Report on New Patented Drugs – Pariet

Brand Name: Pariet

Generic Name: rabeprazole sodium

DIN: 02243796 10 mg/tablet
02243797 20 mg/tablet

Patentee: Janssen-Ortho Inc.

Indications (as per product monograph): For the treatment of conditions where a reduction of gastric secretion is required, such as:

1. Symptomatic relief and healing of erosive or ulcerative gastroesophageal reflux disease (GERD)
2. Long-term maintenance of healing of erosive or ulcerative gastroesophageal reflux disease (GERD)
3. Symptomatic relief and healing of duodenal ulcers
4. Symptomatic relief and healing of gastric ulcers
5. Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Notice of Compliance: May 7, 2001

Date of First Sale: July 3, 2002

ATC Class: A02BC04
Drugs for Peptic Ulcer and Gastroesophageal Reflux Disease (GERD), Proton Pump Inhibitors

Application of the Guidelines

Summary:

The introductory prices of Pariet 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 Pariet was sold.

Scientific Review:

Pariet is a new active substance and the PMPRB's 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.

Pariet is the fifth entry in the 4th level ATC. Members of the 4th level ATC comparators include Losec (omeprazole), Pantoloc (pantoprazole), Prevacid (lansoprazole) and Nexium (esomeprazole). All of these agents share similar indications and clinical use. The HDAP recommended that they all be included in the TCC for Pariet.

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 Pariet and the comparators are based on their respective product monographs and supported by clinical literature. See the table on page 8.

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 in the TCC test, or if it exceeds the prices of the same medicine in the seven countries listed in the Patented Medicines Regulations.

As shown in the following table, the prices of Pariet were within the Guidelines relative to the TCC test, as they did not exceed the prices of the other drugs in the therapeutic class.

1 Liste de médicaments du Québec, June 2003
2 Medis, 2002
3 Ontario Drug Benefit Formulary, 2002
4 Price filed by Janssen-Ortho Inc.

In 2002, Pariet 10 mg/tablet was also being sold in France, Germany, Italy, Sweden, and the United Kingdom, and Pariet 20 mg/tablet was being sold in France, Germany, Italy, Sweden, the United Kingdom and the United States. In compliance with the Guidelines, the price in Canada did not exceed the range of prices in those countries. The price in Canada for Pariet 10 mg/tablet was the lowest, and the price in Canada for Pariet 20mg/tablet was third highest, above the median international 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 — Pariet

1. Product monograph of Pariet (rabeprazole sodium). Janssen-Ortho Inc. Toronto, On. May 31, 2002.
2. Welbanks L, editor. Compendium of Pharmaceuticals and Specialties, 37th Edition. Canadian Pharmacists Association, 2002, Ottawa.
3. Breiter JR, Riff D, Humphries TJ, et al. Rabeprazole is superior to ranitidine in the management of active duodenal ulcer disease Results of a double-blind, randomized North American study. Am J Gastroenterol 2000;95(4): 936-42.
4. Caro JJ, Salas M, Ward A. Healing and relapse rates in gastroesophageal reflux disease treated with the ewer proton-pump inhibitors lansoprazole, rabeprazole, and pantoprazole compared with omeprazole, ranitidine, and placebo: Evidence from randomized clinical trials. Clin Therapeut 2001;23(7):998-1017.
5. Dekkers CPM, Beker JA, Thjodleifsson B, et al. Comparison of rabeprazole 20 mg versus omeprazole 20 mg in the treatment of active duodenal ulcer: a European multicentre study. Aliment Pharmacol Ther 1999;13:179-86.
6. Dekkers CPM, Beker JA, Thjodleifsson B, et al. Comparison of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of active gastric ulcer – a European multicentre study. Aliment Pharmacol Ther 1998;12:789-95.
7. Edwards SJ, Lind T, Lundell L. Systematic review of proton pump inhibitors for the acute treatment of reflux oesophagitis. Aliment Pharmacol Thera 2001;15:17289-36.
8. Erstad BL. Dyspepsia: Initial evaluation and treatment. J Am Pharm Assoc 2002;42:460
9. Farley A, Wruble LD, Humphries TJ, et al. Rabeprazole versus ranitidine for the treatment of erosive gastroesophageal reflux disease: A double-blind, randomized clinical trial. Am J Gastroenterol 2000;95(8):1894-9.
10. Gray J (ed). Therapeutic Choices, 3rd edition. Canadian Pharmacists Association, 2000; Ottawa.
11. Saltiel E, Stein T. Proton pump inhibitors in the treatment of GERD. US Pharmacist 2000;25(4) Supplement:3-13.
12. Tierney LM, McPhee SJ, Papadakis MA (eds). Current Medical Diagnosis and Treatment, 39th ed., 2000. Lange Medical Books/McGraw-Hill, Toronto.
13. Galmiche JP, Zerbib F, Ducrotte P, et al. Decreasing oesophageal acid exposure in patients with GERD: a comparison of rabeprazole and omeprazole. Aliment Pharmacol Ther 2110;15:1343-50.
14. Holtmann G, Bytzer P, Metz M, et al. A randomized, double-blind, comparative study of standard-dose rabeprazole and high-dose omeprazole in gastro-oesophageal reflux disease. Aliment Pharmacol Ther 2002;16:479-85.
15. Lanza F, Dev Bardhan K, Perdomo C, et al. Efficacy of rabeprazole once daily for acidrelated disorders. Dig Dis Sci 2001;46(3):587-96.
16. New Pariet (rabeprazole sodium) Tablets Now Approved in Canada! [press release]. Janssen-Ortho Inc. July 29, 2002.
17. Thjodleiffson B, Beker JA, Dekkers C, et al. Rabeprazole versus omeprazole in preventing relapse of erosive or ulcerative gastroesophageal reflux disease. Digest Dis Sci 2000;45(5):845-53.