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

Maimon Research LLC: A New Research Agenda in Health Technology Assessment

 

 

Supporting the credibility, evaluation and replication of value claims for clinical and cost-effectiveness in pharmaceutical products and devices

Maimon Research LLC is a long established boutique consulting company specializing in health technology assessment, together with advising and implementing market access strategies to support pharmaceutical products and devices over their life cycle.

 

The focus of Maimon Research is on developing claims for pharmaceutical products and devices that are credible, evaluable and replicable.

 

This sets Maimon Research apart from other health technology assessment consultants. Unlike competitors, Maimon Research offers a unique and methodologically acceptable approach to the validation and replication of health technology claims.

This approach puts to one side the modeling of non-testable claims based on the construction of reference case lifetime imaginary worlds which, unfortunately, have come to dominate the health technology assessment literature over the past 30 years, in favor of credible claims which meet the standards of normal science. This technology assessment ‘meme’ is an intellectual and analytical dead end. It has to be abandoned in favor of value assessment frameworks that make sense for formulary committees.

The purpose of this website is to introduce prospective clients to the case made in a number of commentaries authored by Dr Paul C Langley, Director, Maimon Research for the standards required to make product claims that meet those of normal science. Links are provided to over 40 commentaries which have evaluated ICER claims as well as those focused on the development of evidence platforms and patient centric outcomes measures.

Maimon Research services:

 

•developing value claims that are credible, evaluable and replicable through supporting health technology assessments that meet standards of normal science

•supporting payers in developing standards for formulary evaluation that are meaningful and meet the standards of normal science

•developing formulary submission protocols for comparative claims validation

•ensuring claims reflect the needs of patients through outcomes instruments that are patient centric

•supporting the rejection of invalid claims, such as lifetime cost per QALY models, by formulary committees

•seminars and training programs to support the new research agenda

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Publications

 

Langley PC. The Great I-QALY Disaster. Inov Pharm. 2020;11(3): No 7 https://pubs.lib.umn.edu/index.php/innovations/article/view/3359/2517

 

Langley PC. Medicaid Formulary Decisions and the Institute for Clinical and Economic Review: Abandoning Pseudoscience in Imaginary Pharmaceutical Pricing Claims. InovPharm. 2021;12(1):No. 11 https://pubs.lib.umn.edu/index.php/innovations/article/view/3702/2676

 

Langley PC. Let a Thousand Models Bloom: ICER Analytics Opens the Floodgates to Cloud Pseudoscience. InovPharm.2021;2(1): No. 5 https://pubs.lib.umn.edu/index.php/innovations/article/view/3606/2668

 

Langley PC, McKenna SP. Fundamental Measurement and Quality Adjusted Life Years. Value Health. 2021:24(3)(:451

 

Langley PC, McKenna SP. Fundamental Measurement: The Need Fulfilment Quality of Life (N-QOL) Measure. InovPharm.. 2021;12(2)) No. 6  https://pubs.lib.umn.edu/index.php/innovations/article/view/3798/2697

 

Langley PC. The National Pharmaceutical Council: Endorsing the construction of imaginary worlds in health technology assessment. Pharmacy. 2020;8(119);doi:10.3390/pharmacy8030119

 

Langley PC. 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

 

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 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.  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. 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. ICER, ISPOR and QALYs: A Tale of Imaginary Worlds, Inov Pharm. 2019:10(4): No. 10

ttps://pubs.lib.umn.edu/index.php/innovations/article/view/2266

 

Normal science is not new ......

 

 "No human investigation can be termed true   science if it is not capable of mathematical demonstration. If you say that the sciences which begin and end in the mind are true, then it is not to be conceded, but is denied for many reasons, and chiefly the fact that the test of experience is absent from these exercises of the mind, and without it nothing can be certain" (Leonardo da Vinci  d. 1519)

Latest News

 

MAIMON WORKING PAPERS No. 2  JANUARY 2022

 

NOTHING TO CHEER ABOUT: CONTINUING SUPPORT FOR A MULTITUDE OF IMAGINARY MODELED VALUE CLAIMS WITH CHEERS 22

 

Paul C Langley, Ph.D. Adjunct Professor, College of Pharmacy, University of Minnesota, Minneapolis, MN

 

Abstract

One of the more intriguing features of health technology assessment is the tenacity with which leaders in the field and organizations such as the International Society for Pharmacoeconomics and outcomes Research (ISPOR) and the Institute for Clinical and Economic Review (ICER) cling to an evaluation framework that fails to meet the standards of normal science. 

 Continue Here

 

MAIMON WORKING PAPERS No. 1  JANUARY 2022

 

HOODWINKED: THE BLINKERED PERILS OF IMAGINARY LIFETIME MODELING IN TYPE 2 DIABETES

 

Paul C Langley, Ph.D., Adjunct Professor, College of Pharmacy, University of Minnesota, Minneapolis, MN

 

Abstract

 

Value claims for competing products in Type 2 diabetes, as well as any other disease state, must respect the standards of normal science. All value claims must be credible, evaluable and replicable, respecting the axioms of fundamental measurement as single attribute claims with ratio or interval measurement properties. Continue Here

 

 

MAIMON WORKING PAPERS No. 27 DECEMBER 2021

 

MEASUREMENT AND RESPONSE TO THERAPY

 

Paul C. Langley, Ph.D., Adjunct Professor, College of Pharmacy, University of Minnesota, MN

 

ABSTRACT

 

The principal purpose of this Commentary is to alert those undertaking assessments of competing therapies as part of health technology assessment modeling to the critical role played by the axioms of fundamental measurement. This is of particular application to claims based on patient reported outcomes (PRO) instruments. Continue Here

 

 

 

Recent Publications

 

A Critical Examination of Simulation Pricing and Access Recommendations for Atopic Dermatitis

 

Paul C. Langley, Ph.D., Adjunct Professor

College of Pharmacy, University of Minnesota, MN

 

Abstract

 

It has been demonstrated conclusively that value and utility preference scores have only ordinal properties. That means, as has been pointed out on numerous occasions, that quality adjusted life year (QALY) is a mathematically impossible construct. Continue here.

 

 

A Critical Examination for the Pricing of Eculizumab and Efgartigimod in Myasthenia Gravis

 

Paul C. Langley, Ph.D., Adjunct Professor, College of Pharmacy, University of Minnesota, MN

 

ABSTRACT

 

The purpose of this commentary is to focus on the downside of assumption-driven simulation modeling, the potential creation of a multitude of competing models, the mathematically impossible quality adjusted life year (QALY) and the failure to observe the axioms of fundamental measurement in mapping ordinal EQ-5D-5L preferences from the ordinal Quantitative Myasthenia Gravis Continue Here

 

 

Abandoning Eugenics and the QALY

 

Paul C. Langley, Ph.D., Adjunct Professor, College of Pharmacy, Univerity of Minnesota, MN

 

ABSTRACT

 

Should decision making in health care, notably in respect of the allocation of resources between individuals and disease states, rest on notions of the burden of disease and denial of care as assessed by societal evaluations or on the extent to which the need of patients and caregivers is fulfilled. Continue here.

 

 

 

 

 

 

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