Update to the Methods of Health Technology Evaluation for NICE

 

The NICE Decision Support Unit (DSU) has made substantial contributions to every update of NICE’s “Methods for Technology Appraisal” since the unit started in 2003. Given that the last update to this document was in 2013, an update is long overdue. Over the past two years we’ve been engaged in a series of projects to help inform the update that NICE has just put out for consultation and there is an incredible amount of our previous work that was referred to as part of the update process.

This time round, the scope extends beyond Technology Appraisals and encompasses Medical Technologies, Diagnostics and Highly Specialised Technologies. The DSU, including our members based at the Universities of Sheffield, York, Leicester and Bristol, have undertaken a series of studies that were used to help inform discussions on the methods update. These are now available via our website and cover a real variety of areas, some of which are recurrent themes for both ourselves and NICE, whilst others are novel. Examples include:

- when and how should cost-minimisation methods be used,

- whether unrelated future health care costs should be included in cost effectiveness analyses,

- the use of non-standard survival analysis methods,

- the types of “modifiers” to decisions in addition to cost effectiveness information,

- how to measure and value quality of life in more complex situations such as when only limited data are available, for assessing health technologies for children, or when needing to map from different variants of the EQ5D.

- how to use qualitative evidence in the HTA process

- And a whole series of thorny issues in relation to evidence synthesis such as combining observational and randomised evidence, surrogate outcomes and evidence for diagnostics.

Of course, the work of the DSU is only one of many inputs to the changes NICE are proposing but we are pleased to continue to play an important role in the update process. The consultation is now live here where you can find a list of proposed changes and related documents. We’d encourage you to contribute to the consultation exercise. Head to our website here for more information on our reports or more information about our work more generally.  

NICE Methods Guide….it’s changing!

Well, almost. Proposals are out for consultation.  The consultation document is 62 pages long…6 pages of intro, 10 page summary, 6 pages of questions, 40 pages of detail.  There’s also a one hour webinar coming up.  But if all of that is too much, here’s our handy summary:

• End of life is out
• Severity and inequalities are in as factors that could modify the threshold ICER
• Greater emphasis on real world data and expert elicitation
• 5L mapping using the DSU tool
• EVPI is routine…but not mandatory?
• Potential role for ‘cost comparison analysis’….cost-minimisation analysis

And if that’s too much for all you busy pharma company executives out there, just lower your prices and you won’t have any problems.

Details and registration for a webinar on the 25th November are available here.

Simon Dixon

Medtech Innovation Briefings (MIBs)…

Image CC BY Phillip Wong                     
http://bit.ly/37ZxXZi 

… published since our last update in October are listed below.  The MIBs review relevant published evidence and the likely costs of new technologies. They are designed to be fast, flexible and responsive to the need for information on innovative technologies.  MIBs are commissioned by NHS England.  Further details are available here.

• Plus Sutures for preventing surgical site infection
• Optowire for measuring fractional flow reserve
• PIUR tUS for abdominal aortic aneurysm surveillance and endovascular aneurysm repair endoleak detection
• eXroid for internal haemorrhoids
• LQD Spray for treating acute and chronic wounds
• PulmoVista 500 for monitoring ventilation in critical care
• DyeVert for reducing contrast media in coronary and peripheral angiography
• Leukomed Sorbact for preventing surgical site infection
• AmnioSense for unexplained vaginal wetness in pregnancy
• superDimension Navigation System to help diagnostic sampling of peripheral lung lesions
• MR-proADM test for use with clinical deterioration scores in cases of suspected infection

DSU provides 3-part online training on Treatment Switching in clinical trials

This is the second of three commissioned online committee training sessions, this time looking at "Treatment switching in clinical trials: Issues for Committee Members to be aware of"

This has been split into three sessions, the first part concentrating on what is treatment switching and when is treatment switching a problem.  The second part, concentrates on the adjustment methods and what to watch out for when they're used.  And the third part, is a bit of fun, explaining the methods in the context of a football match. 


