Romiplostim (Nplate) — Coverage Criteria for ITP and HSARS
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Defines medical necessity, prior authorization, and site-of-care requirements for romiplostim (Nplate) subcutaneous injection for treatment of immune thrombocytopenia (ITP) and Hematopoietic Syndrome of Acute Radiation Syndrome (HSARS) for Blue Cross NC members.
Reformatted chronic ITP criteria to allow either platelet count ≤ 30 x 10^9/L or platelet count < 50 x 10^9/L with symptomatic bleeding/increased bleeding risk and adjusted trial/failure requirements; added specialist prescriber and prohibition on combination use with other thrombopoietin receptor agonists; extended ITP initial approval to 90 days.
Added HCPCS code J2802 to dosing reference table and adjusted maximum units according to coding unit definition.
Added and clarified Site of Care medical necessity criteria including bypass conditions for inpatient/outpatient hospital administration.
Coverage and Medical Necessity Criteria
Initial Therapy — ITP
Covered when ALL of the following are met for Initial Approval (ITP unless otherwise stated):
Initial Approval for ITP
Diagnosis and Age/Duration
- Diagnosis of chronic immune (idiopathic) thrombocytopenia (ITP).
Age/Duration
- Patient is ≥ 18 years of age.
- Patient is ≥ 1 year of age AND has had a diagnosis of ITP for at least 6 months (medical record documentation required).
Platelet criteria
ONE of
- Platelet count ≤ 30 x 10^9/L (medical record documentation required).
- Platelet count < 50 x 10^9/L AND symptomatic bleeding and/or increased risk for bleeding (examples include ≥ 60 years old, on anticoagulant or antiplatelet therapy, history of bleeding, comorbidities such as peptic ulcer disease, uncontrolled hypertension, anemia or low hemoglobin) (medical record documentation required).
Prior therapy/step requirement
ONE of
- Tried and had an inadequate response to a prior ITP treatment (corticosteroids [prednisone, dexamethasone], immunoglobulins [IVIG or anti‑D], anti‑CD20 monoclonal antibody [rituximab], or splenectomy).
- Intolerance, FDA labeled contraindication, or hypersensitivity to ALL other listed ITP treatments (corticosteroids, IVIG/anti‑D, rituximab, and splenectomy).
Prescriber and combination use
- Prescriber is a specialist in the area of the patient's diagnosis (e.g., hematologist, oncologist) or has consulted with a specialist in the area of the patient's diagnosis.
- Patient will NOT be using the requested agent in combination with another thrombopoietin receptor agonist or mimetic (e.g., avatrombopag, eltrombopag, lusutrombopag, romiplostim).
Quantity and site of care
- Requested quantity does NOT exceed the maximum units allowed for the duration of approval (see dosing/maximum units table).
- For requests for injection administration in an inpatient or outpatient hospital setting, Site of Care criteria applies where outlined.
Continuation Therapy — ITP
Continuation Approval covered when ALL of the following are met:
Continuation Therapy for ITP
Prior approval or retroactive eligibility
- Patient was approved through Blue Cross NC initial criteria for approval.
- Patient would have met initial criteria for approval at the time they started therapy.
- Diagnosis of chronic immune (idiopathic) thrombocytopenia (ITP).
Response criteria (ONE of)
- Patient's platelet count has increased and stabilized to > 50 x 10^9/L (medical record documentation required).
- Patient's platelet count has doubled from baseline (medical record documentation required).
- Patient's platelet count has increased sufficiently to avoid clinically important bleeding (medical record documentation required).
Prescriber and combination use
- Prescriber is a specialist in the area of the patient's diagnosis (e.g., hematologist, oncologist) or has consulted with a specialist in the area of the patient's diagnosis.
- Patient will NOT be using the requested agent in combination with another thrombopoietin receptor agonist or mimetic (e.g., avatrombopag, eltrombopag, lusutrombopag, romiplostim).
Quantity and site of care
- Requested quantity does NOT exceed the maximum units allowed for the duration of approval (see dosing/maximum units table).
- For requests for injection administration in an inpatient or outpatient hospital setting, Site of Care criteria applies where outlined.
Acute Radiation (HSARS)
Covered when ALL of the following are met for HSARS indication:
HSARS indication
- Diagnosis of Hematopoietic Syndrome of Acute Radiation Syndrome (acute exposure to myelosuppressive doses of radiation > 2 gray [Gy]).
