PROGRAM IN SOCIAL AND ADMINISTRATIVE PHARMACY, COLLEGE OF PHARMACY UNIVERSITY OF MINNESOTA
Version 3 of the Minnesota Guidelines, launched in July 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.
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:
These arguments are presented in a recent publication:
Langley P. The National Pharmaceutical Council: Endorsing the construction of imaginary worlds in health technology assessment. Pharmacy. 2020;8(119);doi:10.3390/pharmacy8030119
There are two key components to the Guidelines. These are:
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.