The National Institute for Health and Care Excellence (NICE) produces guidance in a number of forms including technology appraisals. Technology appraisals are recommendations on the use of medicines and treatments within NHS England. The recommendations are based on a review of clinical and economic evidence. NHS England is legally obliged to fund medicines recommended by NICE’s technology appraisals.

NICE and NHS England recently consulted publicly on changes to technology appraisals and highly specialised medicines. Following consideration of the consultation responses, recommendations for making changes to NICE processes were approved by the NICE Board on 15 March 2017. The 3 changes which will be introduced from 1 April 2017 are as follows:

  • Introduction of fast track technology appraisals – The aim is to make an eligible medicine available to patient a month after a marketing authorisation is obtained, nearly 5 months faster than currently. The fast-track will apply to the most promising new medicines which offer exceptional value for money, with a likely cost per extra quality-adjusted life year (QALY) of under £10,000.
  • Introduction of a budget impact test – Medicines costing 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. Where agreement cannot be reached, NHS England will be able to choose to apply to NICE for an extended period in which to introduce the medicine in a phased way.
  • Linking NICE and NHS England processes for evaluating highly specialised technologies for very rare conditions – A £100,00 QALY maximum for medicines evaluated via the Highly Specialised Technologies (HST) programme. The HST Evaluation Committee will in defined circumstances have discretion to apply QALY weighting which will progressively advantage medicines that offer greater QALY gains.

The Association of the British Pharmaceutical Industry (ABPI) has responded claiming that the changes will “prevent patients from receiving NICE approved, cost-effective medicines”. The ABPI says that “thousands of patients will wait longer for treatment for conditions like heart disease, cancers and diabetes while medicines which stand to benefit the most people are caught up in the system. If the NHS became more effective in its planning it could manage the introduction of new medicines in a coherent way”. The ABPI has called on the UK government to withdraw the changes.

The BioIndustry Association (BIA) has also responded that the changes will “limit patient access to novel, breakthrough potentially life-saving medicines, especially for rare diseases”. The £100,000 QALY maximum for medicines evaluated via the HST programme “will effectively stop the flow of new medicines” for very rare diseases, where “many treatments currently funded by NHS England for very rare conditions have costs per QALY in excess of £500,000…It is widely acknowledged in the industry that QALY thresholds are not appropriate for evaluating medicines for very rare diseases”.