Meeting the Standards of Normal Science in Health Outcomes and Market ccess
Meeting the Standards of Normal Science in Health Outcomes and Market ccess
Meeting the Standards of Normal Science in Health Outcomes and Market Access for Pharmaceutical Products and Devices
Meeting the Standards of Normal Science in Health Outcomes and Market Access for Pharmaceutical Products and Devices

Director: PAUL C. LANGLEY, B.Sc. (Econ). M.A., Ph.D.

Dr Paul Langley is a professional economist. His undergraduate training was in the UK, University of Hull (B.Sc [Econ]) with postgraduate training in Canada at Carleton University (M.A.) and Queen’s University (Ph.D.). Dr Langley has taught in the UK (University of Lancaster) and in Australia (La Trobe University) with visiting appointments at Carleton University, the University of Ohio and the University of California (Irvine). Although initially focusing on labor economics, Dr Langley moved into health economics – specifically the economic evaluation of pharmaceutical products - in the early 1990s. The impetus for this move was the decision, in 1992, by the Australian Department of Health to require companies seeking formulary approval for new products to make a cost-effectiveness case in order to justify the unit cost of the product and its formulary listing.

 

Following this decision by the Australian authorities, a number of other countries (Canada, New Zealand) began developing their own formulary submission guidelines and evidentiary and analytical standards for economic evaluations emerged. Although guidelines had not yet been introduced within the United States, there was considerable interest among both drug manufacturers and academic health economics groups in the emergence of guidelines requirements and in the need to improve understanding of the new evaluative techniques as they applied to a range of new products and disease areas. As a result of his early work in Australia, Dr Langley was appointed Associate Professor at the University of Arizona (College of Pharmacy; Center for Pharmaceutical Economics) in July 1994 and moved from Australia to the United States. Following a successful three years at Arizona (where Dr Langley authored some 20 publications in this area and managed a number of significant research projects), Dr Langley was appointed Professor at the University of Colorado (School of Pharmacy, University of Colorado Health Sciences Center) in July 1997. One of Dr Langley’s tasks at Colorado was to establish a Center for Pharmaceutical Economics. Following a successful two years at Colorado, Dr Langley moved to 3M Pharmaceuticals in September 1999 (through July 2005) as US and International Manager, Health Economics with worldwide responsibilities for economic evaluations as they apply to drug development, reimbursement and post-market entry support.

 

Since leaving 3M pharmaceuticals, Dr Langley has managed his consulting company, Maimon Research LLC, undertaking a number of consultancy projects in major disease areas as well as advising on document management and minimum evidentiary standards for drug development decisions and reimbursement.

 

Dr Langley has published in the area of population health, focusing on the societal burden of pain and pain co-morbidities. Three aspects of disease burden are considered: (i) health related quality of life and self-reported health status; (ii) employment status, absenteeism and presenteeism; and (iii) healthcare resource utilization. Ten papers have been published covering the UK, France, Germany, Spain, Italy and China.

 

In mid-2015 Dr Langley was invited to organize a special supplement for the Journal of Medical Economics on ‘The status of modeled claims in pharmacoeconomics’. These were published in November 2015. The papers focus on the credibility of cost-outcomes claims and the importance of developing testable claims to support formulary submissions and ongoing disease area and therapeutic class reviews.

 

This supplement was followed by a number of peer reviewed commentaries in the University of Minnesota Journal INNOVATIONS in Pharmacy, starting in July 2016, on evidentiary standards in formulary submissions and claims for cost-effectiveness. To date (January 2020) over 50 have been published.

 

The focus of these recent papers and commentaries has been to point out that the standards accepted by groups such as NICE in the UK and ICER in the US do not meet those of normal science. Their acceptance of a reference case methodology and its emphasis on cost per QALY models to drive formulary decisions means that claims made for cost effectiveness (and in the case of ICER – a NICE-lite methodology- pronouncements on ‘appropriate’ pricing) does not meet scientific standards. More to the point, it is always possible to ‘reverse engineer’ a reference case model to produce entirely different claims for cost-effectiveness and pricing. The common finding was few cost-effectiveness submissions (and papers published in leading journals) met the standards of normal science for evaluable claims.

 

Most recently Dr Langley has been focused on the treatment of chronic pain and the evidence base requirements to evaluate patient response, including opioid abuse in treatment practice. This has led to consideration of the role of chronic pain management registries to track response to therapy as well as, in a broader context, the role of registries in providing feedback in RCT-based and modeled claims to formulary committees. In addition registries have been proposed in the area of behavioral health and medical marijuana.

 

Most recently, Dr Langley has focused on the need for value assessment frameworks to support formulary sub missions. He continues to counter ICER evidence reports and the imaginary world evaluation meme of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

 

Dr Langley is currently Director, Maimon Research LLC, a health economics consulting and research company based in Tucson, AZ. Dr Langley is also Adjunct Professor, Graduate School, College of Pharmacy, University of Minnesota. Dr Langley, since August 2019 has been also, as a consultant, Advisory Board Member and Research Director, for the Institute for Patient Access 

 

 

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