At Clinical Utility Consulting, LLC, we are a forward-thinking boutique biotech, pharma, and digital health consultancy founded by a leader in evidence-based genomic and molecular medicine, human genetics, and molecular diagnostics with over a decade of post-M.D. experience.
The firm is focused around the concept of clinical utility because it has arguably become the central characteristic underlying both clinical and commercial success in the development and launch of therapeutics, molecular diagnostics, and other healthcare interventions. Current trends suggest that clinical utility will become even more central to future reimbursement decisions made by managed care organizations and other public and private payers.
Our firm aims to assist your organization in maximizing its potential to have a beneficial impact on morbidity and mortality and corresponding commercial success. Several key beliefs inform the work that we do:
1. We believe that the strongest predictor of the success of products in the biotech, pharma, medical device and digital health spaces is the clinical utility of the product--or lack thereof. Clinical Utility impacts several key drivers of sales: physician decisions, payer coverage decisions, formulary inclusion, and patient demand. For obvious reasons, physicians are more likely to prescribe treatments, devices, and information when it has a real, quantifiable impact on their patients. The clinical utility of an intervention will only be more important in the future due to current trends towards more protocol-driven care and restricted formularies in a cost-conscious environment.
2. We believe that companies will make better decisions about their product portfolios when they have a stronger understanding of both the current and plausible potential clinical utility of each product. We can assist by applying rigorous analytical techniques in evaluation of your portfolio.
3. Products lacking clinical utility evidence (particularly in the molecular diagnostics space) often have substantial difficulty getting traction in the market and reimbursement from payers. If this sounds like your product, we can help you produce a solid plan to produce the evidence necessary for reimbursement and commercial success.
4. Products with pre-existing clinical utility evidence can benefit from a strategic approach to positioning this evidence with payers, physicians, and patients. We can assist you in maximizing the value of your previous investments in clinical utility studies.
