Nice work

This week we heard about the way in which new medical devices and drugs reach end users from NICE, MedImmune and Trig1.

The NICE guidelines help NHS staff decide which treatments have proven efficacy and represent good value for money. They are produced by review committees including a wide-range of stakeholders, including health and social care professionals, patients and the public. The evidence on which they are based is painstakingly made public. They provide a national evaluation approach which is robust, transparent, and which establishes a legal right for patients to demand a certain treatment, despite the obvious capacity limitations which constrain a limited team to review guidance for only a high-priority subset of the hundreds of proposals being put forward at any time. Where innovative treatments cannot draw on widespread peer-reviewed journal evidence, they consider unpublished evidence provided by any stakeholder who registers an interest, and there is a new pathway for all Medtech which should accelerate assessment for all devices, diagnostics and genetic tests. What could possibly be better than such a careful sifting of evidence before public money is poured into yet another new cure?

As our South Cambridgeshire MP, Andrew Lansley, recently took over as Secretary of State for Health he spoke of the need to "liberate the NHS" to improve outcomes for patients while cutting the cost of delivery. In his words:

"The NHS today faces great challenges:

• It must respond to the demands of an increasing and ageing population, advances in medical technology and rising expectations;
• It remains stifled by a culture of top-down bureaucracy, which blocks the creativity and innovation of its staff; and
• It does not deliver outcomes in line with the best health services internationally – many of our survival rates for disease are worse than those of our neighbours."

We did invite Andrew along to join his constituents at Granta Park, but sadly previous commitments kept him away. Our hosts Medimmune have a long Cambridge history dating back to 1990, when they started up as Cambridge Antibody Technology in the MRC unit still run by Sir Greg Winter. They developed the first blockbuster antibody treatment for rheumatoid arthritis, Humira, drawing on a long Cambridge tradition of antibody research. Over 50 people attended from Addenbrookes, BSI Product Services, Cambridge Design Partnership, Cambridge IP, Cambridge Temperature Concepts, CGC, Ergomed Clinical Research, Illumina, Ithaka, Judge Business School, Lab Support UK, Lumie, Medical Device Technology, Mills & Reeve, Napp, NHS East of England, NHS Innovations East,  PA Consulting, Panchromos, Plextek, Pneumacare, Product Partners, Pope Woodhead, Team Consulting, Tigenix, Tristam Consultants, The Welding Institute, University of Cambridge amongst others. These organizations are the core of the Cambridge Biomedical Cluster, the northern end of the largest biomedical cluster in Europe. If anybody is qualified to critique the current approach, they probably are.

The speakers from Medimmune and Trig1 brought experience from both drugs and medical devices, from multinational companies and local SMEs, as well as having family-members who both serve as General Practicioners and suffer from the ailments they are trying to cure. They raised some concerns:

• Rheumatoid treaments are being developed what is now a very crowded space, with hundreds of expensive new options being proposed. But will these treatments actually improve quality of life for the patients? The values assessed by NICE of efficacy, safety and convenience are being challenged as technology allows better personalization of treatments, with effective treatments targeting the right people and preventing disease. Arthritis sufferers may have had some of the symptoms alleviated - but often they still feel tired and suffer pain.
• We need to develop global blockbuster drugs. Clinical trials must cover a great range of cultural and social settings around the world. The rapidly expanding needs of the developing world may give a very different balance of priorities for a new drug compared to what the NHS needs for marginal improvements for our population.
• Evidence is ranked in a very conservative way, with much more weight given to peer-reviewed journals. The "Price" study compared asthma inhalers available on the market by checking primary health records to see whether 5,556 asthma sufferers prescribed different types of inhaler needed other kinds of treatment like agonists, antibiotics and GP consultations. They found that patients using breath-activated pressurized metered inhalers needed significantly less of these other treatments, and concluded that the difficulties of using the traditional inhalers meant that sufferers weren't managing to take their drugs. Yet NICE guidelines discount this field experience because this wasn't a double blind randomised trial, and doctors may have introduced bias by selecting some kinds of patients to get some kinds of treatment. 
• If a treatment is submitted with a particular price, NICE will simply assess whether the cost is too high given the benefits. It won't say what price might make the treatment worthwhile, to give manufacturers an incentive to simplify or rationalise the treatment.
• There is a cycle of ever-higher expectations of accuracy of dose precision from NICE. Yet asthma sufferers often have great difficulties inhaling the right amount of drug, and in the field may simply go for a second hit if the first doesn't work. Precise titration in a laboratory may have little to do with how much is dispensed in the field, and adds ever increasing complexity and cost to the devices being developed.
• "Child-proof" packaging is very often "elderly proof", meaning that an increasingly ageing population becomes ever more dependent on carers to help them open and use their medical device, and may be kept in hospital if those conditions cannot be met. NICE guidelines intended to protect children may add hugely to the cost of treating us as we all get older.
• Timelines can be 3,4 years given the limited staff that NICE have available and the hundreds of proposals being submitted at any time. It is common to hear that there has been a 9 month delay because a clinical expert is not available.
• A cynical approach to "game" the current system might simply be to do lots of clinical trials, extend them by a few patients a number of times and get out a peer-reviewed publication each time, and keep some staff constantly watching which treatments were being selected for review by NICE to immediately register an interest as a "stakeholder" and have the opportunity to submit unpublished evidence. But all of this simply adds cost to the process of developing new treatments without necessarily doing anything about making them more effective in the field.

NHS East, who co-fund this Special Interest Group alongside TTP, Philips and Mills & Reeve, asked whether the speakers thought NICE should be shut down, or whether they just wanted it to improve its processes. The response was that regulation was needed - but why are NICE and MHRA both trying to do it?

Clearly from the questions from the medical device and drug technologists and the warm responses of the healthcare payors, all of this community are honestly concerned to help sufferers as quickly and safely as possible and reduce the burden of cost. It is a great privilege to be in a place that can draw together such a diverse range of skills and have such a frank debate, not dominated either by the power of a single multinational giant or a government authority. If Cambridge ideas are to change the world of healthcare, we all need to work together to improve the process of getting innovations into the hands of sufferers.

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