Nplate (romiplostim) coverage and authorization
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Policy IC-0089 defines prior authorization, dosing limits, indications, renewal criteria, and billing/coding rules for romiplostim (Nplate) for Moda Health members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Romiplostim (Nplate)
inv-01: Universal Criteria
Covered when ALL of the following universal criteria are met
inv-02: ITP Initial Therapy
Immune (idiopathic) Thrombocytopenia (ITP) — initial approval
inv-03: HS-ARS Initial Therapy
Hematopoietic Syndrome of Acute Radiation Syndrome (HS-ARS) — initial approval
inv-04: CIT Initial Therapy
Chemotherapy-Induced Thrombocytopenia (CIT) — initial approval
inv-05: MDS Initial Therapy
Myelodysplastic Syndromes (MDS) — initial approval
inv-06: Immune Checkpoint Inhibitor-Related Thrombocytopenia
Management of Immune Checkpoint Inhibitor‑Related Thrombocytopenia — initial approval
Compendia‑recommended indication.
inv-07: Renewal Criteria
Covered when ALL of the following are met
Romiplostim is not intended to be used to normalize platelet counts. Coverage requires that the documented intent of therapy is to decrease the risk of bleeding from thrombocytopenia rather than to achieve or maintain normal platelet values. Requests that indicate an aim to normalize platelets are not consistent with this policy requirement.
When Medicare members are involved, applicable Medicare rules must be followed. National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) — and any Local Coverage Articles (LCAs) used for claims payment or benefit clarification — may apply and must be complied with where relevant. This policy’s criteria are intended for non‑Medicare coverage determinations and do not replace CMS requirements.
Prior authorization renewals may be denied or not renewed if the member develops unacceptable toxicitythrombotic or thromboembolic complications, evidence suggesting progression of myelodysplastic syndromes to acute myelogenous leukemia, or loss of response/neutralizing antibodies to romiplostim. Documentation of ongoing safety and absence of these issues is required for continued coverage.
Billing, Codes, and Quantity Limits
| J2802 | Injection, romiplostim, 1 microgram; 1 billable unit = 1 mcg |
| 55513-0223-xx | Nplate 125 mcg single-dose vial NDC |
| 55513-0221-xx | Nplate 250 mcg single-dose vial NDC |
| 55513-0222-xx | Nplate 500 mcg single-dose vial NDC |
| J2802 | Injection, romiplostim, 1 microgram; 1 billable unit = 1 mcg |
| 55513-0223-xx | Nplate 125 mcg single-dose vial NDC |
| 55513-0221-xx | Nplate 250 mcg single-dose vial NDC |
| 55513-0222-xx | Nplate 500 mcg single-dose vial NDC |
| C93.10 | Chronic myelomonocytic leukemia not having achieved remission |
| D46.0 | Refractory anemia without ring sideroblasts, so stated |
| D46.1 | Refractory anemia with ring sideroblasts |
| D46.20 | Refractory anemia with excess of blasts, unspecified |
| D46.21 | Refractory anemia with excess of blasts 1 |
| D46.4 | Refractory anemia, unspecified |
| D46.9 | Myelodysplastic syndrome, unspecified |
| D46.A | Refractory cytopenia with multilineage dysplasia |
| D46.B | Refractory cytopenia with multilineage dysplasia and ring sideroblasts |
| D46.Z | Other myelodysplastic syndromes |
Prior Authorization, Documentation, and Provider Requirements
Prior authorization required — initial 90 days; renew every 90 days when criteria met
Prior authorization is required before initiating romiplostim. Initial approvals are provided for 90 days (3 months) and may be renewed every 90 days when the member continues to meet the universal and indication‑specific criteria; note that prior authorization validity for Management of Immune Checkpoint Inhibitor‑Related Toxicities and HS‑ARS may NOT be renewed.
- Initial: prior authorization validity 3 months (90 days).
- Renewal: may be renewed every 3 months (90 days) when criteria are met.
- Exceptions: PA validity may NOT be renewed for Management of Immune Checkpoint Inhibitor‑Related Toxicities and HS‑ARS.
