A consolidated patient perspective on the HST process Genetic Alliance UK Patient Charter: Patient perspectives and priorities on NICE’s evaluation of highly specialised technologies Nick Meade Director of Policy Genetic Alliance UK Findacure: Navigating the Highly Specialised Technologies Programme, 29 th January 2016
Declaration of interests Funding for Genetic Alliance UK Ethical collaboration policy • • Resource for the running of the All activities are defined and organisation and its projects comes independently designed by the from a wide range of funders, staff with the approval of our including national governments, the trustees. European Union, the • All of our funding relationships pharmaceutical industry, medical are governed by our ethical research charities, and other grant collaboration policy, which provision organisations. prohibits funders from influencing the outcomes of our work. This can be read here: • All of our income is reported here: www.geneticalliance.org.uk/ethicalcoll www.geneticalliance.org.uk/annual-report.htm aborationpolicy.htm
Developing the HST Patient Charter What is a Patient Charter? • It is a tool that enables us to collate and communicate a patient-driven policy position on a specific issue How does it work? • This is expressed in the form • Patient representatives take of recommendations part in a workshop • Patient groups are invited to • They are given a detailed ‘sign up’ to show their support briefing document • The day includes informative talks and facilitated work- group discussion
The HST Patient Charter workshop • Representatives from 16 patient organisations attended the workshop • Each were provided with a comprehensive briefing document explaining the HST evaluation process and signposting the key issues • On the day, we had talks from: Josie Godfrey Jon Sussex Dr Robin Lachmann Dr Will Evans Consultant NICE OHE Parent
The HST Patient Charter workshop • Patient representatives the took part in work-group disucssion sessions facilitated by: Dr Will Evans Dave Ryner Robert Meadowcroft Jayne Spink • Four key topics were identified – each group addressed at least one of these each and then raised any other issues or concerns Patient Scope and What Evidence evidence transparency next? gaps submission
Collating the findings into a Charter • The minutes from each work group were compiled to ensure all the issues, concerns and proposals for change raised by patient representatives were captured • This information was then formatted into a Patient Charter by Genetic Alliance UK before being made available to work group facilitators for editorial comment: “I thought that the draft was really most excellent and that you captured not only the discussion of the day itself but also place this very neatly into the policy landscape.” Jayne Spink, Tuberous Sclerosis Association • Comments were incorporated into the final document • The Patient Charter was then circulated around the patient group membership of Genetic Alliance UK for endorsement....
The premise It is right that HST evaluation exists as a means of ensuring that the NHS can commission effective, highly priced medicines for small populations There is public, patient and governmental support for the NHS-wide commissioning of highly priced medicines for small patient populations with serious, life-limiting conditions. This is the case particularly when the condition affects children. • Social Value Judgements: Principles for the Development of NICE’s Guidance. NICE, 2005, available at: www.nice.org.uk/media/c18/30/svj2publication2008.pdf • M. Rawlins et al., Pharmacoeconomics: NICE’s approach to decision -making. British Journal of Clinical Pharmacology, 2010, available at: www.ncbi.nlm.nih.gov/pmc/articles/PMC2949905/ • Citizens Council Report, Rule of Rescue. NICE, January 2006, available at: www.nice.org.uk/niceMedia/pdf/Rule_of_rescue_report_final_0606.pdf • Citizens Council Report, Inequalities in Health. NICE, June 2006, available at: www.nice.org.uk/niceMedia/pdf/CCreportonHealthInequalities.pdf • Governmental willingness for ‘appropriate priority’: House of Lords (2013) Hansard, 28 February, Column 1161 [Online], available at: www.publications.parliament.uk/pa/ld201213/ldhansrd/text/130228-0001.htm
Key message Patients are worried about the government and NICE's new approach to evaluating new medicines for very rare diseases. Genetic Alliance UK’s Patient Charter shows patients are concerned that, while greatly needed, the existing process is opaque, potentially disruptive to the wider NHS and risks downplaying the patient voice. The Patient Charter makes 29 recommendations for change and is endorsed by 78 patient groups. Genetic Alliance UK hope it will act as a reference point for the patient perspective on HST evaluation and inform NICE’s review of the process, which is expected before the end of 2014.
Key findings • Potential of straying into risk / benefit analysis • Risk of downplaying the patient voice • Definition of clinically distinct is outdated • Potential disruption to the wider NHS • Lack of transparency in the topic selection process
Lack of transparency in topic selection The process of choosing which drugs to evaluate is a black box. In contrast to the remainder of HST evaluation, the topic selection process lacks transparency. Patients are neither involved in the process nor able to access the deliberations of NICE’s topic selection committee. • Recommendation 7 calls for the process, methodology and deliberations of the topic selection committee to be made available to patients and the public online in a format that can be searched by the name of a condition or a medicine. • The recommendation includes the need for clarification on the role of the NIHR Horizon Scanning Centre in the process of topic identification.
Topic selection at the beginning of a maze...
Transparency of Highly Specialised Technology topic selection at NICE Pre 2015 2015 HST Topics considered 24 9 Results Proceed to develop topic 7 8 Do not proceed 5 20.8% 1 11.1% Confidential 12 TA Topics considered 311 120 Results Proceed to develop topic 181 115 Do not proceed 16 5.1% 2 1.6% Confidential 114 Filtered out 3
Transparency of topic selection at NICE 2015 onwards Following the consultation on the ‘guide to the processes of technology appraisal’ one of the clear messages that came through was from pharmaceutical companies, professionals and patient groups that there was a lack of information publically available on the progress of topics through topic selection at NICE. Therefore the reporting of topic progress on the NICE website is now more open and transparent for technology appraisal and highly specialised technology topics, supporting NICE’s core aim of openness and transparency. This has been agreed following extensive negotiations with the Department of Health, Association of the British Pharmaceutical Industry (ABPI) and the Ethical Medicines Industry Group (EMIG) (as the representative organisations for pharmaceutical companies in the UK). All decisions from January 2015 onwards will be published in this format. NICE website
Transparency of topic selection at NICE 2015 onwards
Transparency of topic selection at NICE 2015 onwards
Transparency of topic selection at NICE 2015 onwards (Single and Multiple Technology Appraisals and Highly Specialised Technologies) 129 topics considered 123 have the following entries: Decision: Topic prioritised for potential technology appraisal guidance production, or Topic appropriate for potential highly specialised technologies (HST) guidance development Rationale: Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources Next steps: Topic passed to scoping team to prepare for a consultation exercise 114 of those have the following next step: Further detail to be added after consultation exercise
Transparency of topic selection at NICE 2015 onwards (Single and Multiple Technology Appraisals and Highly Specialised Technologies) 6 negative decisions in 2015 1 HST – Topic not prioritised Reason: Anticipate NICE guidance will not add value. 5 Single and Multiple Technology Appraisals 3 x Filtered out: out of scope, another work programme, duplicate 2 x Topic not prioritised Reason: NICE has to prioritise its topic selection decisions as it has limited resources and cannot consider everything. The level of the burden of disease and patient numbers may mean conducting an appraisal would not offer good value for money
Transparency of topic selection at NICE Proposals: • Link the topic selection for all programmes, and be flexible with capacity for both. • Describe why each topic is suitable or unsuitable for a next step. • Increase transparency of (and ease of access to information about) steps before and after the topic selection step. • ...wait for the Accelerated Access Review findings!
You can download a copy of the Patient Charter here: www.geneticalliance.org.uk/hstcharter.htm Our NHS England Patient Charter is here: www.geneticalliance.org.uk/nhsenglandcharter.htm For more information please contact: Nick Meade (Director of Policy): nick@geneticalliance.org.uk
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