Stribild (the Quad) Approved in Canada
November 28, 2012
In clinical trials with Stribild, about 10% of participants were women. This is less than ideal. Gilead Sciences is committed to conducting further research with Stribild and HIV-positive women. Also, the safety of Stribild in pregnant women is not known.
The Long and Winding Road
Once Health Canada approves a drug, physicians can prescribe it but patients must pay for it unless their private insurance plan provides coverage. HIV/AIDS is a catastrophic disease that can affect people's ability to work and requires expensive care. In Canada, provincial and territorial ministries of health heavily subsidize the cost of anti-HIV medications. Each ministry has a listing of drugs for which it is prepared to pay. These listings are called formularies.
After federal approval, each HIV medicine must undergo another review process called Common Drug Review (CDR). As part of this review, recommendations are made as to whether the drug in question should be:
The CDR may also result in no decision being made as additional information is gathered. With the exception of Quebec, all provinces and territories, the Departments of National Defense and Veterans Affairs, and the Non-Insured Health Benefits plan participate in the CDR.
Stribild will undergo the CDR process in 2013 with the results available later that year.
Gilead Sciences plans to submit a dossier on Stribild to L'Institut national d'excellence en santé et en services sociaux (INESSS) shortly. Stribild will hopefully be listed on the Quebec formulary -- Liste des médicaments assurés du Québec -- in 2013.
The wholesale price of Stribild in Canada is approximately $16,600 per person per year; this is considerably less than the wholesale price in the U.S., which is about $28,500 per person per year.
Pharmacies will be able to place orders for Stribild from December 31, 2012, and the company will ship them the drug shortly thereafter.
Quad (Stribild) -- safety and effectiveness issues in depth -- TreatmentUpdate 191
The Quad (Stribild) and changes to assessments of kidney health -- TreatmentUpdate 192
Cobicistat and elvitegravir - safe with methadone or buprenorphine and naloxone -- TreatmentUpdate 194
A CATIE Fact Sheet on Stribild is under development.
AIDS Healthcare Foundation Challenges Gilead Over AIDS Drug Price Gouging of U.S. Government Programs on Stribild
This article was provided by Canadian AIDS Treatment Information Exchange. Visit CATIE's Web site to find out more about their activities, publications and services.
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