You can read part 1 of this series, "Access wanted: What it takes for patients to get the drugs they need," here.
According to information provided to BioPharma Dive by PatientView, a UK-based company headed by Dr. Alex Wyke that collects and analyzes the viewpoints of thousands of patient organizations worldwide, different patient groups face a variety of unique challenges that ultimately impact how successful they are at influencing the health technology assessment (HTA) process and gaining access to medications—especially the newest, most innovative treatment options.
For example, groups that represent patients with cancer, rheumatology-related disorders, and CVD diseases feel that they have a hard time getting their messages across to the media, while groups that represent patients with diabetes and patients with mental illness face a great deal of public apathy. For patient groups focused on gastrointestinal issues, as well as those focused on the concerns of patients with endocrine diseases, the main concern is a lack of research interest. Finally, among HIV/AIDS patient groups, as well as those who support the interests of patients with respiratory illnesses, the main concern is a lack of cooperation from the government.
Helping patients become more HTA-savvy
In order for patients to have more influence over access to medicines, they need to understand how the process works. Pharma companies are well positioned to provide that guidance. Eli Lily is a good example. In March 2014, Lilly announced the launch of an online tool to help patient-group advocates influence access to medications.
Lilly collaborated with a group of HTA specialists on developing the tool, eMEET (Medicine Evaluation and Educational Training). Using eMEET is straightforward and allows participants to go at their own pace, while watching videos and taking online quizzes to reinforce their education. The eMEET training program provides patients with a series of modules that focus on drug discovery and development; the concept of HTAs; and how to communicate with HTA panels. The program also provides numerous real-world case studies and examples.
The underlying rationale that is driving Lilly and other companies to support patients as they seek to influence top-line access decisions is that patients are the primary repositories of knowledge about what it’s like to live with an illness; yet, their expenses and expectations are often not factored into the decision-making process when pharmacy benefit managers (PBMs) and agencies, such as the UK’s National Institute of Health and Care Effectiveness (NICE), make decisions about which drugs to approve for funding and which groups will gain covered access to the products.
HTA in the USA?
Currently, HTA requirements exist in about 30 countries, mainly in Europe, with one of the most well-known being NICE. However, the pharmaceutical industry is global. And increasingly, policymakers in the U.S. are looking at the European HTA model as the way to deal with making healthcare allocation decisions in a healthcare environment that has changed dramatically since the inception of the Affordable Care Act, aka Obamacare.
Increased competition among insurers, as well as universal access to health insurance, has made it even more important to weigh benefits and costs versus all available evidence. And though much of the formulary decision-making is still happening on a plan-by-plan basis, there is a movement towards recognition and utilization of HTAs in the U.S.
Currently, the most widely used HTA guidance in the US comes from the Academy of Managed Care Pharmacy (AMCP). The AMCP provides HTA guidance that factors in clinical evidence, cost effectiveness, and impact on the overall budget. Learning to understand how guidance such as that provided by AMCP works is an important first step for patient-group advocates—and the pharmaceutical companies that work hard to develop products to protect, preserve, and enhance patients’ lives.