NICE Draft Guidance: What's in a Name - Is Final Really Final?

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Tom Dever
VP of New Products
Context Matters

 

In my years of experience in the reimbursement space, I have encountered dozens of cases with people mistaking the preliminary decisions of NICE for the final reimbursement decision. The professionals making these mistakes are rarely new to the space. So why is there so much confusion?

I believe that this is due to the multi-track process that NICE employs and the terminology used at each step of these processes. While NICE’s commitment to transparency and public input is laudable and important, each track of the NICE technology appraisal process generates a number of different documents before the final technology appraisal guidance is released. Several of these documents, which are made available to the public and often reported through various news outlets, include preliminary decisions.

What track a product travels in a single technology appraisal depends on whether the Appraisal Committee’s “preliminary recommendations are substantially more restrictive than the terms of the marketing authorisation.” If so, then an Appraisal Consultation Document (ACD), which is “prepared for consultation with the consultees”, will be produced and inform the Final Appraisal Document (FAD). In turn, The FAD is used to inform the final NICE Technology Appraisal Guidance (TAG) and is the draft guidance in a final format. If a product were to go through a multiple technology appraisal, there would be even more potential different tracks and different documents, contributing to the confusion.

If the preliminary recommendations are not “substantially more restrictive” than the marketing authorization, then the ACD will be skipped and the FAD will be the only preliminary or draft publication before a final recommendation. Regardless of which track is taken, the FAD will be followed by the publication of the TAG.  

When laid out sequentially, these tracks seem clear, but the fact that the documents have similar sounding names and all issue some kind of recommendation adds to the confusion. It is important to remember that only the decision in the final TAG is legally binding.

While the confusion caused by the documents’ similar names and recommendations may seem odd, it can have a pronounced commercial impact. A draft may be mistakenly interpreted as a final binding decision. Therefore, it is important to understand how much change can happen throughout NICE’s process.  

For example, let’s look at Multiple Sclerosis. Since 2007, there have been eight NICE evaluations, or NICE Guidances, for MS. Only 38% (or 3 of the 8) of the ACD and FAD documents aligned on their recommendations. That means that each TAG had an associated ACD and over half of the recommendations in the ACDs actually changed when the FAD was published. If a company mistakenly used one of the draft guidances as a proxy for a final guidance, their analysis of the situation could have been erroneous. They may have gained a very different impression about the reimbursement potential of a drug.

Upcoming Presentation at HTAi 2015 Oslo

If you find this post to be interesting, I would love to hear your thoughts. In June, I will be presenting more on this topic at the Health Technology Assessment International conference in Oslo. My presentation will include analysis across several different disease conditions, including oncology and non-oncology, which will provide a deeper understanding of this process. 

If you would like to read more on the topic, we previously wrote on the potential problems in accepting draft guidance as final, last September in a post “NICE: Draft Guidance in Context.”

 


Tom Dever is Vice President of New Products at Context Matters. He has extensive experience in both U.S and ex-U.S. markets and these experiences allow him to understand the nuances that result in successful reimbursement strategies and tactics. Previous to coming to Context Matters, he worked in pricing and access strategy roles across multiple commercial channels at Pfizer and as a consultant at Bridgehead International (now GfK Bridgehead).