Slide 11 is a work-flow diagram of how the proposed PRICE review process will function.
The first step in the process is the receipt of a Patentee submission for a new patented drug which is represented the box in the center of the diagram.
From there, a Maximum List Price (MLP) is established. This is done through an external price review based on the PMPRB12 countries, as proposed in the amendments to the Regulations. The MLP is established as the median of an international price comparison (MIPC) of the countries in the PMPRB12. This is represented in the box below the receipt of the Patentee submission.
In next step in the process, represented by the box below, a Preliminary Clinical and Market Assessment is conducted. Based on the results of this assessment the drug is categorised as one of two categories:
- A Category 1 drug, the attributes of which are included in the box to the left, indicated by an arrow pointing to the box.
- A Category 2 drug, all other drugs that do not have a Category 1 classification. This is represented by the box to the right.
Starting from the top left, Category 1 drugs are those that are either:
- First in class or offer a substantial improvement over existing drugs for clinically significant indication(s)
- Have a Market Size greater than $20M
- Expected to diminish population health ($/QALY>$30K)
Once a drug is classified as a Category 1 drug, it moves down to the box that represents an Economic Value test. To pass this test, the drug’s cost effectiveness value must be below a certain $/QALY threshold.
If the drug passes the economic value test, it moves to the box below which represents an affordability test, based on a market size adjustment. If the drug fails either the economic value test or affordability test it moves to a central box. The central box represents the PMPRB Staff Recommendation stage.
If the a drug passes both the economic value test and affordability test, it then moves down to the last box on the left and the Investigation is closed.
At the top right is the starting box for Category 2 drugs. For this category the Median International Price is compared to the Average of the Therapeutic Class Comparison. The MLP becomes the lower of the two tests as indicated in the second box on the right. From here, the drug moves to the centre box, PMPRB Staff Recommendation stage.
At the PMPRB Staff Recommendation stage, staff review the merits of each drug on a case-by-case basis and make a recommendation to the Board.
At this stage, PMPRB Staff make one of the following recommendations: Close Investigation as indicated in the box at the bottom left; proceed to a Hearing as indicated by the box at the bottom right; or agree to a Voluntary Compliance Undertaking as indicated in the bottom center box.
From the Voluntary Compliance Undertaking box, the drug moves to the Investigation Closed stage on the bottom left once the VCU has been signed.