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


Starting in Q2 2016, the University of Minnesota journal INNOVATIONS in Pharmacy introduced a section entitled Formulary Evaluations. The purpose of this section was to open a forum for discussions and comments on the standards that formulary committees and other health system decision makers should aim for in the assessment of pharmaceutical products and devices. The principal themes was to ensure that formulary committees and other decision makers applied the standards of normal science to the evaluation and replication of credible claims for clinical benefit and cost-effectiveness.


Prompting the introduction of Formulary Evaluations were two concerns: (i) that the approved standards for formulary submissions under the broad title of health technology assessment were irrelevant to decisions for formulary acceptance as the claims made were typically non-evaluable and (ii) that all too often clinical claims were accepted at face value without considering the issue of non-replication of clinical claims.


To date (end December 2016) 14 commentaries have been published. These have include critiques of standards put in place for modeled claims by groups such as the AMCP and ICER in the US and NICE in the UK. The commentaries have pointed to the lack of scientific merit in lifetime cost-per-QALY claims, the failure to include compliance in claims assessment and the contiued willingness of journal editors to accept modeled claims which are best seen as imaginary worlds.


The commentaries are under creative commens and are free to download from


Future commentaries will review the new formulary submission guidelines for the Netherlands, Australia (PBAC) and Canada (CADTH) and selected reoports from organization such as the Institute for Clinical and Economic Review (ICER). In addition there will be ongoing annual reviews of publications in journals such as PharmacoEconomics, Value in Health and the Journal of Medical Economics.


The current list of commentaries is:


Langley PC.  Imaginary worlds: Modeled claims for cost-effectiveness published in PharmacoEconomics January 2015 to December 2015. Inov Pharm . 2016;7(2): No. 9.


Langley PC. Nullius in verba: the University of Minnesota Social and Administrative Pharmacy program proposed Guidelines for Formulary Evaluations.   Inov Pharm. 2016;7(2): No. 10.


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


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


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


Langley PC.  Great expectations: Cost-utility models as decision criteria. Inov Pharm . 2016;7(2): No.14.


Langley PC.  Supporting formulary decisions: The discovery of new facts or constructed evidence?  Inov Pharm. 2016;7(2): No.15.   


Langley PC, Rhee TG.  Imaginary worlds: A systematic review of the status of modeled cost-effectiveness claims published in the Journal of Medical Economics from January 2015 to December 2015.  Inov Pharm . 2016;7(2): No. 16.


Langley PC, Rhee TG.  Imaginary Worlds: The status of simulation  modeling in claims for cost-effectiveness in diabetes mellitus.  Inov Pharm . 2016;7(2): No. 17.


Langley PC, Rhee TG. Imaginary worlds: The status of modeled economic evaluation claims published in Value in Health January 2015 to December 2015. Inov Pharm . 2016;7(2): No. 18.


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. Cost-Effectiveness and Formulary Evaluation: Imaginary Worlds and Entresto Claims in Heart Failure. Inov Pharm. 2016;7(3): No. 6

Langley PC, Rhee TG. Imaginary Worlds: The Status of Modeled Quality Adjusted Life Year Claims for New Oral Anticoagulants in Atrial Fibrillation Published Between January 2012 and February 2016. Inov Pharm. 2016;7(3): No.7


Langley PC. Next Generation Sequencing Claims in Precision Medicine: Questions a Formulary Committee Should Ask. Inov Pharm. 2016;7(4): No. 11


Langley PC. Creative Destruction: Next Generation Sequencing in Drug Development, Formulary Evaluations and Pricing. Inov Pharm. 2016;7(4): No. 13


Langley PC. Nullius in verba: Version 2.0 of the University of Minnesota, School of Social and Administrative Pharmacy Program, Proposed Guidelines for Formulary Evaluation. Inov Pharm. 2016;7(4): No 16




Print Print | Sitemap
© Maimon Research LLC