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Sharing of real world data, getting patients involved, is needed for better pharma collaborations

Pharma wants to be a part of value-based programs for risk-based arrangements with payers.

Susan Morse, Managing Editor

Rasu Shrestha, chief strategy officer for Atrium, speaks at the Pharma Forum at HIMSS19.Rasu Shrestha, chief strategy officer for Atrium, speaks at the Pharma Forum at HIMSS19.

Payers and pharma are at the early stages of collaborating in value-based agreements for risk-sharing, according to speakers who took part in the new pharma forum of HIMSS19.

Pharma wants to become part of healthcare's risk-based agreements, said Erik Dasbach, data strategy and partnerships lead, Merck Center For Observational and Real-World Evidence. This is tying reimbursement of a drug to real world data in an arrangement between a manufacturer and a payer.

"We're thinking about outcomes-based risk sharing," Dasbach said.

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Critical to designing a risk sharing model is having discussions earlier, having research grade evidence and having a joint value lab venture across stakeholders to work out what arrangements might look like for different types of diseases.

There's been an uptick in such value-based programs since 2013, but hurdles still exist in legal and compliance considerations and regulatory barriers that make it challenging to collect and link data, said Jeffrey Morgan, managing director, Life Sciences, Deloitte Consulting.

Plus, the data itself is an issue.

"Data is messy," Morgan said. "There's big distinction between real world evidence and real world data."

The 21st Century Cures Act, passed in 2016, places additional focus on the use of these types of data to support regulatory decision-making, including approval of new indications for approved drugs.

In addition, FDA guidance in June 2018 from 21st Century Cures Act relates to  dissemination to payors information about medical products that are not yet cleared for use.

The protection and use of patient data is highlighted in Aetna and Apple's recent announcement of the use of Apple Watch for an Attain app, a combination health tracker and reminder for personalized goals that tracks daily activity levels and other healthy actions and rewards wearers for improving their well-being.

Users have the additional option to share their Attain program data and health history with Apple anonymously.

In this collection of data through the  Apple Watch, said Rasu Shrestha, MD, chief strategy officer for Atrium, "what we're really talking about is behavioral change. You do that through nudges."

Data is at the bottom of a pyramid of a patient-focused health system, Shrestha said. The challenge is moving from data to knowledge about the preferences around the patient being treated.  This information must be married to the social determinants.

"And then put that into context of what that data is screaming at us," Shrestha said. "That gets to the top of the pyramid," which is wisdom, he said.

Population health and precision medicine is coming together, he said. The launch of a drug typically costs upwards of $2.5 billion. The AI landscape for drug discovery is proliferating on a daily basis.

"I think there's tremendous potential between AI and medicine," said Anthony Chang, pediatric cardiologist, Children's Hospital of Orange County.

Robert Stevens, head of digital strategy for Novartis, said to broaden the conversation, get the patient's perspective.

The new rule from the ONC requires better data sharing with patients.

John Halamka, a Harvard professor, said, "I read the rules. These various rules require the opening of the EHR and the opening of payer databases. We'll see in the next year or two the evolution of these helper apps."

In January 2017, Partners HealthCare Pivot Labs and UCB, a multi-national pharmaceutical company, collaborated around innovative solutions for those with epilepsy. Involved in the collaboration, and on the panel was Whitney Petit, a patient advocate who lives with epilepsy, who was able to tell providers, among other information, that the reason for a 50-percent non-compliance with physician appointments is that doctors often take away the driver's licenses of patients with epilepsy.

Twitter: @SusanJMorse
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