Report on New Patented Drugs – Sutent

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: Sutent

Generic Name: (sunitinib malate )

DIN: 02280795 (12.5 mg capsule)
02280809 (25 mg capsule)
02280817 (50 mg capsule)

Patentee: Pfizer Canada Inc.

Indication - as per product monograph:
For the treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance.

Date of Issuance of First Patent(s) Pertaining
To the Medicine: March 21, 2006

Notice of Compliance: May 26, 2006

Date of First Sale: June 24, 2006

ATC Class: L01XE04
Antineoplastic and Immunomodulating Agents; Antineoplastic Agents; Other Antineoplastic Agents.

Application of the Guidelines

Summary:

The introductory prices of Sutent 12.5 mg, 25 mg and 50 mg capsules were 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 the prices did not exceed the range of prices in other comparator countries where Sutent was sold.

Scientific Review:

Sutent is a new active substance and the PMPRB´s Human Drug Advisory Panel (HDAP) recommended that it be classified as a category 3 new medicine as it provides moderate, little or no therapeutic advantage in the treatment of GIST.

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 Anatomical Therapeutic Chemical (ATC) System that are clinically equivalent in addressing the approved indication. The Guidelines provide that it may, however, be appropriate to include products from other ATC classes if they are clinically equivalent for the appropriate indication to the drug product under review. 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 identified Gleevec (imatinib) as a comparator to Sutent 50 mg capsule as it is indicated and used for the treatment of GIST. Since the 12.5 mg and 25 mg capsules doses are used primarily for downward dose adjustments, a comparable dosage regimen cannot be defined. Therefore, the HDAP recommended that the 12.5 mg and 25 mg capsules be compared on a milligram to milligram basis with the 50 mg capsule.

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 Sutent and the comparator Gleevec are based on respective product monographs and comparative clinical trial data.

Price Review:

Under the Guidelines, the introductory price for 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 TCC test, or if it exceeds the prices of the same medicine in the seven countries listed in the Patented Medicines Regulations, 1994.

The price of Sutent 50 mg capsule was within the Guidelines as the cost of treatment did not exceed the cost of treatment of the comparator medicine.

Introduction Period (July to December 2006)

Name Strength Dosage Regimen
(6 weeks)		 Unit Price Cost per Treatment
(6 weeks)
Sutent 50 mg capsule 28 capsules $248.1425 1 $6,947.9900
Gleevec 400 mg tablet 84 tablets $102.3283 2 $8,595.5772

Sources:
1) No publicly available price for 2006. PPS Pharma January 2007.
2) Ontario Drug Benefit Formulary, January 6, 2006

As no comparators were identified for Sutent 12.5 mg and 25 mg capsules, the prices were compared to the price of the 50 mg capsule in a Reasonable Relationship test. The prices of $62.0357 1 for the 12.5 mg capsule and $124.0711 1 for the 25 mg capsule were within the Guidelines at introduction.

In 2006, all three strengths of Sutent were being sold in France , Germany , Sweden , Switzerland , United Kingdom and the United States . In compliance with the Guidelines, the prices in Canada did not exceed the range of prices in those countries. The prices of Sutent in Canada were the lowest of those countries.

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 - Sutent

  1. Baker, D, Levien TL, editors. Sunitinib malate capsules [monograph on the Internet]. Philadelphia : Wolters Kluwer Health, Inc.; 2005.

  2. British Columbia Cancer Agency. Cancer Management Guidelines: Musculoskeletal and Sarcoma: 6. Management. Available from: http://www.bccancer.bc.ca/HPI/Cancer/CancerManamgementGuidelines/ MusculoskeletalandScaroma/Management/03SpecialSurgicalConsiderat ions.htm#GIST (accessed 22 June 2006 )

  3. British Columbia Cancer Agency. Protocol Summary for Treatment of Advanced c-kit positive Gastrointestinal Stromal Cell Tumours (GIST´s) using imatinib (Gleevec). SAAGI. Available from: http://www.bccancer.bc.ca/HPI/ChemotherapyProtocols/Sarcoma/ USAAVI.htm

  4. Blackstein ME et al. Gastrointestinal stromal tumours: consensus statement on diagnosis and treatment. Can J Gastroenterol 2006;20:157-163.

  5. Blanke CD, Corless CL. State-of-the-art therapy for gastrointestinal stromal tumors. Cancer Invest. 2005;23(3):274-80.

  6. Cancer Care Ontario . Imatinib Mesylate (Gleevec TM) for the Treatment of Adult Patients with Unrespectable or Metastatic Gastrointestinal Stromal Tumours: A Clinical Practice Guideline. April 6, 2006 . Available from: http://www.cancercare.on.ca/pdf/pebc11-7s.pdf (accessed 20 June 2006 )

  7. Casali PG et al. Abstract. Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part 1. Vol 24;18S (June 20 Supplement), 2006;9513.

