Health Net romiplostim (Nplate) Coverage Update

Coverage Criteria

Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS) - Initial

Covered when ALL of the following are met

HS-ARS initial criteria: 1. Diagnosis of Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS); 2. Prescriber attestation of suspected or confirmed exposure to radiation > 2 gray (Gy); 3. Prescribed by or in consultation with a hematologist; 4. Dose does not exceed 10 mcg/kg.dose <= 10 mcg/kg

Approval duration: 4 weeks (1 dose only)

Immune Thrombocytopenia (ITP) - Initial

Covered when ALL of the following are met

ITP initial criteria: 1. Diagnosis of immune thrombocytopenia (ITP); 2. Prescribed by or in consultation with a hematologist; 3. Age ≥ 1 year; 4. One of the following: (a) current (within the last 30 days) platelet count < 30,000/µL; OR (b) member has an active bleed; 5. Failure of a systemic corticosteroid unless contraindicated or clinically significant adverse effects are experienced; 6. Failure of eltrombopag (generic Promacta), unless contraindicated or clinically significant adverse effects are experienced; 7. Romiplostim is not prescribed concurrently with rituximab or another thrombopoietin receptor agonist or a spleen tyrosine kinase inhibitor; 8. Dose does not exceed 10 mcg/kg per week.platelets <30,000/µL or active bleed; dose <=10 mcg/kg/week

Approval duration: 12 months

Recommended NCCN uses (off-label) - Initial

Covered when ALL of the following are met

NCCN-recommended off-label initial criteria: 1. Diagnosis of one of: (a) Myelodysplastic syndromes (MDS); (b) Chemotherapy-induced thrombocytopenia (CIT); or (c) Immune checkpoint inhibitor–related toxicities; 2. Prescribed by or in consultation with an oncologist or hematologist; 3. For MDS: lower-risk per IPSS-R AND severe or refractory thrombocytopenia following progression or no response to hypomethylating agents, immunosuppressive therapy, or clinical trial; 4. Failure of eltrombopag unless contraindicated; 5. For CIT: age ≥ 18 years AND platelets < 100,000/µL for ≥ 3 weeks after last chemotherapy and/or chemotherapy delays due to thrombocytopenia; 6. For immune checkpoint inhibitor–related toxicities: no response to corticosteroids after 1–2 weeks; 7. Romiplostim is not prescribed concurrently with rituximab or another thrombopoietin receptor agonist; 8. Request meets one of: (a) dose does not exceed 10 mcg/kg per week; OR (b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).CIT platelets <100,000/µL for >=3 weeks; steroid nonresponse 1-2 weeks for ICI-toxicity; dose <=10 mcg/kg/week

Prescribed regimen must be FDA-approved or recommended by NCCN; Approval duration: 12 months

Continuation / Re-authorization criteria

Covered when ALL of the following are met

HS-ARS re-authorization: Re-authorization is not permitted; members must meet the initial approval criteria.N/A

Approval duration: Not applicable

ITP continuation: 1. Member currently receiving medication via Centene benefit or previously met initial approval, or is in continuity-of-care per applicable state rules; 2. Member is responding positively to therapy (e.g., increased platelet count or reduced bleeding); 3. Current (within the last 90 days) platelet count is < 400,000/µL; 4. Romiplostim is not prescribed concurrently with rituximab or another thrombopoietin receptor agonist or a spleen tyrosine kinase inhibitor; 5. If request is for a dose increase, new dose does not exceed 10 mcg/kg per week.platelets <400,000/µL; dose <=10 mcg/kg/week

Approval duration: 12 months

NCCN off-label continuation:

Covered Indications and Dosing

Covered when ALL of the following are met (indication-specific rules summarized from the document):

ITP Initial Therapy: Initial dose 1 mcg/kg subcutaneously once weekly based on actual body weight; adjust weekly in 1 mcg/kg increments to achieve and maintain platelet count ≥ 50,000/µL; maximum 10 mcg/kg/week; do not dose if platelet count > 400,000/µL.platelets >=50,000/µL; max 10 mcg/kg/week

Initial approval duration revised to 12 months for ITP and NCCN supported uses

HS-ARS: Single subcutaneous injection 10 mcg/kg administered as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray (Gy); maximum dose 10 mcg/kg.single 10 mcg/kg dose

Approval duration: 4 weeks (1 dose only)

NCCN-supported off-label uses: Includes chemotherapy-induced thrombocytopenia (CIT) and immune checkpoint inhibitor–related toxicities (for ICI-related toxicities when no response to corticosteroids after 1–2 weeks); dosing up to 10 mcg/kg/week or dose supported by guidelines/literature with submitted evidence.

