Questions remain on responsibility for data collection as part of HTA reassessments in Canada

Country : Canada

Keywords :
by Thomas Meek
LONDON, 22 May (APM) - Questions remain on the responsibility for the collection of real-world evidence during potential reassessments of the value of drugs in Canada, according to a senior Canadian official.
Canada is looking to implement powers for its health technology assessment (HTA) body CADTH to re-evaluate drugs after they have been funded.
This could be for a number of reasons, according to a document from CADTH. These include revised indications for a product; emergence of new comparators; availability of new clinical data; expiration of reimbursement agreement; and an uncertain or potentially high budget impact.
One of the biggest challenges in this process will be who is responsible for collecting the data for reassessment and how this data will be collected, according to Brent Fraser, vice president of pharmaceutical reviews at CADTH, who was speaking on Tuesday in a virtual conference held by ISPOR, the leading professional society for health economics and outcomes research.
"We know that the manufacturers have a lot of this information available to them. But there are a lot of concerns around the rigor of some of this data that's available and drug plans are stressed resource wise as well as financially.
"And so there are a lot of concerns around who's going to do the analysis and who is going to fund the analysis and so we're working through that right now."

Health technology management

The reassessment plans are part of ambitions in Canada to move from an HTA approach to a 'health technology management' approach in an effort to address high volumes of expensive products and demand for early access to medicines that may be approved on limited data, said Fraser earlier in the session.
This includes working with regulator Health Canada to identify technologies that are the most disruptive and where there is the greatest need to provide early access.
The country is also looking to take a more lifecycle approach to health technology analysis, with the possibility of pre-market dialogue, managed entries, post-market surveillance, reassessment and even managed exits following reassessment.

Conditional recommendations

This means the potential for conditional type recommendations where the CADTH expert advisory committees identifies that a drug surpasses a certain threshold for recommendation but there are questions that need to be addressed with further data.
England has a similar managed access process for cancer drugs where drugs can be reimbursed on the national Health Service (NHS) for a limited time period while more data is collected on their efficacy to support routine reimbursement.
The Canadian system would aim for confirmation of clinical outcomes, for example, said Fraser. "The typical one that we see is overall survival. Does that align with the progression-free survival that we see in many of the clinical trials for cancer drugs?"

Potential for defunding

These data would be used for any reassessment process, said Fraser.
These processes would fall into three categories, including standard assessments, which is conducted to address questions related to comparative clinical benefit and/or cost-effectiveness of a single drug that is currently reimbursed.
A targeted reassessment is conducted to address changes in contextual factors that may affect the ability of the drug programmes to implement existing recommendations from CADTH.
"Often this would be encountered if for example they there is another treatment that has been approved that is impacting the use of another drug within that category," said Fraser.
And a therapeutic review would be necessary if there are questions regarding the comparative safety, clinical effectiveness and cost-effectiveness of multiple drugs, such as in recent years when multiple hepatitis C drugs came to market, said Fraser.
Reassessment may lead to difficult decisions on the use of a drug, including the possibility of a more restricted use or defunding particular treatment options, said Fraser.
"Obviously that is not something that people are supportive of and so we would be looking at how - if the data is not as strong as we thought it was - are there ways that we can put some parameters around which patients would benefit the most from accessing that treatment."



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