What changes are we making?

The Voluntary Scheme for Branded Medicines Pricing and Access (2019 VS), agreed by government and the ABPI in December 2018, commits NICE to scoping and initiating a review of its methods for both technology appraisals (TAs) and highly specialised technologies (HSTs), including a review of the process of guidance production for HST.

We are taking this opportunity to extend this exercise to include the methods and processes of the Medical Technologies Evaluation Programme and the Diagnostics Assessment Programme as well, aligning them where appropriate.


Webinar

In November 2019 we held a webinar to share how and why health technology evaluation is changing and what it means for patients.


Meindert Boysen, director of the Centre for Health Technology Evaluation, hosted the webinar, joined by:

  • Helen Knight, programme director
  • Jenniffer Prescott, associate director
  • Lizzie Thomas, senior public involvement advisor
  • Ian Watson, senior technical advisor.

The webinar includes a presentation and panel discussion based on questions sent in by the audience.

Get involved

Consultation: autumn 2020

There will be a 6 week public consultation on the evidence and considerations for change to our methods and processes in October and November 2020. A stakeholder consultation on the draft programme manual will follow in early 2021. We'll be engaging with stakeholders informally throughout this process. During this time we'll ask for targeted feedback on elements of the review.

You'll be able to access the consultation from this page when it opens.

Subscribe to our bulletin for updates and information about this review.


Who else is involved?

We've set up a steering group and working group with external membership to oversee the review.

The steering group will have senior oversight of the methods and process review, while considering the changing national policy landscape and its impact.

The methods working group will commission the development of topics by short-life task and finish groups.  It'll review and consider the proposals from these groups in detail, before making recommendations to the steering group on the methods.

The steering group

Steering group members:

  • Gareth Arthur, director of strategy and policy, NHS England
  • Meindert Boysen, director, centre for health technology evaluation, NICE
  • Paul Chrisp, director, centre for guidelines, NICE
  • Mike Drummond, independent advisor, Centre for Health Economics, University of York
  • Helen Knight, programme director, centre for health technology evaluation, NICE
  • Mirella Marlow, programme director, centre for health technology evaluation, NICE
  • Jenniffer Prescott, associate director, centre for health technology evaluation, NICE
  • Ian Watson, senior technical advisor, centre for health technology evaluation, NICE
  • Elizabeth Woodeson, director of medicines and pharmacy, Department of Health and Social Care.

The steering group will use its collective knowledge of the health and care landscape to consider the changing national policy landscape and its impact. They'll also oversee the entire review and update. 

Patient working group

We've set up a patient working group so that we can:

  • get feedback from patient organisations
  • look at international examples of patient involvement
  • identify themes that are important to patients.

The group will feed back their proposals for improved patient involvement and has representatives from the following organisations:

  • Arrhythmia Alliance
  • Breast Cancer Now, and member of The Charity Medicines Access Coalition
  • Genetic Alliance UK and member of the Patients Involved in NICE executive group
  • Myeloma UK
  • NET Patient Foundation
  • Psoriasis and Psoriatic Arthritis Alliance.

The methods working group

Working group members:

  • Dr Jane Adam, chair, NICE appraisal committee
  • Doris Ann-Williams, CEO, British In Vitro Diagnostics Association
  • Paul Blakeley, senior policy advisor, Office for Life Sciences
  • Sarah Byron, associate director, diagnostics and Medical Technologies Evaluation Programme, NICE
  • Paul Catchpole, director of value & access, Association of British Pharmaceuticals Industry
  • David Chandler, chief executive, Psoriasis and Psoriatic Arthritis Alliance
  • Kirsty Edwards, Charity Medicines Access Coalition
  • Steve Edwards, director of health technology assessment, BMJ Technology Assessment Group
  • Leslie Galloway, chair, Ethical Medicines Industry Group
  • Charlotte Galvin, general manager UK and Ireland (amicus), UK Bio Industry Association
  • Jasdeep Hayre, associate director, technology appraisals, NICE
  • Rosie Hill, policy manager, NHS England
  • Johanna Hulme, associate director, centre for guidelines, NICE
  • Adrian Jonas, associate director, transformation, NICE
  • Pall Jonsson, associate director, science policy & research, NICE
  • Helen Knight, programme director, centre for health technology evaluation, NICE
  • Daniel Law, deputy director, medicines and pharmacy analysis, Department of Health and Social Care
  • Greg Manuel, policy manager, NHS England
  • Mirella Marlow, programme director, centre for health technology evaluation, NICE
  • Kieran Murphy, senior director market access (nevro), Association of British HealthTech Industries
  • Danny Palnoch, head of medicines analysis, NHS England / NHS improvement
  • Jenniffer Prescott, associate director, centre for health technology evaluation, NICE
  • Jayne Spink, chief executive, Genetic Alliance
  • Matt Stevenson, professor of health technology assessment, School of Health and Related Research, Sheffield
  • Nichole Taske, associate director, centre for guidelines, NICE
  • Lizzie Thomas, senior public involvement advisor, public involvement, NICE
  • Allan Wailoo, decision support unit, University of Sheffield
  • Ian Watson, senior technical advisor, centre for health technology evaluation, NICE.

The methods working group will use their expertise to make operational decisions about the project. They'll also oversee the delivery of work, as instructed by the steering group. 


Timeline

17 July 2019

July 2019 to June 2020

  • Commission research on specific methods topic areas.
  • Work with stakeholders as required throughout the review.

June to September 2020

  • Review findings and proposals.

October and November 2020

  • 6 week consultation on evidence and considerations for change.

January 2021

  • Review the public consultation responses.

February and March 2021

  • Stakeholder consultation on the draft programme manual.

April and May 2021

  • Reviews responses to stakeholder consultation.
  • Finalise new programme manual.

May 2021

  • Publish new programme manual.

June 2021 onwards

  • Implementation of new processes and methods begins.

Why we're making these changes

The purpose of our review is to optimise NICE evaluation methods to support the ambition of the NHS to provide high quality care that offers good value to patients and to the NHS.

The review is not starting with a blank sheet of paper. This is an incremental development of NICE’s existing world class approach to evaluating new health technologies.

Changes to the healthcare system

The healthcare system is changing. Products are becoming more complicated to evaluate. This is due to innovations such as personalised medicine, digital health technologies, and cell therapy.

There's also demand for products to be made available more quickly, sometimes with a lower evidence base than was previously the case. This means there's more demand for the guidance and advice that we produce.

Our stakeholders are asking us to get involved with commercial discussions, as well as supporting commercial decisions. This is increasing the complexity of our operations.

We need to be faster and more efficient

Feedback from our stakeholders tells us that we need to speed up the way we work and become more efficient. This one of the many ways we'll improve how we do things, and respond to external changes.


Improvements we hope to see

We hope to:

  • speed up patient access to new and promising health technologies
  • support better market access
  • simplify the health technology evaluation process.

Highly specialised technologies criteria review

We're reviewing the criteria used to decide whether a new technology should be evaluated through the HST programme, or the TA programme. The purpose of reviewing the criteria is to make them clearer and more specific, and the outcome easier to understand and more predictable for our stakeholders. It is not intended that revised wording will increase or decrease the number of HST topics. We'll ask for comments from our stakeholders on the wording changes later this year.