Report on New Patented Drugs – Hectorol

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: Hectorol

Generic Name: doxercalciferol

DIN: 02243790 2.5 mcg capsule

Patentee: Draxis Health Inc.

Indication (as per product monograph):

For the reduction of elevated intact parathyroid hormone (iPTH) levels in the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis.

Notice of Compliance: April 30, 2001

Date of First Sale: February 28, 2003

ATC Class: A11CC

Vitamins

Vitamin A & D,

Vitamin D and analogues

Application of the Guidelines

Summary:

The introductory price of Hectorol 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 Hectorol was sold.

Scientific Review:

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

Of the vitamin D and vitamin D analogues that are members of the same 4th level ATC class as Hectorol, only One Alpha (alfacalcidol) and Rocaltrol (calcitriol) share the same indication as Hectorol. They are available in comparable dosage forms. The HDAP identified One Alpha and Rocaltrol as the most appropriate comparators.

The 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 Hectorol and the comparators 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 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 Hectorol was within the Guidelines as the weekly cost of therapy did not exceed the cost of therapy with the comparator medicines.

1 Association québécoise des pharmaciens propriétaires (AQPP), October 2003

At the time of introduction, Hectorol was also sold in the U.S. In compliance with the Guidelines, the price in Canada did not exceed the price in the other country in which it was sold.

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 :

Welbanks L, editor. Compendium of Pharmaceuticals and Specialties, 37th Edition. Canadian Pharmacists Association, 2002, Ottawa.

Lindberg JS. New vitamin D analogs. Dialysis Clinic 2001;14(3):229-30.

Cunningham J. What is the optimal regimen for vitamin D? Kidney Int 1999;56(suppl 73):S-59-S-64.

Martin KJ, Gonzalez EA. Vitamin D analogues for the management of secondary hyperparathyroidism. Am J Kidney Dis 2001;38(5, Suppl 5):S34-S40.

Brown AJ. Therapeutic uses of vitamin D analogues. Am J Kidney Dis 2001;38(5, Suppl 5):S3-S19.

Tan AU, Levine BS, Mazess RB et al. Effective suppression of parathyroid hormone by 1"-hydroxyvitamin D2 in hemodialysis patients with moderate to severe secondary hyperparathyroidism. Kidney International 1997;51:317-23.

Frazao JM, Elangovan L, Maung HM et al. Intermittent doxercalciferol (1"-hydroxyvitamin D2) therapy for secondary hyperparathyroidism. Am J Kidney Dis 2000;36(3):550-61.