Maimon Research, under the direction of Dr Paul C Langley, has extensive experience with the development of evidence-based global market access document management systems to support products in all phases of drug development and reimbursement in all major global markets, and in tracking products to support comparative effectiveness research.
The primary focus of Maimon Research is to apply the standards of normal science, the formulation of hypotheses and hypothesis testing, to health technology assessment. 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 reporting 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 testable 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, modeled claims which fail to generate testable predictions have no place in health technology assessment. Such claims should be rejected by formulary committees. 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 modeled claims for product impacts that are testable is entirely consistent with the standards of normal science. 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.
Recent Publications
Coming soon!
•health technology assessments that meet standards of normal science
•quality assessments to ensure global value dossiers and comparative modeled claims meet the standards of normal science
•protocols for comparative modeled claims validation
•access to 'big data' to evaluate modeled claims
•protocols for comparative product assessments in disease area and therapeutic class reviews
•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
"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)