HEOR Across the Globe
Editor’s Note: Value & Outcomes Spotlight is pleased to introduce “HEOR Across the Globe” as a recurring section in the magazine. The Section Editors work with a small team of Regional Reporters from Asia Pacific, Latin America, and Eastern Europe, Middle East, and Africa to cover developments in health policies, news, and events from these regions. If you have ideas for a story or want to contribute an update, please email voseditor@ispor.org.
ASIA PACIFIC
Section Editor: Paula Lorgelly, PhD, Auckland, New Zealand
The Impact of the Trade War on the Medicine Supply and Pricing: Australia’s PBS Faces Scrutiny
Jing Jing Li, Centre for Health Economics, Monash University, Australia
Australia’s Pharmaceutical Benefits Scheme (PBS), a cornerstone of the country’s universal healthcare system since 1948, is facing renewed scrutiny amid escalating trade tensions with the United States.
In early 2025, US President Donald Trump reiterated plans to impose tariffs on countries that, in his view, benefit from lower pharmaceutical prices at the expense of American innovation. Australia, with its cost-effectiveness–based PBS pricing model, was explicitly named in this context. Industry groups in the United States have echoed these concerns, labeling Australia’s approach as unfair trade practice.
While no tariffs have yet been implemented, the threat has raised concern among health policy observers. Tariffs on pharmaceutical imports or pressure through trade negotiations could make it more costly or commercially less attractive for manufacturers to supply medicines to Australia. This may result in delayed access to new treatments or added budget pressures for the PBS.
The PBS relies on centralized procurement and economic evaluation to ensure value for money and broad access. If US tariffs increase costs for global manufacturers or reduce the commercial attractiveness of the Australian market, consequences may include delays in accessing new treatments or rising prices.
These developments coincide with other US pharmaceutical pricing proposals, including the recently announced reference pricing, linking US prices to those in peer countries. This was widely discussed at the ISPOR meeting in Montreal as the executive order was signed just days before the meeting. While it is aimed at domestic (United States) reform, such policies may have global pricing impacts, particularly if companies respond by raising prices in lower-cost markets or delaying their launches in those countries.
The Australian government has responded by reaffirming its position: the PBS will not be part of any trade negotiations. Nonetheless, growing alignment between trade and pharmaceutical policy internationally suggests this issue will warrant ongoing monitoring to ensure Australia’s access and affordability objectives remain secure; this will be true for all countries in the Asia-Pacific and elsewhere that effectively employ economic evaluation methods to price technologies so they deliver value-for-money.
Disclosure: Jing Jing Li, through Monash University, has a contract with the Australian Government Department of Health and Aged Care, providing independent evaluations of company submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme (PBS).
Broader Value Assessment in HTA Decision Making for the Asia Pacific: ISPOR Singapore Chapter BRAVER Report Launch
Carsten Schousboe, Roche; Zhiyu Qiu, ISPOR Singapore; John Cheong, Roche; Aaron Jason Martin, MSD; Alec Morton, National University of Singapore
An Office of Health Economics report, “Beyond Health: The BRAVER Roadmap to Broader Assessment of the Value of Health Interventions in the Asia Pacific Region,” commissioned by Roche, MSD, and J&J, explores health technology assessment (HTA) practices across Asia-Pacific (APAC). The report explores the integration of broader value elements into regional HTA frameworks, on the premise that adopting a more comprehensive perspective is necessary for advancing healthcare decision making beyond traditional clinical and cost metrics. It recommends HTA bodies to incorporate wider societal impacts and patient-centered outcomes in their assessment methodologies.
On 26 May, the ISPOR Singapore Chapter organized a launch event bringing together key HTA stakeholders to introduce the report and discuss broader value recognition in local practice. The event focused on the need for APAC HTA frameworks to evolve beyond clinical and direct cost assessments to capture indirect costs like productivity losses and caregiver burden.
The BRAVER report observes that while APAC HTA frameworks are strong in evaluating clinical effectiveness and direct costs, they often lack mechanisms to capture broader societal outcomes. This limitation creates an opportunity for regional HTA bodies to evolve their methodologies while maintaining their foundational strengths.
