Report on New Patented Drugs - Telzir

Under its transparency initiative, the PMPRB publishes the results of the reviews of new patented drugs by Board Staff, for purposes of applying the PMPRB's Price Guidelines, for all new active substances introduced after January 1, 2002.

Brand Name: Telzir

Generic Name: (fosamprenavir calcium)

DIN:

• 02261545 700 mg tablet
• 02261553 50 mg/mL suspension

Patentee: GlaxoSmithKline Inc.

Indication - as per product monograph:

In combination with low dose ritonavir for the treatment of HIV-1 infection in adult patients, in combination with other antiretroviral agents

Notice of Compliance: December 10, 2004

Date of First Sale:

• January 26, 2005 700mg tablet
• February 28, 2005 50 mg/mL suspension

ATC Class: J05AE07

Antiinfectives for Systemic Use, Antivirals for Systemic Use, Direct Acting Antivirals, Protease Inhibitors

APPLICATION OF THE GUIDELINES:

Summary:

The introductory prices of Telzir were found to be within the Guidelines because the cost of therapy did not exceed the cost of therapy of existing drugs in the therapeutic class comparison and the prices did not exceed the prices in the other comparator countries where Telzir was sold.

Scientific Review:

Telzir is a new active substance and the PMPRB's Human Drug Advisory Panel (HDAP) recommended that Telzir be reviewed as a category 3 new medicine (provides moderate, little or no therapeutic advantage over comparable medicines).

The Therapeutic Class Comparison (st1:stockticker w:st="on">TCC) test of the Guidelines provides that the price of a category 3 new drug product cannot exceed the prices of other drugs that treat the same disease or condition. Comparators are generally selected from among existing drug products in the same 4th level of the Anatomical, Therapeutic, Chemical (ATC) System that are clinically equivalent in addressing the approved indication. See the PMPRB's Compendium of Guidelines, Policies and Procedures for a more complete description of the Guidelines and the policies on TCCs.

The HDAP recommended Fortovase (saquinavir), Invirase (saquinavir), Viracept (nelfinavir), Crixivan (indinavir) Reyataz (atazanavir) and Kaletra (lopinavir/ritonavir) as the most appropriate comparators for Telzir 700 mg tablet, and the oral liquid dosage forms of Viracept and Kaletra for Telzir 50 mg/mL. These products share the same fourth level ATC class, and are all indicated for the treatment of HIV-1 infection in adults.

The PMPRB's Guidelines provide that the dosage recommended for comparison purposes will normally not be higher than the maximum of the usual recommended dosage. The recommended comparable dosage regimens for Telzir and the comparators are based on their respective product monographs and the U.S. Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents.

Price Review:

Under the Guidelines, the introductory price of a new category 3 drug product will be presumed to be excessive if it exceeds the price of all of the comparable drug products in the TCC test, or if it exceeds the prices of the same medicine in the seven countries listed in the Patented Medicines Regulations. The prices of Telzir were within the Guidelines as the daily cost of therapy did not exceed the cost of therapy with the comparator medicines.

1PPS Pharma, 2005
2Ontario Drug Benefit Formulary, 2005

1PPS Pharma, 2005
2Ontario Drug Benefit Formulary, 2005

In 2005, Telzir 700 mg/tablet was being sold in four of the seven countries listed in the Patented Medicines Regulations, that is France, Italy, United Kingdom and the United States; Telzir 50 mg/mL suspension was being sold in France, Switzerland and United Kingdom. In compliance with the Guidelines, the prices in Canada did not exceed the range of prices in those countries; the prices of Telzir in Canada were the lowest of those countries, below the median international price.

Where comparators and dosage regimens are referred to in the Summary Reports, they have been selected by the PMPRB Staff and the HDAP for the purpose of carrying out the PMPRB's regulatory mandate, which is to review the prices of patented medicines sold in Canada to ensure that such prices are not excessive. The publication of these reports is also part of the PMPRB's commitment to make its price review process more transparent.

The information contained in the PMPRB's Summary Reports should not be relied upon for any purpose other than its stated purpose and is not to be interpreted as an endorsement, recommendation or approval of any drug nor is it intended to be relied upon as a substitute for seeking appropriate advice from a qualified health care practitioner.

References:

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