Report on New Patented Drugs - Cipralex

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: Cipralex

Generic Name: (escitalopram oxalate)

DIN: 02263238 10 mg tablet
02263254 20 mg tablet

Patentee: Lundbeck Canada Inc.

Indication - as per product monograph:

For the symptomatic relief of Major Depressive Disorder (MDD).

Notice of Compliance: December 24, 2004

Date of First Sale: February 14, 2005

ATC Class: N06AB10
Nervous System, Psychoanaleptics, Antidepressants, Selective Serotonin Reuptake Inhibitors.

Application of the Guidelines:

Summary:

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

Scientific Review:

Cipralex is a new active substance and the PMPRB's Human Drug Advisory Panel (HDAP) recommended that Cipralex 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 Celexa (citalopram), Luvox (fluvoxamine), Paxil and Paxil CR (paroxetine), Prozac (fluoxetine) and Zoloft (sertraline) as the most appropriate comparators for Cipralex. The HDAP noted that although the most appropriate comparator for Cipralex is Celexa (citalopram), the other agents were also recommended as they are of the same 4th level, share the same indication and are clinically equivalent in addressing the approved indication of Cipralex.

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 Cipralex 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 price of Cipralex was within the Guidelines as the daily cost of therapy did not exceed the cost of therapy with the comparator medicines.

1 PPS Pharma, July 2005
2 Ontario Drug Benefit Formulary, 2005
3 Voluntary Compliance Undertaking, Paxil CR, www.pmprb-cepmb.gc.ca
4 Liste de médicaments, Régie de l'assurance maladie du Québec, February 2005

In 2005, Cipralex 10 mg was being sold in all the seven countries listed in the Patented Medicines Regulations, that is France, Germany, Italy, Sweden, Switzerland, United Kingdom and the United States and the 20 mg was sold in Germany, Italy, Sweden, United Kingdom 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 10 mg in Canada was the 3rd highest above the median international price and the price of the 20 mg in Canada was the lowest of the countries in which it is sold, 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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