Report on New Patented Drugs - Valcyte

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.

Valcyte

Brand Name (generic): Valcyte (valgancyclovir hydrochloride)

DIN: 02245777 450 mg tablet

Patentee: Hoffman-La Roche Limited

Indication (as per product monograph):

For the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).

Notice of Compliance: May 3, 2002

Date of First Sale: July 15, 2002

ATC Class: J05AB14

Antivirals for systemic use, Direct acting antivirals, Nucleosides and nucleotides, excluding reverse transcriptase inhibitors

APPLICATION OF THE GUIDELINES:

Summary:

The introductory price of Valcyte 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 Valcyte was sold.

Scientific Review:

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

Cytomegalovirus (CMV) occurs in approximately 25% of AIDS patients and can become a sight-threatening infection. The objective of treatment is to prevent disease progression and systemic infection.

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.

Members of the same 4th level ATC class as Valcyte that are commercially available in Canada include Zovirax (acyclovir), Herplex-D (idoxuridine), Cytovene (ganciclovir), Famvir (famciclovir), Valtrex (valaciclovir), Virazole (ribavirin) and ribavirin combinations. Of these, only Cytovene is indicated for the treatment of CMV retinitis. As a result, the HDAP recommended Cytovene as the sole comparator for Valcyte.

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 Valcyte and its comparator are based on the respective product monographs and supported by clinical literature.

Price Review:

Under the Guidelines, the introductory price for a new category 3 drug product will be presumed to be excessive if it exceeds the price of all 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 Valcyte was within the Guidelines as the daily cost of therapy did not exceed the cost of therapy with the comparator medicine.

1 Liste de médicaments, Régie de l'assurance maladie du Québec, 2002

In 2002, Valcyte was also sold in 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 these countries; the price in Canada was the lowest of these countries.

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 - Valcyte

1. Welbanks L, editor. Compendium of Pharmaceuticals and Specialties, 35th Edition. Canadian Pharmacists Association, 2000, Ottawa.

2. Curran M, Noble S. Valganciclovir. Drugs 2001;61(8):1145-50.

3. Cocohoba JM, McNicholl IR. Valganciclovir: an advance in cytomegalovirus therapeutics. Ann Pharmacother 2002;36:1075-9.

4. Riley TN, DeRuiter J. Does valganciclovir hydrochloride offer advantages over oral ganciclovir in the treatment of cytomegalovirus retinitis in patients with AIDS ? US Pharm 2002;27:60-5.

5. Segarra-Newnham M, Salazar MI. Valganciclovir: a new oral alternative for cytomegalovirus retinitis in human immunodeficiency virus-seropositive individuals. Pharmacotherapy 2002;22:1124-8.

6. Martin DF, Sierra-Madero J, Walmsley S et al. A controlled trial of valganciclovir as induction therapy for cytomegalovirus retinitis. N Engl J Med 2002;346(15):1119-26.

7. Boivin G, Gilbert C, Gaudreau A et al. Rate of emergence of cytomegalovirus mutations in leukocytes of patients with acquired immunodeficiency syndrome who are receiving valganciclovir as induction and maintenance therapy for CMV retinitis. JID 2001;184(12):1598-602.

8. Sande MA, Gilbert DN, Moellering RC (eds). The Sanford Guide to HIV/AIDS Therapy (11th ed). Antimicrobial Therapy Inc., Hyde Park, VT, 2002.