Professor Alec Morton (National University of Singapore) opened the event, acknowledging that many of the directions in the BRAVER report resonated with key Singapore policy priorities (eg, protecting the workforce, taking care of the worst off, and ensuring efficient operation of the health system). He outlined opportunities for learning from his research and other jurisdictions, especially The Netherlands, United Kingdom, and Nordic countries in making these concepts operational. Carsten Schousboe (Roche) offered insights from New Zealand’s experience with adopting broader value assessment and the progress Canada is making, addressing methodological, political, and ethical concerns in adopting a societal perspective.
Polling at the launch showed strong support for incorporating novel value elements into Singapore’s HTA, although readiness to model them was lower. Participants proposed solutions to improve readiness by having more open discussions with the Agency for Care Effectiveness and the Ministry of Health, as well as hosting multistakeholder workshops and training on societal perspectives in modeling.
The report and launch event represent an important step towards more holistic, patient-centered healthcare evaluation across APAC.
Eastern Europe, Middle East, and Africa
Section Editor: Bertalan Németh, PhD, Budapest, Hungary
Toward HTA in Oman
Said Wani, MSc, Semmelweis University, Budapest, Hungary
Healthcare decisions are complex, especially in a scarcity of resources scenario, where the trade-off between available choices becomes a necessity. Aligning with Oman Vision 2040, the implementation of health technology assessment (HTA) has become one of the priorities of the Ministry of Health, in order to enhance the evidence base for decision making and use available resources more efficiency.
The journey of HTA in Oman begins with drawing a roadmap to analyze the gap between the current and future status of HTA implementation. This goal was determined through the engagement of stakeholders and decision makers. The implementation roadmap outlines a 10-year phased approach and 8 domains: (1) Capacity building, (2) Funding, (3) Legislation, (4) Scope, (5) Decision criteria, (6) Quality and transparency, (7) Use of local data, and (8) International collaboration. In the short run, the roadmap focuses on capacity building through training, initial funding models of HTA, evaluating high-impact pharmaceuticals, and developing decision criteria.
In addition, the long-run strategy aims to integrate HTA into academic programs, bordering HTA coverage scope to other ranges of healthcare technologies such as prevention programs and ensuring the publication of recommendations.
In April 2025, the Ministry of Health launched the methodological guidelines of HTA. This is one of the important steps to improve the evidence base of policy decisions. The guidelines provide a standardized and transparent approach to judge the value and affordability of health technologies, aligning with international best practices and local healthcare needs and priorities. It consists of 6 sections, including targeted indication, medical assessment, economic evaluation, budget impact analysis, social and ethical considerations, and transparency requirements. As per the guidelines, economic evaluation assessments will use cost-utility analysis for any technologies with health gain, expressed in incremental quality-adjusted life years (QALYs), and cost-minimization analysis for technologies with no health gain to the comparator.
Also, Oman cost-effectiveness thresholds have been developed. The baseline threshold is linked to gross domestic product (GDP) per capita and complemented by multipliers that account for priority disease setting, rarity, and health gain. The willingness to pay for a QALY gain in Oman cannot exceed 1x GDP per capita for new health technologies with minor health benefits in common diseases. However, based on health policy priorities, the maximum threshold value can be increased up to 12x GDP per capita for a QALY gain in case of curative medicines for rare cancer diseases.
Oman cost-effectiveness thresholds align with the broader societal perspective, allowing for a higher willingness to pay for technologies addressing rare diseases to promote equity, prioritizing areas like cancer with unmet medical needs, and valuing interventions that offer QALYs improvements. Through a phased roadmap, tailored cost-effectiveness thresholds, the launch of a national methodological guideline and critical appraisal checklist, Oman is laying the groundwork for a sustainable HTA framework that supports national health priorities. The strategy is to establish a single centralized HTA unit under the Ministry of Health.
