Majority of the products not assessed by respective HTA body are very recent entrants and likely to be assessed in the near future.
In Germany, a clear majority of drugs that were assessed were given ‘not quantifiable’ or ‘added benefit not proven’ as outcomes. The majority of the outcomes are not quantifiable, which may be due to the additional clinical benefit rating in certain circumstances for orphan drugs under AMNOG.
In the UK, more favourable HTA outcomes were observed from the 40 drugs that launched via a CMA in comparison to both France and Germany. Like France and Germany, orphan drugs also achieved more favourable HTA outcomes in the UK as opposed to non-orphan drugs.
Interestingly, the most common HTA outcome in the UK was recommended via CDF, which shows that oncology drugs may be the main driver for CMA products obtaining a favourable HTA outcome. Moreover, the future prospect of an Innovative Medicines Fund for the UK may act in a similar way to the CDF for oncology drugs, opening the opportunity for non-oncology products to pursue a conditional reimbursement route.
Now that we have established our observations, we are now in the position to ask deeper questions. Through our observations, we are able to pinpoint criticalities that will reshape our understanding of the CMA pathway and its implications on HTA and price.
If you are considering launching your drug via a CMA or if you have an orphan drug, reach out and find out more about what we can do for you.
About the authors
Dr. Jesvin Samuel