The National Institute for Health and Care Excellence’s (NICE) treatment appraisal is a voluntary process. If companies opt not to submit, the result is merely a statement from NICE that the appraisal was terminated due to non-submission. However, this is not looked upon favorably by the National Health Service (NHS), the largest buyer of specialized medicines.
Non-submissions may not matter much for treatments that are not very clinically effective or cost-effective (unless inflexible pricing rules are the issue). However, non-submissions are a mixed bag for NICE. On the one hand, there is less to do. On the other hand, companies are charged for appraisals so when companies forgo them, it means less income for NICE. And many companies are only too willing to forgo NICE appraisals because doing so does not seem to impact their reputations negatively. Ultimately, non-appraisals can inhibit easy availability of effective treatments. Thus, the ones who stand to lose the most, as always, are the patients. Read more here.
(Source: Leela Barham, Pharmaphorum, September 4, 2020)