Product Details

Erivedge

Vismodegib
150 mg
Capsule


DIN/PIN/NPN

02409267

Manufacturer

Hoffmann-La Roche Limited

Formulary Listing Date

2019-04-30  

Unit Price

313.1904

Amount MOH Pays

313.1904

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01XJ01

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Vismodegib

  • Brand(s): Erivedge
  • Dosage Form/Strength: 150 mg tablet

For the treatment of metastatic basal cell carcinoma (BCC) or locally advanced BCC (including patients with basal cell nevus syndrome, i.e. Gorlin syndrome) in patients who meet the following criteria:

  1. Patient must have measurable metastatic disease or locally advanced disease; AND 

  2. Patient’s disease must be considered inoperable or inappropriate for surgery1; AND 

  3. Patient’s disease must be considered inappropriate for radiotherapy2; AND

  4. Patient is 18 years or age or older; AND

  5. Patient has an ECOG ≤ 2

Dose: 150 mg orally once daily taken until disease progression or unacceptable toxicity.

Requests must include the following information:
Physicians must provide rationale for why surgery AND radiation cannot be considered

  • The request must include a surgical consult note that provides a preoperative/surgical evaluation why surgery is not appropriate for the patient; AND 

  • A consult note as to why radiation therapy is not appropriate for the patient; AND 

  • Both of the above evaluations must come from a physician who is not the requesting physician; AND 

  • The request must include confirmation that the patient has been discussed at a multi-disciplinary cancer conference (MCC) or equivalent.

1Considered inoperable or inappropriate for surgery for at least ONE of the following reasons:

  • Technically not possible to perform surgery due to size/location/invasiveness of BCC (either lesion too large or can be several small lesions making surgery not feasible); OR 

  • Recurrence of BCC after two or more surgical procedures and curative resection unlikely; OR 

  • Substantial deformity and/or morbidity anticipated from surgery.

2Considered inappropriate for radiation for at least ONE of the following reasons:

  • Contraindication to radiation (e.g., Gorlin syndrome); OR 

  • Prior radiation to lesion; OR 

  • Suboptimal outcomes expected due to size/location/invasiveness of BCC.

Note: Patient preference for oral therapy will not be considered

Renewals will be considered where the physician has confirmed that the patient has not experienced disease progression while on Erivedge therapy.

Duration of Approval: 1 Year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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