Romiplostim (Nplate) is not indicated for thrombocytopenia due to myelodysplastic syndrome (MDS) or for causes of thrombocytopenia other than immune thrombocytopenia (ITP), except where specific NCCN-recommended off-label criteria in this policy permit use. Requests for MDS or other non-ITP diagnoses must meet the NCCN-based off-label criteria and any supporting evidence requirements described elsewhere in the policy.

Concurrent prescribing of romiplostim with other agents that stimulate platelets is restricted. The policy excludes concurrent use with rituximab or another thrombopoietin (TPO) receptor agonist for off-label indications, and for ITP specifically also excludes concurrent use with a spleen tyrosine kinase (SYK) inhibitor (e.g., Tavalisse). Such concurrent combinations are not permitted and will render a request non-compliant with the concurrent-use rules in the policy.

Use of romiplostim for non–FDA approved indications that are not specifically addressed in this policy is not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the payer's off‑label use policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53) or applicable evidence-of-coverage documents. Lack of the required off‑label documentation may result in denial.

For chemotherapy‑induced thrombocytopenia (CIT) and other NCCN-recommended off‑label uses, the policy requires adult age limits. Specifically, CIT use is limited to members who are age ≥ 18 years, reflecting NCCN guidance that routine pediatric use is not supported by sufficient data. Requests for pediatric CIT must therefore include compelling evidence per the off‑label criteria to be considered.

Covered Regimens and Dosing

Regimen	Indication	Coverage
Romiplostim up to 10 mcg/kg/week (or dose supported by practice guidelines or peer‑reviewed literature with submitted evidence)
NCCN‑recommended off‑label uses including myelodysplastic syndromes (MDS), chemotherapy‑induced thrombocytopenia (CIT), and immune checkpoint inhibitor‑related toxicities when all policy criteria are met (prescribed by/with oncologist or hematologist; indication‑specific requirements such as age and prior therapy/eltrombopag failure; not concurrent with other TPO agonists)
Approval duration: 12 months; dose must not exceed 10 mcg/kg/week unless supported by submitted guidelines/literature evidence; failure of eltrombopag required unless contraindicated (step therapy exceptions per IL HB 5395)

Regimen	Dosing Details	Product Availability
Start 1 mcg/kg SC once weekly; adjust by 1 mcg/kg weekly to achieve/maintain platelets ≥50,000/µL; maximum 10 mcg/kg/week; do not dose if platelet count >400,000/µL
Dose adjustments in 1 mcg/kg increments based on actual body weight and platelet response; initial approval duration: 12 months for ITP when criteria met
Single‑dose vials: 125 mcg, 250 mcg, 500 mcg (lyophilized powder)

Regimen	Timing/Threshold	Coverage
Single subcutaneous injection of romiplostim 10 mcg/kg
Administer as soon as possible after suspected or confirmed radiation exposure >2 gray (Gy); HS‑ARS maximum dose = 10 mcg/kg (one dose)
Approval duration: 4 weeks (single dose only); re‑authorization not permitted

Coding

HCPCS CodesHCPCS

J2802

Injection, romiplostim, 1 microgram

Platelet count thresholds — ITP and other indications summarized

ITP (initial)Coverage requires current platelet count <30,000/µL within last 30 days or an active bleed; age ≥1 year and prescriber is/consults a hematologist; dose ≤10 mcg/kg/week

CIT (NCCN off-label)Coverage for chemotherapy‑induced thrombocytopenia requires age ≥18 years and platelets <100,000/µL for ≥3 weeks after last chemotherapy (or chemotherapy delays due to thrombocytopenia); prescriber is/consults an oncologist or hematologist; dose ≤10 mcg/kg/week (or guideline‑supported dose with evidence)

