PMPRB Publishes New Proposed Guidelines

The PMPRB published a Draft Compendium of Guidelines, Policies and Procedures yesterday, August 20th and is seeking comments by October 6th, 2008. The new Compendium is available at: http://www.pmprb-cepmb.gc.ca/english/view.asp?x=271&id=133. Highlights from the new Compendium and other proposals follow:

• New section on Legal framework and Policies (includes origin and mandate of PMPRB, Structure and Operation, pre-patent jurisdiction, and fact that confidential info provided to Board can be provided to provincial Ministers in a Hearing).
• Retroactive jurisdiction, patent dedication and “merest slender thread” of a nexus to patent are all included in Legal and Policies sections.
• Definition of drug product as strength of an individual, final dosage form of a patented medicine, and includes drugs available through clinical trial application and special access program/investigational new drugs.

Levels of Tx Improvement & Scientific Review:

• Levels of Tx Improvement replace categories. Secondary factors considered include duration of treatment or time to optimal effect, route of administration, improved convenience & compliance (where improved clinical outcome), savings.
• New level of improvement: Moderate improvement.
• Comparators selected for TCC will include superior and inferior medicines where clinically equivalent comparators are not available. Unclear whether both clinically equivalent AND superior/inferior medicines will be included, where clinically equivalent comparators are available.
• High quality Level 1 evidence (published randomized clinical trials) required for establishing breakthrough/substantial improvement. Lower levels of evidence may be considered for establishing lower levels of therapeutic improvement. This means that selecting comparators outside the TCC (or other than what would normally be considered the norm) will not necessarily require head-to-head clinical trials.
• No scientific review of OTC and Vet medicines unless a complaint is received.

Price Tests:

• New Drugs
• Breakthrough – international median test
• Substantial improvement – higher of international median test and TCC
• Moderate improvement – higher of mid-point between international median test and TCC, and TCC.
• Slight/No improvement – TCC.
• No comparators – no mention (price test not specified). Under these new Guidelines, this could occur if neither clinically equivalent nor superior/inferior comparators are identified, or if the comparators identified are considered to have an excessive price.
• New DINs of existing chemical – RR test
• Combination medicine – sum of components
• TCC pricing:
• Board Staff will use an “appropriate public source” (no longer ODB). No definition of “appropriate”.
• Use highest non-excessive ATP of comparators to establish MNE price of new product, where new drug product sold by same patentee as comparator drug (reduced ATP due to benefits would not affect TCC price of new entrant). Clarification needed whether this option is possible for the same patentee only if this price is published.
• If highest non-excessive ATP is published, this price will also be used in TCC for new drug products whether or not the new drug is sold by the same patentee as the comparator drug.
• Note that the highest list price, which is published, would be very close to the “highest non-excessive ATP”. It is unclear why Board Staff insists on using only confidential information (highest ATP price), even if published.
• International TCC: Not a primary test, but only to be used for information in cases of investigation and a Hearing. 2 possible methods. Includes only medicines used in domestic TCC (also excludes medicines that were excluded on grounds of excessive pricing).
• Generic Patented Drugs:
• Primary test is modified TCC against same or referenced brand product, or RR test if no brand available.
• International price comparison test conducted, but relevant only if brand no longer sold in Canada.
• No test proposed for existing generic patented medicines.
• No mention of changing the Regulations, as recommended in the CGPA/PMPRB Working Group report.
• Existing Drugs:
• CPI-adjustment – ATP can increase by greater than CPI when increase is due solely to change in sales-mix.
• De-linking – Applies when price increase due solely to termination of benefits.
• Only mentions the “dip” phenomenon, and not the “gap”. Looking for comments on the cap for the “gap” and the CPI methodology.
• “Benefits” include everything currently included in the definition/calculation of the ATP. Excludes new sales to a new class of customer at a lower price.
• “Evidence” required to use the De-linking methodology (generally must include the form of benefit (e.g. contract), data, and timing).
• GAP – Board agrees with Working Group on Price Tests recommendations to limit price increases to 33% of the “gap”, capped by 10-15% of the ATP. However, the PMPRB is seeking input from stakeholders with regard to this CAP, especially as it relates to an ATP that includes all benefits.

Any market review:

• At introduction for all drugs
• Case-by-case basis for existing drugs (in the case of an investigation).
• No methodology was agreed upon as to method of calculating excess revenue. PMPRB is seeking comments on appropriate methodology to calculate excess revenues.

• No change to re-setting the MNE based on international median in cases of fewer than 5 countries.
• Science-based Re-setting: No Guideline. Case-by-case basis. HDAP to identify weaknesses or gaps in scientific evidence to potentially be used as a basis for re-setting under new evidence.
• Cost-based Re-setting: No Guideline. Only considered if unable to determine excessiveness of price based on other factors.
• Patentees forced to re-set their price downward would have until the end of the following calendar year to adjust their price without incurring excess revenues.

• PMPRB Fundamentals Seminar is being held on September 18 in Montreal and September 19 in Toronto. This is a day-long introduction to the Patented Medicine Prices Review Board rules and policies including Scientific Review Procedures, Excessive Price Guidelines, Compliance and Enforcement Policy and Data Filing. Special attention will be given to the Board’s new proposed Guidelines. Click_here_for_Fundamentals_Seminar_registration.


• PMPRB Advanced Seminar is being held on October 28 in Montreal and October 29 in Toronto. This in-depth, day-long session provides a greater understanding of the PMPRB, especially in the areas of Voluntary Compliance Undertakings, Hearings, Category 2 Drugs, and Category 3 Drugs. Special attention will be given to the Board’s new proposed Guidelines. Barb Ouellet, Executive Director of the PMPRB, and Ginette Tognet, Director of Compliance at the PMPRB, will join us for a brief presentation in the afternoon. Click_here_for_Advanced_Seminar_registration.