Concept of value and recommendations for cell therapies – NICE & Centres for Medicare & Medicade Services perspective

Mark Campbell and Louis Jacques delivered a presentation last week at the last day of the World Stem Cells & Regenerative Medicine Congress about perspective of value in cell based therapies.

Setting out its history and approach to selection and routing, beginning with engagement (discussing promising products), moving to notification and proceeding to selection and routing. As to selection for evaluation, NICE is looking for “plausible promise”. Mark set out detailed procedures for assessing the value proposition, looking at clinical performance, cost and appropriate evaluation method. Matching this was a presentation by Louis Jacques of CMS (Centres for Medicare and Medicade) about the concept of value and recommendations for cell therapies from an equivalent US perspective.  Adequate evidence to conclude that the item or service improves the therapy or outcome of a particular patient.  The benefit category may be a service to physicians, inpatient hospitals, parenteral drugs incident to a physician service, oral anti-emetics in the context of cancer chemotherapy, – and durable medical equipment.  Louis also set out a detailed account of the Medicare National Coverage Process.  Delegates heard that the preferred road to therapeutic coverage requires adequate evidence that a treatment strategy using the new therapeutic technology compared to alternatives, leads to improved clinically meaningful health outcomes for Medicare beneficiaries.

Check back here in a couple of days for the full presentation.