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 which, unfortunately, have come to dominate the pharmacoeconomics literature and the content of global value dossiers, in favor of credible claims which meet the standards of normal science.

Although supported by groups such as the Academy of Managed Care Pharmacy (AMCP) in their Format for Formulary Submissions and the Institute for Clinical and Economic Review (ICER), modeled claims which fail to generate testable predictions have no place in health technology assessment. Such claims are typically ignored by PBMs and formulary comittees as irrelevant to decision making.

They are best seen as thought experiments (or imaginary worlds or speculative fiction). Why?  Because we have no idea as to whether the modeled claim is right, or even whether it is wrong! Such claims, even if justified by the realism of the model generating such claims, have the potential to mislead formulary committees. Unfortunately, we have no idea as to how misleading the claims are, in particular those for comparative product effectiveness, actually – which leads, obviously, to the likelihood that, on such a weak (or absent) evidence base formulary decisions to be challenged.

The focus of developing value claims for product impacts that are testable 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

Maimon Research recognizes that in the focus of models that generate testable claims much of what we have been taught under the rubric of ‘health technology assessment’ or ‘pharmacoeconomics’ over the past 20-25 years has to be put to one side; a prospect that may face significant opposition. This is a challenge that has to be met; we have to abandon thought experiments in favor of techniques for product impact that are testable and which meet the same evidentiary standards that underpin randomized clinical trials.    

In providing clients with the tools, including the drafting of validation protocols to support comparative product claims, Maimon Research can provide a range of other services to support market access and a favorable formulary position,. As detailed in this website, these include critical assessments of global value dossiers, global electronic databases and, econometric modeling for burden of illness and retrospective evaluations of product impact.   

    

Maimon Research services:

 

developing credible value claims that are evaluable and replicable through supportinghealth 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 high cost and targeted precision medicine claims are justifiable

•supporting targeted claims evaluation and reporting to formulary committees

•seminars and training programs to support the new research agenda

•global evidence databases to support claims validation and value propositions

•comparative burden of illness evaluations

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)

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