Gene Chieh

Senior Analyst, Pricing and Market Access

Optimizing Medicines, Improving Lives

The Academy of Managed Care Pharmacy (AMCP) is a leading professional association in the United States dedicated to improving patient access to affordable medicine. The AMCP Managed Care & Specialty Pharmacy Annual Meeting is held each spring for managed care professionals who manage health benefits of more than 270 million Americans. The annual meeting brings together all the voices and visions of managed care pharmacy, healthcare, and breakthrough drug therapies. Members of the Academy seek to optimize medicine by focusing on value-based care strategies while promoting cost-effectiveness of treatment.

The annual meeting provides a fertile ground for market access solutions dialogue and for recruitment of additional advisors for ICON’s already robust research panel, AccessLine. More than 4000 managed care professionals, including pharmacy directors at national and regional managed care organizations (MCOs), clinical pharmacists serving on P&T committees, health economics and outcomes research (HEOR) specialists, medical science liaisons, student pharmacists, and more attended the 2019 meeting. Moreover, the meeting’s Expo featured 120 exhibitors from industry stakeholders, such as biopharmaceutical manufacturers, CROs, consultants, and vendors. 

Some of the key topics and trends observed during the 2019 annual meeting included the legislative initiative to allow for the early exchange of product information between manufacturers and health plans prior to obtaining FDA approval, the shifting trend toward incorporating cost-effectiveness analysis as part of the therapy value assessment, and best practices on value-based contracting.

The Pharmaceutical Information Exchange (PIE) Act

One of the key initiatives of AMCP this year is to gather bipartisan support for the passage of H.R.2026—The Pharmaceutical Information Exchange (PIE) Act, which failed to pass in 2017. The bill aims to improve patient access to emerging therapies by clarifying the legal framework that would allow for the sharing of clinical and health economic information for therapies that are not yet approved by the FDA.

While recent FDA guidelines aim to clarify the scope and communications of healthcare economics information (HCEI) for investigational therapies, the guidelines are nonbinding and do not establish legally enforceable responsibilities.

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Some health plans have noted that the restriction on HCEI exchange causes delays in critical planning, budgeting, and forecasting associated with health benefit design. If the bill passes, manufacturers may provide clinical and economic information 12 to 18 months before FDA approval, thereby facilitating timely access to emerging therapies.

Value-based Care Management and Contracting

Besides legislative and regulatory matters, topics on value-based care management and contracting were popular among attendees. The recent influx of high-cost therapies with uncertain long-term benefits has prompted health coverage decision-makers to explore consensus framework for value assessment and innovative funding mechanisms to cope with budget constraint. Additionally, there is a concerted effort by various organizations to place a higher emphasis on the cost-effectiveness of treatment as part of the formulary coverage decision. 

The Institute for Clinical and Economic Review (ICER) was prominently featured in all the talks surrounding value assessment. Premera Blue Cross, a regional MCO in the Northwest (Washington and Alaska), has incorporated ICER reports in their P&T review workflow. Premera shared key learnings and best practices on using ICER reports to address the marketplace challenges the organization faced. While it is unclear how many MCOs have incorporated ICER assessments as part of their formulary review, the shifting trend toward cost-effectiveness may spur the use of ICER reports on a broader basis.

In terms of value-based contracting, interest remains high despite challenges in defining and measuring the appropriate outcomes in certain disease areas. James Kenney, an ex-payer at Harvard Pilgrim, discussed best practices in designing and data processing for an outcome-based contract. While some manufacturers may be reluctant to enter into a risk-sharing agreement due to a lack of objective outcomes measurement, Kenney argued that payers would be willing to consider proxy measures, such as prescription fill rate, medication adherence, etc, as short-term metrics while waiting for additional data to be generated. Additionally, manufacturers could structure the contract such that it could be used as an offensive or defensive strategy in the marketplace. An offensive strategy requires a demonstration of value in order to improve uptake and grow market share. A defensive strategy, on the other hand, entails a preferential placement on the formulary (or preferred status) to protect current position and maintain market share. Regardless of the type of contract, the ease of data collection and processing has been highlighted as one of the key drivers for success.

In closing, the meeting was a prominent venue to highlight to the market the end-to-end strategy and execution capabilities of ICON’s Access, Commercialisation and Communications (ACC) team. We connected with many biopharmaceutical clients and stakeholders, and it was encouraging to see how ICON’s integrated solutions are indeed well-positioned to help address our clients’ needs in the ever-changing US healthcare marketplace, as observed over the course of the meeting.