Report on New Patented Drugs - Yasmin

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: Yasmin

Generic Name: (drospirenone/ethinyl estradiol)

DIN: 02261723 tablet 21-day pack
02261731 tablet 28-day pack

Patentee: Berlex Canada Inc.

Indication - as per product monograph:

Conception control

Notice of Compliance: December 10, 2004

Date of First Sale: December 22, 2004

ATC Class: G03FA17

Progestogens and Estrogens in Combination - Progestogens and Estrogens, fixed combinations

G03AA12

Hormonal Contraceptives for Systemic Use - Progestogens and Estrogens, fixed combinations

APPLICATION OF THE GUIDELINES:

Summary:

The introductory prices of Yasmin 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 Yasmin was sold.

Scientific Review:

Yasmin is a new active substance and the PMPRB's Human Drug Advisory Panel (HDAP) recommended that Yasmin 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 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 Brevicon, Cyclen, Demulen, Loestrin, Marvelon, Minestrin, Ortho-Novum, Ortho, Ortho-Cept, Ovral, Min-Ovral, Select 1/35 and Alesse as comparators for Yasmin as they share the same 4th level ATC, the same indication and are clinically equivalent in addressing the approved indication of Yasmin.

The PMPRB's Guidelines provide that the dosage recommended for comparison purposes will normally not be higher than the maximum of the usual recommended dose. The recommended comparable dosage regimens for Yasmin and the comparators are based on their respective product monographs and supported by clinical literature.

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 Yasmin were within the Guidelines as the daily cost of therapy did not exceed the cost of therapy with the comparator medicines.

Yasmin 21-day Therapeutic Class Comparison

1. Liste de médicaments, Régie de l'assurance maladie du Québec, 15th Ed., Update 10, June 2005
2. Ontario Drug Benefit Formulary, No. 38 , Update G, May 2005
3. Liste de médicaments, Régie de l'assurance maladie du Québec, 15th Ed., Update 9, February 2005

Yasmin 28-day
Therapeutic Class Comparison

1. Liste de médicaments, Régie de l'assurance maladie du Québec, 15th Ed., Update 10, June 2005
2. Ontario Drug Benefit Formulary, No. 38 , Update G, May 2005
3. Liste de médicaments, Régie de l'assurance maladie du Québec, 15th Ed., Update 9, February 2005

In 2005, Yasmin 21-day pack was also being sold in six of the seven countries listed in the Patented Medicines Regulations, that is France, Germany, Italy, Sweden, Switzerland and the United Kingdom; and Yasmin 28-day pack was being sold in Sweden and the United States. In compliance with the Guidelines, the prices in Canada did not exceed the prices in those countries; the price of the 21-day pack was third highest, above the median international price, and the price of the 28-day pack was 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:

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