Report on New Patented Drugs – Amevive
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: Amevive
Generic Name: alefacept
DIN: 02259052 injectable 15mg/vial
Patentee: Biogen Idec Canada Inc.
Indication - as per product monograph: For the treatment of moderate to severe chronic plaque psoriasis of adults who are candidates for phototherapy or systemic therapy.
Notice of Compliance: October 6, 2004
Date of First Sale: October 12, 2004
ATC Class: L04AA15
Antineoplastic and Immunomodulating Agents, Immunosuppressive Agents, Selective Immunosuppressive Agents
Application of the Guidelines
The introductory price of Amevive 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 the price did not exceed the range of prices in other comparator countries where Amevive is sold.
The PMPRB's Human Drug Advisory Panel (HDAP) recommended that Amevive be reviewed as a category 3 new drug product (provides moderate, little or no therapeutic advantage 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 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 to 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 recommended Enbrel (etanercept), Remicade (infliximab), Neoral (cyclosporine), Methotrexate (methotrexate) and Soriatane (acitetrin) as comparators to Amevive. Enbrel, Remicade and Neoral share the same 4th level ATC classification as Amevive and are currently used in the management of moderate to severe chronic plaque psoriasis.
The HDAP also recommended the inclusion of Methotrexate and Soriatane. Methotrexate is commonly used and considered to be standard treatment for systemic therapy of plaque psoriasis. Soriatane is indicated and used for the systemic treatment of plaque psoriasis.
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 Amevive and the comparators are based on product monographs, guidelines and published clinical trials.
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.
The price of Amevive was within the Guidelines as the cost of treatment did not exceed the cost of treatment of the comparator medicines.
||Dosage Regimen per year
||Price per unit
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1 Publicly available price as per the Patented Medicines Regulations
2 Liste de médicaments, Régie de l'assurance maladie du Québec, February 2005
3 Ontario Drug Benefit Formulary No. 38, January 2003; Update E, November 2004
In 2004 Amevive was also sold in Switzerland and the United States. In compliance with the Guidelines, the price in Canada did not exceed the price in those countries; Canada ranked lowest, below the median.
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.
Kruger et al. A randomized, double-blind, placebo-controlled phase III study evaluating efficacy and tolerability of 2 courses of alefacept in patients with chronic plaque psoriasis. J Am Acad Dermatol 2002;47:821-33.
Lebwohl M et al. An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis. Arch Dermatol 2003;719-727.
Carlin S et al. A 50% reduction in the Psoriasis Area and Severity Index (PASI 50) is a clinically significant endpoint in the assessment of psoriasis. J Am Acad Dermatol 2004;50:859-66.
Feldman SR et al. Improved health-related quality of life following a randomized controlled trial of alefacept treatment in patients with chronic plaque psoriasis. Br J Dermatol 2004:150-317-326.
Anon. Alefacept (Amevive) for treatment of psoriasis. Med Letter 2003;45(1154):31-2.
Boehncke WH. Immunomodulatory drugs for psoriasis. BMJ 2003;327:634-5.
Callen JP, Krueger GG, Lebwohl M, et al. AAD consensus statement on psoriasis therapies. J Am Acad Dermatol 2003;49(5):897-9.
Carlin CS, Feldman SR, Krueger JG. A 50% reduction in the Psoriasis Area and Severity Index (PASI 50) is a clinically significant endpoint in the assessment of psoriasis. J Am Acad Dermatol 2004;50:859-66.
Craze M, Young M. Integrating biologic therapies into a dermatology practice; Practical and economic considerations. J Am Acad Dermatol 2003;49:S139-42.
Da Silva AJ, Brickelmaier M, Majeau GR, et al. Alefacept, an immunomodulatory recombinant LFA-3/IgG1 fusion protein, induces CD16 signaling and CD2/CD16-dependent apoptosis of CD2+ cells. J Immunol 2002;168:4462-71.
de Rie MA, Goedkoop AY, Bos JD. Overview of psoriasis. Dermatologic Ther 2004;17:341-9.
Ellis CN, Krueger GG. Treatment of plaque psoriasis [author reply]. N Engl J Med 2001;345(25):1854-5.
Ellis CN, Krueger GG, et al. Treatment of chronic plaque psoriasis by selective targeting of memory effector T lymphocytes. N Engl J Med 2001;345(4):248-55.
Ellis CN, Mordin MM, Adler EY. Effects of alefacept on health-related quality of life in patients with psoriasis. Am J Clin Dermatol 2003;4(2);131-9.
Finlay AY, Salek MS, Haney J, et al. Intramuscular alefacept improves health-related quality of life in patients with chronic plaque psoriasis. Dermatology 2003;206:307-15.
Finnish Medical Society Duocedim. Psoriasis . May 7, 2002. Available from: http://www.guideline.gov/summary/summary.aspx?doc_id=3388&nbr=2614&string=psoriasis
Gade JN. Clinical update on alefacept: Consideration for use in patients with psoriasis. J MCP 2004;10(3 Supplement b):S33-7.
Goedkoop AY, de Rie MA, Picavet DI, et al. Arch Dermatol Res 2004;294:465-73.
Goffe, Cather JC. Etanercept: An overview. J Am Acad Dermatol 2003;49:S105-11.
Gordon KB, Vaishaw AK, O'Gorman J, et al. Treatment of psoriasis with alefacept. Arch Dermatol 2003;139:1563-70.
