Considerable time at this year’s NICE annual conference was given to ensuring the audience knew about and understood the recent changes for technology appraisals and how these changes will affect all stakeholders including manufacturers, health-care professionals, commissioners and importantly, patients. Meindert Boysen, Programme Director, Health Technology Appraisals, NICE, led discussions focused on the new ‘fast track’ appraisal process, the introduction of a ‘budget impact test’, highly specialised technology appraisals and how to engage with NICE for early advice.
The new ‘fast track’ appraisal process is aimed at those technologies where there is no uncertainty the QALY will be less that £10K and incorporates the previously suggested abbreviated technology appraisal. The process entails a shorter manufacturer submission, with no requirement for a cost effectiveness model, removing around 11 weeks from the single technology appraisal route. It’s likely the majority of technologies to qualify for this route will be in the primary care setting and with 30-days for implementation (as opposed to the regular 90 days) it will be important to engage with Clinical Commissioning Group commissioners to ensure optimal adoption. Ten technologies have already been identified as potential candidates for appraisal via this route in 2017.
The ‘budget impact test’ has been designed to encourage early dialogue between manufacturers, NICE and NHS England, help the NHS introduce products that will have significant budget impact and encourage flexible commercial deals. Helen Jones, Strategy and Policy Lead Specialised Commissioning, NHS England, emphasised that £20 million isn’t a capped amount the NHS will pay or change the decision NICE has made but it will act as a trigger to open a conversation on how introduction is managed. Suggested methods for introduction may include a commercial agreement to reduce the net budget impact below £20 million or a managed access agreement to phase the introduction. The finer details of how this ‘test’ will all work in practice are yet to be clarified. One size won’t fit all and NICE are still waiting for the first technology to trigger those discussions.
The highly specialised technology appraisal process is the most challenging, allowing for fair appraisal. Only four pieces of guidance have been published to date. Many require managed access agreements and/or collection of real-world data to allow positive recommendation and introduction. A £100,000 QALY has been retained from the consultation document and activates automatic funding. For technologies with a higher cost per QALY, an incremental health weighting system has been introduced. Only 3 technologies can go through the highly specialised appraisal route per year, so one key concern from the audience was what happens to those products that fall in the gap between the highly specialised and single technology appraisal routes.