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

ICER Evidence Reviews

The Institute of Clinical and Economic Review (ICER) business model has one product: the evidence reviews and recommendations for pharmaceutical products that have or are believed shortly to receive marketing approval in the US. ICER sees its mission as providing an independent assessment of the clinical and cost-effectiveness of selected products. This assessment involves a clinical appraisal and then, inevitably, the construction of a reference case imaginary world. This ‘value assessment framework’ matches the modeled ‘approximate information’ evidence created by the model against willingness to pay thresholds. The value recommendations may involve price discounting and ‘affordability alerts’. Needless to say the ICER value assessment framework does not meet the standards of normal science. It is pseudoscience.

 

In the last 3 years Dr Paul C Langley, Director, Maimon Research has published a number of commentaries on ICER product evidence reports. These have pointed to the lack of scientific merit in the ICER modeled cost-per-QALY imaginary world. The commentaries are:

 

 

 

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

 

https://pubs.lib.umn.edu/index.php/innovations/article/view/449

Langley PC. Multiple Sclerosis and the Comparative Value Disease Modifying Therapy Report of the Institute for Clinical and Economic Review (ICER). Inov Pharm. 2017;8(1): No.12

https://pubs.lib.umn.edu/index.php/innovations/article/view/492

Langley PC. Imaginary Worlds and the Institute for Clinical and Economic Review (ICER) Evidence Report: Targeted Immune Modulators for Rheumatoid Arthritis. Inov Pharm. 2017;8(2): No. 10.

 

https://pubs.lib.umn.edu/index.php/innovations/article/view/515

 

Langley PC. Rush to Judgement: Imaginary Worlds and Cost-Outcomes Claims for PCSK9 Inhibitors. Inov Pharm. 2017;8(2): No. 11

 

https://pubs.lib.umn.edu/index.php/innovations/article/view/516

 

Langley PC. Another Imaginary World: The ICER Claims for the Long-Term Cost-Effectiveness and Pricing of Vesicular Monoamine Transporter 2 (VMAT2)

 

https://pubs.lib.umn.edu/index.php/innovations/article/view/927

 

Langley PC. Another Rush to Judgement: The Imaginary Worlds of ICER and Recommendations in Duchenne Muscular Dystrophy. Inov Pharm. 2019;10(3):No. 11

 

https://pubs.lib.umn.edu/index.php/innovations/article/view/2152

 

Langley PC. Yet another Ersatz World: The ICER Final Evidence Report for Additive Cardiovascular Therapies. Inov Pharm.2019;10(4); No 22.

 

 https://pubs.lib.umn.edu/index.php/innovations/article/view/2337

 

Langley PC.  More Unnecessary Imaginary Worlds - Part 1: The Institute for Clinical and Economic Review’s Evidence Report on Janus Kinase (JAK) Inhibitors in Rheumatoid Arthritis.  Inov Pharm . 2020;11(1):No 2

 

https://pubs.lib.umn.edu/index.php/innovations/article/view/2402

 

Langley PC. More Unnecessary Imaginary Worlds – Part 2: The ICER Evidence Report on Modeling Oral Semaglutide for Type 2 Diabetes. Inov Pharm. 2020;11(1):No 10

 

https://pubs.lib.umn.edu/index.php/innovations/article/view/2420

 

Langley PC. Nonsense on Stilts – Part 1: The ICER 2020-2023 Value Assessment Framework for Constructing Imaginary Worlds. InovPharm. 2020;11(1):No. 12

 

https://pubs.lib.umn.edu/index.php/innovations/article/view/2444

 

Langley P. More Unnecessary Imaginary Worlds – Part 3: Cystic Fibrosis and the Institute for Clinical and Economic Review’s Draft Evidence Report. Inov Pharm;11(1):No. 15

 

https://pubs.lib.umn.edu/index.php/innovations/article/view/3056

 

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