HTA Quarterly | Spring 2019

In December 2016, then-President Barack Obama signed the 21st Century Cures Act (Cures Act) into law. This key piece of bipartisan legislation increased funding for medical research and development and innovation, opioid addiction treatment and prevention, mental health, and developments in health information technology. The Act has the potential to have a significant effect on those involved in the US healthcare system, particularly for strategic evidence development and market access. In this article, we summarize the significant provisions of the Cures Act and highlight areas of impact for pharmaceutical and device manufacturers, payers, and patients.

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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.

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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.

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