The CRA Report has an underlying assumption that the EU is as globally competitive in generics and biosimilars as it is in innovative products. There is no evidence to support this. The correct industrial strategy for the EU may well be to focus on the development, manufacture and export of innovative products, rather than on lower value generics where EU global competitiveness appears to be weaker.
The CRA report makes estimates of effect using a number of assumptions, data and calculations that we do not find to be correct or which are not explained. Until these anomalies are addressed, our view is that the CRA analysis is not a fit basis for an impact assessment to guide policy.
Maignen, F., Berdud, M., Hampson, G., and Lorgelly, P.
This report explores the consequences of the exit of the United Kingdom (UK) from the European Union (EU) on public health in the UK and in the EU. It also provides an estimate of the economic impact for pharmaceutical companies.
The centralised procedure was created in 1995 to facilitate access to innovative medicines across the European Union. Since then the scope of authorisation via the centralised procedure has been broadened and made mandatory for orphan and oncology medicines.
We analysed routine funding in the NHS for new medicines recently authorised via the centralised procedure with a particular focus on oncology and orphan medicines. We utilised a database of outcomes of health technology assessment (HTA) evaluations conducted in the UK by NICE, AWMSG and SMC: OHE’s Medicines Tracker. We considered centrally authorised products (CAP) approved between 1 January 2011 and 31 December 2016.
We find that a substantial number of products that received an EU authorisation between 2011 and 2016 were not referred for a HTA evaluation in the UK. We also show that there is both variation across agencies and variation across therapeutic classes in terms of adoption decisions and access across England, Scotland and Wales.
Lee, E.K., Park, J.A., Cole, A., and Mestre-Ferrandiz, J.
In 2015, OHE published a report which set out the core principles that should govern how Real-World Data (RWD) is accessed or generated, and used credibly to generate Real-World Evidence (RWE), thereby working toward a set of “international standards”. The analysis was based on a study of governance arrangements in eight key markets: the UK, France, Italy, Sweden, Germany, the Netherlands, Australia and the U.S.
In recognition of the expanding market for health care data in South Korea, the authors partnered with collaborators from SungKyunKwan University to extend this assessment to South Korea. In this report, the authors outline the current arrangements for the collection, sharing and use of RWD in South Korea, and assess how these compare with an “ideal”, facilitative framework for data governance.
Zamora, B., Maignen, F., O’Neill, P., Mestre-Ferrandiz, J. and Garau, M.
The European Commission’s (EC) Orphan Medicinal Products Regulation intended to incentivise the research, development and marketing of new treatments for rare and chronically disabling or life-threatening diseases. Marketing authorisation granted to orphan medicinal products (OMPs) is however only the first step; patients have access to medicines once reimbursement or health technology assessment (HTA) decisions are implemented by national health systems.
In 2016 the University of York undertook a review exercise to determine whether NICE’s existing methods and processes are appropriate for assessment of regenerative medicines. The purpose of this OHE report is to explore this review exercise and to assess whether or not the resulting conclusions are appropriate.
Hernandez-Villafuerte, K., Garau, M., Towse, A., Garrison, L. and Grewal, S.
PhRMA commissioned OHE Consulting to explore options and recommend methods that could help middle-income countries efficiently and effectively identify medicines for formulary inclusion.
This report presents a framework for developing medicines formularies which combines macro-level decision making factors (focusing on the health system organisation and its priority setting), and micro-level factors (looking at intervention-specific effects) to determine the overall value of medicines.
Cole, A., Lundqvist, A., Lorgelly, P., Norrlid, H., Karlsberg Schaffer, S., Lewis, F., Hernandez-Villafuerte, K., Lindgren, P., Garau, M., Welin, K-O., Bianchi, S., Althin, R., O’Neill, P., Persson, U., and Towse, A.
The economic burden that cancer poses on our society is staggering – 25 million years of healthy life lost, at cost of €126 billion including €52 billion in lost productivity – and continues to grow with the ageing of the population. It is imperative, in light of growing financial pressures on our health care systems, that we find ways to make the best use of available resources to deliver high quality cancer care to patients.
Marsden, G., Martin, A., Zamora, B., Exley, J., Sussex, J. and Towse, A.
The Oxford Academic Health Science Network (Oxford AHSN) wishes to demonstrate the value of the various projects and programmes that the network has developed and implemented since it was established in 2013.