Report on New Patented Drugs - Relpax

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: Relpax

Generic Name: eletriptan

DIN: 02256290 tablet 20 mg, 02256304 tablet 40 mg

Patentee: Pfizer Canada Inc.

Indication - as per product monograph:

For the acute treatment of migraine with or without aura in adults.

Notice of Compliance: August 5, 2004

Date of First Sale: November 1, 2004

ATC Class: N02CC06
Nervous System, Analgesics, Antimigraine Preparations; Selective serotonin (5HT1) agonists

Application of the Guidelines

Summary:

The introductory prices of Relpax 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 did not exceed the range of prices in other comparator countries where Relpax was sold.

Scientific Review:

Relpax is a new active substance and the Human Drug Advisory Panel (HDAP) reviewed it as a category 3 new medicine (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.

The agents in the same 4th level as Relpax include Imitrex (sumatriptan), Amerge (naratriptan), Maxalt (rizatriptan), Zomig (zolmitriptan) and Axert (almotriptan). The HDAP recommended these products as the most appropriate comparators for Relpax. All these agents share the same 4th level ATC classification, the same indication and have comparable efficacy rates to Relpax.

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 Relpax and its comparators are based on available comparative clinical trials as well as guidelines relevant to the subject matter.

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 prices 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 Patented Medicines Regulations.

The prices of Relpax were within the Guidelines as the daily cost of therapy did not exceed the cost of therapy with the comparator medicines.

1. PPS Pharma, January 2005
2. AQPP, October 2004
3. Liste de médicaments, Régie de l'assurance maladie du Québec, February 2005

Amerge and Zomig are not included in the TCC for Relpax 40 mg. Amerge and Zomig are not available at a higher strength, only as 2.5 mg tablets. The above TCC shows that the market for the triptan drug products is one where although many of the drugs are available in two strengths, all drugs are priced at the same level regardless of strength.

At the time of introduction, Relpax 20mg and Relpax 40mg were also sold in France, Germany, Italy, Sweden, the United Kingdom and the United States, while Relpax 40mg was additionally sold in Switzerland. In compliance with the Guidelines, the prices in Canada did not exceed the range of prices in those countries; Canada ranked 2nd highest for both strengths, above the medians.

Evidence/References

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:

1. Product monograph of Relpax (eletriptan hydrobromide). Pfizer Canada Inc., July 26, 2004.

2. Goadsby PJ, Ferrari MD, Olesen J, et al. Eletriptan in acute migraine. A double-blind, placebo-controlled comparison to sumatriptan. Neurology 2000;54:156-163.

3. Sandrini G, Färkkilä M, Burgess G, et al. Eletriptan vs sumatriptan. A double-blind, placebo-controlled, multiple migraine attack study. Neurology 2002;59:1210-17.

4. Mathew NT, Schoenen J, Winner P, et al. Comparative efficacy of eletriptan 40 mg versus sumatriptan 100 mg. Headache 2003;43:214-22.

5. Diener HC, Ryan R, Sun W, et al. The 40 mg dose of eletriptan. Comparative efficacy and tolerability versus sumatriptan 100 mg. Eur J Neurol 2004;11:125-34.

6. Steiner TJ, Diener HC, MacGregor EA, et al. Comparative efficacy of eletriptan and zolmitriptan in the acute treatment of migraine. Cephalalgia 2003;23:942-52.

7. Garcia-Ramos G, MacGregor EA, Hilliard B, et al. Comparative efficacy of eletriptan vs. naratriptan in the acute treatment of migraine. Cephalalgia 2003;23:869-76.

8. Diener HC, Jansen JP, Reches A, et al. Efficacy, tolerability and safety of oral eletriptan and ergotamine plus caffeine (Cafergot) in the acute treatment of migraine. A multicentre, randomized, double-blind, placebo-controlled comparison. Eur Neurol 2002;47:99-107.

9. Stark R, Dahlöf C, Haughie S, et al. Efficacy, safety and tolerability of oral eletriptan in the acute treatment of migraine. Results of a phase III, multicentre, placebo-controlled study across three attacks. Cephalalgia 2002;22:23-32.

10. Sheftell F, Ryan R, Pitman V. Efficacy, safety, and tolerability of oral eletriptan for treatment of acute migraine. A multicentre, double-blind, placebo-controlled study conducted in the United States. Headache 2003;43:202-13.

11. Fukuuchi Y, Sakai F, Iwata M, et al. Efficacy and safety of eletriptan 20 mg, 40 mg and 80 mg in Japanese migraineurs. Cephalalgia 2002;22:416-23.

12. Sakai F, Diener HC, Ryan R, et al. Eletriptan for the acute treatment of migraine. Results of bridging a Japanese study to western clinical trials. Curr Med Res Opin 2004;20(3):269-277.

13. Färkkilä M, Olesen J, Dahlöf C, et al. Eletriptan for the treatment of migraine in patients with previous poor response or tolerance to oral sumatriptan. Cephalalgia 2003;23:463-71.

14. Diamond ML, Hettiarachchi J, Hilliard B, et al. Effectiveness of eletriptan in acute migraine. Primary care for Excedrin nonresponders. Headache 2004;44:209-16.

15. Chia YC, Lim SH, Wang SJ, et al. Efficacy of eletriptan in migraineurs with persistent poor response to nonsteroidal anti-inflammatory drugs. Headache 2003;43:984-90.

16. Olesen J, Diener HC, Schoenen J, et al. No effect of eletriptan administration during the aura phase of migraine. Eur J Neurol 2004;11:671-7.

17. Snow V, Weiss K, Wall EM, et al. Pharmacologic management of acute attacks of migraine and prevention of migraine headache.
Ann Intern Med 2002;137:840-9.

18. Ferrari MD, Roon KI, Lipton RB, et al. Oral triptans (serotonin 5-HT1B/1D agonists) in acute migraine. A meta-analysis of 53 trials.
Lancet 2001;358:1668-75.

19. Dahlöf CGH, Dodick D, Dowson J, et al. How does almotriptan compare with other triptans? A review of data from placebo-controlled clinical trials.
Headache 2002;42:99-113.

20. Smith LA, Oldman AD, McQuay HJ, et al. Eletriptan for acute migraine. The Cochrane Database of Systematic Reviews 2000, Issue 4. No.: CD003224. DOI: 10.1002/14651858.CD003224.

21. Wells NEJ, Steiner TJ. Effectiveness of eletriptan in reducing time loss caused by migraine attacks. Pharmacoeconomics 2000;18:557-66.

22. Wells N, Hettiarachchi J, Drummond M, et al. A cost-effectiveness analysis of eletriptan 40 and 80 mg versus sumatriptan 50 and 100 mg in the acute treatment of migraine. Value in Health 2003;6:438-47.