The Board of the National Institute for Health and Care Excellence, NICE, has recently approved changes to its technology appraisal processes, including the fast tracking of some low ICER products and possible delays to funding for products with a particularly high budget impact.
After ongoing consultation from both NICE and NHS England, in March the NICE Board approved a range of changes to its technology appraisal processes aimed at taking a more flexible approach. NICE's current decisions relate to a technology's predicted ICER (Incremental Cost-Effectiveness Ratio), a measure that calculates the cost of a technology per Quality Adjusted Life Year (QALY). Typically, NICE has been reluctant to recommend technologies with an ICER above £20,000 to £30,000 per QALY, on the basis that these would not present good value for money for the NHS. However the latest changes allow for some flexibility at both ends of the spectrum.
On the lower end of pricing, technologies with an expected ICER of less than £10,000 per QALY will be eligible for a fast track appraisal process on the basis that they are expected to be highly cost-effective. This process is designed to be "equally robust but less resource-intensive" than the current approach, and could shorten the standard appraisal process from 43 weeks to 32. Instead of the usual Evidence Review Group report, the ERG and NICE will work together to produce a technical briefing that will be considered as part of the appraisal process. In addition, while clinical, patient and commissioning organisations will be invited to participate throughout the process, there will not be a formal consultation stage as is usual in technology appraisals. Instead, after the first appraisal committee meeting, the committee will proceed directly to issue its final appraisal determination (FAD). This process is designed to both speed up the process of getting highly cost effective technologies to patients (NHS England has committed to providing funding within 30 days of a recommendation), and to reduce the time and resources spent by companies on appraisals that are very likely to exceed in any event.
At the other end of the spectrum, other amendments will enable NICE to grant NHS England an extension of the usual three months to fund new recommendations which may cost the NHS over £20 million in any of the first three financial years after recommendation (known as the Budget Impact Test, "BIT"). When NICE receives a company submission that may exceed the BIT, it must inform NHS England, who may begin commercial engagement with the company. This commercial engagement will take place alongside the NICE process, and this engagement should not affect the NICE process; the commercial engagement process between the manufacturer and NHS England may not result in a new price where the total budget impact would then fall below the BIT.
At any point during the commercial agreement, NHS England may apply to NICE for a variation of the funding requirement, i.e. a variation of the usual commitment to begin funding within three months the recommendation. This variation may be up to three years to fund the new recommendation, or a phased introduction, which must then be approved by the NICE Guidance Executive before going out to a public consultation for three weeks.
These recommendations have received considerable press coverage, and the Association of British Pharmaceutical Industry (ABPI) has already raised the possibility of a judicial review. Patient groups are positive about faster access but have voiced concerns that some drugs that meet existing NICE criteria could be delayed in reaching patients for potentially years. If there is to be a challenge any judicial review, any application would need to be made as soon as possible and in any event no more than three months after the Board decision to approve the new procedures. While the fast track process is likely to be of benefit to both manufacturers and patients, the BIT process may slow down access for a number of treatments to patients, although it will make it easier for commissioners to plan their budgets. In the absence of a legal challenge or a change of approach, the new procedures will apply to topics where the first evidence submissions are submitted after 1 April 2017.