Report on New Patented Drugs - Levitra

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: Levitra

Generic Name: (vardenafil)

DIN: 02250462 5 mg tablet
02250470 10 mg tablet
02250489 20 mg tablet

Patentee: Bayer, Inc.

Indication - as per product monograph:
For the treatment of erectile dysfunction (difficulties or the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance).

Date of Issuance of First Patent(s) Pertaining to the Medicine: December 3, 2002

Notice of Compliance: March 17, 2004

Date of First Sale: March 17, 2004

ATC Class: G04BE09
Genitourinary System and Sex Hormones; Urological: Other Urological, including antispasmodics; Drugs Used in Erectile Dysfunction (ED)

Application of the Guidelines

Summary

The introductory prices of the Levitra drug products 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 Levitra is sold or did not do so by an amount sufficient to trigger any of the investigation criteria under the Compliance and Enforcement Policy.

Scientific Review

The PMPRB's Human Drug Advisory Panel (HDAP) recommended that Levitra 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. See the PMPRB's Compendium of Guidelines, Policies and Procedures for a more complete description of the Guidelines and the policies on TCCs.

Erectile dysfunction affects 26% to 52% of men (depending on ages surveyed). Levitra inhibits the enzyme phosphodiesterase type 5 (PDE5) in the corpus cavernosum which ultimately leads to penile erection. The HDAP identified two other PDE5 inhibitors in the same 4th level ATC that are clinically equivalent for the treatment of erectile dysfunction; Viagra (sildenafil) and Cialis (tadalafil).

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

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.

The prices of Levitra 10 mg and 20 mg were within the Guidelines as the cost per treatment did not exceed the cost per treatment of the comparator medicines.

Introductory Period (March to June 2004)

Name Strength Price per tablets1
Levitra 10 mg tablets
20 mg tablets 		$11.25
$11.70
Viagra 50 mg tablets
100 mg tablets 		$11.25
$11.70
Cialis 10 mg tablets
20 mg tablets 		$11.70
$11.70

1. PPS, July 2004

In 2004, both strengths of Levitra were also sold in France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the United States. In compliance with the Guidelines the price in Canada for the 10 mg tablet and the 20 mg tablet strengths did not exceed the range of prices in those countries.

Levitra 5 mg tablets

The price of Levitra 5 mg tablet did not exceed the prices of the comparable medicines in the TCC test. In 2004, Levitra 5 mg tablet was also sold in France, Germany, Switzerland, Sweden, the United Kingdom and the United States. The Canadian price for Levitra 5 mg tablet exceeded the range of prices in those countries but by an amount which did not trigger the criteria for commencing an investigation. As a result, the benchmark price for review in future periods is established by the International Price Comparison test.

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 - Levitra

  1. Brock G, Nehra A, Lipshultz LI, et al. Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy. J Urol 2003;170:1278-83.
  2. Product Monograph for Levitra (vardenafil hydrochloride) Bayer Inc, Toronto, ON, March 10, 2004
  3. Crowe SM, Streetman DS. Vardenafil treatment of erectile dysfunction. Ann Pharmacother 2004;38:77-85.
  4. Keating GM, Scott LJ. Vardenafil : A review of its use in erectile dysfunction. Drugs 2003;63(23) :2673-703.
  5. Ormrod D, Easthrope SE, Figgit DP. Vardenafil. Drugs & Aging 2002;19:217-27.
  6. Pryor J. Vardenafil: update on clinical experience. Int J Impot Res 2002;14(suppl 1):S65­9.
  7. Rosen R, Kostis JB. Overview of phosphodiesterase 5 inhibition in erectile dysfunction. Am J Cardiol 2003;92 (suppl):9M-18M.
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  9. Hellstrom WJG, Gittelman M, Karlin G, et al. Sustained efficacy and tolerability of vardenafil, a highly potent selective phosphodiesterase type 5 inhibitor, in men with erectile dysfunction: results of a randomized, double-blind, 26-week placebo controlled pivotal trial. Urology 2003;61(Suppl 4A):8-14.
  10. Goldstein I, Young JM, Fischer J, et al. Vardenafil, a new phosphodiesterase type 5 inhibitor, in the treatment of erectile dysfunction in men with diabetes. Diabetes Care 2003;26:777-83.
  11. Porst H, Rosen R, Padma-Nathan H, et al. The efficacy and tolerability of vardenafil, a new, oral, selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial. Int J Impot Res 2001;13:192-9.
  12. Porst H, Young JM, Schmidt AC, Buvat J. Efficacy and tolerability of vardenafil for treatment of erectile dysfunction in patient subgroups. Urology 2003;62:519-24.
  13. Klotz T, Sachse R, Heidrich A, et al. Vardenafil increases penile rigidity and tumescence in erectile dysfunction patients: a RigiScan and pharmacokinetic study. World J Urol 2001;19:32-9.
  14. Hatzichristou D, Montorsi F, Buvat J, et al. The efficacy and safety of flexible-dose vardenafil (Levitra) in a broad population of European men. Eur Urol 2004;45:634-41.
  15. Potempa AJ, Ulbrich E, Bernard I, et al. Efficacy of vardenafil in men with erectile dysfunction: a flexible-dose community practice study. Eur Urol 2004;46:73-9.
  16. Anon. American association of clinical endocrinologists medical guidelines for clinical practice for the evaluation and treatment of male sexual dysfunction: a couple's problem – 2003 Update. Endocrine Practice 2003;9(1):77-95. http://www.aace.com/clin/guidelines/sexdysguid.pdf, accessed July 6, 2004
  17. Vickers MA, Satyanarayana R. Phosphodiesterase type 5 inhibitors for the treatment of erectile dysfunction in patients with diabetes mellitus. Int J Impot Res 2002;14:466-71.
  18. Snow KJ. Erectile dysfunction: a review and update. Formulary 2004;39(5):261-8.
  19. Basson R. Male Sexual Dysfuntion. Chapter 78. In: Gray J (ed). Therapeutic Choices (4th ed). Canadian Pharmacists Association, Ottawa, ON, 2003.
  20. Reid K, Morales A, Harris C, et al. double-blind trial of yohimbine in treatment of psychogenic impotence. Lancet 1987:421-3.
  21. Sonda LP, Mazo R, Chancellor MB. The role of yohimbine for the treatment of erectile dysfunction. J Sex Marital Ther 1990;16(1):15-21.
  22. Anon. Intracavernous injections for impotence. New Drugs/Drug News 1995;13(3):III-IV.
  23. Pomara G, Morelli G, Pomara S et al. Cardiovascular parameter changes in patients with erectile dysfunction using pde-5 inhibitors: a study with sildenafil and vardenafil. J Androl 2004;25:625-9.
  24. Sommer F, Mathers M, Klotz T et al. Which PDE-5 inibitor do patients prefer: a comparative randomized multicentre study of sildenafil, tadalafil and vardenafil. Presented at the 6th Conbress of the European Society of Sexual Medicine, Istabul, Turkey, November 2003. Abstract availablet at: http://www.seniorjournal.com/NEWS/Health/3-11-17erectile.htm.
  25. Porst P. Unknown. Available at: http://www.urologytimes.com/urologytimes/content/printContentPopup.jsp?id=94362.
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