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PMPRB Releases Adderall XR Decision
The PMPRB issued its decision in the Adderall XR hearing. The decision departs from the Guidelines by allowing a premium for Adderall XR over the price of existing ADHD drugs.
You may access the decision here:
http://www.pmprb-cepmb.gc.ca/CMFiles/Adderall_XR_Decision_on_Merits_-_Apr_10_0838MSW-4112008-1104.pdf.
Highlights of the Board’s Findings
- Adderall XR improvement was not deemed to be a substantial improvement over existing therapies (para 38).
- Non-therapeutic benefits of Adderall XR (unique to ADHD as well as avoidance of diversion - para 47) provide "real advantages that will improve the lives beyond the mere benefits of convenience" (para 37). Adderall XR deemed a “moderate improvement”.
- Adderall XR (10, 20, 30mg) is permitted to price at a level half-way between the international median and the therapeutic class comparison (40, 44) plus inflation (46).
- Adderall XR (5, 15, 25mg) is permitted to price based on the reasonable relationship test (45) plus inflation (46).
- Board Staff may consider VCUs when dealing with other similar cases of “moderate therapeutic improvement”, absent changes to the Guidelines to address the issues raised in the decision (50).
Concerta:
- Price of Concerta appears to be calculated based on Adderall XR prices with subsequent inflation addition (58).
Note that para 58 appears to indicate that the MNE for Adderall XR can increase to the international median - this is not consistent with the wording of the previous paragraphs.
Strattera:
- Strattera is deemed to be in the same therapeutic class as Adderall XR and Concerta even though its active ingredient is not a stimulant.
- Patentee of Strattera and Board Staff are invited to consider any reasons why it should be otherwise, absent which the patentee is invited to consider a VCU based on the price of Adderall XR.
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