HS-ARSCoverage requires prescriber attestation of suspected or confirmed exposure >2 Gy, diagnosis of HS-ARS, hematologist involvement, single dose 10 mcg/kg (max 10 mcg/kg)

Continuation / re-authorization thresholdFor continuation, current platelet count within last 90 days must be <400,000/µL; not prescribed concurrently with another TPO receptor agonist; dose if increased ≤10 mcg/kg/week

Radiation exposure threshold

Provider Actions and Requirements

Documentation Required

Required documentation and clinical details

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Providers should document indication-specific dosing and response (for example, platelet counts for ITP), prior therapies tried, reasons for discontinuation or intolerance, and any supporting literature when requesting off-label uses.

Include office chart notes, recent lab results (e.g., platelet counts), and documentation of prior therapy failures or contraindications (systemic corticosteroids, eltrombopag)
For ITP and MDS requests, document prior trial and failure of eltrombopag (generic Promacta) unless contraindicated or clinically significant adverse effects occurred
If requesting an off‑label indication, include supporting evidence per off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Step Therapy

Step therapy requirements and exceptions

Step therapy applies for certain indications. For ITP and NCCN‑supported off‑label uses (e.g., MDS, CIT, immune checkpoint inhibitor‑related toxicities), Nplate (romiplostim) requires prior failure of recommended agents before authorization. For ITP this includes failure of a systemic corticosteroid (unless contraindicated) and failure of eltrombopag (generic Promacta) unless contraindicated or intolerant. Exceptions (medical contraindication or significant adverse effects) must be documented. Note: For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

Line of Therapy / Salvage

salvage

MDS salvage: Use in lower-risk MDS is considered in salvage context when patient has severe or refractory thrombocytopenia following progression or no response to hypomethylating agents, immunosuppressive therapy, or clinical trial; prescriber must be an oncologist or hematologist and failure of eltrombopag is required unless contraindicated.

Off-label per NCCN; approval requires supporting evidence if dose exceeds 10 mcg/kg/week.

salvage

CIT salvage: Chemotherapy-induced thrombocytopenia use is considered salvage therapy: patient age ≥ 18 years and platelets <100,000/µL for ≥3 weeks after last chemotherapy and/or chemotherapy delays related to thrombocytopenia; prescriber must be an oncologist or hematologist.

Approval duration: 12 months

salvage

Biomarker / Test Requirements

Biomarker requirements

Biomarker requirementNone specified — no biomarker or genetic test required for coverage

NCCN referencesPolicy references NCCN compendia and guidelines for off-label uses but does not mandate biomarker testing

Clinical indicesCoverage decisions are driven by clinical thresholds (platelet counts, radiation exposure, prior therapy failures), not biomarkers

Background

Romiplostim is a thrombopoietin receptor agonist approved to treat thrombocytopenia in adults and pediatric patients with immune thrombocytopenia (ITP) after inadequate response to corticosteroids, immunoglobulins, or splenectomy, and to increase survival following significant radiation exposure (HS‑ARS). The policy implements indication‑specific requirements and dosing limits: for ITP, therapy is typically initiated and managed to achieve a target platelet response (start at 1 mcg/kg weekly and titrate to maintain platelets ≥ 50,000/µL, maximum 10 mcg/kg/week); for HS‑ARS a single SC dose of 10 mcg/kg is authorized when exposure to >2 Gy is suspected or confirmed. Documentation of diagnosis, prescriber specialty (hematology/oncology), prior therapy failures where required, and laboratory monitoring (platelet counts) is necessary for authorization and continuation.

Revision History

11.12.24coding_update

HCPCS code J2802 added and J2796 deleted.

09.23.25policy_revision

Redirected to eltrombopag (generic Promacta) for ITP and MDS; removed redirection to immune globulin for ITP when corticosteroids are intolerant or contraindicated; revised initial approval duration for ITP and NCCN-supported uses from 6 to 12 months.

10.22.25policy_updateLatest