Sponsored byJanssen Health 6 December 2017 Reimbursing medicines in a new age of innovation The UK is slow to adopt advances in medical science, but it’s possible to learn from other countries. SHUTTERSTOCK / SCIENCE PHOTO NSSign UpGet the New Statesman's Morning Call email. Over the last decade, advances in biology and bioinformatics have revolutionised drug discovery. At companies like Janssen, this has led to the development of pioneering new medicines that target diseases more precisely than ever before. Our research and development model continues to evolve as we respond to advances such as large genome sequencing and artificial intelligence. We collaborate with experts from a range of scientific disciplines in pursuit of the next breakthrough, and the future for medicines development is bright. Despite these positive advances in science and our network of partnerships, many groundbreaking medicines do not reach UK patients quickly enough – if at all. The UK reimbursement process can be lengthy and often dwells on the lack of comparative evidence supporting pioneering new products compared to existing, often long-studied standards of care. As a result, the Office for Life Sciences recognises a “low and slow” uptake of innovative medicines that undoubtedly affects patient outcomes in the UK. For example, the UK’s five-year cancer survival rates are lower than most other European countries, which have been quicker to adopt new medicines and dedicate more healthcare expenditure per capita. For many years, the National Institute for Health and Care Excellence (NICE) has been regarded as a world leader in assessing the clinical value and cost effectiveness of new drugs. However, its methodology has remained largely the same since its inception nearly 20 years ago. During this time, regulatory bodies such as the European Medicines Agency have modernised their evaluation processes, enabling them to give the go-ahead for new medicines, where there are significant unmet needs based upon early clinical trial data. This has created a significant barrier for patients hoping to access new medicines, as NICE considers these types of datasets to be immature or incomplete. In short, regulators are saying “yes” whilst health technology appraisers are saying “no”. This, coupled with NHS financial pressures, presents a growing concern for patients. In a drive to find £30 billion in savings by 2020, measures introduced in April by NHS England and NICE restrict spend on new medicines to the degree that even when NICE deem a medicine to be cost-effective, NHS England can now choose not to adopt it. As such patients must wait even longer to access new medicines, while the NHS works out if and how it can pay for these treatments. This is despite an existing agreement – the Pharmaceutical Price Regulation Scheme (PPRS) – through which the UK medicines bill is already capped and pharmaceutical companies rebate the NHS if the cap is exceeded. Under this agreement the industry has already rebated over £1.9bn. Importantly, there is currently no other area in the NHS that is subject to the same rigorous cost-effectiveness analysis than medicines (with the exception of a few medical devices and diagnostics). Targeting medicines that have been recommended as cost-effective by NICE – particularly in areas of high unmet need such as cancer – is simply not the answer when there is room to make so many other efficiencies in the system. Janssen and our parent company Johnson & Johnson, have worked in partnership with healthcare systems around the world for many years, continually seeking to improve the way we deliver products in collaboration with regulators and governments. This includes developing flexible payment schemes that support accelerated access to medicines, whilst encouraging up-to-date methods to assess their value. Many of today’s medicines – and many more in research and development – are likely to be effective for multiple diseases, known as indications. In each of these different indications, the medicine will have a different impact and therefore a different value, but the current assessment system in the UK isn’t set up with this in mind. This must be resolved so that agreements can be reached for treatments that work across different patient populations, which is ultimately one of the main reasons behind delays to the introduction of new medicines in the UK. Firstly, there is an urgent need to introduce more flexible, multiple-indication pricing if we are to overcome the issues patients experience with accessing new treatments in the UK. This must be central to the Pharmaceutical Price Regulation Scheme (PPRS) that is set to commence at the start of 2019. The need has already been recognised in other European countries where they have kept up with the pace of change. For example, in Italy, patient-level, indication-specific data are collected for new drugs in registries maintained by AIFA (the Italian medicines agency), allowing health authorities to track every medicine that they pay for, per indication. Essentially, they’re tracking patient outcomes per drug, per disease and using this to implement flexible pricing schemes with pharmaceutical companies. This allows the Italian healthcare system to spend its budget more efficiently. The recent Life Sciences Industrial Strategy published in August recognised the need for change if the UK is to remain an attractive place to invest in research and development, and the Accelerated Access Review highlighted the need for faster access to new treatments. Our goal now is to work closely with NICE, the NHS and the Department of Health to help solve the affordability challenge facing the UK healthcare system. With the backdrop of Brexit and an economic downturn, there has never been a better time. Jennifer Lee is director of health economics, market access & advocacy at Janssen UK. The patient’s view Roger Brown, chair of Waldenstrom’s Macroglobulinemia UK (WMUK). “As a lucky survivor of a rare blood cancer, whose many friends diagnosed at the same time have died, I naturally ask why our survival rates are lower than other EU countries, when we have many of the world’s top specialists. The answer is simple: adoption of new and effective treatments doctors can use is slow, and we spend substantially less on treatment per patient. NICE and NHS England increasingly seem more concerned about financial impacts than effectiveness or quality of life for patients. Applying a further layer of budget rationing of drugs will make our situation even worse and seems uniquely applied to this area of NHS expenditure”. › Why “regulatory alignment” must apply to the whole of the UK after Brexit Subscribe To stay on top of global affairs and enjoy even more international coverage subscribe for just £1 per month!