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Increasing costs, loss of drug exclusivity and crowded drug classes have prompted the need for better outcomes data to ensure optimization of payer resources
Manufacturers are still behind the eight ball in understanding what payers need in terms of information, both clinical and economic data, said Nathan White, director, NucleusX Market Access, a medical communications company and Katya Svoboda, a partner with Percipient LLC, a strategic consulting firm in pharmaceuticals and biotech.
White and Svoboda explored what U.S. drug manufacturers need to do to catch up to their global counterparts in sharing the economic value of new products in AMCP Session 207.
“Manufacturers are mostly focused on product development, safety, clinical efficacy and regulatory approval, but now payers are demanding more data to effectively assess drug costs and outcomes,” White said.
NucleusX Market Access and Percipient conducted research based on interviews with 20 pharmacy and medical directors from U.S. payers, both national and regional as well as four payers across Europe and Australia, and manufacturers involved in market access or health outcomes.
The discussion covered:
• Ways to identify the evidence payers seek when a new product is launched;
• How payers are applying data and will in the next three to five years;
• Limitations of current evidence and opportunities for improvement and what types of data are most useful to payers.
Svoboda said that increasing costs, loss of drug exclusivity, growth in technology and crowded drug classes have prompted the need for better outcomes data to ensure optimization of resources.
“Outcomes data can help payers make more informed decisions to increase quality and lower costs,” she said.
Despite indicating a desire for such data, payers are skeptical about the credibility of clinical outcomes and peer-reviewed articles on new drugs from manufacturers when they suspect the literature might be biased. While payers want head-to-head studies of products, what they often have available are placebo-controlled trials.
"There are gaps," said Svoboda."Payers question manufacturer data credibility for a variety of reasons."
One reason why data is questioned is because negative results are often not published. She also said that in today's healthcare environment, payers are increasing their expectations for transparency.
The research the speakers presented indicates that payers are asking that study results be more applicable and actionable, illustrate credible and objective endpoints and demonstrate cost savings. However, payers also want more intelligence applicable to their member populations.
U.S. payers will use more outcomes data as accountable care organizations assume more risk and payers are required to demonstrate “rational” management decisions.
“The United States is five years behind Europe and Australia in setting requirements for presenting health economic data and outcomes,” said White. “These other countries have already established a collaborative, transparent process for disseminating information, while providing an opportunity for dialogue prior to a clinical development program.
Unlike many European countries, the United States does not have a single entity responsible for reviewing outcomes data, but AHRQ, PCORI and AMCP can provide resouces, according to the presenters.