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NICE publishes new manual information for health tech evaluation programmes

By February 4, 2022No Comments

The National Institute for Health and Care Excellence (NICE) has published a new combined methods and processes manual and a topic selection manual for its health technology evaluation programmes.

The changes outlined in the manuals came into effect from 1 February 2022 for new evaluations and will give patients earlier access to innovative new treatments. NICE has set out the key changes in the manuals as below:

  • Giving additional weight to health benefits in the most severe conditions to allow more equitable access to treatments for these conditions, not just to treatments used at the end-of-life.
  • Adopting new approaches to the evidence NICE considers in its assessments. For example, NICE will expand on and improve how it considers real-world evidence from the lived experiences of patients.
  • Allowing more flexibility for NICE’s independent committees in cases where its particularly difficult to generate enough evidence. Sometimes, research into conditions affecting children, rare diseases or where the new treatment is innovative or complex can be problematic. The changes will allow NICE’s committees to consider uncertainty appropriately and to manage the risks to patients and the NHS while preventing inappropriate barriers to valuable innovations.
  • Adopting a clearer vision, principles and routing criteria for treatments for very rare diseases that NICE will evaluate under its Highly Specialised Technologies (HST) Programme. This will improve the efficiency, predictability and clarity when routing topics to the programme and build upon NICE’s ambition to provide fairer access to highly specialised medicines and treatments within the NHS.
  • Earlier engagement with NHS England and NHS Improvement and companies about commercial/managed access proposals that allow NHS patients to receive a treatment while further data is collected on its effectiveness. There will also be greater clarity around the circumstances in which NICE committees can make a managed access recommendation.
  • “Our vision at NICE is to be at the forefront of delivering access for patients in the NHS to valuable, evidence-based innovative medicines, medical devices and diagnostics”, said former NICE Chief Executive Gillian Leng.

    Since 1 February, Dr Samantha Roberts has taken over from Gillian Leng as NICE’s Chief Executive.