Report on New Patented Drugs – Trelstar LA

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 Excessive Price Guidelines (Guidelines) for all new active substances introduced after January 1, 2002.

Brand Name: Trelstar LA

Generic Name: (triptorelin pamoate)

DIN: 02243856 (11.25 mg / vial)

Patentee: Paladin Labs Inc.

Indication - as per product monograph:

For the palliative treatment of hormone dependent advanced carcinoma of the prostate gland (Stage D2).

Date of Issuance of First Patent(s)
Pertaining to the Medicine: January 25, 1994

Notice of Compliance: July 06, 2005

Date of First Sale: August 15, 2006

ATC Class: L02AE04

Antineoplastic and Immunomodulating Agents; Endocrine Therapy; Hormones and Related Agents; Gonadotropin releasing hormone analogues.

APPLICATION OF THE GUIDELINES

Summary

The introductory price of Trelstar LA 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 did not exceed the range of prices of the same medicine in the comparator countries listed in the Patented Medicines Regulations, 1994 (Regulations) where Trelstar LA was sold.

Scientific Review

Trelstar LA is a new active substance and the PMPRB's Human Drug Advisory Panel (HDAP) recommended that Trelstar LA be classified as a category 3 new medicine (provides moderate, little or no therapeutic 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 World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) System that are clinically equivalent in addressing the approved indication. See the PMPRB's Compendium of Guidelines, Policies and Procedures for a more complete description of the Guidelines and the policies on TCCs.

The HDAP recommended Eligard PSF (leuprolide acetate), Lupron Depot PFS (leuprolide acetate), Suprefact (buserelin acetate), Zoladex (goserelin acetate), and Zoladex LA (goserelin acetate) as the most appropriate comparators to Trelstar LA (triptorelin pamoate). All these medications share the same 4th level ATC class, are indicated for the treatment of advanced cancer of the prostate and are considered clinically equivalent for this indication.

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 Trelstar LA and the comparable drug products were based on the 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 based on the TCC test, or if it exceeds the prices of the same medicine in the seven countries listed in the Regulations.

The Guidelines also provide that the PMPRB reserves the right to exclude from the TCC test any drug product it has reason to believe is being sold at an excessive price. At the time of this review the price of Eligard 45 mg was under investigation. It was therefore excluded from the TCC test.

The introductory price of Trelstar LA was within the Guidelines as the cost per treatment did not exceed the cost per treatment of the comparator medicines.

Introductory Period (August to December 2006)

Sources:
(1) Publicly available price as per the Regulations
(2) For all comparators, Ontario Drug Benefit Formulary, June 2006.

In 2006, Trelstar LA was being sold in one of the seven countries listed in the Regulations, namely the United States. In compliance with the Guidelines, the Canadian price was not the highest price.

Where comparators and dosage regimens are referred to in the Summary Reports, they have been selected by 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 – Trelstar LA

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2. BC Cancer Agency. Systemic management of prostate cancer. http://www.bccancer.bc.ca/HPI/CancerManagementGuidelines/Genitourinary
/Prostate/Management/SystemicManagementofProstateCancer/
MedicalCastration.htm (accessed November 20, 2006)

3. Bouchot O, Soret JY, Jacqmin D, et al. Three-month sustained-release form of triptorelin in patients with advanced prostatic adenocarcinoma: results of an open pharmacodynamic and pharmacokinetic multicenter study. Horm Res 1998;50:89-93.

4. Canadian Cancer Society, Public Health Agency of Canada, and Statistics Canada. Canadian Cancer Statistics 2005. http://www.ncic.cancer.ca/vgn/images/portal/cit_86751114/60/42/393678947ncic
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5. Cancer Care Ontario Genitourinary Disease Site Group. Maximal androgen blockade for the treatment of metastatic prostate cancer. Practice guideline report # 3-1. February 5, 2003.

6. ESMO Guideline Task Force. ESMO minimum clinical recommendations for diagnosis, treatment and follow-up of prostate cancer. Ann Oncol 2005;16 (suppl 1):i34-6.

7. Loblaw DA, Mendelson DS, Talcott JA, et al. American Society of Clinical Oncology recommendations for the initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer. J Clin Oncol 2004;22:2927-41.

8. Minkov NK, Zozikov BI, Yaneva Z, et al. A phase II trial with new triptorelin sustained release formulations in prostatic carcinoma. Int Urol Nephrol 2001;33:379-83.

9. National Comprehensive Cancer Network. Prostate Cancer. V.2.2005.

10. Product Monograph of Anandron. CPS electronic version 2005.

11. Product Monograph of Androcur. CPS electronic version 2005.

12. Product Monograph of Casodex. CPS electronic version 2005.

13. Product Monograph of Eligard. CPS electronic version 2005.

14. Product Monograph of Euflex. CPS electronic version 2005.

15. Product Monograph of Lupron. CPS electronic version 2005.

16. Product Monograph of Megace. CPS electronic version 2005.

17. Product Monograph of Superfact and Superfact Depot. CPS electronic version 2005.

18. Product monograph of Trelstar (triptorelin for injectable suspension). Pharmacia Canada Inc. Mississauga, ON. May 30, 2002.

19. Product Monograph of Trelstar for advanced carcinoma of the prostate gland and endometriosis and Trelstar LA for advanced carcinoma of the prostate gland, dated March 1, 2006.

20. Product Monograph of Zoladex and Zoladex LA. CPS electronic version 2005.

21. Teillac P, Heyns CF, Kaisary AV, et al. Pharmacodynamic equivalence of a Decapeptyl 3-month SR formulation with the 28-day SR formulation in patients with advanced prostate cancer. Horm Res 2004;62:252-8.

22. Tortorice PV. Prostate cancer. In: Schumock GT, Brundage DM, Richardson MM, et al, eds. Pharmacotherapy self-assessment program, 5th ed. Hematology and oncology. Kansas City, MO: American College of Clinical Pharmacy, 2006:123-44.

23. Wood L, Wilke D, Rendon R, et al. Guidelines for the management of prostate cancer. Genitourinary Cancer Site Team, Cancer Care Nova Scotia, 2005.