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 Formulary Submissions: Value Claims, Protocols, and Outcomes Based Contracting in Rare Disease  
August 17, 2022

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FORMULARY SUBMISSIONS 

Patients Rising – Patient Access and Affordability Project – The New Start Formulary Submission and Evaluation Guidelines for Value Claims with Pharmaceutical Products and Devices

May 5, 2022May 23, 2022 Dr Paul Langely

Version 2.0 May 2022

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

Executive Director: Terry Wilcox
Patients-Rising-Guidelines-V9-REV-1Download

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Latest News

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  • FORMULARY SUBMISSIONS
  • Patient Voice: Patients Rising
  • Nonsense on Stilts
  • Assumptions and Models
  • Fundamental Measurement
  • The Mystical Viral QALY
  • ICER Fantasy
  • Tufts' Ordinal Oversight
  • Cheers 22 Meets Catch 22
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  • Minnesota Formulary Guidelines
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Latest Publications

Langley PC. Nothing to Cheer About: Endorsing  Imaginary Economic Evaluations and Value Claims with CHEERS 22 [version 1; peer review: awaiting peer review]

Abstract

One of the more unfortunate 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.

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, University 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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