Report on New Patented Drugs - Bondronat

Brand Name: Bondronat

Generic Name: ibandronate sodium

DIN: 02232770 1mg/ml 2ml ampoule for injection

Patentee: Hoffmann-La Roche Limited

Indication - as per product monograph: For the treatment of tumour-induced hypercalcemia with or without metastases.

Notice of Compliance: June 8, 1998

Date of First Sale: May 31, 2004

ATC Class: M05BA06
Drugs used for the treatment of bone diseases. Drugs affecting bone structure and mineralization; bisphosphonates

Application of the Guidelines

Summary

The introductory price of Bondronat 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 Bondronat is sold.

Scientific Review

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

The HDAP identified Pamidronate (pamidronate disodium), Zometa (zoledronic acid) and Ostac or Bonefos (clodronate) as the most appropriate comparators for Bondronat. All these drug products share the same 4th level WHO ATC class and are indicated for the treatment of tumour-induced hypercalcemia.

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 Bondronat and the comparators are based on their respective product monographs and supported by clinical literature.

Price Review

Under the Guidelines, the introductory price of 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 Therapeutic Class Comparison test, or if it exceeds the prices of the same medicine in the seven countries listed in the Patented Medicines Regulations.

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

In 2004, Bondronat was also sold in France, Germany, Sweden, Switzerland and the United Kingdom. In compliance with the Guidelines, the price in Canada did not exceed the range of prices in those countries. The price in Canada was the 3rd lowest, below the median international price.

1. PPS, January 2005
2. Publicly available price as per the Patented Medicines Regulations
3. AQPP, October 2004

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.

Published in the April 2005 NEWSletter

Bondronat

Bondronat. Product Monograph dated February 17, 2004.

Solimando DA. Overview of hypercalcemia of malignancy. Am J Health Syst Pharm 2001;58(Suppl 3):S4-S7.

Pecherstorfer M, Steinhauer EU, Rizzoli R, Wetterwald M, Bergstrom B. Efficacy and safety of ibandronate in the treatment of hypercalcemia of malignancy: a randomized multicentric comparison to pamidronate. Support Care Cancer 2003;11:539-47.

Pecherstorfer M, Herrmann Z, Body JJ, et al. Randomized Phase II trial comparing different doses of the bisphosphonate ibandronate in the treatment of hypercalcemia of malignancy. J Clin Oncol 1996;14(1):268-76.

Ralston SH, Thiebaud D, Herrmann, et al. Dose-response study of ibandronate in the treatment of cancer-associated hypercalcemia. Br J Can 1997;75(2):295-300.

Burckhardt P. Ibandronate in oncology. Cancer 1997;80(suppl 8):1696-8.

Oleffe V, Dumon JC, Body JJ. Tumor-induced hypercalcemia in a patient with extensive soft tissue sarcoma: effects of bisphosphonate therapy and surgery. J Surg Oncol 1996;63:125-9.

Dooley M, Balfour JA. Ibandronate. Drugs 1999;57(1):101-8.

Zojer N, Keck AV, Pecherstorfer M. Comparative tolerability of drug therapies for hypercalcemia of malignancy. Drug Safety 1999;21(5):389-406.

Davidson TG. Conventional treatment of hypercalcemia of malignancy. Am J Health Syst Pharm 2001;58(Suppl 3):S8-S15.

Woloschuk DMM, Watral W. Hypercalcemia (Chapter 86). In: Gray J (ed). Therapeutic Choices (4th ed), Canadian Pharmacists Association, Ottawa, ON, 2003.

Bondronat. Scientific Discussion. European Medicines Evaluation Agency. November 19, 2004. Available at: http://www.emea.eu.int/humandocs/Humans/EPAR/bondronat/bondronat.htm

British Columbia Cancer Agency. Protocol Summary of the Guidelines for the Diagnosis and Management of Malignancy Related Hypercalcemia. April 1, 2003. Available at: http://www.bccancer.bc.ca/HPI/ChemotherapyProtocols/SupportiveCare/SCHYPCAL.htm.

Cancer Care Ontario. Formulary. May 2004. Zolendronic acid. Pamidronate. Clodronate. Available at: http://www.cancercare.on.ca/access_144.htm.