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




Version 3 of the Minnesota Guidelines, launched in October 2020, marks a complete break with previous guidelines published by groups such as the Academy of Managed Care Pharmacy (AMCP). The focus is on real world evidence. Attempts to create evidence through the constriction of simulated lifetime cost-per-QALY models must be rejected together with the belief that simulations generate approximate information to support formulary deliberations.

Langley P. Guidelines for Formulary Evaluations [Proposed]. Program in Social and Administrative Pharmacy, College of Pharmacy, University of Minnesota. Version 3.0. October 2020.
Maimon Guidelines 2020 V40 FINAL DEF.pdf
Adobe Acrobat document [5.8 MB]

The reasons for this rejection of the approach championed by groups such as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Institute for Clinical and Economic Review (ICER) are:


  •  Creating evidence to support formulary decisions from imaginary worlds defies the standards of normal science – it is pseudoscience
  • Assumption driven simulations are unacceptable
  • Claims that are neither credible nor evaluable are unacceptable
  • QALYS are an impossible mathematical construct because they fail the axioms of fundamental measurement
  • By extension, claims for value based on incremental cost-per-QALY simulations with cost-perQALY thresholds are nonsensical


There are two key components to the Guidelines. These are:


  • A commitment to protocols to drive evaluable claims assessment for clinical, quality of life and resource utilization
  • A commitment to feedback to the formulary committee of the results of claims assessment in a meaningful timeframe I all cases claims must be credible and evaluable. If claims do not meet these standards they must be rejected. We cannot reject hypothesis testing.


Certainly, the guidelines recognize that product launch data to assess product value will be missing. Rather than constructing simulated evidence, the way forward is to establish the evidence base to assess claims. In short, the discovery of new facts not the ISPOR/ICER recycling of old facts. Patients, caregivers and providers must have confidence in the claims made for new products. 

Print Print | Sitemap
© Maimon Research LLC