  8. Demetri G, van Oosterom A, Garrett C, Blackstein M, Shah M, Verwij J, et al. Sunitinib malate (SU11248) prolongs progression-free survival and overall survival for GIST patients after failure of imatinib mesylate therapy: update of a phase III trial [abstract]. European Journal of Cancer Supplements. 2005 Oct;3(2):203. Available from: http://ex2.excerptamedica.com/ciw-05ecco/index.cfm?fuseaction=CIS2002&hoofdnav=Abstracts&content=abs.details&what= AUTHOR&searchtext=demetri&topicselected=*&selection=ABSTRACT& gryStartRowDetail=5

  9. Demetri GD, van Oosterom AT, Blackstein M, Garrett C, Shah M, Heinrich M, et al. Phase 3, multicenter, randomized, double-blind, placebo-controlled trial of SU11248 in patients (pts) following failure of imatinib for metastatic GIST [abstract]. Journal of Clinical Oncology, 2005 ASCO Annual Metting Proceedings. Vol 23, No. 16S, Part I of II (June 1 Supplement), 2005:4000. Available from: http://www.asco.org/portal/site/ASCO/template.RAW/menuitem.34 d60f5624ba07fd506fe310ee37a01d/?javax.portlet.tpst=0e116779df458209ada2be0aee37a01d_ws_RW&java xpor tlet.prp_0e116779df458209ada2be0aee37a01d_viewID=abst_detail_ rawview&javax.portlet.begCacheTok=com.vignette.cachetoken&javax. portlet.endCacheTok=com.vignette.cachetoken&index=n&confID=34&a bstractID=34169

  10. Faivre S et al. Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitarget tyrosine kinase inhibitor, in patients with cancer. J Clin Oncol 2006;24:1-11.

  11. George S, Casali PG, Blay J, Le Cescne A, Tyler AR, Guigley MT, et al. Phase II study of sunitinib abministered in a continuous daily dosing regimen in patients (pts) with advanced GIST. Journal of Clinical Oncology, 2006 ASCO Annual Metting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006:9532. Available from: http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506 fe310ee37a01d?vgnextoid=76f8201eb61a7010VgnVCM100000ed730ad1RCRD&vmview= abst_detail_view&confID=40&index=y&abstractID=33566

  12. Gleevec (imatinib mesylate). Criteria for reimbursement. Conseil du medicament du Quebec.

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  16. National Comprehensive Cancer Network [homepage on the Internet]. Clinical practice guidelines in oncology: soft tissue sarcoma = v.2.2006. Available from: http://www.nccn.org/professionals/physician_gls/PDF/sarcoma.pdf (accessed 23 June 2006 )

  17. National Institute for Health and Clinical Excellence. Imatinib for the treatment of unresectable and/or metastatic gastrointestinal stromal tumours. Technology Appraisal 86, October 2004. Available from: http://www.nice.org.uk/download.aspx?o=TA086guidance (accessed 20 June 2006 )

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  19. Pfizer Canada Inc. Sutent Product Monograph. Kirkland , Quebec . May 26, 2006 .

  20. Raut CP, Posner M, Desai J, Morgan JA, George S, Zahrieh D, et al. Surgical management of advanced gastrointestinal stromal tumours after treatment with targeted systemic therapy using kinase inhibitors. J Clin Oncol. 2006 May 20;24(15):2325-31.

  21. Sanborn RE, Blanke CD. Gastrointestinal stromal tumors and the evolution of targeted therapy [abstract]. Clin Adv Hematol Oncol. 2005 Aug;3(8):647-57. Available from: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?orig_db=PubMed&deb=PubMed&cmd=Search&term=%22Clinical+advances +in+hematology+%26+oncology+:++H%26O%22[Jour]+AND+647[page]+AND+2005[pdat]

  22. Sarcoma Foundation of America [homepage on the Internet]. Maryland : The Foundation; c2004-2005. Sarcoma Subtype Information: Sarcoma – Cancer of the Connective Tissues. Available from: http://www.curesarcoma.org/subtypes.htm (accessed 19 June 2006 )

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  24. Susman E. New drug increases survival in stomach cancer. Available from: oncology.thelancet/com_Vol_7_April_2006-07-11.

  25. Verma S et al. Imatinib mesylate (Gleevec) for the treatment of adult patients with unresectable of metastatic gastrointestinal stromal tumours: a clinical practice guideline. Cancer Care Ontario . April 6, 2006 .

  26. WHO Collaborating Centre for Drug Statistics Methodology. ATC Index [database on the Internet, cited 19 June 2006 ]. Available from: http://www.whocc.no/atcddd/

  27. Zalcberg JR, Verwij J, Casali PG, Le Cesne A, Reichardt P, Blay JY, et al. Outcome of patients with advanced gastro-intestinal stromal tumours crossing over to a daily imatinib dose of 800 mg after progression on 400 mg [abstract]. Eur J Cancer. 2005 Aug;41(12):1751-7. Available from: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16098458&q uery_hl=4&itool=pubmed_docsum

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