Gottlieb A. Immunobiologic agents for the tretment of psoriasis. Arch Dermatol 2003;139:791-2.
Gottlieb AB. Infliximab for psoriasis. J Am Acad Dermatol 2003;49:S112-7.
Gottlieb AB, Casale TB, Frankel E, et al. CD4+ T-cell-directed antibody responses are maintained in patients with psoriasis receiving alefacept: Results of a randomized study. J Am Acad Dermatol 2003;49:816-25.
Granstein RD. New treatments for psoriasis. N Engl J Med 2001;345(4):284-7.
Granstein RD. Treatment of plaque psoriasis . N Engl J Med 2001;345(25):1855.
Hanauer L. Treatment of plaque psoriasis.N Engl J Med 2001;345(25):1854.
Haserick JR. Treatment of plaque psoriasis N Engl J Med 2001;345(25):1854.
Health Canada Therapeutic Products Dictorate. Drug Product Database. Available from: http://www.hc-sc.gc.ca/hpb/drugs-dpd/index.html
Hodak E, David M. Alefacept: a review of the literature and practical guidelines for management. Dermatol Ther 2004;17:383-92.
Krueger GG. Current concepts and review of alefacept in the treatment of psoriasis. Dermatol Clin 2004;22:407-26.
Krueger GG. Clinical response to alefacept: results of a phase 3 study of intravenous administration of alefacept in patients with chronic plaque psoriasis. J Euro Acad Dermatol Venereol 2003;17(Suppl 2):17-24.
Krueger GG, Callis KP. Development and use of alefacept to treat psoriasis. J Am Acad Dermatol 2003;49:S87-97.
Krueger GG, Ellis CN. Alefacept therapy produces remission for patients with chronic plaque psoriasis. Br J Dermatol 2003;:148:784-8.
Krueger GG, Papp KA, Stough DB, et al. A randomized, double-blind, placebo-controlled phase III study evaluating efficacy and tolerability of 2 courses of alefacept in patients with chronic plaque psoriasis. J Am Acad Dermatol 2002;47:821-33.
Lebwohl M. Appropriate use of alefacept therapy for psoriasis [reply]. Arch Dermatol 2004;140:240.
Lebwohl M, Christophers E, Langley R, et al. An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis. Arch Dermatol 2003;139:719-27.
Leone G, Rolston K, Spaulding G. Alefacept for chronic plaque psoriasis: a selective therapy with long-lasting disease remissions and an encouraging safety profile. Dermatol Nursing 2003;15(3):216-25.
Low NJ, Gonzalez J, Bagel J, et al. Repeat courses of intravenous alefacept in patients with chronic plaque psoriasis provide consistent safety and efficacy. Int J Dermatol 2003;42:224-30.
Millard TP, Birch KE, Young ER. Treatment of plaque psoriasis [letter]. N Engl J Med 2001;345(25):1853-4.
Naldi L. Alefacept for psoriasis: Promising drug, open questions. Arch Dermatol 2002;138:1238-40.
Ortonne JP. Clinical response to alefacept: results of a phase 3 study of intramuscular administration of alefacept in patients with chronic plaque psoriasis. J Euro Acad Dermatol Venereol 2003;17(Suppl 2):12-16.
Ortonne JP, Lebwohl M, Griffiths CEM, et al. Alefacept-induced decreases in circulating blood lymphocyte counts correlate with clinical response in patients with chronic plaque psoriasis. Eur J Dermatol 2003;13:117-23.
Ortonne, Prinz JC. Alefacept: a novel and selective biologic agent for the treatment of chronic plaque psoriasis. Eur J Dermatol 2004;14:41-5.
Pham DQ, Bandy V, Song JC. Alefacept. Formulary 2002;37:346-53.
Prescribing Information for Enbrel (etanercept) Amgen Inc. Available from: http://www.wyeth.com/content/ShowLabeling.asp?id=101
Product monograph of Amevive (alefacept). Biogen Idec Canada Inc. Mississauga, ON. October 6, 2004.
Repchinsky C, ed. Compendium of Pharmaceuticals and Specialties. Canadian Pharmacists Association. Ottawa, ON. 2004.
Rich SJ, Bello-Quintero CE. Advancements in the treatment of psoriasis: Role of biologic agents. J Manag Care Pharm 2004;10(4):318-25.
Sterry W, Barker J, Boehncke WH, et al. Biological therapies in the systemic management of psoriasis: International Consensus Conference. Br J Dermatol 2004;151(Suppl69):3-17.
Thornton A, Honeywell M, LeBron AL, et al. Understanding treatment options for psoriasis. US Pharm 2004;4:89-98.
Weinberg JM. An overview of infliximab, etanercept, efalizumab, and alefacept as biologic therapy for psoriasis. Clin Ther 2003;25(10):2487-2505.
Whitmore SE. Appropriate use of alefacept therapy for psoriasis [letter]. Arch Dermatol 2004;140:239-40.
WHO Collaborating Centre for Drug Statistics Methadology. ATC Index 2004. [database online]. Available from: www.whocc.no/atcddd/
Anon. Criteria for nonformulary use of biologic agents for psoriasis. VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory Panel. 13 August 2004. Available from: http://www.vapbm.org/criteria/biologics.pdf
EMEA. Committee for Medicinal Products for Human Use. Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. London. November 18.2004.
Available from: http://www.emea.eu.int/pdfs/human/ewp/245402en.pdf