This these and our other online training session, please follow the link below:
http://nicedsu.org.uk/training/online-training/  

NICE DSU Review methods used to estimate and model utility values for children and adolescents in NICE technology appraisals

Review of methods used to estimate and model utility values for children and adolescents in NICE technology appraisals

Researchers in HEDS, on behalf of NICE DSU, undertook a review of methods used in NICE technology appraisals to estimate and model utility values for children and adolescents. The review included 31 NICE appraisals, and found limited use of child and adolescent population-specific measures to generate health state utility values for children and adolescents in technology appraisals submitted to NICE. Often appraisals used an adult specific measure to reflect the health of children and adolescents.

For the full report please visit the NICE DSU website at this link http://nicedsu.org.uk/utility-values-in-children/

The Decision Support Unit (DSU) is commissioned by the National Institute for Health and Care Excellence(NICE) to provide a research and training resource to support the Institute’s Technology Appraisal Programme.

New HEDS project for NICE - Cost Minimisation

HEDS Professors Simon Dixon and Allan Wailoo are working on a project for NICE called Cost Minimisation. NICE sometimes uses a ‘cost minimisation’ or ‘cost comparison’ method to determine value for money for the NHS. Generally, cost minimisation analysis has tended to be both less well explored academically, and less frequently used for health technology assessments compared with cost utility analysis. 

NICE have therefore decided to commission the DSU to review and suggest changes (if necessary) to the existing ‘cost minimisation, consequences or comparison’ methods to ensure they are informed by the latest and best available health economic methodological research. Unless the outcome of this project indicates otherwise, the aim is to have a single standard method in the Centre for Health Technology Evaluation’s guidance.

New projects: New NICE topic - Sodium zirconium cyclosilicate for treating hyperkalaemia

ScHARR-TAG has been allocated the following STA topic:

Sodium zirconium cyclosilicate for treating hyperkalaemia

New project: NICE topics

ScHARR-TAG has been allocated the following STA topics:

·         Moxetumomab pasudotox for hairy-cell leukaemia [ID1142]

·         Pembrolizumab for untreated gastric or gastro-oesophageal junction cancer [ID1305]

·         Clostridium botulinum neurotoxin type A for treating hypersalivation associated with neurological conditions [ID1150

NICE to work with ScHARR on developing new ways to measure quality of life across health and social care

NICE is taking part in a project that will examine how quality of life measures used to evaluate healthcare treatments such as drugs can be extended into areas of social care and public health. NICE to work with partners on developing new ways to measure quality of life across health and social care

The research, called the ‘Extending the QALY’ project, is being led by the School of Health and Related Research (ScHARR) at the University of Sheffield, with collaborators from the University of Kent, the Office of Health Economics and the EuroQol Research Foundation.

The project is being co-funded by a grant from the Medical Research Council (MRC) and the EuroQol Research Foundation. 

When NICE looks at the cost effectiveness of a healthcare intervention such as a new drug or diagnostic, the benefit of the intervention is measured in terms of how many quality-adjusted life years (QALYs) it provides. The ‘quality’ adjustment is based on a measurement of health-related aspects of quality of life.

However, some people feel that the existing measures of health-related quality of life might not capture important benefits of treatments beyond health-related quality of life, such as independence or improved relationships with friends, family and carers.

At the same time, different measures are used in healthcare, social care and public health, making it difficult to compare across these sectors, which is important when thinking about the wider health and social care budget.

The ‘Extending the QALY’ project will explore these issues and look at the importance of other aspects, such as social and emotional wellbeing, as well as physical and mental health. 

