Report on New Patented Drugs - Avodart

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.

Avodart

Brand Name: Avodart

Generic Name: dutasteride

DIN: 02247813 0.5 mg capsule

Patentee: GlaxoSmithKline Inc.

Indication - as per product monograph:

For the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with enlarged prostates.

Notice of Compliance: July 22, 2003

Date of First Sale: January 7, 2004

ATC Class: G04CB02
Genito Urinary System and Sex Hormones, Urologicals, Drugs used for Benign Prostatic Hypertrophy; Testosterone-5-Alpha Reductase Inhibitors

Application of the Guidelines

Summary:

The introductory price of Avodart was found to be within the PMPRB's 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 range of prices in other comparator countries where Avodart is sold.

Scientific Review:

Avodart is a new active substance and the PMPRB's Human Drug Advisory Panel (HDAP) recommended that Avodart 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.

At introduction, there was only one medicine in the same 4th level ATC. As it is indicated for benign prostate hyperplasia, the HDAP identified this medicine as the sole comparator.

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 Avodart and the comparator 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 Avodart was within the Guidelines as the daily cost of therapy did not exceed the cost of therapy with the comparator medicine.

* Régie de l'assurance maladie du Québec (RAMQ)
** Ontario Drug Benefit (ODB) Program

In 2004, Avodart was also being sold in France, Italy, Germany, Sweden, Switzerland, the United Kingdom and the United States. In compliance with the Guidelines, the price in Canada did not exceed the range of prices in those countries; the price of Avodart in Canada was the third highest of those countries, 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.

Evidence/References:

Product Monograph of Avodart (dutasteride). GlaxoSmithKline Inc., Mississauga, ON. September 2003.

New Medicine Scientific Review of Avodart prepared by the DIC, May 11, 2004 including:

1. Roehrborn CG, Boyle P, Nickel JC, et al. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Urology 2002;60:434-41.

2. Barkin J, Guimaraes M, Jacobi G et al. Alpha-blocker therapy can be withdrawn in the majority of men following initial combination therapy with the dual 5-alpha-reductase inhibitor dutasteride. Eur Urol 2003;44:461-6.

3. O'Leary MP, Roehrborn C, Andriole G, et al. Improvements in benign prostatic hyperplasia-specific quality of life with dutasteride, the novel dual 5-alpha-reductase inhibitor. BJU International 2003;92:262-6.

4. American Urological Association Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol 2003;170:530-47.

5. Thompson IM, Goodman PJ, Tangen CM, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med 2003;349(3):215-24.

6. CCOHTA, Emerging Drug List: Dutasteride for the treatment of benign prostatic hyperplasia, May 2003. Available on the web at: http://www.ccohta.ca/publications/pubs_e.asp.