Report on New Patented Drugs - Vantas

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: Vantas

Generic Name: (histrelin acetate)

DIN: 02278383 (50 mg subdermal implant)

Patentee: Paladin Labs Inc.

Indication - as per product monograph:
For the palliative treatment of hormone-dependent advanced prostate cancer (Stage M1 [TNM] or Stage D2 [AUA]).

Date of Issuance of First Patent(s) Pertaining
To the Medicine: May 28, 1996

Notice of Compliance: March 10, 2006

Date of First Sale: July 14, 2006

ATC Class: H01CA03
Systemic Hormonal Preparations, Excluding Sex Hormones and Insulins; Pituitary and Hypothalamic Hormones and Analogues; Hypothalamic Hormones; gonadotropin-releasing hormones.

APPLICATION OF THE GUIDELINES

Summary:

The introductory price of Vantas 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 Vantas was sold.

Scientific Review:

Vantas is a new active substance and the PMPRB's Human Drug Advisory Panel (HDAP) recommended that Vantas 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 PFS (leuprolide acetate), Lupron Depot PFS (leuprolide acetate), Suprefact Depot (buserelin acetate), Zoladex (goserelin acetate) and Zoladex LA (goserelin acetate) as comparator drug products to Vantas. Although these agents do not share the same 4 th level ATC as Vantas, they are indicated and used to treat the same indication as Vantas.

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

Introductory Period (July to December 2006)

Name Strength Dosage Regimen Unit Price Cost per Treatment
(12 months)
Vantas 50 mg 1 implant $3,564.00(1) $3,564.00
Eligard PFS 7.5 mg 12 vials $343.58(2) $4,122.96
Eligard PFS 22.5 mg 4 vials $891.00(2) $3,564.00
Eligard PFS 30 mg 3 vials $1,285.20 (2) $3,855.60
Eligard PFS 45 mg 2 vials --- (3) --- (3)
Lupron Depot PFS 7.5 mg 12 vials $387.97 (2) $4,655.64
Lupron Depot PFS 22.5 mg 4 vials $1,071.00 (2) $4,284.00
Lupron Depot PFS 30 mg 3 vials $1,428.00 (2) $4,284.00
Suprefact Depot 6.3 mg 6 vials $670.00 (2) $4,020.00
Suprefact Depot 9.45 mg 4 vials $990.00 (2) $3,960.00
Zoladex 3.6 mg 13 vials $381.75 (2) $4,962.75
Zoladex LA 10.8 mg 4 vials $1,087.98 (2) $4,351.92

Sources:
(1) Publicly available price as per the Regulations
(2) Ontario Drug Benefit Formulary, June 2006
(3) The price of Eligard PFS 45 mg is under investigation

In 2006, Vantas 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 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 - Vantas

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  2. BC Cancer Agency. Systemic management of prostate cancer: Medical castration. Updated: 22 Jul 2005 . Available from: http://www.bccancer.bc.ca/HPI/CancerManagementGuidelines/Genitourin ary/Prostate/Management/SystemicManagementofProstateCancer/Medical Castration.htm (accessed 20 Dec 2006 )

  3. Canadian Cancer Society. Prostate cancer stats. Last modified: 11 April 2006. Available from: http://www.cancer.ca/ccs/internet/standard/0,3182,3172_14471_371299_ langId-en,00.html (accessed 20 Dec 2006)

  4. Canadian Pharmacists Association. e-CPS [database on the Internet; cited 20 Dec 2006]. Ottawa: Canadian Pharmacists Association; 2006.

  5. Cancer Care Ontario. Prostate Cancer Incidence and Mortality in Ontario, 1964-2002. Available from: http://www.cancercare.on.ca/index_statisticsProstate.htm (accessed 17 Dec 2006)

  6. Cancer Care Ontario. Maximal androgen blockade for the treatment of metastatic prostate cancer. Practice Guideline Report #3-1. February 5, 2003. Available from: http://www.cancercare.on.ca/pdf/pebc3-1f.pdf (accessed 20 Dec 2006)

  7. Chertin B, Spitz IM, Lindenberg T, et al. An implant releasing the gonadotropin hormone-releasing hormone agonist histrelin maintains medical castration for up to 30 months in metastatic prostate cancer. The Journal of Urology. 2000;163:838-44.

  8. Health Canada. Drug Product Database [database on the Internet; cited 16 Dec 2006]. Available from: http://www.hc-sc.gc.ca/hpb/drugs-dpd/

  9. Health Canada. Notice of Compliance Search [database on the Internet; cited 16 Dec 2006]. Available from: http://www.nocdatabase.ca/

  10. Kantoff PW. Prostate Cancer [electronic article]. ACP Medicine. 2005.

  11. Lepor H. Comparison of single-agent androgen suppression for advanced prostate cancer. Rev Urol. 2005;7 Suppl 5:S3-S12. Available from: http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1477619&blobtype=pdf (accessed 20 Dec 2006)

  12. 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.

  13. Marks LS. Luteinizing hormone-releasing hormone agonists in the treatment of men with prostate cancer: timing, alternatives, and the 1-year implant. Urology. 2003 Dec 22;62(6 Suppl 1):36-42.

  14. National Cancer Institute. Prostate Cancer (PDQ®): Treatment. General Information. Available from: http://www.cancer.gov/cancertopics/pdq/treatment/prostate/HealthProfes sional/page1 (accessed 16 Dec 2006)

  15. National Cancer Institute. Prostate Cancer (PDQ®): Treatment. Stage Information. Available from: http://www.cancer.gov/cancertopics/pdq/treatment/prostate/HealthProf essional/page3 (accessed 16 Dec 2006)

  16. National Cancer Institute. Prostate Cancer (PDQ®): Treatment. Stage IV prostate cancer. Available from: http://www.cancer.gov/cancertopics/pdq/treatment/prostate/HealthProfes sional/page8 (accessed 16 Dec 2006)

  17. National Comprehensive Cancer Network. Clinical practice guidelines in oncology: prostate cancer – v.2.2005. January 25, 2006. Available from: http://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf (accessed 20 Dec 2006)

  18. Paladin Labs Inc. Vantas Product Monograph. Montreal, Quebec. March 10, 2006.

  19. Sato N, Akakura K, Isaka S, et al. Intermittent androgen suppression for locally advanced and metastatic prostate cancer: preliminary report of a prospective multicenter study. Urology. 2004;64:341-5.

  20. Schlegel PN; Histrelin Study Group. Efficacy and safety of histrelin subdermal implant in patients with advanced prostate cancer. The Journal of Urology. 2006;175:1353-8.

  21. Schlegel PN, Kuzma P, Frick J, et al. Effective long-term androgen suppression in men with prostate cancer using a hydrogel implant with the GnRH agonist histrelin. Urology. 2001;58:578-82.

  22. Thomson Healthcare, Inc. USP DI® Drug Info. for the Health Care Pro. - 26th Ed. (2006). ). In: STAT!Ref Online Electronic Medical Library [database on the Internet; cited 20 Dec 2006]. Greenwood Village: Thomson MICROMEDEX; 2006.

  23. WHO Collaborating Centre for Drug Statistics Methodology. ATC Index [database on the Internet; cited 16 Dec 2006]. Available from: http://www.whocc.no/atcddd/

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