Access delayed, transparency denied

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posted February 11, 2014

Yet another patient appears on Global TV News unable to get an expensive prescription drug reimbursed by the Ontario provincial government, and the Minister of Health and Long-Term Care responds that “the provinces and territories are working together to negotiate with manufacturers to get the best possible prices for drugs.” What no one gets to know is precisely how that’s happening or how quickly, leaving us all in the dark about access to a vital component of modern medical care.

The health minister was referring to what has become the Pan-Canadian Pricing Alliance (PCPA), an initiative announced in the summer of 2010 to negotiate prices with pharmaceutical companies. According to presentations given by bureaucrats from the Ontario Public Drug Plan, the PCPA’s objectives are to increase access to drugs; improve the consistency of drug listing decisions across Canada; capitalize on combined buying power of jurisdictions; achieve consistent and lower pricing of drugs; and reduce duplication in provincial negotiations. Prices for 20-30 drugs are said to have been negotiated. However, no information is available to the public about these negotiations or their outcomes.

The process lacks transparency – there is no information on a governance structure, there are no reports on the negotiations and not even a website. Nothing is publicly available from the work of the consulting company hired in February of 2013 to develop a governance structure to facilitate PCPA negotiations and provide greater transparency either. The Canadian Security Intelligence Service has more transparency than the PCPA.

The process of getting a new prescription drug approved for marketing and reimbursement by provincial drug plans is a long and tortuous one in Canada. A drug is reviewed by branches of the federal and provincial governments as well as a multiplicity of agencies such as the Canadian Agency for Drugs and Technologies in Health, the Pan-Canadian Oncology Drug Review, the Patented Medicines Prices Review Board, and the Pharmaceutical Advertising Advisory Board. Significant delays in the process have been reported for years. The little that is known about the PCPA process does not bode well for improving the timeliness of prescription drug access in Canada.

Here’s what we do know: Before the PCPA process for negotiation about a drug begins, provinces and territories must declare whether or not they intend to join in the negotiation. For new drugs, all jurisdictions tend to participate, but they are not required to do so – they may already have an agreement with the manufacturer. Participating in the negotiation implies that, if an agreement is reached and a Letter of Intent signed, the drug will be listed in any subsequent Product Licensing Agreement at the agreed price and with the agreed listing criteria specified in the Letter.

But provinces and territories are not mandated to list a drug that has been successfully negotiated through the PCPA process, so the PCPA does not guarantee an eventual listing agreement in all provinces and territories. Each jurisdiction is also free to negotiate further price or other concessions from the manufacturer before a Product Licensing Agreement is signed. These appear to negate the PCPA’s objectives of consistency of listing decisions and reduction of duplication in provincial negotiations.

In addition, there is presently no timeline or performance standard for the PCPA or the subsequent provincial negotiations, and no formal process to prioritize important, potentially life-saving drugs.

New drugs can have a meaningful impact on the wellbeing and survival of those stricken with illness. Not surprisingly then, patients want access to them, or at least information about progress in provincial negotiations. At the very least, they should easily be able to find out what drugs are being reviewed and how long that process is expected to take. Even better, reasons for drugs not being reimbursed should be given to them, as should explanations for why these lengthy delays before funding approval are required.

Canadian drug approval and reimbursement processes generally lack transparency and the PCPA is no exception. When Canadian patients are denied access to an expensive new drug, especially if it is reimbursed in other provinces, it is at least inadequate for a Minister of Health to simply state that negotiations are in process. The PCPA was established nearly four years ago. It is time for transparency regarding the process and outcomes of the system.

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