- Prescriber is a specialist in the area of the patient's diagnosis (e.g., hematologist, oncologist) or has consulted with a specialist in the area of the patient's diagnosis.
- Single one‑time dose of romiplostim 10 mcg/kg subcutaneous administered as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation.
- Requested quantity does NOT exceed the maximum units allowed for HSARS (one dose).
Romiplostim is not indicated for treatment of thrombocytopenia caused by myelodysplastic syndrome (MDS) or for any cause of thrombocytopenia other than immune thrombocytopenia (ITP). This exclusion aligns with the FDA‑approved limitations of use and should be applied when evaluating medical necessity for authorization.
Romiplostim should not be used with the goal of normalizing platelet counts. Per the FDA‑approved limitations of use, therapy is intended for patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding, and use to attempt to normalize platelets would be inconsistent with labeled indications and would not meet medical necessity criteria.
Billing Codes, Dosing, and Platelet Thresholds
| J2802 | romiplostim, subcutaneous injection |
Prior Authorization, Documentation, and Denial Conditions
Prior Authorization Required
Prior authorization is required. Requests must demonstrate the patient meets initial or continuation medical necessity criteria for the requested agent.
- Prior authorization required for all requests for the restricted product(s).
- Medical record documentation must be submitted to support diagnosis, patient age, duration of ITP (pediatrics), platelet counts, symptomatic bleeding or bleeding risk factors, prior therapies tried and response or documented intolerance/contraindication, and specialist involvement/consultation.
Prior Therapy / Step Requirement
A trial and inadequate response to prior ITP treatment must be documented when applicable. If prior therapies are not appropriate, documentation of intolerance, contraindication, or hypersensitivity to ALL listed alternatives is required.
- Required prior therapies include corticosteroids (e.g., prednisone, dexamethasone), immunoglobulins (IVIG or anti-D), anti‑CD20 monoclonal antibody (rituximab), or splenectomy.
- If the patient has not tried these therapies, provide documentation explaining why (e.g., contraindication, intolerance, prior adverse reaction).
Required Documentation
Provide clinical records to support all elements of medical necessity. For pediatric patients, include documentation of age and duration of ITP (must be ≥1 year and ≥6 months duration when applicable). Include laboratory results showing platelet counts and any notes describing symptomatic bleeding or bleeding-risk factors.
- Medical records documenting diagnosis of chronic ITP or HSARS.
- Recent platelet counts (e.g., ≤30 x 10^9/L or <50 x 10^9/L with symptomatic bleeding/increased bleeding risk).
- Documentation of prior treatments, treatment dates, and clinical response or documented intolerance/contraindication.
- Specialist consultation or attestation if prescriber is not a hematology/oncology specialist.
- Site-of-care documentation for infusion/administration requests in hospital settings, when applicable.
Denial Triggers / Watch For
Requests that do not meet the medical necessity criteria may be denied. Common denial triggers include missing or insufficient documentation, failure to meet age/duration or platelet threshold criteria, lack of prior therapy trial or documented contraindication, use in combination with another thrombopoietin receptor agonist, or requested quantity exceeding allowed limits.
- Missing medical record evidence for diagnosis, platelet counts, bleeding symptoms, or prior therapy.
- Pediatric requests without documentation of ITP duration ≥6 months when age 1 year or older.
- Platelet counts above policy-specified thresholds without supporting bleeding-risk justification.
- Concurrent use with another thrombopoietin receptor agonist or mimetic.
- Requested dosing or quantity exceeding maximum units allowed for the approval period.
Key Definitions and Pediatric Criteria
Drug Background
Romiplostim (Nplate) is a thrombopoietin receptor agonist approved to treat immune thrombocytopenia (ITP) in adults and in pediatric patients ≥1 year of age with ITP duration ≥6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. It is also approved to increase survival after acute high‑dose radiation exposure (Hematopoietic Syndrome of Acute Radiation Syndrome, HSARS). The FDA‑approved labeling includes specific limitations: it is intended only for patients with ITP whose thrombocytopenia and clinical condition increase bleeding risk, it is not indicated for thrombocytopenia due to MDS or other non‑ITP causes, and it should not be used to attempt to normalize platelet counts.
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