NOVEMBER 2019 Research Alert

This month we added five new studies to the Best Practice Database, the research repository for Best Practices, LLC. This month's new studies focus on three topical areas: co-pay accumulator programs, MSL involvement in Phase IV studies; and the market entry of CAR-T therapies. The co-pay accumulator studies turn a lens on how these programs have affected oncology manufacturers; the first document reviews impact and challenges while the second study looks at strategies and tactics to counter these programs. The Phase IV studies, meanwhile, are focused on the role that MSLs play in these important safety reviews; the third document looks at how the objectives and team structure of MSLs impacts Phase IV studies while the fourth document reviews MSL roles and training around Phase IV. The fifth and last document is a case study of the two ground breaking CAR-T therapies on the market and the opportunities and challenges facing this important class of drugs.

The new Best Practices, LLC studies listed below under Newly Added Research explore how leading companies have made their operations more effective across these different areas.

	Download: Co-pay Accumulator Programs: Oncology Manufacturer Impact and Challenges (5583) Payers and PBMs have turned to co-pay accumulators with different names to counter rising pharmaceutical costs, but it resulted in patients paying more out-of-pockets and switching to generics or other lower cost therapies. This study will help market access leaders in oncology to understand the threat, impact and challenges that co-pay accumulator programs present to the pharmaceutical industry and patients.
	Download: Co-pay Accumulator Programs: Oncology Manufacturer Strategies & Tactics for Ensuring Patient Access (5584) Payers are using co-pay programs to block traditional forms of manufacturer-sponsored financial assistance for therapies, which push patients to pay more out-of-pockets. Best Practices, LLC conducted this study to highlight the tactics and strategies that oncology and other specialty manufacturers are using to counter “co-pay accumulator” (CA) programs and measure the success of CA mitigation.
	Download: Raising Phase IV Performance & Value through Optimal MSL Involvement: Objectives and Team Structure (5585) Pharmaceutical and biotech companies are driving their efforts towards maximizing the impact of MSLs on Phase IV studies to generate real world data that serves the needs of vital stakeholders such as payers and regulatory bodies. This study characterizes MSL contributions and delivers benchmarks around the field team structures that maximize MSL impact on Phase IV studies.
	Download: Raising Phase IV Performance & Value through Optimal MSL Involvement: MSL Roles, Impact & Training and Development (5586) As payers and regulatory bodies increasingly demand real world evidence for key decision making, it is important to reflect key stakeholder perspectives in Phase IV study design and execution. This benchmarking research spotlights Phase IV opportunity fronts for MSL deployment, along with the field team skills and training to maximize MSL impact on Phase IV studies.
	Download: CAR-T & Cell Therapy Products: Next Generation of Oncology Products Create Chance for Boom or Bust (5587) The potential of Novartis' Kymriah and Gilead's Yescarta fueled blockbuster projections and a flurry of industry interest in CAR-T development. But large price tags, manufacturing challenges, and serious side effects have stymied wide-scale utilization of the therapies. This extensive research project examines the genesis and gives critical insights into the potential and challenges facing CAR-T development and launch.