Product Details

Nplate

Romiplostim
250 mcg/0.5 mL
Powder for Solution for Subcutaneous Injection
Single-Dose 0.5-mL Vial (Preservative-Free)

DIN/PIN/NPN

02322854

Manufacturer

Amgen Canada Inc.

Formulary Listing Date

2022-04-29  

Unit Price

1033.0200

Amount MOH Pays

1033.0200

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

B02BX04

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Blood Modifiers

Romiplostim

  • Brand(s): Nplate
  • Dosage Form/Strength: 250 mcg/0.5 mL 500 mcg/mL

For the treatment of refractory chronic idiopathic thrombocytopenic purpura (ITP) with bleeding complications in patients who meet the following criteria:

  1. Patient has undergone a splenectomy1 

  1. Patient has tried and is unresponsive to other treatment modalities2. 

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:

  • Corticosteroids 

  • IV anti-D 

  • Intravenous immune globulin (IVIG) 

2Appropriate second-line treatment modalities may include:

  • Azathioprine 

  • Cyclosporine 

  • Cyclophosphamide 

  • Mycophenolate 

  • Rituximab 

  • Danazol 

  • Dapsone 

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. 

Duration of Approval: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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