Report on New Patented Drugs - Sensipar
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: Sensipar
Generic Name: (cinacalcet hydrochloride)
02257130 30 mg tablet
02257149 60 mg tablet
02257157 90 mg tablet
Patentee: Amgen Canada Inc.
Indication - as per product monograph:
For the treatment of secondary hyperparathyroidism in patients with Chronic Kidney Disease (CKD)
Notice of Compliance: August 9, 2004
Date of First Sale: September 29, 2004
The first patent pertaining to Sensipar was issued on August 30, 2005 and it came under the PMPRB's jurisdiction at that time.
ATC Class: H05BX01
Systemic Hormonal Preparations Excluding Sex Hormones and Insulins, Calcium Homeostasis, Anti-parathyroid Hormones
Application of the Guidelines
The introductory prices of Sensipar 30 mg and 60 mg tablets were found to be within the Guidelines because the price in Canada did not exceed the median of the prices of the same drug in those countries listed in the Patented Medicines Regulations (Regulations) in which they were sold or did not do so by an amount sufficient to trigger any of the investigation criteria under the Compliance & Enforcement Policy. The introductory price of Sensipar 90 mg tablet exceeded the median of the prices of the same drug in those countries listed in the Regulations in which it was sold in the introductory period. However, its price was considered within the Guidelines in the subsequent reporting period.
Sensipar is a new active substance and the PMPRB's Human Drug Advisory Panel (HDAP) recommended that Sensipar be reviewed as a category 2 new medicine (breakthrough or substantial improvement) as it provides a substantial improvement in the treatment of secondary hyperparathyroidism in patients with Chronic Kidney Disease (CKD) where the current standard of care is insufficient to control parathyroid hormone (PTH) levels because there is currently a lack of effective therapy for patients who do not meet the National Kidney Foundation Disease Outcome Quality Indicators; failure to meet these indicators has been shown to result in morbidity and mortality.
The HDAP did not identify any comparators for the conduct of a Therapeutic Class Comparison (TCC) Test.
Under the Guidelines, the introductory price of a new category 2 drug product will be presumed to be excessive if it exceeds the prices of all comparable drug products, based on a TCC Test, and the median of the international prices identified in an International Price Comparison (IPC) Test.
As no comparable drug products were identified for purposes of conducting a TCC Test, the introductory prices were reviewed based on the median of the IPC Test. When Sensipar was first sold in 2004, the price of the 30 mg tablet was within the Guidelines; the price of the 60 mg was considered within the Guidelines as its price did not exceed the MNE price by a margin which would trigger the investigation criteria; and the price of the 90 mg tablet exceeded the MNE price by a margin which would have triggered the criteria for commencing an investigation. The price of the 90 mg tablet was considered within the Guidelines in the following reporting period.
Introductory Period (September to December 2004
30 mg tablet
60 mg tablet
90 mg tablet
Source: Publicly available prices as per the Patented Medicines Regulations
The Guidelines provide that when a medicine is sold in fewer than five countries at the time of its introduction, the introductory price will be treated as the interim benchmark price. The interim benchmark price may be reviewed at the end of three years or when the medicine is sold in at least five countries, whichever comes first.
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 – Sensipar
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