Real World Evidence, Digital Health and Market Access

Transcription

1 Real World Evidence, Digital Health and Market Access Dr. Kyle E. Dolbow Oncology Market Access

2 Market Access It s going to be a fact of life that we have to accept a slower uptake, Mr. Jimenez told the Financial Times. Consolidation among US insurers and healthcare providers has given payers more bargaining power over drug companies and President Barack Obama s Affordable Care Act has created new incentives for cost savings.

3 Real World Evidence Salford Lung Study SLS is an innovative project with the aim of evaluating the safety and effectiveness of an investigational medicine in a real-world setting. Data from SLS will allow a better understanding of the risk/benefit profile of the FF/VI combination in the wider COPD community. The study will likely be a role model for future evaluation of effectiveness of new therapies.* *

4 Real World Evidence - SLS We believe this study is just the beginning. As outcomes become the preferred metric in healthcare, bringing evidence from outside the controlled, clinical trial setting to the table will be the difference between success and failure for a drug launch.* *

5 Four Options for Pharma First, companies can go on with business as usual in clinical trials and then hope for the best in the discussion with payers. Perhaps sitting in a poor position in a pay-for-performance negotiation, but hopeful the rebates will be small enough to still make it worthwhile.

6 Four Options for Pharma A second option is to go about the clinical trials in much the same way as always, but make a real effort post-launch to take control over outcomes. This means not only supporting patients to adhere to the treatment, but also capturing the necessary data to be able to monitor and analyze the outcomes. Right now, for example in the Cigna-Novartis/Sanofi/Amgen deals, Cigna owns the data and pharma may have to stand by and accept their interpretation of it. It also means, starting to look at the broader care pathway beyond the drug treatment to understand pain-points and value leaks.

7 Four Options for Pharma The third option is to do what GSK did in Salford, rethink the clinical trial to take it out to a real world setting. That way, you get robust evidence to make your case in the payer negotiation and you learn more about how the medicine will work in everyday practice, which takes us back to the care pathway point we just made.

8 Four Options for Pharma The fourth option is to combine the second and the third option, and think of research, development and commercialization of a drug as an integrated whole. This means, bringing the clinical trial into a real world setting and develop ways of driving improved outcomes beyond just the drug.

9 Driving Improved Outcomes and Value Two common value issues in outside of drug performance Finding the right patient Breaking down the barriers to patient success

10 Opportunities to create new value along entire patient journey Diagnosis Diagnostic aids Predictive modeling Genetic screening Outcomes Measurement Predictive modeling and outcomes measurement Quality Management Biomarkers Coordinated management Treatment Assessment Treatment Selection Comprehensive patient information Remote, virtual always on Virtual coaching Treatment Monitoring Treatment Delivery Integrated and coordinated treatment management Standardized treatment pathways / processes Include self-care, remote delivery and at premises 10