PA considered due to drug cost (NQTL)
Prior authorization is applied to romiplostim in part because the NQTL checklist identified drug cost as a factor to consider for PA.
- NQTL checklist: Cost of drug = Yes (Consider for PA).
Document prerequisite therapies for ITP and MDS
Provide documentation of prior therapies as applicable to the indication: for ITP, prior treatment with corticosteroids, immunoglobulins, or splenectomy (or chronic ITP meeting corticosteroid trial criteria) must be documented; for MDS, documentation of progression or lack of response after hypomethylating agents or immunosuppressive therapy is required.
- ITP: prior failure of corticosteroids OR immunoglobulins OR splenectomy (or chronic ITP meeting corticosteroid requirement: no response to ≥3‑month trial or corticosteroid‑dependent).
- MDS: progressed, no response to, or relapsed after hypomethylating agents or immunosuppressive therapy.
Provider action highlight: intent and concurrent‑therapy restrictions
Ensure intent of therapy is to decrease bleeding risk and not to normalize platelet counts; do not prescribe romiplostim concurrently with another TPO receptor agonist or fostamatinib.
- Therapy must be used to decrease bleeding risk (will NOT be used to normalize platelet counts).
- No concurrent treatment with any other thrombopoietin receptor agonist/mimetic or fostamatinib.
Required clinical documentation — current platelet within 28 days and indication details
Include a current platelet laboratory value drawn within the previous 28 days with PA requests and other indication‑specific documentation as applicable.
- Current platelet count must be from a specimen drawn within the previous 28 days (note: does not apply to HS‑ARS).
- Also provide documentation supporting the specific indication (e.g., timing after chemotherapy, risk category for MDS, corticosteroid trial results for ITP).
Coding and drug identification — use HCPCS J2802; NDCs may be referenced
Bill romiplostim using HCPCS code J2802 (Injection, romiplostim, 1 microgram); NDCs for the single‑dose vial strengths may be referenced on claims when applicable (55513‑0223‑xx, 55513‑0221‑xx, 55513‑0222‑xx).
- HCPCS: J2802 — Injection, romiplostim, 1 microgram; 1 billable unit = 1 mcg.
- NDCs (may be referenced): 55513‑0223‑xx (125 mcg), 55513‑0221‑xx (250 mcg), 55513‑0222‑xx (500 mcg).
Denial/non‑renewal triggers — unacceptable toxicity, progression risk, loss of response
Prior authorization may be denied or not renewed if the member experiences unacceptable toxicity (examples provided include thrombotic/thromboembolic complications), if there is risk of progression of MDS to AML, loss of response or presence of neutralizing antibodies, or if duration limits are exceeded.
- Unacceptable toxicity examples: thrombotic/thromboembolic complications.
- Other denial triggers: risk of progression of MDS to acute myelogenous leukemia (AML); loss of response to romiplostim/presence of neutralizing antibodies; duration limits exceeded.
PA considered because drug cost identified as a factor in NQTL checklist
Prior authorization consideration for romiplostim was influenced by cost according to the NQTL factor checklist; document that PA may be applied for utilization management because drug cost was marked 'Yes' on the checklist.
- Appendix A NQTL checklist: Cost of drug = Yes, consider for PA.
Background and Clinical Context
Romiplostim (Nplate®) is a thrombopoietin receptor agonist that stimulates platelet production and is used to increase platelet counts to reduce bleeding risk in conditions such as immune (idiopathic) thrombocytopenia (ITP), chemotherapy‑induced thrombocytopenia (CIT), lower‑risk myelodysplastic syndromes (MDS), management of immune checkpoint inhibitor‑related thrombocytopenia, and hematopoietic syndrome of acute radiation syndrome (HS‑ARS). Coverage under this policy is provided for FDA‑approved and compendia‑recommended indications when the specific clinical and documentation criteria are met.
Definitions and Referenced Guidance
Line of Therapy / Salvage Use
inv-28: Salvage
Salvage therapy criteria
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