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

Assessment Standards

If a manufacturer submits a proposal for a new product to a formulary committee, it is reasonable to expect that the claims, whether in clinical and or cost-effectiveness terms meet the standards of normal science. This may seem unexceptionable. It has been recognized since the 17th century that if we are to discover new facts, e.g., therapy impacts in target patient populations, then we should be focused on the construction of empirically verifiable theories and hypotheses.

 

But health technology assessment is not like that. It is made quite clear that the focus is on construction of ‘for approximate information’ imaginary worlds not hypothesis testing. This approach is well entrenched in the health technology assessment meme, endorsed by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the Academy of Managed Care Pharmacy (AMCP) and the Institute for Clinical and Economic Review (ICER).

 

Few recognize how absurd this situation is. Rather than seeking new evidence, ISPOR mandates the construction of imaginary worlds to support cost per QALY claims. ICER agrees and each evidence report is an imaginary construct. For ISPOR, AMCP and ICER evidence is constructed, presented and, unfortunately, taken at face value by health care decision makers. The absence of evaluable claims means it can never be contradicted. It is designed to provide ‘approximate information’ (or disinformation). There are no testable predictions.

 

Creating imaginary worlds to support cost-effectiveness claims, typically by constructing incremental cost-per-QALY claims, fails the standards of normal science. Rather, in rejecting evidence evaluation and the discovery of new facts, the imaginary world meme sees evidence as constructed where, among practitioners, truth is consensus. Imaginary claims are pseudoscience and join similar creations such as intelligent design.

Maimon Research rejects the creation of imaginary, assumption driven models to support formulary decisions. While they are defended as providing ‘approximate information’ they are, quite simply, nonsense. We have no idea if they are ‘right’ or ‘wrong’; we will never know and we will never know

Such claims, even if justified by the realism of the model generating such claims, have the potential to mislead formulary committees. Maimon Research is committed to developing value claims for product impacts that are testable. An approach that is entirely consistent with the standards of normal science and not intelligent design. Such an approach provides clients with a firm evidence base to support pricing decisions, formulary placement and support for products over their life cycle.

 

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