Payer Engagement in HEOR

Since the inception of ISPOR more than 25 years ago, the Society has led major efforts to further the scientific evidence used to inform payer decisions, as well as approaches to effectively engage stakeholders in these decisions. Payers are key stakeholders that regularly participate in the Society’s HTA Council, HTA Roundtables, Payer Summits, and many sessions at ISPOR conferences, summits, and other events. The topics featured at payer-focused events and sessions are identified and led by member experts who follow emerging trends and challenges in healthcare decision making. These sessions also offer ample time for discussion, allowing participants to share lessons learned, solutions, and priorities for moving forward. ISPOR’s commitment to engaging payers is also demonstrated through a number of real-world evidence initiatives that are aimed at furthering the use of real-world data in regulatory and HTA processes. In addition, ISPOR member experts have developed a widely recognized value assessment frameworks as part of broader efforts to identify the elements of value and how to measure them. 

Details about these initiatives are provided below.

In April 2021, ISPOR sponsored a Payer Summit designed to provide a forum to discuss performance-based managed entry agreements (MEAs). The Summit drew more than 60 stakeholders who considered the benefits and challenges of MEAs, efficient approaches to develop and scale up these types of agreements, and best practices in their development and implementation. Attendees included representatives from public and private payers from North America and Europe, HTA bodies, pharmaceutical and medical devices companies, patient groups, and academia.

The Payer Summit agenda included 2 segments with the first offering a series of short presentations by experts from a variety of backgrounds and perspectives who shared the benefits and challenges of implementing performance-based agreements on their institutions and sectors. The presentations included: 

Dr Martin Wenzl and Ms Suzanne Chapman, health policy analysts at the Organisation for Economic Co-operation and Development (OECD) Directorate for Employment, Labour, and Social Affairs summarized the results from an OECD survey and publication on performance-based MEAs for new medicines. The OECD work included assessing the effectiveness of performance-based MEAs in achieving their stated goals of increasing access for new therapies and identifying good practices and opportunities for improvement.

Dr Detlev Parow, head of the Department of Medicines, Therapeutic Appliances and Remedies at DAK-Gesundheit in Germany provided an overview of the German healthcare system and explained that while Germany does not use MEAs, they do use a form of selective contracting for one-time therapies that closely resembles the MEA process.

Dr Donna L. Sullivan, chief pharmacy officer, Washington State Prescription Drug Program shared her perspective as a payer in the United States. She highlighted some of the barriers that US payers face when considering the use of MEAs and cited several examples, including the unmet needs for payers on the design and implementation of the MEAs and the challenges faced by smaller purchasers. 

Dr Indranil Bagchi, senior vice president and head, Global Value and Access at Novartis provided an industry perspective that highlighted the contributions pharmaceutical companies make to increase access for patients. An example outlining the current and future landscape of cell and gene therapies was provided to illustrate the benefits of implementing-MEAs.

The second segment of the Summit consisted of breakout sessions in which attendees addressed specific topics and strategies to capitalize on the benefits of performance-based MEAs. Participants divided into 6 breakout groups—2 groups focused on the types of products suitable for performance-based contracts, 2 groups discussed implementation barriers and opportunities to scale up performance-based contracting, and 2 groups reviewed best practices by highlighting some successful and unsuccessful examples of performance-based MEAs. 

The results of the breakout sessions were then shared with all participants. Each breakout group also offered their recommendations on ways ISPOR could support mechanisms to improve patient outcomes and support the healthcare decision making process through approaches such as MEAs. Suggestions included:

• Convene stakeholder groups to help identify relevant and meaningful outcomes for various conditions. The main barriers recognized during the summit were those involving the level of uncertainty and the lack of trust. The group felt that ISPOR could help facilitate multistakeholder working groups or task forces to foster horizon scanning; develop guidelines, templates, and methodologies; and to centralize and standardize outcomes for various therapeutic areas.

   

• Promote transparency among MEA’s participants by leveraging ISPOR’s member groups and councils including the HTA and Patient Councils.

   

• Update best practice guidance documents to reflect the current state of performance-based MEAs.

ISPOR continuously works to create guidelines and tools to help improve decision making and to bridge gaps between stakeholders. ISPOR provides many training opportunities through workshops, short courses, and webinars. Several areas were identified by the participants for consideration by the Society. ISPOR recognizes and appreciates the engagement and collaboration of all Payer Summit participants.

The Summit was organized by the ISPOR HTA Council and moderated by Mark Trusheim, Strategic Director at NEWDIGS and Visiting Scientist at MIT, Boston, MA.

A detailed summary of the Payer Summit 2021 can be found here.

The ISPOR Payer Summit 2020—the Society’s first payer summit—was held on September 30 and focused on the theme, “Quality, Access, and Use of Real-World Data by Payers: Where Are We Now? Where Do We Want to Be in the Future?”. One of the biggest challenges payers face today is the impact of innovative, new therapies for diseases with unmet-needs, such as oncological and rare diseases. These novel therapies are often highly effective for a proportion of patients. However, many are costly compared to current therapies and while they may offer dosage regimens (1 or 2 doses) that can increase patient compliance, may also front load all of the cost to the beginning of care. This creates strain on healthcare system budgets, raises affordability and equity issues, and creates a great deal of uncertainty for assessment bodies and payers. This challenge is being addressed through a variety of approaches, including programs such as coverage with evidence development and outcomes-based agreements. Real world data (RWD) is critical to ensuring the success of these approaches. Beyond its use in managed entry agreements, RWD also plays a role increasing the critical mass of scientific evidence for medical technologies, particularly for these innovative therapies that are often approved with a smaller amount of data than other traditional therapeutics. The use of RWD can empower payers to enhance decision making that can reduce wasteful spending, improve patient outcomes, and lead to more sustainable healthcare systems.

