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NICE guidance on real-world evidence to usher innovative treatments

Real-world evidence to be intertwined with NICE’s health technology evaluation programmes

The popularity of real-world evidence (RWE) will continue to grow in 2022. One indicator of its wider adoption is the FDA’s use of RWE for drug approvals. Additionally, NICE published new guidance in January 2022, which combines the methods and processes manual for its health technology evaluation programmes. The new guidance came into effect on 1 February 2022 and was established to give patients early access to innovative treatments by allowing greater flexibility considering a broader evidence base, making it easier for innovative and promising treatments to reach the patient incorporating the usage of RWE.

Changes included in the manuals are:

  • Additional health benefits to more severe conditions: Allowing more equitable access to treatments for these conditions, not just to treatments used at the end of life.
  • New approaches to evidence review allowing for more flexibility: Adopting new approaches to the evidence NICE considers in its assessments. NICE will expand on and improve how it considers RWE from the lived experiences of patients. Allowing more flexibility for NICE’s independent committees in cases where it’s particularly difficult to generate enough evidence, understanding unmet needs. NICE will also give better guidance on quality-of-life measurements to use when EQ-5D is not a feasible measurement.
  • Developing clearer vision, principles, and routing criteria:  For treatments for very rare diseases evaluated under the NICE Highly Specialised Technologies (HST) programme, enabling taking into account that there is a higher development cost for these treatments as well as allowing more drugs into the programme.
  • Early engagement:  With NHS England and NHS Improvement and companies about commercial/managed access proposals allowing NHS patients to receive treatment while collecting further effectiveness data.

The change in the guidance is in line with the UK’s proposal to improve patients’ access to treatment and technologies. It remains to be seen what effect the changes will have, especially in the field of RWE and the substitution of EQ-5D.

NICE will continue to work on identifying topics that may need modular updates. Potential topics might include processes to facilitate rapid entry to managed access and to manage technologies with multiple indications, methods issues for digital, genomic, and antimicrobial technologies, and further methods issues, such as the societal value of health benefits in severe diseases and health inequalities.

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