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Sharon Kell rang in to this interesting virtual meeting of key personnel from parliament, Association of British Pharmaceutical Induistry (ABPI) National Institute for health and Care Excellence (NICE) and patient organisations about the future of medicines evaluation:
- Lord Bethell of Romford, Parliamentary Under Secretary of State, Department of Health and Social Care
- Professor Gillian Leng CBE, Chief Executive, National Institute for Health and Care Excellence (NICE)
- Samantha Benham-Hermetz, Director of Policy and Public Affairs, Alzheimer’s Research UK
- Dr Richard Torbett, Chief Executive, Association of the British Pharmaceutical Industry
- Eleonora Harwich, Director of Research, Reform (Chair)
The purpose of the meeting was to discuss how the current pandemic has changed medicines valuation in the UK. The pandemic has acted as an important reminder that we need to have the most effective policies in place to support the discovery and development of new treatments, medicines and vaccines. A thriving life sciences ecosystem in the UK today has enabled the UK to show global leadership, through world leading studies on the vaccines and treatments necessary to combat COVID-19.
New treatments can deliver both health and wealth benefits for the country, and the Government has stated its ambition to accelerate patients’ access to the most effective medicines whilst ensuring best value for the NHS. NICE plays a crucial role by evaluating the cost effectiveness of new treatments, and it is currently undergoing a review of its evaluation methods and processes so that it is able to respond to technological change and innovation to ensure the right access, for the right patients, at the right value.
This event focussed on the opportunities and challenges that lie ahead in medicines valuation, as well as how to ensure that the most effective drugs reach patients.
Lord Bethelll of Romford, Parliamentary Under Secretary of State, Department of Health and Social Care:
- The ultimate aim is to give patients longer, better lives and increase empowerment of patients for their own self-care. Disparities in healthcare across the country need to be addressed.
- The main future changes for healthcare are genomics, artificial intelligence (AI) and big data/digitisation to create radical reform
- Clinical trials need to be super-driven, with an improved regulatory framework (Medicines and Healthcare products Regulatory Agency, MHRA and NICE) and diagnostics regime
- Science needs to be adapted and given room for improvement. NICE has an excellent global reputation and is considered the gold-standard by many developed countries. The NICE review needs to build on this.
Samantha Benham-Hermetz, Director of Policy and Public Affairs, Alzheimer’s Research UK
- We need to build life-science ecosystems and better access to clinical trials
- There needs to be a regulatory pull through to the NHS to prevent patient delays. New technologies are challenging for the NHS, but the delays aren’t good enough for patients. COVID has highlighted this.
Dr Richard Torbett, Chief Executive, Association of the British Pharmaceutical Industry
- There needs to be be improved access for patients that safeguards money for the NHS
- We need to make the most of our successes, e.g. genomics, AI, and big data need to be targeted and effective means of improving treatment for patients
- We are in a golden age of drug discovery
- NICE review is very important and acts as an international pricing reference. Determines how well medicines work for patients and whether research and development costs are worthwhile
- We need to ensure value for money and fair security of value – the NICE review is very timely for this. Pharmaceutical pricing needs to be responsible and fair, especially for rare diseases and on a level playing field.
Professor Gillian Leng CBE, Chief Executive, National Institute for Health and Care Excellence (NICE)
- NICE built their own methods in 1999, which have evolved for highly specialised technologies (HST), cancer drugs fund (CDF) and rare technologies. The last review was in 2013
- The new methods and processes need to be future-proof and take into account new technologies such as AI, genomics, digitisation and big data
- The regulatory landscape is changing with Brexit and the role of the MHRA is still uncertain – tolerance to uncertainty is growing, e.g. the Innovative Medicines Fund (IMF) that replaces the CDF
- There are 10 areas if review during the NICE methods review, of which modifiers, e.g. end of life, uncertainty, e.g. genomics and discounting are the most important. The 6-week consultation begins in November, manuals will be available in February and will be the strategy for the next 3-5 years.
During the Q&As that followed, the following topics were raised:
- We need to get more innovative medicines into the system earlier, reassure pharmaceutical companies (listen, serious discussions, understand, collaborate) and make sure patients, especially with rare/less common diseases, have access to medicines quickly. However, safety should never be compromised
- There needs to be a partnership between NICE and the MHRA who need to work together to make this happen
- The patient voice needs to be stronger regarding the outcomes valued by patients, factoring these into clinical trials, and the medicines appraisal process. There is a need for stronger real world data (RWD) that needs to be collected over longer periods of time. The NHS needs to track patients and co-morbidities. There needs to be the patient voice at every point in the process, including NICE HTAs
- NICE needs to use more RWD efficiently and there needs to be a fresh look at how to take the patient voice into account
- ABPI – we need early dialogue with patients for clinical trial design and HTAs. Clinical trials need to be fit-for-purpose and views of patient organisations taken into account and captured by big pharmaceutical companies. There is some concern that patient organisations will lose their independence from pharmaceutical companies, but the industry wants to move further down this path
- Pharmaceutical companies need to do clinical trials differently – wider partnerships with patient organisations and hospitals to boost the clinical trial offering. Patients need to be involved early in the design of clinical trials and there needs to be further reach into hard to reach areas of the country
- Telemedicine, digital consent, home visits etc. are becoming commonplace during the pandemic and will assist with this going forward
- NICE guidelines need to be given more ‘teeth’ with respect to interpretation by Clinical Commissioning Groups (CCGs) to avoid a ‘postcode lottery’ in terms of treatment.
- Late stage acute development needs to move to early stage intervention via digitisation, clinical trials and better regulation
- Need more investment to bring about change and to have enough capacity in NICE for clinical trials and research, and to pull new treatments through for patients
- UK is the best in the world for discovery and development of new medicines of the future. We need to improve patient outcomes and increase pharmaceutical investment
- NICE needs to be made attractive to the life science industry and improve access to patients.