Product Details
Nplate
Romiplostim500 mcg/1 mL
Powder for Solution for Subcutaneous Injection
Single-Dose 1-mL Vial (Preservative-Free)
DIN/PIN/NPN
02322862
Manufacturer
Amgen Canada Inc.
Formulary Listing Date
2022-04-29
Unit Price
2066.0700
Amount MOH Pays
2066.0700
Coverage Status
Exceptional Access Program Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
B02BX04
Interchangeable Products
NOLU Clinical Criteria
NOEAP Criteria
| Therapeutic Class | Reimbursement Criteria |
|---|---|
| Blood Modifiers | Romiplostim
For the treatment of refractory chronic idiopathic thrombocytopenic purpura (ITP) with bleeding complications in patients who meet the following criteria:
1Requests for romiplostin where the requesting physician has stated that the patient is not a candidate for splenectomy will be assessed on a case-by-case basis. The requesting physician must provide rationale for why a splenectomy cannot be considered, and where possible, to include a preoperative evaluation on the patient’s surgical risks to splenectomy to include consideration of risks of laparoscopic and open surgical interventions if these are available. Note: The Executive Officer (EO) may revise the criteria if the frequency of patients who are not eligible for splenectomy exceeds published estimates. 2Appropriate first-line treatment modalities may include:
2Appropriate second-line treatment modalities may include:
Patients need to have failed at least two second-line therapies prior to requesting Nplate. Duration of Approval: 1 year Renewal of requests will be considered in patients who have a stable platelet response and reduced symptoms of ITP-related bleeding events. |