Product Details

Aptivus

Tipranavir
250 mg
Capsule


DIN/PIN/NPN

02273322

Manufacturer

Boehringer-Ingelheim (Canada) Ltd./Ltee

Formulary Listing Date

2022-04-29  

Unit Price

8.7972

Amount MOH Pays

8.7972

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

J05AE09

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Anti-Infectives

Tipranavir

  • Brand(s): Aptivus
  • Dosage Form/Strength: 250 mg capsules
  • Updated April 29, 2022

Initiation criteria

Reimbursement of Aptivus will be considered on a case-by-case basis in patients meeting the following criteria:

  1. are 18 years of age or older AND

  2. have failed (or failed to tolerate – nature of intolerance must be specified) at least two previous protease-inhibitor (PI) containing regimens AND

  3. genotyping/phenotyping indicates that response to tipranavir/ritonavir is likely AND

  4. tipranavir will be used with at least one other antiretroviral medication (in addition to ritonavir) for which sensitivity has been demonstrated on resistance testing (the intended regimen must be stated).

Approval period: 1 year

Renewals criteria:

Renewal of funding will be considered for patients who are responding to therapy and who have a viral load that is undetectable or CD4 count that is increasing or is stable (i.e., two recent CD4 counts are at least within 20% of one another).

Requests to EAP should include the following information:

  • The complete regimen with which Aptivus will be used.

  • A chronology of the past PI regimens that the patient has tried and reason(s) for discontinuation (i.e., virologic failure or intolerance to include viral loads and CD4 at the time of discontinuation)

If discontinuation was the result of an intolerance, include the nature of intolerances experienced as applicable.

  • A copy of resistance testing results, genotype/phenotype tests as applicable.

  • A copy of the most recent viral load and CD4 count obtained during the past three months.

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Renewals of HIV Drugs – Telephone Request Service (TRS) Drugs

Tipranavir

  • Brand(s): Aptivus
  • Dosage Form/Strength: 250 mg capsules

Initial approvals require case-by-case review through the EAP upon receiving sufficient clinical information.

EAP will renew for patients who have responded to therapy and have undetectable viral load or increasing / stable CD4 count.

Standard Approval Duration: 12 months

Product Monograph

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