Report on New Patented Drugs - Humira
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: Humira
Generic Name: (adalimumab)
DIN: 02258595 40 mg syringe
Patentee: Abbott Laboratories Limited
Indication - as per product monograph:
For reducing the signs and symptoms, and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Notice of Compliance: September 24, 2004
Date of First Sale: September 29, 2004
ATC Class: L04AA17
Antineoplastic and Immunomodulating Agents, Immunosuppressive Agents, Immunosuppresive Agents, Selective Immunosuppresive Agents
Application of the Guidelines
The introductory price of Humira 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 the price did not exceed the prices in the other comparator countries where Humira was sold.
Humira is a new active substance and the PMPRB's Human Drug Advisory Panel (HDAP) recommended that Humira be reviewed 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 HDAP recommended Enbrel (etanercept), Remicade (infliximab) and Kineret (anakinra) as the most appropriate comparators for Humira. These products share the same fourth level ATC class, are all biological agents and are all indicated for the treatment of moderate to severe RA in patients who failed to respond to one or more synthetic disease modifying anti-rheumatic drugs.
As the treatment of RA is considered a chronic situation, the HDAP recommended that the maintenance dosage regimen of Enbrel, Remicade and Kineret be compared to the maintenance dosage regimen of Humira. Since the dosing frequency of the comparators varies so widely, the amount of respective drugs that needs to be administered during one year was recommended for the purpose of establishing the Therapeutic Class Comparison (TCC).
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. The price of Humira was within the Guidelines as the daily cost of therapy did not exceed the cost of therapy with the comparator medicines.
||Dosage Regimen/per year
||Cost Per Year
||40 mg every 2 weeks (26 syringes)
||25 mg twice weekly (104 vials)
||5 mg/kg every 8 weeks (22.75 vials)
||100 mg daily (365 syringes)
1 PPS Pharma, January 2005
2 Régie de l'assurance maladie du Québec, February 2005
3 Le Guide du pharmacien propriétaire, Liste de l'AQPP, October 2004
In 2004, Humira was being sold in all of the seven countries listed in the Patented Medicines Regulations, that is France, Germany, Italy, Sweden, Switzerland, 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 of Humira in Canada was the lowest of those countries, below 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.
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