References:
Al Rashdi I, Al Balushi S, Al Shuaili A, et al. A roadmap towards implementing health technology assessment in Oman. J Health Organ Manag. 2024;38(9):241–257. https://doi.org/10.1108/JHOM-01-2024-0012
Al Rashdi S, AlRashdi I, AlBalushi S, et al. HTA315 Framework for cost-effectiveness threshold values: the case of Oman. Value Health. 2024;27(12, Suppl):S416–S417. https://doi.org/https://doi.org/10.1016/j.jval.2024.10.2140
Guidelines for Health Technology Assessment. Ministry of Health, Sultanate of Oman. https://moh.gov.om/media/txzllfqa/book.pdf. Accessed May 26,2024.
Hungary Hosts Key Regional Congress
Bertalan Németh, PhD, Budapest, Hungary
The 13th Adriatic Congress of Pharmacoeconomics and Outcomes Research took place in Budapest, Hungary this year. It was the first time that Hungary was selected as a host of the annual event, and the Hungarian ISPOR Chapter took a pivotal role in organizing the Congress, in close collaboration with the team of permanent organizers. The 3-day congress was attended by experts both from Central, Eastern, and Western European countries, and a representative from Oman.
Among many illustrious guests, ISPOR’s Chief Science Officer, Laura T. Pizzi, PharmD, MPH, was among the participants. Laura’s presence and involvement at the Congress further emphasized the importance of the EMEA region to the Society. She served as a panelist to discuss how to incorporate the societal perspective in HEOR analyses. She also engaged in strategic discussions with ISPOR’s regional leaders to further strengthen the collaboration between ISPOR and its chapters. The SUSTAIN-HTA project workshop was organized as a satellite event of the Congress. Here, Laura took part in discussing HTA methods implementation and sustainability approaches. In addition to attending the Congress, Laura also visited 2 Hungarian universities and met with HTA and Health Policy experts in the region.
Latin America
Section Editor: Diego Rosselli, MD, Bogotá, Colombia
Regulating Risk-Sharing Agreements: A Key to Accessing Innovative Therapies
Magda V. Gutiérrez, MD, Director, ISPOR Chile Chapter, Bogota, Colombia
In Chile, access to innovative medicines constitutes one of the primary barriers to ensuring effective treatments for the entire population, particularly for individuals facing high-cost diseases. In this context, risk-sharing agreements (RSAs; ARC in Spanish) emerge as a pivotal solution. These agreements enable pharmaceutical providers and healthcare systems to share financial risks associated with the efficacy or utilization of specific medicines. However, the effective implementation of such agreements necessitates progress in establishing a clear and consensual regulatory framework.
Regulating RSAs would yield benefits for patients, insurers, and providers—fostering access to cutting-edge therapies through a sustainable financial model. Moreover, it would help reduce health inequalities by enabling access to costly treatments for those most in need without compromising the financial stability of the healthcare system.
The recent Exempt Resolution 410, issued by the Minister of Health, which approves the technical guidelines for the implementation of risk-sharing agreements, marks a significant step toward achieving this goal in the country. This technical framework lays the foundation and pillars to develop and apply RSAs transparently and efficiently. Such progress positions Chile closer to ensuring equitable access to innovative medicines, thereby benefiting thousands of patients and enhancing the sustainability of the healthcare system.
Mexico Tightens Drug Sourcing Rules Amid Global Trade War
Diego Rosselli, MD, EdM, MSc, Pontificia Universidad Javeriana, Bogotá, Colombia
The trade war started by the Trump administration has significantly impacted its neighbor, Mexico. As extensively debated in the media, President Trump’s vision of bringing back home manufacturing processes currently done abroad will likely have many predictable and unpredictable consequences. Surprisingly, in April, Mexican President Claudia Sheinbaum announced a similar measure for her country, set to begin in 2026.
Her proposal targets pharmaceuticals and medical devices purchased by any government agency, including the vast Instituto Mexicano de Seguro Social (which covers roughly half of Mexico’s 130 million citizens), the military, Pemex (the national oil company), and all healthcare programs for the uninsured. Only providers with a manufacturing plant in Mexico would be considered.
The predicted consequences of this measure will likely affect high-tech biopharmaceuticals, many of which are produced in only 1 or 2 plants worldwide, as well as biosimilars and generics from large Asian manufacturers. While stimulating local pharmaceutical production might seem appealing, simple ideas may not always be the best solution.