ISPOR’s Health Technology Assessment Council works to:

• Provide a platform for regional ISPOR HTA Roundtables to share issues and recommendations
• Offer guidance in the translation and use of outcomes studies as useful information in the health technology assessment and healthcare decision-making processes
• Address issues and concerns of decision makers globally
• Assist in the development and implementation of initiatives related to the use of outcomes research information by healthcare decision makers

ISPOR’s Health Technology Assessment Roundtables provide a platform to advance scientific methods; facilitate information sharing about the current state of HTA, its development, and its role in optimizing healthcare decisions; and bridge the gap between technology assessors, private and public payers, regulators, and patients to improve health globally. HTA Roundtables convene annually in Asia Pacific, Europe, Latin America, Middle East and Africa, and North America. The first HTA Roundtable was founded in North America in 2006 and was comprised of invited members of pharmacy and therapeutics (P&T) committees in the United States and Canada. The HTA Roundtables have expanded over time to the current regional formats.

The latest updates on Health Technology Assessment Roundtables can be found here. 

Virtual ISPOR Health Technology Assessment – Pharmacy and Therapeutics Roundtable – North America 2021 

On May 12, 2021, the HTA Roundtable – North America drew representatives from the Canadian Agency for Drugs and Technologies in Health (CADTH), the Institute for Clinical and Economic Review (ICER), a variety of health insurers in the United States, and a number of other organizations involved in HTA across North America. The roundtable was divided into 2 topics categories: (1) Racial disparities and health equity: A panel with representatives from the Sickle Cell Disease Association of the Midwest, the Canadian Organization for Rare Disorders, and the recently created ISPOR Special Interest Group on Health Equity Research was held and followed by open discussion. (2) The need for a lifecycle approach to HTA: Suzanne McGurn, president and CEO of CADTH spoke and her presentation was followed by an open discussion.

Virtual ISPOR Health Technology Assessment Roundtable – Middle East and Africa 2021

On October 12, 2021, attendees from HTA bodies across 14 different countries met. Representatives from each country provided an update on the status of HTA implementation in their respective countries and offered their perspectives on managed entry agreements as a potential mechanism to improve patient access. The Roundtable began with a short course training on performance-based risk sharing agreements facilitated by Professor Emeritus Adrian Towse. 

Virtual ISPOR Health Technology Assessment Roundtable – Latin America 2021

On September 22, 2021, representatives from HTA bodies representing 18 countries in Latin America met virtually. Participants discussed the challenges and opportunities of integrating evidence from the real world into the HTA process. Representatives from HTA bodies in the region spoke and highlighted the need to develop frameworks to adapt this type of evidence into their decision-making processes. Presentations were also featured with speakers from the National Institute for Clinical Excellence (NICE) and the Canadian Agency for Drugs and Technologies in Health (CADTH) discussing best practices on the HTA for medical devices. 

Virtual ISPOR Health Technology Assessment Roundtable – Asia Pacific 2021

On November 9, 2021, participants representing HTA bodies from 18 countries in Asia Pacific attended the ISPOR HTA Roundtable – Asia Pacific. This Roundtable focused on 2 main topics: (1) The Lifecycle HTA Approach and (2) Best Practices on Contracting.
Speakers from HTA bodies discussed the use of the lifecycle approach in processes; from horizon scanning to scientific advice until disinvestment decisions. Regional best practices were also shared on contracting, in addition to novel ways to provide access for new therapies, such as the development of managed entry agreements and the implementation of a tendering system as a potential solution. 

Virtual ISPOR Health Technology Assessment Roundtable – Europe 2021

On November 23, 2021, attendees from 20 different European countries convened for the Virtual ISPOR HTA Roundtable – Europe. This Roundtable focused on 2 relevant topics: (1) The Role of HTA in Assessing Digital Technologies and Virtual Care and 2) HTA of Potentially Curative Therapies. Speakers focused on the need to adapt and organize HTA activities around emerging trends and included experts from HTA bodies and academic institutions, including the National Health Fund HQ, INFARMED, IQWiG, Gdańsk Medical University, and AIFA, among others. 

ISPOR’s Health Technology Assessment Central  is a comprehensive repository of resources and tools to support health technology assessment (HTA) and that helps bridge the gap between health economics and outcomes research (HEOR) and other disciplines that inform HTA and healthcare decisions. 

HTA Central is freely available to all and offers information and news pertaining to HTA in Asia Pacific, Europe, Latin America, Middle East and Africa, and North America. The site aims to address broad questions about how to promote an equitable, efficient, and high-quality health systems, the steps for conducting a thorough health technology assessment, and much more.

To learn more about HTA visit: Health Technology Assessment Central. 

Joint HTAi - ISPOR Deliberative Processes for HTA Task Force

ISPOR HTA Council Working Group on HTA in Pluralistic Healthcare Systems: Challenges of Health Technology Assessment (HTA) In Pluralistic Healthcare Systems