Patented Medicine Prices Review Board
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Report on New Patented Drugs - Aerius

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.

Aerius

Brand Name (generic): Aerius (desloratadine)

DIN: 02243919 5 mg tablet

Patentee: Schering Canada Inc.

Indication (as per product monograph):

For the fast relief of nasal and non-nasal symptoms associated with seasonal allergic rhinitis (SAR), including sneezing, nasal discharge and itching, congestion/stuffiness, itching of the palate, and coughing associated with these symptoms, as well as itching, tearing, and redness of the eyes.  It is also indicated for the rapid relief of symptoms associated with chronic idiopathic urticaria, such as pruritus and hives.

Notice of Compliance: May 29, 2001

Date of First Sale: January 10, 2002

ATC Class: R06AX27

Antihistamines for Systemic Use: other antihistamine for systemic use

APPLICATION OF THE GUIDELINES:

Summary:

The introductory price of Aerius was found to be within the Guidelines as its cost of therapy did not exceed the cost of existing drugs in the same therapeutic class comparison and the price did not exceed the range of prices in other countries where Aerius was sold.

Scientific Review:

Aerius is a new active substance and was categorized 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) Classification System that are clinically equivalent in addressing the approved indication. The Guidelines also provide that it may 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.

Members of the same 4th level ATC class as Aerius available in Canada include Periactin (cyproheptadine), Optimine (azatadine), Claritin (loratadine), Zaditor (ketotifen), and Allegra (fexofenadine). The fourth level ATC R06AX represents a Acatch-all@ grouping for antihistamines that do not share similar chemical structures with the other antihistamines classified within the 3rd level ATC R06A Antihistamines for Systemic Use.

Generally antihistamines have been classified according to their tendency to cause sedation, sedating and non-sedating antihistamines. Aerius (desloratadine) is classified as a non-sedating antihistamine. Other non-sedating antihistamines on the Canadian market include Claritin (loratadine), Allegra (fexofenadine), and Reactine (cetirizine).

A recently published article that focused on antihistamines and quality of life in allergic rhinitis patients concluded that non-sedating antihistamines (with or without decongestants) are first line for the treatment of very mild intermittent symptoms (see reference number 8). Nasal corticosteroids are first-line in moderate to severe symptoms.

As a result, the non-sedating antihistamines available on the Canadian market, Claritin, Allegra and Reactine were included for purposes of a TCC for Aerius.

The PMPRB´s Guidelines provide that the dosage regimen recommended for comparison purposes will normally not be higher than the maximum of the usual recommended dosage taking into account relevant clinical variables.  The recommended comparable dosage regimens for Aerius and the comparable drug products are based on their respective product monographs and supported by clinical literature.

Price Review:

Under the Guidelines, the introductory price of a category 3 new drug product will be presumed to be excessive if it exceeds the prices 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 Aerius was within the Guidelines as the daily cost of therapy did not exceed the cost of therapy of the comparator medicines.  Aerius and the comparator drug products are available without a prescription.  The prices in the table below are published list prices and represent a range of prices per package size.

Name Strength Dosage Regimen Unit Price1 Cost Per Day
Aerius 5 mg/tab 5 mg/day $0.82 $0.82
Claritin (loratadine) 10 mg/tab 10 mg/day $0.84 - $0.94 $0.84 - $0.94
Apo-loratadine 10 mg/tab 10 mg/day $0.64 - $0.65 $0.64 - $0.65
Allegra 24 hour 120 mg/tab 120 mg/tab $0.73 - $0.85 $0.73 - $0.85
Reactine (cetirizine) 10 mg/tab 10 mg/tab $0.47 - $0.58 $0.47 - $0.58
Apo-cetirizine 10 mg/tab 10 mg/day $0.5260 - $0.6408 $0.5260 - $0.6408

1 Le Guide du pharmacien propriétaire – Liste de l´AQPP, April 2002

Aerius was also sold in Germany, Sweden, Switzerland, U.K. and the U.S. in 2002. In compliance with the Guidelines, the price in Canada did not exceed the range of prices in those countries; the price in Canada was second highest.

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 – Aerius

1. Gray J (ed). Therapeutic Choices, 3rd edition. Canadian Pharmacists Association, 2000; Ottawa.

2. Levine M, Lexchin J, Pellizzari R (eds). Drugs of Choice: A formulary for general practice, 2nd edition. Canadian Medical Association 1998, Ottawa.

3. Drug Product Database on the Health Canada Website. Accessed on March 27, 2002.

4. Welbanks L, editor. Compendium of Pharmaceuticals and Specialties, 37th Edition. Canadian Pharmacists Association, 2002, Ottawa.

5. NayakAS, Schenkel E. Desloratadine reduces nasal congestion in patients with intermittent allergic rhinitis. Allergy 2001; 56:1077-80.

6. Meltzer EO, Prenner BM, NayakAS. Efficacy and tolerability of once-daily 5 mg desloratadine, an H1-receptor antagonist, in patients with seasonal allergic rhinitis. Clin Drug Invest 2001; 21:25-32.

7. Ring J, Hein R, Gauger A, et al. Once-daily desloratadine improves the signs and symptoms of chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled study. Int J Dermatol 2001; 40:72-6.

8. Larsen JS. Antihistamines and quality of life in allergic rhinitis patients. US Pharmacist 2001;26(5):87-96.