NICE introduces new fast-track appraisal process

NICE has introduced changes to its evaluation process for new treatments. NICE says that the changes, which apply to technologies for which a first evidence submission was received after 1 April, mean that patients will benefit from access to the most cost-effective treatments up to five months sooner.

The new fast-track appraisal process applies to new treatments that offer “exceptional value for money”, so that they can be made available to patients within 30 days of approval (the standard introduction period is within 90 days). Exceptional value for money is defined as drugs with a likely cost per quality-adjusted life year (QALY) gained of under £10,000. The upper end of NICE’s standard threshold range for cost-effectiveness is £20,000–£30,000 per QALY gained. NICE also intends to consider broadening this fast-track approach to a wider range of treatments, including medical devices and diagnostics over the next two years.

Other changes to NICE’s evaluation processes include a budget impact test, in which drugs that will cost more than £20 million in any one year of the first three years of use will require commercial discussions between the drug company and NHS England in order to minimise impact on the rest of the NHS. If an agreement cannot be reached, the NHS will be able to apply to NICE for an extension period (of up to three years) in which to introduce the drug in a phased way.

Under its highly specialised technologies programme, NICE will consider extending the original limit of £100,000 per QALY gained for treatments for very rare conditions to a maximum threshold of £300,000 per QALY gained in the case of drugs that offer “transformational health benefits”. However, treatments 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 by NICE.

NICE says these changes are designed to address the challenge of providing faster access to cost-effective treatments alongside the need to safeguard the future financial sustainability of the NHS.

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