HTA Quarterly | Spring 2019

By Xcenda

In this issue, we explore the proposed rule from the Centers for Medicare & Medicaid Services on managed care value-based formulary decisions and consider how patient input can help influence drug development.


Opening the Gate on Protected Classes: How CMS’ Proposed Rule May Unleash a Wave of Value-Based Decision Making

As the war on drug prices wages on, the Centers for Medicare & Medicaid Services (CMS) continues to explore innovative ways to afford Part D plan sponsors the flexibility to more effectively negotiate with manufacturers on their behalf. In contrast, European Health Technology Assessment (HTA) agencies have long utilized value assessment to more tightly restrict coverage policies and maintain lower drug prices. By empowering managed care organizations to make value-based formulary decisions, it may be that a new, more competitive marketplace will help drive utilization toward more cost-effective treatment options and ultimately lower drug costs; however, questions remain about the impact on access.
balancing balls


Can patients help influence drug development? Where are we with respect to patient input on early scientific advice in North America and Europe?

Regulatory agencies, including the Food and Drug Administration (FDA) and European Medicines Agency (EMA), and many health technology assessment (HTA) groups offer scientific advice, for a fee, to pharmaceutical manufacturers to elicit input on their clinical and economic evidence generation plans during the drug development process. Patient input is now actively being sought from many stakeholders and, in countries where universal health care predominates, patient input may even be mandated; for example, the National Institute for Health and Care Excellence (NICE) is required by the UK government to demonstrate that it has consulted with patient groups, and the EMA is legislated to implement specific forms of interaction with patients. This article reviews the current status of patient input into early scientific advice and the ensuing opportunities for the pharmaceutical industry.
Close up provider/patient input

Heard on the Street

“For the first time in Canada, drug evaluation and price negotiation could be carried out by a single entity—resulting in lower prescription drug prices for Canadians and their families. By acting as a single evaluator and negotiator on behalf of Canada’s drug plans, the proposed agency could reduce drug spending by billions of dollars per year, compared to baseline projections, within 10 years of implementation.”

– Canadian Finance Minister Bill Morneau, presenting the proposed budget on March 19. The budget calls for creation of a new drug agency that would be responsible for both assessing the effectiveness of approved medicines and negotiating prices with a goal of reducing costs. The agency would also establish a national formulary and create consistent drug coverage across the country. 

HTA by the Numbers

£1 Billion

NHS England has entered into a £1 billion agreement with Gilead Sciences, Merck & Co., and AbbVie to purchase hepatitis C drugs at competitive prices in an effort to eradicate hepatitis C over the next 3 years.