On September 1, 2022 the Patented Medicine Prices Review Board (PMPRB) issued its determination regarding the cause Procysbi (cysteamine delayed merchandise capsules).[1] The PMPRB recovered the terms of Procysbi to beryllium excessive. Interestingly, this substance recovered its mode earlier the PMPRB pursuing a ailment by the pan-Canadian Pharmaceutical Alliance (“pCPA”). Under the Guidelines, receipt of a ailment triggers an automatic investigation.
The determination offers adjuvant insights pursuing the Federal Court of Appeal’s determination successful Alexion Pharmaceuticals Inc. v Canada (Attorney General), 2021 FCA 157 (“Soliris FCA”) and however the PMPRB volition reappraisal the prices of medicines nether investigation, including:
- What is the mandate of the PMPRB?
- What is simply a medicine?
- What is the therapeutic comparator?
- What is the Level of Improvement and Price Test?
What Is the Mandate of the PMPRB?
The PMPRB focused connected excessive pricing alternatively than “reasonable pricing”, which the Federal Court of Appeal had recovered problematic successful Soliris FCA. The determination contains a lengthy treatment of the PMPRB’s mandate:
“the Board’s mandate is to guarantee that patentees bash not maltreatment their statutory monopoly rights by charging excessive prices and, successful this respect, the Board does person a user extortion mandate”.[2]
What is the Medicine?
As a archetypal step, the PMPRB considered whether Procysbi and Cystagon were the aforesaid medicine fixed the beingness of the aforesaid progressive ingredient, cysteamine bitartrate, and usage for the aforesaid indication, nephropathic cystinosis. The cardinal contented was whether the beingness of the aforesaid progressive ingredient, albeit successful antithetic formulations, meant that the drugs are the aforesaid medicine. The PMPRB recovered that the “term “medicine” refers to the commercialized formulation (Procysbi), and not simply the progressive constituent (cysteamine bitartrate)””.[3]
This investigation is absorbing successful airy of the PMPRB’s Galderma re-determination decision.[4] In that instance, the PMPRB paid person attraction to the progressive constituent and recovered that a aboriginal patent claiming 0.3% adapalene pertained to an earlier 0.1% formulation of that medicine.[5]
What is the Therapeutic Comparator?
Although the PMPRB did not find Procysbi and Cystagon to beryllium the aforesaid medicine, it did find that Cystagon is simply a therapeutic comparator to Procysbi connected the ground of progressive constituent and indication. The PMPRB recovered that proviso of Cystagon done the peculiar entree programme amounted to it being “sold successful the applicable market” for the purposes of comparison.
What is the Level of Improvement and Price Test?
The PMPRB past considered the level of betterment offered by Procysbi to find the due pricing test. The PMPRB recovered that Procysbi offered mean betterment implicit its therapeutic comparator, Cystagon.[6] As such, the Moderate Improvement Test was appropriate. The Moderate Improvement Test involves an investigation of the Therapeutic Class Comparison (TCC) Test, the Median International Price Comparison (MIPC) Test, and the midpoint betwixt those 2 tests. The terms of a mean betterment cause is constrained by the higher of the TCC Test and the midpoint betwixt the TCC Test and the MIPC Test.
In applying the TCC trial and comparing against Cystagon, the PMPRB recovered the median ex-factory terms of Cystagon to beryllium C$0.0197 / mg. In applying the MIPIC trial the PMPRB recovered the median planetary ex-factory terms of Procysbi to beryllium C$0.4207 / mg. The midpoint betwixt the TCC Test and the MIPC Test is C$0.2202 / mg and marks the maximum non-excessive terms of Procysbi successful Canada.
Given that Procysbi entered the Canadian marketplace astatine C$0.4140 / mg, Horizon was ordered to trim the terms of Procysbi and wage the excess revenues derived by Horizon to Canada.[7]
English (US)