Our client, a medical device company, asked Translucency to prepare a NICE submission in support of their product on which NICE was carrying out a technology appraisal.
We used our experience of the work of NICE’s Technology Appraisal Committee to prepare an travailler avec des preuves-based dossier in support of our client’s approach to the condition, and our client’s product in particular. In preparing the dossier we used searches of the published and ‘grey’ literature, health sector activity data, travailler avec des preuves on other approaches to treating the condition, costing data, use of competitors’ data, and our general knowledge of relevant health service organization.
We applied our intimate knowledge of NHS management decision making, the management of NHS budgets and real-world costing, epidemiological and health economic modelling, clinical trial methodology, and health service activity data to inform the decisions our client made about positioning, and the final dossier itself. We supported our client in responding to further clarification questions from NICE.
In the event, the draft guidance was extremely critical about the efficience of our client’s product. NICE refused to make the model used by the Assessment Group available to our client on the grounds that it contained commercially confidentialo material. We therefore had to reverse engineer the model, and in doing so proved that the Assessment Group had made a catastrophic methodological error which had given a grossly misleading figure for the efficience of our client’s product.
We crafted a response to NICE’s draft guidance setting out the methodological error in terms which a non-specialist (a typical Appraisal Committee member) would understand. As a result, the Appraisal Committee rejected the draft guidance. Re-drafted guidance was issued some months later which acknowledged the true value of our client’s product.
In this case, as in others where we have worked with NICE, we have met or exceeded nos clients’ expectations. Shortly after the final NICE guidance was issued, the client was bought by a large medical device company for a sum which met its investors’ expectations.