The Patented Medicine Prices Review Board has announced that it has issued a Notice of Hearing, the third in 2007 to date, into the price of the patented medicine ZEMPLAR which is sold in Canada by Abbott Laboratories, Limited. ZEMPLAR is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure. A new active substance, it received a Notice of Compliance (NOC) from Health Canada in 2005 but has been available under the Special Access Program (SAP) since 1999.
Among other things, the Statement of Allegations filed by Board Staff alleges that Abbott had failed to file price and sales information as required by the Patented Medicines Regulations prior to the issuance of the NOC in 2005. For purposes of the pricing allegations that are the subject of the Notice of Hearing, Board Staff has relied on evidence with respect to prices in 1999 when ZEMPLAR was first sold under the SAP.
The PMPRB's Human Drug Advisory Panel recommended that ZEMPLAR be classified as a category 3 new drug product as it provides moderate, little or no therapeutic advantage over comparable medicines. Furthermore, it recommended the product CALCIJEX as the most appropriate, and only, comparator medicine for purposes of a therapeutic class comparison (TCC) in 1999. The Statement of Allegations does not indicate the submissions that Abbott may have made with respect to categorization and appropriate comparator medicines, but it does note that oral vitamin D analogs were not considered appropriate comparators by Board Staff in this case because they are not comparable dosage forms.
Although the publicly available Statement of Allegations does not show the comparable prices in 1999, it alleges that the price of ZEMPLAR at that time exceeded the price of CALCIJEX on a price per course of treatment (per week) basis by 65%. It further alleges that the price has continued to be above the PMPRB's guidelines since then. It states that the price of ZEMPLAR was $30.23 per ml in 2007, according to publicly available information. According to the Statement of Allegations, the price of ZEMPLAR in Canada is lower than the price in the U.S., the only country in the basket of countries used by the PMPRB for price comparison purposes in which it is sold.
Interestingly, Board Staff also alleges that the price of ZEMPLAR exceeds the appropriate price limit based on "the international TCC test", even though the Board has no guidelines in this regard. The Statement of Allegations sets out criteria that, in the view of Board Staff, should be satisfied in conducting an international TCC test:
the comparators must be those identified in the domestic TCC test; and
the drug price will be deemed excessive if it exceeds the median of the international TCC test.
In this case, "Board Staff conducted an international TCC test for ZEMPLAR" which consisted of the publicly available prices in other countries for CALCIJEX. As a result, it alleges that the price of ZEMPLAR in Canada exceeded the median price of CALCIJEX, $17.9393 per ml, by more than 50% for the period January to June 1999.
The Board has scheduled a pre-hearing conference for November 13, 2007 and a hearing date of December 10, 2007. The deadline for notice of interventions by provincial ministers of health, and applications for leave to intervene by other interested persons, is August 24, 2007.
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