Romiplostim (NPlate®)

Restricted Product(s)

• Romiplostim (NPlate) subcutaneous injection for administration by a healthcare professional

FDA Approved Use

• For treatment of immune thrombocytopenia (ITP) in:
  • Adult patients with ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy 
  • Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy 
• To increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HSARS])

Criteria for Medical Necessity

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval

1. The patient has a diagnosis of chronic idiopathic thrombocytopenia (ITP); AND 
   1. ONE of the following: 
      1. The patient is 18 years of age or older; OR 
      2. The patient is 1 year of age or older AND has had a diagnosis of ITP for at least 6 months [medical record documentation required]; AND 
   2. The patient has a platelet count ≤ 30 x 109 /L [medical record documentation required]; AND 
   3. ONE of the following: 
      1. The patient has tried and had an inadequate response to corticosteroids or immunoglobulins (IVIG or anti-D); OR 
      2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to corticosteroids or immunoglobulins (IVIG or anti-D); OR 
   4. The patient has had an insufficient response to or is not a candidate for splenectomy; OR 
2. The patient has been diagnosed with Hematopoietic Syndrome of Acute Radiation Syndrome (HSARS) (i.e., acute exposure to myelosuppressive doses of radiation); AND 
3. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
4. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

Duration of Approval:

ITP: 8 weeks
HSARS: 30 days (1 dose)

Continuation Criteria for Approval

1. The patient was approved through Blue Cross NC initial criteria for approval; OR 
2. The patient would have met initial criteria for approval at the time they started therapy; AND 
3. The patient has a platelet count of ≥ 50 x 109 /L; OR 
4. The patient’s platelet count has increased sufficiently to avoid clinically important bleeding; AND 
5. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
6. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*
   
   Duration of Approval: 365 days (1 year)

*Site of Care Medical Necessity Criteria

1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR 
2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met:
   1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR 
   2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR 
   3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR 
   4. Re-initiation of therapy, defined as ONE of the following: 
      1. First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR 
      2. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR 
   5. Requirement of a change in the requested restricted product formulation; AND 
3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional.

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

October 2021: Criteria change: Added Site of Care medical necessity criteria. Policy notification given 8/2/2021 for effective date 10/1/2021.
August 2021: Criteria update: Reformatted age and diagnosis criteria for clarity, no change to policy intent.
June 2021: Criteria change: Added new indication for HSARS; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.
*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.