COVID-19: Challenges and Opportunities for the Global Health Technology Assessment Community

Brian O’Rourke, PharmD, Chair of the ISPOR HTA Council, Ottawa, Ontario, Canada; Lucinda S. Orsini, DPM, MPH, Vice President for Value and Outcomes Research, COMPASS Pathways, New York, NY, USA; John Guerino, MHS, Manager, Scientific & Health Policy Initiatives, ISPOR, Lawrenceville, NJ, USA

The COVID-19 pandemic has disrupted global healthcare systems and created significant challenges for the health technology assessment (HTA) and payer communities.¹ To better understand these challenges, ISPOR conducted a qualitative survey involving all participants of the ISPOR Regional HTA Roundtables. In this article, we present the results of these surveys and discuss the implications of the identified challenges and opportunities.

As described on the ISPOR website², the ISPOR Health Technology Assessment (HTA) Council is a global body of healthcare decision makers who advise the Society on ways to bridge the gap between outcomes research and healthcare decision making. One of the primary activities of the Council is the convening of HTA Roundtables. These roundtables provide a platform for technology assessors and payers to discuss issues related to the reimbursement of health technologies. Attendees include representatives from public and not-for-profit HTA agencies, public and private payer organizations, patient group representatives, and government-contracted academic centers (if no HTA body exists in the country). ISPOR convenes annual HTA Roundtables in the Asia Pacific region, Europe, Latin America, the Middle East and Africa, and North America.

The survey consisted of one open-ended question: “What are the top three HTA/Payer challenges or opportunities that have surfaced during the COVID-19 pandemic?” Respondents were asked to identify challenges and opportunities related to the diagnosis and treatment of COVID-19 and also to discuss how the pandemic has impacted HTA unrelated to COVID-19.

Too many people were dying, hospitals were overflowing, and economies were crashing—governments and public health officials were under extreme pressure to remedy the situation with a prevailing attitude for them to “just do something.”

Main Challenges Identified
Results from the regional surveys were compiled in a rolling fashion and presented during each of the HTA Roundtables held in 2020. Global results and uniquely regional results were presented and discussed. Later roundtables received the benefit of being presented with a cascading summary of key challenges and opportunities identified in other regions. Following the final roundtable held on November 10, 2020, the results from all surveys were analyzed by the authors in consultation with other members of the HTA Council during a meeting held on December 9, 2020. The points presented below reflect the most pressing challenges common to all regions.

• Speed Versus Quality: During the pandemic—especially during the early months of the crisis—politicians, officials, healthcare providers, the media, and citizens had an insatiable appetite for answers. How does the disease spread? What protective equipment and public health measures should we employ? What diagnostic tests are available, and how accurate are they? What treatments are effective? Too many people were dying, hospitals were overflowing, and economies were crashing—governments and public health officials were under extreme pressure to remedy the situation with a prevailing attitude for them to “just do something.” As a result, there seemed to be a never-ending requirement to provide evidence-based advice as rapidly as possible. HTA agencies responded by producing ultra-rapid reviews, conducting rolling reviews and updating reports as new evidence emerged, and increasingly used evidence-grading methodologies and processes for expert elicitation. Although there was concern from agency personnel regarding the quality and other risks associated with expedited reviews, the concept of ultra-rapid reviews has been well-received by policy makers and healthcare providers, and it is likely that there will be pressure to incorporate this type of review in the postpandemic environment.

• Economies in Distress: Many survey respondents identified financial challenges as the most significant issue impacting their countries’ ability to respond to the pandemic and to recharge their economies following the pandemic. Several mentioned that their country was already facing major economic burdens prior to the pandemic. To minimize the impact of lockdowns and business closures, governments offered substantial stimulus packages to individuals and businesses, adding further strain to their financial sustainability. This was further compounded with the need to procure protective equipment, diagnostic tests, treatments, and ultimately, vaccines. These fiscal challenges will extend well past the end of the pandemic, which should heighten the need for HTA as governments are faced with making tough choices on where best to allocate their scarce resources. The economic challenges could provide additional incentive to establish or augment HTA capacity in countries with limited formal HTA resources.

• Accelerated Approval of Health Technologies: During the pandemic, global regulators were under considerable pressure to expedite their approval of diagnostic tests, treatments, and vaccines designed to combat the virus. Most regulators have accelerated pathways to review breakthrough technologies, and they can provide special authorization or conditional approval. HTA practitioners, payers, and clinicians believe that accelerated approvals create significant uncertainty at market launch—uncertainty related to the comparative clinical benefit, harm, and value of the technology. Respondents to the survey indicated that during the pandemic, the reduced level of evidence for providing regulatory approval was creating even higher levels of uncertainty. There was also concern that some payers were bypassing HTA and going from regulatory approval directly to price negotiation (with some agreements being negotiated prior to regulatory approval). Rather than focusing on this as a growing risk, the HTA and payer communities should embrace concepts that promote early access to promising medicines and technologies by implementing a life-cycle approach to technology reviews. Key elements of life-cycle HTA include enhancing horizon scanning and early scientific advice; providing conditional reimbursement based on rolling reviews; implementing structured processes to collect and analyze real-world data³; reassessing technologies based on new evidence; employing risk-sharing initiatives via managed entry agreements; and developing innovative payment strategies.

