NICE’s remodel plans focus on delivering faster and fairer access to treatments by optimising approval processes and expanding currently effective initiatives. From increased flexibility, to more market access agreements and weight given to drugs for severe diseases, read on to find out the details of the upcoming changes.
Severe and Rare Disease Treatments
Extra QALY Weighting
Innovative medicines that treat severe diseases at any stage, such as epilepsy and multiple sclerosis, may be given extra value in NICE’s decision making process.
NICE propose to introduce a ‘severity’ modifier, with higher QALY weighting for those conditions considered to have the highest impact on health, to replace the existing ‘end-of-life’ QALY modifier.
Highly Specialised Technologies
As for the Highly Specialised Technologies (HST) appraisal program, NICE plans to update the qualifying criteria, removing those criteria regarded as redundant with the rise of one-off cell and gene therapies (i.e the requirement for the disease to be “chronic and severely disabling” and the treatment to have “lifelong” use). The four criteria points will now only reflect the rarity of the disease, the impact on health and the lack of established treatment options.
Flexibility in Approvals and Guidance
NICE plans to simplify and streamline its assessment processes to allow for more flexible decision making where evidence generation is particularly difficult. For example, with complex treatments, rare diseases and medicines for children. NICE will also continue exploring ways to use new data sources such are RWE, expert testimony and qualitative surveys.
Additionally, NICE plans on releasing more recommendations on all types of guidance for diagnostics and medical technologies without consultation where outcomes are “clear and unlikely to change”.
More Managed Access Agreements
Lastly, NICE plans on expanding its use of managed access agreements. Managed access agreement allow companies to offer their drugs at reduced prices whilst they continue to gather evidence to prove their effectiveness.
NICE plans to initiate its remodel by January 2022.
If you would like any help in exploring how these changes may shape obtaining market access in the UK for you, email Paul and Graham, managing directors, today at: firstname.lastname@example.org