CC BY 2.0 Thomas Haynie http://bit.ly/2t28VES

Nick Crabb (Programme Director, Scientific Affairs) at NICE said: “NICE relies on an accurate assessment of quality of life when making decisions about interventions across health and social care. Research is needed  to develop new tools to assess quality of life that are equally relevant across these sectors and capture the key things – not just health – that are important to people. We look forward to working with our partners on this important project which aims to develop a new broad generic measure of quality of life that is relevant across health and social care. Depending on the research results, NICE will consider whether and how to include any new quality of life measure in its work.”

The project began in May 2017 and will last two and a half years. During this time the team will conduct interviews and surveys with patients, social care users, carers and the general public to explore what aspects of quality of life are important and identify the best questions to ask to measure quality of life. 

The original news story appears on the NICE website

New project: New NICE topic

ScHARR-TAG has been allocated the following HST topic:

• Recombinant human alpha-mannosidase for treating alpha-mannosidosis (16/27/06) [ID800]

Image: NICE by Sasha Cresdee

Threshold for NICE Highly Specialised Technologies

NICE and NHS England are consulting on a proposal to introduce a cost effectiveness level of £100,000 per QALY for NICE’s Highly Specialised Technologies (HST) programme.

The consultation, here, is open until 13th January 2017.

New ‘light touch’ appraisal process for NICE?

A consultation is open on a proposal that treatments that are likely to have a cost per QALY (quality adjusted life year) of up to £10,000 would be dealt with more quickly under a ‘lighter touch’ process.

Sir Andrew Dillon, NICE chief executive, said: “We want to be more agile and flexible in the way we make decisions about new drugs, medical devices and diagnostics, so that patients can get access to them more quickly and the NHS can manage its resources fairly and efficiently. NICE and NHS England have worked together to develop these proposals.”

The consultation, here, is open until 13th January 2017.

Image: DSC_0052 by Ajith K

Real World Data: guidance from the DSU

The NICE Decision Support Unit, based in HEDS, has published a report that provides guidance on the use of real world data (RWD) for the estimation of treatment effects in NICE decision making.

It builds on the NICE Decision Support Unit (DSU) Technical Support Document (TSD17) “The use of observational data to inform estimates of treatment effectiveness in technology appraisal: methods for comparative individual patient data” (Faria et al, 2015), which focused on methods commonly used to estimate treatment effects from non-randomised studies, where individual patient data (IPD) is available.

This report expands on the TSD by considering how RWD has been used to inform decision making in seven of NICE’s programmes, how it could have been used and the guidance that NICE currently provides to those responsible for submitting evidence, critiquing evidence and making decisions based on those assessments.

Project update: NICE guidelines on harmful sexual behaviour in children and young people

Fiona Campbell, Andrew Booth, Anthea Sutton 

ScHARR have been involved in two systematic reviews of evidence that informed new NICE guidelines on harmful sexual behaviour in children and young people. Fiona Campbell, Anthea Sutton and Andrew Booth were part of a team - including Simon Hackett (Durham University) and Evgenia Stepanova (Barnardo's) - that undertook the review using quantitative and qualitative evidence to inform the development of the NICE guidance.

This is the first time NICE has published guidance to enable practitioners to help children and young people who display harmful sexual behaviour. For too long, this is an issue that has gone under the radar. ScHARR in collaboration with Durham university and Barnardo's undertook an appraisal of the evidence to inform the assessment and treatment of harmful sexual behaviour in children and young people.

Recommendations include a joined up approach between universal services, child health services, children's social services and the voluntary sector. Other recommendations include engaging with families and carers before beginning an intervention and tailoring it to meet the needs of the individual child or young person. The evidence reviews also highlighted gaps in existing research and recommendations were made for further research into the impact of electronic media on sexual behaviour.

NICE has published the guidance and also the systematic reviews and can be viewed below.

https://www.nice.org.uk/guidance/ng55

What’s bothering NICE?

If you want to know which methodological issues are bothering NICE about their Technology Appraisal Programme, then having a look at what the DSU is doing is a good start.  The DSU, based in HEDS is currently involved in work in the following areas:

• New Technical Support Documents (TSDs) in partitioned survival analysis and in the calibration of treatment effects
• Quality assurance of models which inform NICE Technology Appraisals

Further information is available here.

