Report on New Patented Drugs - Alphagan
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: Alphagan
Generic Name: brimonidine tartrate
DIN: 2236876 2 mg/mL (0.2%)
Patentee: Allergan Inc.
Indication (as per product monograph):
For the control of intraocular pressure (IOP) in patients with chronic open angle glaucoma (OAG) or ocular hypertension (OH).
Alphagan 0.5% is indicated for the prevention of post-operative IOP spikes and for lowering IOP from pre-operative levels in patients undergoing argon laser trabeculoplasty (ALT).
Notice of Compliance: November 24, 1997
Date of First Sale: December 17, 1997
Date of First Patented Sale: September 3, 2002
In most case, patents are issued before the drug comes to market. In this case, the first patent pertaining to Alphagan was issued September 3, 2002 and it came under the PMPRB's jurisdiction at that time.
ATC Class: S01EA05
Ophthalmologicals, Antiglaucoma Preparations and Miotics, Sympathomimetics in Glaucoma therapy.
Application of the Guidelines
The introductory price of Alphagan 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 did not exceed the range of prices in other comparator countries where Alphagan was sold.
Alphagan 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. The Guidelines provide that it may, however, 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.
The HDAP identified only one agent in the same 4th level ATC that is indicated and used for the control of intraocular pressure in patients with chronic open angle glaucoma or ocular hypertension, Propine (dipivefrin). Based on comparative clinical trials, the HDAP also identified Trusopt (dorzolamide), Xalatan (latanoprost), Isopto Carpine and Timoptic (timolol) as comparators as these drug products are used in the control of intraocular pressure in patients with chronic open angle glaucoma or ocular hypertension.
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 Alphagan and the comparators are based on respective product monographs and comparative clinical trial data.
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 Alphagan was within the Guidelines as the daily cost of therapy did not exceed the cost of therapy with the comparator medicines.
||Cost per Day1
|Alphagan (brimonidine tartrate)
||4 drops (0.2 mL)
||4 drops (0.2 mL)
||6 drops (0.3 mL)
||2 drops (0.1 mL)
|Isopto Carpine (pilocarpine)
||8 drops (0.4 mL)
||4 drops (0.2 mL)
1 Ontario Drug Benefit Formulary, January 2003
At the time of introduction, Alphagan was also being sold in France, Germany, the United Kingdom and the United States. In compliance with the Guidelines, the price in Canada did not exceed the range of prices in these countries; the price of Alphagan was the lowest of these countries. In 2003, Alphagan was sold in all seven comparator countries (France, Germany, Italy, Sweden, Switzerland, U.K. and U.S.) and the price in Canada was 4th highest of these countries.
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.
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