FDA Paves the Way for Greater Adoption of Value-Based Partnerships

Jun 21, 2018

Value-based partnerships have been steadily gaining momentum as a new payment model meant to ensure patients have access to breakthrough therapies and that drug manufacturers are reimbursed for the value they bring to the patient and the healthcare system. These types of arrangements are especially critical as more curative treatments come to market, made possible by incredible advances in science. Although these drugs often have high upfront costs, they often can eliminate the need for costly chronic care.

At its core, value-based partnerships, sometimes referred to as outcomes-based contracts, are when an insurer and a drug manufacturer enter into an agreement where the insurer pays for a treatment based on the value it provides to a patient. While this sounds like a common-sense idea, one of the biggest hurdles has been how to collect and share the necessary data to measure the treatments’ effectiveness on individual patients and whole patient populations. In many cases, existing laws and regulations limit or even prohibit certain communications and information sharing needed to implement effective VBPs.

The good news is that the FDA is making moves to remove those roadblocks, and just last week published final guidelines that explain how drug manufacturers can share product information with payers while remaining compliant with FDA rules on communication.

As FDA Commissioner Scott Gottlieb wrote in a statement, “This call to action is taking place against the backdrop of an information transformation. In the era of “big data,” scientists, drug makers, regulators, payors and others have unprecedented access to new sources of information. Already, the ability to harness this information and use it to help establish the value of medicines is providing the foundation for a shift toward innovative, value-based payment arrangements.”

The FDA’s goal is to “help nurture this change by providing clear guidance to pharmaceutical companies about open, responsible communication with payors, formulary committees and others… The ultimate goal is to help facilitate a market that is more competitive, based on the outcomes that matter most –the benefit to patients. Helping facilitate appropriate company communications with these audiences may help foster these outcomes, and enable better access to medical products and possibly more affordable options for Americans.”

Patients will only realize the immense benefits of healthcare innovation if they are granted access, and that means our regulatory bodies must keep up with the level of innovation we’re seeing in the life sciences industry. Just as important, we must be able to measure the value these drugs bring to patients, and that means collaboration and information sharing between all parties involved. We applaud the FDA for taking this critical step in paving the way for greater adoption of value-based arrangements, and for working in the best interest of patients.

Read the full statement from FDA Commissioner Gottlieb.

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