revision

Selected revision dated 12/01/2024: Updated HCPCS coding — added J2802 (effective 1/1/2025) and J2796 (code effective until 12/31/2024).

07/15/2025

Policy Summary

PayerCigna

PolicyThrombocytopenia - Nplate (romiplostim)

Policy CodePolicy IP0155

Change TypeAnnual and selected revisions (coding, criteria, new indication, documentation)

Effective Date

Next Review Date

Key ActionPrior Authorization is required for Nplate; obtain required documentation and follow the specified approval durations and dosing limits per indication.

SourceLink

On This Page

a: Patient has thrombocytopenia at least 3 weeks after the most recent dose of chemotherapy

b: Patient has experienced a delay in chemotherapy administration related to thrombocytopenia

iv: Medication is prescribed by or in consultation with a hematologist or an oncologist

B) Patient is Currently Receiving Nplate

i: Patient is ≥ 18 years of age
ii: Patient continues to receive treatment with chemotherapy
iii: Patient demonstrates a beneficial clinical response according to the prescriber
Documentation required; beneficial response can include increased platelet counts, maintenance of platelet counts, and/or decreased frequency of bleeding episodes

Dosing: Approve up to 10 mcg/kg subcutaneously no more frequently than once weekly

ANY of the following

A) Initial Therapy
- i: Patient has low- to intermediate-risk myelodysplastic syndrome
- ii. Platelet criteria
  - a: Patient has a platelet count < 30 x 10^9/L (< 30,000/mcL)< 30 x 10^9/L
    Documentation required
  - b
    (1): Patient has a platelet count < 50 x 10^9/L (< 50,000/mcL)< 50 x 10^9/L
    Documentation required
    (2): According to the prescriber the patient is at an increased risk for bleeding
- iii: Medication is prescribed by or in consultation with a hematologist or an oncologist
B) Patient is Currently Receiving Nplate
- i: According to the prescriber the patient demonstrates a beneficial clinical response
  Documentation required; beneficial response can include increased platelet counts, maintenance of platelet counts, and/or decreased frequency of bleeding episodes
- ii: Patient remains at risk for bleeding complications
Dosing: Approve up to 1,500 mcg subcutaneously no more frequently than twice weekly

ANY of the following

A) Initial Therapy
- i: Patient has tried at least one systemic corticosteroid
  Documentation required; examples include methylprednisolone and prednisone
- ii: Patient has a platelet count < 50 x 10^9/L (< 50,000/mcL)< 50 x 10^9/L
  Documentation required
- iii: Medication is prescribed by or in consultation with a hematologist or an oncologist
B) Patient is Currently Receiving Nplate
- According to the prescriber, the patient demonstrated a beneficial clinical response
  Documentation required
Dosing: Approve up to 1,500 mcg subcutaneously no more frequently than twice weekly

Documentation of beneficial clinical response (e.g., increased or maintained platelet counts, decreased bleeding)

Billing Rule

Dose and frequency limits

Dosing and frequency limits are specified per indication: approve up to 10 mcg/kg subcutaneously no more frequently than once weekly for ITP and chemotherapy‑induced thrombocytopenia; approve up to 1,500 mcg subcutaneously no more frequently than twice weekly for MDS and for thrombocytopenia due to immune checkpoint inhibitor therapy.

Up to 10 mcg/kg subcutaneously, no more frequently than once weekly (ITP; chemotherapy‑induced)
Up to 1,500 mcg subcutaneously, no more frequently than twice weekly (MDS; checkpoint inhibitor–related)

Documentation Required

Specialist prescribing requirement

For many indications Nplate must be prescribed by or in consultation with a hematologist or an oncologist (for ITP specifically, by or in consultation with a hematologist).

Prescriber must be or consult a hematologist (ITP) or a hematologist/oncologist (other indications) as noted in the criteria

Denial Risk

Not medically necessary for other uses

Use of Nplate for any other use not listed in the policy is considered not medically necessary and will be denied.

Annual Revision dated 07/15/2025: Thrombocytopenia due to Immune Checkpoint Inhibitor Therapy condition and approval criteria were added to the policy (including dosing).

09/01/2025non_material_revisionLatest

Selected revision dated 09/01/2025: Added documentation requirements throughout the policy.