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

Global Formulary Submissions

As a meme, a unit of cultural transmission or imitation, the health technology assessment commitment to the construction of imaginary cost-per-QALY worlds has travelled well. For over 25 years health technology assessment agencies in countries with single payer health systems have embraced the reference case model; most effectively by the National Institute for Health and Clinical Excellence (NICE) in the UK, supported by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). The level of copying fidelity has been remarkable, with the same emphasis on lifetime models to support ‘approximate information’ (or disinformation) rather than any concern with hypothesis testing and the discovery of new facts.


Since 2016, Dr Paul C Langley, Director, Maimon Research has published a series of commentaries that have pointed to the lack of scientific merit in guidelines published by countries embracing the construction of ‘evidence’ through imaginary worlds as well as the Academy of Managed Care Pharmacy (AMCP) and the Institute for Clinical and Economic Review (ICER) in the US. Putting ICER to one side (see the ICER sections), the commentaries are:


United States


Langley PC. Modeling imaginary worlds: Version 4 of the AMCP Format for Formulary Submissions. Inov Pharm. 2016;7(2): No. 11



United Kingdom


Langley PC. Sunlit uplands: the genius of the NICE reference case. Inov Pharm. 2016;7(2): No.12.



New Zealand

Langley PC. He ao pohewa: The PHARMAC Prescription for Pharmacoeconomic Analysis in New Zealand and the standards of normal scienceInov Pharm. 2016;7(2): No. 13.


European Union

Langley PC. Imaginary Worlds: The European Network for Health Technology Assessment (EUnetHTA) Recommendations for Health Economic Evaluations. Inov Pharm. 2016;7(3): No. 3


Langley PC. Denkbeeldige Wereld: The New Dutch Guidelines for Economic Evaluations in Healthcare. Inov Pharm. 2017;8(1): No. 4




Langley PC. Dreamtime: Version 5.0 of the Australian Guidelines for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC). Inov Pharm. 2017;8(1): No.




Langley PC. HAS Should Not Be NICE: Rejecting Imaginary Worlds in the French Technology Assessment Guidelines. Inov Pharm. 2017;8(1): No 8.


Langley PC. Imaginary Worlds and Efficiency Frontiers: Should We Abandon the IQWiG Health Technology Assessment Model? Inov Pharm. 2017;8(1): No. 13




Langley PC. True North: Building Imaginary Worlds with the Revised Canadian (CADTH) Guidelines for Health Technology Assessment. Inov Pharm. 2017;8(2): No. 9.


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