• Heightened Need for Harmonization and Collaboration: During the pandemic, HTA agencies were inundated with requests to conduct reviews on a multitude of technologies, many of which went well beyond the scope of their prepandemic mandate. This included masks and other protective equipment, public health measures, ventilation systems, repurposing of drugs, vaccines and treatments for COVID-19, and a seemingly unending basket of diagnostic tests. Many respondents indicated that they struggled to stay ahead of the demand, while regulators, despite their own COVID-19 workload, were able to adhere to timelines by issuing market authorizations for a growing pipeline of novel non–COVID-19 drugs and technologies.

As reported in the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research annual report for 2020, there were 53 novel drugs approved, compared to 48 approved in 2019, and 68% of the novel drugs were approved under one or more of the FDA expedited pathways.⁴ In Europe, the Human Medicines Highlights for 2020 summary from the European Medicines Agency (EMA) reported that the EMA issued 97 positive opinions, which included marketing authorization for 39 new active substances,⁵ and a similar pattern emerged for regulators in other countries. Compounding the issue, many HTA agency staff were reassigned to clinical roles in hospitals or policy roles in government to aid in the management of the pandemic.

The totality of the public health burden of these diagnostic and treatment delays is uncertain; however, providers are concerned that there will be a major increase in morbidity and mortality.

Even prior to the pandemic, a shortage of trained and experienced HTA practitioners was the number one challenge identified in a survey conducted by the International Network of Agencies for Health Technology Assessment in 2018.⁶ HTA roundtable survey respondents stressed that they were forced to prioritize their workloads and, in some cases, had to suspend or delay non–COVID-19 work. This fostered a distinct shift to increased regional, national, and cross-border collaborations. As one respondent reported, “We were collaborating in areas where it felt forced prior to the pandemic.” Respondents also signaled that there is a strong desire to continue to forge partnerships and promote harmonized approaches to market access once we move past the pandemic. However, to fully embrace collaboration, there will need to be a concerted effort by the HTA and payer communities to go beyond information sharing to encourage harmonization and build meaningful partnerships, perhaps building on a published summary of good practices in HTA.⁷

Could the World Health Organization (WHO) be engaged to develop HTA standards and practices, particularly for low- and middle-income countries? What lessons can be learned from collaborative initiatives established by the regulatory community? Regulators harmonize their processes and methods via the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, the International Coalition of Medicines Regulatory Authorities, and benchmarking by the Center for Innovation in Regulatory Science. Via these partnerships, regulators have developed structured approaches for “Reliance” (whereby a regulatory authority in one jurisdiction gives significant weight to work performed by another regulator) and “Recognition” (the routine acceptance of the regulatory decision of another regulator).⁸ Should these models be replicated for HTA agencies and payers?

• Assessing the Impact of Delayed Diagnosis and Treatment of Non–COVID-19 Diseases: During the early stages of the pandemic, non–COVID-19 patient care was severely disrupted, and there was a significant shift to the provision of virtual care. The totality of the public health burden of these diagnostic and treatment delays is uncertain; however, providers are concerned that there will be a major increase in morbidity and mortality. What this means for the HTA and payer communities is unclear; however, it is expected that there will be requirements to reassess the effectiveness of treatments that were approved for use during earlier stages of a disease, to advise clinicians on new combinations and treatment regimens, and to review the impact of treatment delays on downstream healthcare costs. In addition, as patients have begun to appreciate the benefits of virtual care, there will be a need to assess the clinical effectiveness and value of these virtual approaches to healthcare.

In addition to the issues mentioned above, there were a number of other challenges identified by survey respondents, including a confusing and competitive evidence ecosystem, especially in the early stages of the pandemic, as numerous organizations attempted to position themselves as the trusted source for evidence; supply chain challenges and drug shortages; an increase in the spread of misinformation (myths, rumors, conspiracy theories), with many agencies using this as an opportunity to enhance their knowledge-sharing with members of the media and the general public; and there were equity issues associated with the hoarding of drugs and supplies and vaccine nationalism with wealthy countries purchasing the bulk of available supplies.

There were also challenges identified that were unique to a particular region. For example, respondents from the Asia Pacific HTA Roundtable expressed concern with their ability to meet the WHO targets for Universal Health Coverage during the pandemic, while participants from the Middle East and Africa worried that the pandemic would inhibit the growth of HTA in their region. Respondents to the North American roundtable included several comments related to inconsistent application of government regulations, removing preauthorization criteria, and providing a 60- to 90-day supply of medications to minimize patient travel to pharmacies.

Where Do We Go From Here?
This survey has identified some of the major challenges for HTA agencies and payers arising during the COVID-19 pandemic. Many of these challenges had their genesis prior to the outbreak, but they gained prominence during the pandemic. It also became clear that the pandemic may serve as a stimulus for change. Of note, the ongoing debate between speed and rigor will continue to flourish in the postpandemic environment. Regulators will continue to approve new drugs and devices using accelerated pathways with increasing levels of uncertainty; clinicians and patients will continue to demand early access to promising technologies; and policy makers will continue to push for timely HTA advice. To meet these challenges, life-cycle HTA, harmonization, and collaboration will need to be exploited. The ISPOR HTA Council will engage with stakeholders to further analyze challenges and advance opportunities arising from this survey.

References

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