Consulting Report

Towse, A., Hernandez-Villafuerte, K. and Shaw, B.
Consulting Report
May 2018

This OHE Consulting Report reviews “Estimated costs of production and potential prices of medicines for the World Health Organization Essential Medicines List” (Hill et al., 2018) in which the authors argue for “greater transparency in drug pricing” and propose generating estimates of the cost of manufacturing essential medicines to inform negotiations on drug pricing.

Towse, A., Cole, A., and Zamora, B.
Consulting Report
May 2018

The notion that the price of a medicine should be linked in some way to value it generates for patients and the health system is generally accepted. Yet, how can this be achieved, when increasingly medicines are being developed that derive patient benefit across many different indications? Indication-based pricing (IBP) has been proposed as a way to tackle this issue, permitting price to vary according to indication and – critically – according to value.

This OHE Consulting report, funded by AstraZeneca, provides an overview of the key literature that has contributed to this debate, and of how IBP has been implemented – in its various forms – to date in the U.S., France, Germany, Italy, Spain and the UK.

IBP increases the potential number of patients who can benefit from a medicine and thus most economists regard it as efficient. It also sends the right signals for R&D investment. Differences of opinion remain, however, as to whether IBP is in the interests of payers. IBP may lead to some prices being higher than with a uniform price, as well as some prices being lower. The value at which prices are currently set in a single-price system will impact on the consequences of a move to a multiple-price system. A number of US payers see the potential for IBP to increase price competition in some indications, and the NHSE in England has used contracting by genotype in Hep C drug procurement to increase competition and help it get lower prices.

The literature evaluated as part of this report demonstrates that most of the debate is in the realms of theory, with little evidence in practice. The barriers are numerous. These include legal or regulatory hurdles, data collection problems, as well as contractual or financial flow issues.

Towse, A. and Garau, M.

Consulting Report
March 2018

The report addresses the implications of NICE appraising treatments for very rare diseases using a cost-per-QALY gained decision rule of the type used by NICE in its Technology Appraisal Programme to appraise therapies for more common conditions.

Given the importance of non-QALY elements in the assessment of HSTs, such as treatment impact on the process of care and on the patients’ or their carers’ ability to go to school or to work respectively, and issues in measuring quality of life when the population affected are infants or young children, it is inappropriate to focus the appraisal of treatments for very rare diseases solely on a cost-per-QALY measure. Given the lack of empirical basis, the new £100,000 cost per QALY threshold and its further possible uplift up by a factor of three seem arbitrary.

Cole, A., O'Neill, P., Sampson, C., and Lorgelly, P.

Consulting Report
March 2018

Surgical practice has and continues to develop at a tremendous pace, reflecting the evolving technological landscape as well as the expanding skillset of the surgical workforce. Minimal access surgery (MAS) can offer improved recovery prospects for patients, but uptake in the UK is variable across both procedures and hospitals.

Through in-depth interviews with key stakeholders (surgeons from both the NHS and private sector, clinical directors and finance directors), supported by an evaluation of the literature, we assess the benefits of minimal access surgery, the extent to which these benefits are realised in practice, and the major barriers to wider adoption.

Mestre-Ferrandiz, J., Berdud, M., and Towse, A.

Consulting Report
January 2018

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.

Consulting Report
December 2017

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.

Zamora, B., Maignen, F., and Lorgelly, P.

Consulting Report
December 2017

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.

Consulting Report
September 2017

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.

Consulting Report
March 2017

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.

Marsden, G. and Towse, A.

Consulting Report
February 2017

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.

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