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

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.


A major focus of Dr Langley’s activities both at universities and as a consultant has been in the development of training programs in pharmaceutical economics, health economics and the burden of illness. At the University Of Arizona Dr Langley was instrumental in establishing the Certificate Program in Pharmacoeconomics in the mid-1990s. A similar program was developed at the University of Colorado. Dr Langley has developed packages for distance learning in pharmaceutical economics as well as general and disease specific training programs for healthcare systems and pharmaceutical companies.


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.


One of the major forums for developing and publicizing new ideas is through management monographs. Dr Langley has published a number of these: Pharmacoeconomics: Achieving Gold Standards (London: Financial Times Healthcare, 1997); Disease Management Outcomes (London: Financial Times Healthcare, 1998). Dr Langley’s management monograph is Health Economics in the Drug Life Cycle (London: Urch Publishing 2002) established critical paths for drug development to incorporate health outcomes activities over the drug life cycle.


Dr Langley has extensive experience in working with pharmacy and therapeutics committees in drug evaluation. He was the first author to publish guidelines for formulary evaluation of pharmaceuticals in the US (Foundation Health of California, 1996; Blue Cross and Blue Shield of Colorado and Nevada 1999) and was instrumental in developing the guidelines recommended by the Academy of Managed Care Pharmacy. Dr Langley has strong links with managed care and is often asked to speak at their conferences. Needless to say, Dr Langley has extensive experience in pharmacoeconomics and in the wider area of health technology assessment. He brings a global perspective to this area. Dr Langley has pioneered the notion of document management and dossier development to support a product through drug development, market entry and the balance of the product life cycle. Such a dossier brings together all the relevant components of the health technology assessment case for a product (epidemiology, comparator clinical assessments, cost-effective models, system impact models) to meet reimbursement requirements for market segments with the US and at national levels globally. At the same time Dr Langley is advising pharmaceutical companies on the most appropriate way to develop an evidentiary base to support value proposition for clinical, cost-effectiveness and budget impact claims. Notably for the US, Canada, the EU and Australia/New Zealand.


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.


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.


Dr Langley has also considerable experience in the area of precision medicine. This has two principal objectives: (i) to ensure that clients are aware of the evidentiary requirements at a global level for reimbursement of diagnostics and (ii) to identify evidence gaps in the case that is proposed to support a diagnostic submission for reimbursement as well as to support negotiations with health care systems and other payers for the role of diagnostics in care management pathways.


Most recently Dr Langley has published a number of commentaries detailing the evidence standards that should be applied (i) to consider competing next generation sequencing (NGS) platform claims and (ii) the assessment of new compounds for target patient populations defined by mutation load within an NGS claims assessment model. This has prompted the publication of version 2.0 of the Minnesota Guidelines for Formulary Evaluation (see link to site: )



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