Diabetes developments – by Simon O’Neill
In a regular blog series, Simon O’Neill, Diabetes UK’s Director of Health Intelligence and Professional Liaison, rounds up the latest diabetes news. Simon was diagnosed with Type 1 diabetes in 1992.
Accelerated Access Review
The Accelerated Access Review aims to speed up access to innovative drugs, devices and diagnostics for NHS patients. Chaired by Sir Hugh Taylor, it is set to make recommendations to government ministers next spring following a wide consultation exercise, with healthcare professionals, lay people, commissioners and others.
The aims of the review are to ensure that patients have access to cutting-edge medical products sooner than they do at present. It also wants to ensure that patients are integral to the development of new products, from the outset, and should be key players in setting up research trials. In doing so, it aims to keep the UK at the centre of drug and device development, thus stimulating new investment and economic growth to support the NHS.
So far three potential areas of reform have been identified: regulation, reimbursement and uptake.
Regulation will consider how we could more quickly assess the safety and efficacy of innovations, enabling them to be brought to market more quickly. This is especially important for conditions where there are few treatment options currently available, but where the condition may rapidly deteriorate, leaving only a small window for effective treatment to be used – such as in Duchenne Muscular Dystrophy. People in such groups are also more likely to accept a higher level of risk with new therapies and may be willing to try them at an earlier stage in the research process (as they do now if they can get on to clinical trials) This may mean bringing drugs to a limited market, whereby they can undergo an ‘in vivo’ assessment on an actual patient group, rather than waiting for full completion of Phase 3 studies.
Under reimbursement they will consider how we might adapt our current systems of health economic assessment to reflect technological advances, which are increasing all the time, as well as considering how we can reduce the time needed for clinical trials without increasing the risk to patients. They also want to see if we can better pioneer new models of reimbursement for innovative products, including payment by results and Evaluation through Commissioning, which is already used as part of the Cancer Drugs Fund, to allow drugs that wouldn’t currently meet NICE approval to be assessed through actual use in patients.
For uptake they are considering how the NHS can better support and drive medical innovation (including through specialist commissioning).
The Review produced their interim report in October and have further consulted on that report. They have now developed five propositions which they will be developing over the coming months with a wide range of stakeholders. These are:
• Putting the patient centre stage
• Getting ahead of the curve – how do we develop a radically new approach to accelerate and manage entry into the health care system of the most promising emerging products
• Supporting all innovators – being more responsive to new developments at all levels of the system, where it will benefit patients
• Galvanising the NHS – ensuring there are incentives in place to adopt new products and systems
• Delivering change – developing new local and national systems to accelerate new product development and adoption
US ban on medicines advertising?
Since 1997, it has been legal for the pharmaceutical industry to advertise its prescription only products directly to consumers in the USA. New Zealand is the only other developed country in the world to permit this, with bans having been in place since the 1940s in most of Europe and Australia.
But in November this year, the American Medical Association (AMA) has called for a ban on all direct to consumer advertising of prescription drugs and medical devices. The new policy also calls for the federal government to limit anticompetitive behavior by drug companies. The AMA have come to believe that direct to consumer advertising inflates demand for new and more expensive drugs that may not necessarily be the most appropriate for an individual patient. There is also concern that such advertising may be one reason behind escalating drug prices, leading to the US having the highest prices in the world for prescription drugs. U.S. prices for the world’s 20 top-selling medicines are, on average, three times higher than in Britain, six times higher than in Brazil and sixteen times higher than the average in the lowest-price country, which is usually India.
This is directly impacting on patients who often have to cover part of that cost, even with health insurance in place. Unlike the UK, the US federal government is not legally allowed to negotiate with drug companies to get a lower price on medicines for Medicare or Medicaid patients. These are the national social insurance programmes.
Not surprisingly the Pharmaceutical Research and Manufacturers of America organisation have retaliated, saying that direct to consumer advertising makes patients more aware of the conditions they have, some of which may not have been diagnosed, and of the treatments available to them. They also claim that such advertising increases patients’ awareness of the benefits and risks of new medicines, and encourages patients to visit their doctors for important doctor-patient conversations about health that might otherwise not take place.
In November the latest QoF figures on diabetes were released. They show that the number of people diagnosed with diabetes has increased by 120,000 since 2014 to 3,453,034. Using the APHO model for undiagnosed diabetes, we now estimate that there are 549,000 people with undiagnosed Type 2 diabetes, a decrease of 40,000.
This means that for the first time we have a total population of people with diabetes in the UK of over 4M (4,002,077).
At the same time, the latest version of the IDF Diabetes Atlas was produced. This has shown that worldwide, the total number of cases of diagnosed diabetes has risen by 28 million to a new all-time high of 415 million people. That means that now 1 in 11 people in the world has some type of diabetes (previously this was 1 in 12). One person dies as a result of diabetes every 6 seconds – 5 million deaths a year. And IDF predict that the number of people living with diabetes is set to rise to 642 million by 2040 – 1 in 10 of the global population.
Although we know that much of the rise is due to an increase in cases of Type 2 diabetes, data also shows that incidence of Type 1 is increasing. Since the 4th edition of the Atlas in 2008 and the current edition, the number of children under the age of 15 with T1D has increased by 13%, with an extra 10,000 new cases each year. Part of this may be due to children in developing countries surviving longer with T1D because of better access to insulin and care.
Other data presented at IDF World Diabetes Congress looked at how far we’ve come in dealing with complications over the last 30 years, which is encouraging news for those living with T1D.
Data from people who had lived with T1D for over 30 years was presented, comparing a group of such people in 1978 with a similar group in 2009. In 1978, 31% of people had developed severe vision loss, 12% had had an amputation and 38% were suffering with nephropathy (kidney damage). Many people, at that time, thought that improving glycaemic control could reduce such complications but there was little evidence that this was the case. Therefore a large clinical trial – the DCCT – was launched in 1983 and ran for 10 years comparing tight glucose control, aiming for an HbA1c as near to 42 mmol/mol (6%) as possible, with standard care. The results were so positive that aiming for tighter glucose control became the new standard of care.
Following up some of the people in that study, who have now lived with T1D for more than 30 years, the rates of complications are very different. Only 1% have severe visual loss, 1% have had an amputation and only 6% have some degree of nephropathy. Interestingly, the average HbA1c during DCCT in the intervention group was still only 55 mmol/mol (7.2%) – so few people reached the much harder target of 42 mmol/mol (6%) – but in the 20 years since then, average HbA1c is actually 64 mmol/mol (8%) in both groups but the early years of tighter control have continued to have a long term benefit on outcomes.