News Alert: NICE to Make Therapy Assessments More “Flexible” With Amendments

PRICENTRIC BRIEF:

  • The National Institute for Health and Care Excellence (NICE) has announced plans to change the way it evaluates new medicines and health technologies – according to the organization, it is committed to “greater flexibility” in its evaluation process, with an aim to increase patient accessibility and greater equality of access.
  • The changes, if approved by the NICE Board, will come into effect early next month following a discussion on the implementation of the amendments at a meeting on January 19.
  • Formed as a reaction to the advent of innovations like cell and gene therapies, as well as the UK’s breakaway from the European Union (EU), the reforms will hopefully give NICE better bargaining power by allowing greater flexibility over decisions about value for money and consideration of a broader evidence base.

 THE DETAILS

LONDON, United Kingdom — The National Institute for Health and Care Excellence (NICE) has announced plans to change the way it evaluates new medicines and health technologies.

According to the organization, it is committed to “greater flexibility” in its evaluation process, with an aim to increase patient accessibility and greater equality of access. The changes, if approved by the NICE Board, will come into effect early next month. The relevant parties discussed the implementation of the amendments at a meeting on January 19.

Formed as a reaction to the advent of innovations like cell and gene therapies, as well as the UK’s breakaway from the European Union (EU), the reforms will hopefully give NICE better bargaining power by allowing greater flexibility over decisions about value for money and consideration of a broader evidence base.

The most impactful of the changes are expected to be:

  • Giving additional weight to health benefits in the most severe conditions that will allow for more equitable access to treatments for the most severe diseases, not just those used at the end of life – known as a severity modifier. This change has been made because evidence shows that people in the UK highly value health benefits from treatments for the most severe diseases.
  • 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 (RWE) from the lived experiences of patients. This will allow NICE to get more insights from people affected by its guidance.
  • Allowing more flexibility for NICE’s independent committees in cases when generation of evidence is particularly difficult. Sometimes, research into conditions affecting children, rare diseases or those for which the new treatment is innovative or complex can be problematic. While the strongest evidence base will always be required, the proposed changes will allow NICE’s committees to consider uncertainty appropriately and proportionately 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 Specialized Technologies (HST) Program. This will improve efficiency, predictability and clarity when routing topics to the program and build upon NICE’s ambition to provide fairer access to highly specialized medicines and treatments within the NHS. Key to this is a reduction in the number of different criteria that must be met to enter the HST program, from seven to four, and a more explicit acknowledgement of the wider impact on the NHS and the displacement of healthcare resources that occurs when NICE recommends a treatment through the HST program.
  • Engaging earlier with NHS England and NHS Improvement and companies about commercial/managed access proposals, as well as providing greater clarity around the circumstances in which NICE committees can make a managed access recommendation, such as when NHS patients can receive a treatment while further data is collected on its effectiveness.
  • Aligning NICE’s methods and processes across different types of evaluation, spanning medicines, medical devices and diagnostics, to ensure that health technology evaluation is pragmatic, agile and robust while also being able to adapt to environmental changes and system partners’ requirements.

When announcing the changes, Professor Gillian Leng, CBE, NICE chief executive, said that NICE’s vision is to be at the “forefront of delivering access for patients in the NHS to valuable, evidence-based innovative medicines, medical devices and diagnostics.”

Leng added that the changes being discussed “will provide a robust foundation for our evaluations now and in the future and enable us to continue to lead the way in rapid, independent health technology assessments.”

In addition to the primary changes, NICE identified a number of potential future modular updates to the methods, such as:

  • Processes to enable rapid entry to managed access agreements and to manage technologies that are licensed to treat more than one condition.
  • Method issues for digital, genomic and antimicrobial technologies.
  • Further method issues, such as the societal value of health benefits in severe diseases, health inequalities, quality of life in children and carers, and further support for a comprehensive evidence base.

Helen Knight, program director in the Centre for Health Technology Evaluation, noted that the group has engaged “extensively” with stakeholders throughout the process, listening to concerns and taking on suggestions.

Response

On the news of the potential changes, the Association of the British Pharmaceutical Industry (ABPI) said that they could “move the needle in the right direction for NHS patients.”

Paul Catchpole, Value and Access Policy Director at the ABPI, added that the changes could “help support better access to life-changing medicines, today and in the future, while helping to deliver the UK government’s Life Sciences Vision.”

He added, “These long-awaited changes mean that NICE’s methods and processes will better reflect the incredible advances in medicines discovery.”

According to the ABPI, the changes would specifically help patients with very rare diseases to benefit from “game-changing” cell and gene therapies by providing better access via the HST Program.

Additionally, the new severity modifier could help the UK better recognize the impact and value that medicines bring to society. However, on this note, the ABPI voiced disappointment that “NICE has not been able to take forward at this time evidence-based changes to the discount rate used in economic evaluations.”

It is anticipated that the final NICE documents on the changes will be published on January 31, with changes to come into effect in February for new evaluations.

NICE in the Process of Reform

NICE first launched a public consultation on its health technology assessment methods and processes in August last year, as part of its largest-ever review. It also launched a five-year strategy in April 2021, aiming to “keep ahead of the challenges of a rapidly changing health and care landscape.”

Hopefully, according to the pricing negotiator, the series of reforms will allow it to evolve from producing full guidelines to adopting a more modular, living style of recommendations, allowing rapid updates that incorporate the latest evidence to reach healthcare professionals faster than ever before.

According to the group, the pandemic “provided a catalyst for the type of change that we already knew we needed to make,” including expediting access to new treatments and technologies and integrating RWE into evaluations.

With this strategy, NICE has “a renewed determination to prioritize [its] work to reduce those health inequalities that have been highlighted during the pandemic, to work seamlessly across boundaries, to reduce bureaucracy and to speed up access to the latest and most effective treatments,” explained NICE Chair Sharmila Nebhrajani and Leng.

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