Report on New Patented Drugs - Zenapax

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: Zenapax

Generic Name: daclizumab

DIN: 02241473 25 mg/5 ml vial

Patentee: Hoffmann-La Roche Canada Limited

Indication - as per product monograph: As an adjunct agent for the prophylaxis of acute organ rejection in patients receiving renal transplants. In clinical studies the majority of the patients received Zenapax in combination with cyclosporine, corticosteroids, and azathioprine.

Notice of Compliance: January 4, 2000

Date of First Sale: July 19, 2000

In most cases, patents are issued before the drugs come to market. In this case, the first patent pertaining to Zenapax was issued on August 13, 2002 and it came under the PMPRB´s jurisdiction at that time.

ATC Class: L04AA08
Antineoplastic and Immunomodulating agents, Immunosuppresive agents, Selective immunosupresive agents

APPLICATION OF THE GUIDELINES:

Summary:

The introductory price of Zenapax at the date of first sale 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 range of prices in other comparator countries where Zenapax was sold. The price continued to be within the Guidelines in 2002 when Zenapax came under the PMPRB´s jurisdiction.

Scientific Review:

Zenapax 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).

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.

The HDAP recommended Atgam (antilymphocyte immunoglobulin equine) as the sole comparator for Zenapax. Atgam shares the same 4th level ATC as Zenapax and shares a similar indication and clinical use.

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 Zenapax and the comparator are based on product monographs and 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 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.

The price of Zenapax was within the Guidelines as the cost of therapy did not exceed the cost of therapy with the comparator medicine.

1 Medis, August-October 2002
2 PPS, July 2002

At the date of first sale, Zenapax was also being sold in France, Italy, 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 of Zenapax was third highest, above the median international price.

Evidence/References:

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:

1. Gray J (ed). Therapeutic Choices, 3rd edition. Canadian Pharmacists Association, 2000; Ottawa.

2. Levine M, Lexchin J, Pellizzari R (eds). Drugs of Choice: A formulary for general practice, 2nd edition. Canadian Medical Association 1998, Ottawa.

3. Drug Product Database on the Health Canada Web site.

4. Welbanks L, editor. Compendium of Pharmaceuticals and Specialties, 38th Edition. Canadian Pharmacists Association, 2003, Ottawa.

5. Vincenti F, Kirkman R, Light S et al. Interleukin-2-receptor blockade with daclizumab to prevent acute rejection in renal transplantation. N Engl J Med 1998;338:161-5.

6. Nasham B, Light S, Hardie IR et al. Reduction of acute renal allograft rejection by daclizumab. Transplantation 1999;67(1):110-5.

7. Bumgardner GL, Hardie I, Johnson R et al. Results of 3-year phase III clinical trials with daclizumab prophylaxis for prevention of acute rejection after renal transplantation. Transplantation 2001;72(5):839-45.

8. Berard JL, Velez RL, Freeman RB, Tsunoda SM. A review of interleukin-2 receptor antagonists in solid organ transplantation. Pharmacotherapy 1999;19(10):1127-37.

9. Health Canada Notice of Compliance Web site at: www.hc‑sc.gc.ca/hpb‑dgps/therapeut/htmleng/noc_drugs.html#2003 [accessed January 22, 2003].

10. Product monograph of Simulect (basiliximab), Novartis, Dorval, September 1, 2000.

11. Nashan B, Moore R, Amlot P et al. Randomised trial of basiliximab versus placebo for control of acute cellular rejection in renal allograft recipients. Lancet 1997;350(9086):1193-8.

12. Ahmad I, Ketel B, Barone G. Comparison of basiliximab to rabbit anti-thymocyte globulin induction in kidney transplant recipients. Poster presentation #179.