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Changes in the 2010 Guidelines compared to March 2009 Proposals
Below are a summary of the substantive changes in the Guidelines published late yesterday (see links below) – compared to the draft version published in March 2009. The first 3 changes are considered to be the most significant from an operational perspective:
1. Price Sources for Comparators (unless sold at an excessive price): lowest of:
- AQPP price
- McKesson
- ODB
- PPS Pharma
- IMS
- RAMQ
If no price is available for a comparator from these sources, Board Staff will explore additional sources until a public price is found (p18).
This rule replaces the use of average transaction price when the new DIN was from the same patentee as the comparator (TCC or RRT).
2. Schedule 6 – Highest International Price Comparison (HIPC)
- 1.2 & 3.1 Highest international test applies to national and market specific prices, including under exceptional circumstances. However, Canadian wholesale average prices will not be subject to the HIPC, except within the context of the national review. Similarly, customer class “other” is not reviewed as a separate market. No mention of different international prices for different markets. (p32)
- 1.2 The allowable price for a higher strength will not be forced to a price below the Canadian ATP of a lower strength based on the HIPC. (p32)
3. Schedule 10 – DIP Methodology
DIP methodology no longer allows a price to increase to the highest previous non-excessive price based using the DIP methodology. The Guidelines only permit the price to increase to the highest concurrent market price.(p38)
4. Other Changes:
Mandate: Returned to a simplified mandate - included the other components of contributing to decision making and protecting consumer interests to the "Origin of PMPRB" section (p2)
Protection of International Prices: Returned to full protection of information submitted by patentees to PMPRB under Section 87 of the Patent Act. International prices filed by patentees appear to be protected. References to the fact that information collected by Board Staff or review status of a medicine are not confidential have been removed. Similarly, the change in protection during a hearing is no longer explicit. However, it is presumed that these facts remain(p9)
Policies: B.6.2 Pivotal drug products used for comparison purposes will be assessed against the price tests described in the Guidelines.
Assessment of Therapeutic improvement: No change
Application of price tests:
- New “line extensions” that have the same indication or use but materially different dosage regimens will be compared against the existing formulations unless a therapeutic improvement exists. (p14)
- Price of combination products will be limited to the sum of its components (when these same chemicals are available in Canada), unless the patentee delivers a submission claiming therapeutic improvement and HDAP identifies improvement – (p14)
Price review of existing medicines
- Removed from Guidelines: provisions for existing patented drug products subsequently sold by another patentee (p21 of March 2009 N&C) (No indication of why this has been removed)
Investigations: No Change
Schedule 1 -Submissions by patentees on Level of Tx Improvement: No Change
Schedule 4 – Reasonable Relationship Test: See Price Sources for Comparators (#1) above
Schedule 5 – Median International Price Comparison: No change
Schedule 6 Highest International Price Comparison: See # 2 above
Schedule 8 – Application of Price tests
Schedule 9 – CPI Adjustment Methodology: removed the commitment to publish CPI figures...or that they be published in April newsletter (36)
Schedule 10: DIP Methodology See # 3 above
Schedule 11 – Criteria for Commencing an Investigation: No Change
Schedule 12 – “any Market” Price Reviews: if the MAPP is set by HIPC this will not apply for the wholesaler class of customer, this market will be limited to domestic introductory price tests. (p41)
Schedule 13 – Offset of Excess Revenues: allows for “market specific” price to return up to “market specific” non-excessive average price if reduced as part of an offset (p43)
Links to PMPRB Summary of Changes and revised Compendium:
http://www.pmprb-cepmb.gc.ca/cmfiles/RESULTS_ConsultationonGuidelines-June909.pdf
http://www.pmprb-cepmb.gc.ca/cmfiles/COMPENDIUM_REVISED_June909.pdf
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