New project: NICE topic

ScHARR-TAG has been allocated the following STA topic:

• Sarilumab after TNFnhibitors for treating active rheumatoid arthritis [ID994] (16/108/06)

Image: Rheumatoid Arthritis in the hand by Wellcome Images

Inaugural lecture…..

“Assessing the evidence: a NICE journey” given by Eva Kaltenthaler, Professor of Health Technology Assessment.

In her inaugural lecture, Professor Eva Kaltenthaler will describe her work as a systematic reviewer undertaking technology appraisals for the National Institute for Health and Care Excellence (NICE), the process used to assess new treatments for use in the NHS. Professor Kaltenthaler will discuss changes to research methods in systematic reviewing as well as changes to the NICE technology appraisal process over the past 15 years. She will outline her involvement in a range of research projects exploring the methods used in technology appraisal.  Professor Kaltenthaler will also briefly outline her earlier work using mixed methods research to study hygiene behaviour.

The lecture is on Wednesday 21 September 2016, 5.15pm-6.00pm (followed by a wine reception) in Lecture Theatre 4, The Diamond.

The lecture is free to attend and your place can be booked here.

New NICE Technical Support Document (TSD)

Well sort of…..it’s an updated version of TSD 2, “A general linear modelling framework for pair-wise and network meta-analysis of randomised controlled trials”.  Specifically, the coding to Example 6 (Psoriasis, from page 83 of the TSD) has been revised.

All TSDs are available from the DSU website here.

What are TSDs?  The TSDs are commissioned by NICE with the aim of providing further information about how to implement the approaches described in the current NICE Guide to the Methods of Technology Appraisal. They provide a review of the current state of the art in each topic area, and make clear recommendations on the implementation of methods and reporting standards where it is appropriate to do so. They aim to provide assistance to all those involved in submitting or critiquing evidence as part of NICE Technology Appraisals, whether companies, assessment groups or any other stakeholder type.

Image: nice by wallsdontlie

New NICE biosimilars policy

The official position has been published here.  The main points are:

• NICE has decided that normally all relevant published guidance that includes the originator molecule will apply to the biosimilar medicinal product at the time it is made available for use in the NHS.
• Biosimilars will only be appraised together with the reference products as part of a Multiple Technology Appraisal.
• Recommendations will refer to the British approved name of the medicine and will not differentiate between the originator and biosimilar products. The guidance will state that treatment should be initiated with the cheapest available product.

HEDS work in NICE public health guidance

"Give young people and gay men free condoms to reduce STIs" is how the Guardian reports NICE's latest draft guideline on condom distribution schemes.  A ScHARR team carried out the cost-effectiveness analysis used by the NICE public health advisory committee when making its recommendations.

NICE wanted to understand the potential costs and benefits of schemes which distribute condoms in order to prevent sexually transmitted infections (STIs). ScHARR developed an economic model which took into account the effects on both health and savings to the NHS of these schemes in four populations.

For young people, we replicated the C-card scheme, which is already running in many areas of the UK (for example, the pan-London Come Correct scheme) and aims to increase condom use and reduce condom failure among those aged 13-24. Our analysis estimated that a scheme like the C-card would be cost effective, with a cost of around £17,000 per quality adjusted life year (QALY) gained. Averting cases of HIV was particularly beneficial, since HIV not only reduces quality of life and life-expectancy of patients considerably, but also has high costs to the NHS.

There was limited published evidence from trials of condom distribution schemes on which to base these analyses. For MSM, black Africans and the general population there was a lack of evidence for the effectiveness of schemes in these populations. However, threshold analysis suggested that schemes could be cost-effective in both MSM and black Africans even at quite a high cost (£10 per person in the target population), due in the main to the higher prevalence of HIV in these groups.

Our full report can be viewed here.