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NDHI NAT IONAL DIALOGUE FOR Healthcare Innovation Anthem and Eli Lilly Policy Collaboration Organization Overview • Anthem, Inc. is one of the nation’s leading health benefits companies, offering a broad range of medical and specialty products and covering one in nine Americans’ health benefits. • Eli Lilly and Company (Lilly) is one of the country’s leading innovation-driven, researchbased pharmaceutical and biotechnology corporations. It is devoted to seeking answers for some of the world’s most urgent medical needs through discovery and development of breakthrough medicines and technologies. Background The Affordable Care Act introduced public policy changes that are transforming today’s healthcare market. This transformation includes the shift from fee-for-service to value based payments. It also introduced new timelines that health plans must follow to establish annual health insurance plan rates. These policy changes present both opportunities and challenges relative to how innovative medicines are reimbursed and made available to patients. While Anthem, Inc. and Eli Lilly and Company appear to come from opposite sides of the table, both share common ground in promoting discovery and the cost-effective use of innovative treatments to improve people’s lives. These two thought-leading companies have come together to help accelerate the transition towards a value-based system with policy proposals that will help drive payment innovation. Program Details Anthem, Inc. and Eli Lilly and Company came together in November 2014 in a policy collaboration to help accelerate the transition to a value-based system. Through this collaboration, the companies identified two policy proposals to help drive payment innovation. These proposals include: 1. Facilitating Open Communication about Emerging Therapies: Create a legislative or regulatory exemption that would allow manufacturers and health plans to communicate about emerging products prior to U.S. Food & Drug Administration (FDA) approval. –– Objective: Clarify federal law to confirm that manufacturers may speak openly with health plans about drugs going through the FDA approval process, particularly with regard to product efficacy, safety, and pharmacoeconomic information. 2. Promoting Value-Based Contracting Arrangements: Establish safe harbors in the Anti-Kickback Statute that would allow for manufacturers and plans to increase experimentation with value based arrangements. An Initiative of the 95 | Anthem and Eli Lilly Policy Collaboration
NDHI NAT IONAL DIALOGUE FOR Healthcare Innovation –– Objective: Create a policy environment conducive to allowing health plans and manufacturers to enter into a variety of value-based contracting arrangements, aligned with the shift toward value-based payment and the goal of promoting access to high-value care. This may include creation of legislative/regulatory exceptions for Best Price and all other relevant government pricing calculations and requirements as they relate to products sold or transferred under value-based contracts, as well as additional safe harbors (adherence safe harbor, data analytics safe harbor, warranty safe harbor) to the federal Anti-Kickback Statute (AKS) that protect value-based contracts from AKS liability. Value Delivered Many stakeholders can benefit from more open communication between biopharmaceutical manufacturers and health benefit companies as well as from a policy environment more conducive to value-based payment arrangements: • Health plans would be able to establish rates and benefits more effectively with increased information and greater ability to drive value through innovation in payment arrangements • Manufacturers would be able to demonstrate the value of their products for patients and for the healthcare system sooner and more directly ensuring the right patients are getting treatment at the right time Path Forward • In the short term, both companies will continue educating policy decision-makers and health policy thought-leaders on these issues. In the long term, they hope to achieve the goals of the collaboration, achieving policy changes that enable communication and innovation to thrive in the healthcare industry, in order to more successfully provide access to state-of-the-art treatments to improve health and cure illness. • Patients would benefit from enhanced access to medicines and more predictable insurance rates Anthem and Eli Lilly Policy Collaboration | 96
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Foreword The U.S. healthcare indust
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Section 1 Collaborations to Enable
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