Reports on New Patented Drugs - Pegasys

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: Pegasys

Generic Name: peginterferon alfa-2a injection

DIN: 02248077 pre-filed syringe (180 mcg / 0.5mL)

02248078 single-use vial (180 mcg / 1mL)

Patentee: Hoffmann-La Roche Limited

Indication - as per product monograph:

For the treatment of chronic hepatitis C in adult patients without cirrhosis and in adult patients with compensated cirrhosis.

Notice of Compliance: August 13, 2003

Date of First Sale: August 14, 2003

ATC Class: L03AB11

Cytokines and Immunomodulators - Interferons

APPLICATION OF THE GUIDELINES:

Summary:

The introductory prices of Pegasys 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 introductory prices of Pegasys did not exceed the range of prices in other comparator countries where Pegasys was sold.

Scientific Review:

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

The Therapeutic Class Comparison (TCC) test of the PMPRB´s Price 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.

Although there are a number of other medicines in the same 4th level ATC class only Roferon (interferon alfa-2a), Intron A (interferon alfa-2b), and Unitron (peginterferon alfa-2b) share the same indication as Pegasys. The HDAP identified Unitron as the most appropriate comparable medicine, as like Pegasys, it is a pegylated interferon.

The Guidelines provide that the dosage recommendation for comparison purposes will normally not be higher than the maximum of the usual recommended dosage. The recommended comparable dosage regimens for Pegasys and the comparator are based on the respective product monographs and supported by clinical literature.

Price Review:

Under the PMPRB´s Price Guidelines, the introductory price of a new category 3 drug product will be presumed to be excessive if it exceeds the prices 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 (Regulations). The introductory prices of Pegasys were within the PMPRB´s Price Guidelines as they did not exceed the cost of therapy with the comparator medicine.

Name DIN Strength Dosage Regimen Unit Price Cost Per Week
Pegasys 02248077 180 mcg/0.5mL 180 mcg / week $395.841 $395.84
Unitron Peg 02242968 120 mcg/0.5mL 1.5 mcg / kg / week $395.852 $395.85
Pegasys 02248078 180 mcg/1mL 180 mcg / week $395.841 $395.84
Unitron Peg 02242968 120 mcg/0.5mL 1.5 mcg / kg / week $395.852 $395.85

1 PPS Pharma, January 2004
2 Liste de médicaments, Régie de l´assurance maladie du Québec, October 2003

In 2003, Pegasys pre-filled syringe was being sold in all of the countries listed in the Regulations and Pegasys single use vial was being sold in Italy, Sweden, Switzerland and the United States. In compliance with the PMPRB´s Price Guidelines, the introductory prices of Pegasys in Canada did not exceed the range of prices in those countries; the prices of Pegasys in Canada were the second highest, above 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 – Pegasys

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