Forging a Path to Outcomes-Based High-Quality Patient Care

The way we view and work in the healthcare economy is changing dramatically. Implementation of the Affordable Care Act, significant medical advances against diseases and the focus on population health management are among the many forces challenging traditional paradigms. As a result, stakeholders throughout the healthcare system are exploring new approaches that place greater emphasis on quality over quantity and value over volume.

At Astellas, we understand that the path to successfully evolving the U.S. healthcare system begins and ends with the patient. We are working to turn novel science into value for patients – and part of that requires asking difficult questions about what value and quality really mean.

This is a debate that needs real solutions, not platitudes, and it is with that perspective that we are convening diverse experts to find new and better ways to incorporate patient input into our efforts and make patient centricity more than a talking point. By bringing together the most consequential voices in health care to tackle the questions that matter most to patients, providers, payers and biopharmaceutical companies, we can start to identify solutions to key challenges in the shift from volume to value.

Biopharmaceutical innovation is transforming what it means to be a patient battling some of our most difficult diseases, such as cancer, HIV/AIDS, diabetes and cardiovascular disease. New medicines are not only saving and extending lives, but doing so with better safety profiles that improve quality of life.

But are we capturing these benefits in the ways we measure the value of medicines – and in the decisions that inform access to these therapies?

Since the Medicare Prescription Drug Improvement and Modernization Act of 2003, the Centers for Medicare and Medicaid Services has put in place myriad quality reporting and performance programs – and recently HHS set a goal of tying 85 percent of all traditional Medicare payments to quality or value by 2016 and 90 percent by 2018.

However, a key hurdle in this transformation is the development of credible, patient-focused quality measurements centered on real outcomes.

Astellas is proud to work with organizations such as the National Quality Forum, Pharmaceutical Quality Alliance and National Pharmaceutical Council, who are helping guide this evolution. But we need to be careful to not assume that the measures being used are the right ones to determine value-based payments. A recent Avalere study showed that many medical conditions are not fully represented in Medicare pay-for-quality programs, which limits Medicare's ability to pay for value. Whereas conditions such as diabetes and chronic renal disease have 21 measures each, prostate and lung cancer each have only three measures. More importantly, regardless of quantity, quality metrics need to relate to patient outcomes — not just processes.

At Astellas, we strive to begin defining the value of an investigational medicine early in the development process. And if we want to get it right, we need to know that decisions impacting a drug's future viability from a payer perspective are going to be based on appropriate, credible, patient-centered outcomes metrics.

Fortunately, there's reason for optimism. In December, CMS laid out its quality measure development plan for the transition to the Merit-based Incentive Payment System and Alternative Payment Models. The agency indicated a commitment to work collaboratively to address key challenges — including the need to engage patients in measure development and the creation of meaningful outcomes measures.

Astellas has engaged in efforts to better understand the unique needs of integrated health care systems. We are learning valuable lessons that can help inform how we deliver quality and value beyond our medicines.

We are listening to the voices of payers, providers and patients earlier in the R&D process. And we are collaborating with diverse organizations on new value propositions. One example is a partnership with Humana that brings together researchers and healthcare experts to reduce inefficiencies in the management of oncology, urology and immunology conditions.

No matter our collective challenges, these are exciting times. We have an opportunity to create a more efficient system that delivers high-quality, outcomes-based care — but we can't let the focus on processes inhibit our efforts. Our greatest risks are inflexibility and apathy. We need to be open to new ideas — and all stakeholders need to be engaged. Most importantly, the patient voice must be heard loud and clear.