As of March 2015, when the FDA approved the first biosimilar drug in the United States, biosimilars started to make a much-anticipated impact in the U.S. pharmaceutical market. Biosimilars are expected to offer cost savings, with efficacy and safety that are comparable to innovator products. Yet the overall value of a biosimilar is determined by more than pricing. As with all therapeutics, optimizing economic efficiency is part of the health care decision-making process. Based on the European experience with biosimilars, significant impact of this new class of drugs in the U.S. market will require buy-in from specialists, physicians, payers, and patients. What type of decision-analytic models are needed for formulary/reimbursement, clinical use, and prescribing decisions? This session will review issues related to biosimilar uptake by major U.S. stakeholders, including cost-effectiveness models and other analyses such as opportunity cost and cost-minimization. Representative payer and provider decision makers will discuss what each would require to establish a value proposition for biosimilars and to actualize their market penetration and appropriate use. Lessons learned from European biosimilar models will be discussed. Cost-effectiveness and budget-impact analyses for both long- and short-term decision making will be presented, with an emphasis on building and interpreting these models for biosimilars in the U.S..Through a moderated-panel format, this symposium will offer insights into the methodologies that can provide needed information to key stakeholders as biosimilars make their debut in the United States, and to reaffirm cost-effectiveness throughout their life cycle.
This symposium will discuss the relative affordability of new therapies for advanced cancers, current pricing models and their drawbacks, methods for innovation in pricing from new medicines in advanced cancers, and practical application of innovative pricing models.
1. A review of current approaches to pricing for innovative medicines for advanced cancers, including risk sharing, and the uncertainties generated from these approaches
2. Building a more sustainable model in pricing of new medicines for advanced cancers
3. Practical application of new pricing methods in different health care systems
Real world evidence, such as large scale patient registries, have often been proposed as potential sources of clinical, economic, patient reported, and safety outcomes evidence that can aid decision making in health care. The impact on payer reimbursement decisions will be discussed.
Trends in sharing health economic information under Section 114 will be discussed. Perspectives of how pharmaceutical companies are handling the dissemination of health economic information as well as receipt of information by managed care will be shared and discussed in detail.
Real-world evidence (RWE) has deep roots in outcomes research, pharmaco-epidemiology, and phase IV studies. In fact, there are thousands of experts sitting in pharma companies every day producing thousands of RWE studies with the intention of informing payer decisions. They are leveraging new electronic data sources, interrogation technology, novel analytic methodologies, and deeper understanding of health care issues and tradeoffs. But whereas regulators are already seeing the benefits from improved safety and drug utilization studies, payers have not adopted RWE as widely. And where they do use it, they widely restrict the input coming from pharma companies. Why? We wanted to know, too.
This symposium is the result of several steps in exploration of this situation. The exploration included leveraging direct experience supporting pharma as well as engaged payers and Integrated Delivery Networks (IDN) directly on this topic. Research on 100+ known cases of RWE use in payer decisions was conducted. A joint symposium with the Johns Hopkins Center for Drug Safety and Effectiveness (including pharma, academic, and payer participants) was held, and RWE-specific research in a survey with 70 US payers was conducted. This symposium will discuss how RWE has informed payer and IDN decisions to date and other findings from the research and case studies. Tangible opportunities for life sciences to accelerate engagement and impact of RWE and its generation will also be explored. Faculty will include representatives of payers, IDNs, academics, and senior experts from IMS Health.