NICE and NHSE to Impose £20m Budget Impact Negotiation Threshold and Set £300,000 ICER Threshold for HST
Following the consultation launched in October 2016, NICE are amending their appraisal process to include:
- The introduction of a new fast-track option for appraising treatments which offer exceptional value for money. The aim is for them to be available to patients a month after they are licensed. The fast track appraisals will apply to drugs with a likely cost per extra year of quality-adjusted life of under £10,000, offering exceptional value for money. NICE has indicated that it intends to consider broadening the fast-track approach to a wider group of treatments, including medical devices and diagnostics, over the next two years.
- A budget impact test, where drugs that will cost more than £20m in any one of their first three years of use will trigger commercial discussions between the company and NHS England to mitigate the impact on the rest of the NHS.
- Where agreement to minimise the impact of those drugs cannot be reached, NHS England will be able to choose to apply to NICE for an extended period in which to introduce the drug in a phased way. This will usually be for no more than three years.
- Drugs for very rare diseases will be evaluated against a sliding scale, so that the more the medicine costs the greater the health benefit it must provide in order to be approved for routine NHS use by NICE. Treatments evaluated through the HST programme that are deemed to provide significant QALY benefits could benefit from being assessed against a maximum threshold of £300,000 per QALY, rather than the £100,000 per QALY limit in the original proposal.
These changes will be introduced for topics for which a first evidence submission is received after 1 April 2017.