KCSN is a member of the Association of the British Pharmaceutical Industry (ABPI) Patient Organisation Forum. The ABPI aims to encourage the collaboration of the pharmaceutical industry and charities and to ensure that the patient is at the heart of their work to deliver medicines that have the most impact on people’s health and wellbeing.

The National Institute of Health and Clinical Excellence (NICE) set about reviewing its methods and processes last year. The review was meant to go for public consultation during this summer, but because of COVID-19, has been delayed about 6 months. KCSN attended a meeting in July for an update on what has been happening over the spring and summer to get the review back on track, and how patient groups can work with the ABPI on this initiative.

The meeting was chaired by Alan Maine, Government Affairs, ABPI.

 

NICE Process Review

The process review is focussed on 4 main areas:

  1. Scope of the review – includes health technology appraisals (HTAs), highly specialised technologies (STAs), medical technologies (equipment), diagnostics and topic selection
  2. Alignment of programmes – consistent experience of stakeholders across all appraisals, e.g. nomenclature, committee forms, contribution from stakeholders, structure and process of committee meetings
  3. Improvement of processes – simpler, more efficient, better, faster using lessons learnt during the COVID-19 pandemic
  4. Stakeholder engagement – insight group, public consultation, single manual.

 

There are a number of task and finish groups looking at stakeholders, scoping, submission, committees and consultations. There are 6 patient organisations in the working groups who have identified improvements in the following:

  • Documenting process needs to be clearer
  • Submission process needs to be consistent and innovative e.g. identification of needs of patient experts, use of video conferencing if patients experts are unable to attend meetings etc.
  • Transparency of decisions – feedback is required on how the decisions are made and how patient expert/groups contributed to the decision
  • Support for patient groups and patient experts during the whole HTA process – e.g. how to contact NICE, skill-up patient experts for high quality evidence, logistics of the committee meeting to allay patient fears etc.

 

There is a stakeholder insight group of 500 people from patient groups, pharma, NICE committee members and professional societies. This group helps NICE to get the detail right so that it works for stakeholders. It also gets involved with topic selection and follow-up using surveys etc.

Timelines have been put back 6 months and are now as follows:

  • July 2019 – Sept 2020 – research by task and finish groups and stakeholder insight group
  • Oct 2020 – Nov 2020 – public consultation
  • Jan 2021 – NICE internal and board review
  • Feb 2021 – March 2021 – finalise manual, further stakeholder consultation
  • May 2021 – publish and implement new NICE processes

 

The COVID-19 pandemic has identified new ways of working, such as video conferencing and MS Team meetings etc.

 

NICE Methods Review

There was an ABPI Patient Organisation Forum workshop on this topic back in May 2019 where the main items discussed were the ABPI extended value appraisal (EVA) versus cost/QALY for rare and less common indications, prioritisation of topics, the scope of methods review, engagement via the stakeholder insight group, overlap between methods and processes, and priorities:

  • Clinical and patient input
  • Consistency and transparency
  • Join up of expert opinion
  • Review of the technical engagement
  • Process for identifying new technology that will challenge NICE methods

The methods review aims to:

  • Evolve the way medicines are assessed ensuring NICE is fit for purpose in the future and recognised internationally
  • Use full potential of voluntary scheme (pharma) to ensure patients can access medicines with risks to the NHS budget
  • Support improvement of health outcomes
  • Manage uncertainty – NICE decision-making needs to reduce uncertainty and form solutions to access to treatments – this is especially important for rare conditions with small numbers of patients
  • Discounting currently doesn’t account for long-term value of the treatment
  • Rare diseases – need to close the gap between STAs and HTAs. NICE needs to accept evidence package for rare diseases to help patients access potentially effective treatment.

 

This review is needed because of the fast changing environment with respect to new treatments, such as changes in clinical trials, more long-term/chronic diseases, early diagnosis being potentially curative, more rare diseases, vaccine development, histology and genetic markers etc. There have not been any changes to the NICE methods since 2013.

NICE must be given a clear mandate. Methods must have a long-term view and be fit for purpose in the future. The voice of patients must be heard. The ABPI also wants to see a broader framework and less reliance on cost/QALY for appraising drugs for use on the NHS. NICE needs to consider the extended value of medicines to the NHS in its methods evaluation; there is opportunity for medicines to reduce the strain on the NHS, such as provision of treatment at the patient’s home, rather than use hospital facilities.

In summary, the ABPI wants to support patients getting access to new medicines, help sustain UK-based research and development investment and improve clinical outcomes to help deliver the NHS Long Term Plan.

 

Patient Group Priorities

NICE processes:

  • Patient engagement in appraisals and how patient input is considered in decision-making
  • Review technical engagement step to make it easier for patients to understand/get involved.

 

NICE methods:

  • Managing uncertainty
  • Bridge the gap between STA and HTA
  • More flexibility of cost/QALY and less reliance on cost/QALY
  • Aligning discount rate of health benefits to Treasury Green book
  • Impact of decision on carers
  • Use of real world evidence in decision-making.

 

The ABPI is supporting the task and finish groups and methods working group, they are having ongoing discussions with Government and NHS leaders and they are members of the NICE Industry Council that meet 2x a year with NICE leadership.

For more information visit the NICE Methods Review page on the ABPI website here.

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