The European Society for Medical Oncology (ESMO) recently held its first in-person congress since the COVID-19 pandemic. The conference, held in Paris, brought together more than 22,000 attendees to share and discuss the latest evidence and issues in cancer care. A common thread running through the congress program was ESMO’s Vision 2025—a commitment of “shared determination to secure the best possible outcomes for patients.” Vision 2025 outlines a three-tiered approach to achieving this:
- One oncology community: Building an international, cross-functional community
- Education for life: Supporting development through continuous education
- Accessible cancer care: Developing sustainable models of prevention, diagnosis and treatment
A key component of the third tier relates to market access and the reimbursement of cancer treatments. In line with this commitment, results of two ESMO studies related to reimbursement were shared during the congress—the ESMO Economic Model project and ESMO ANMS (Availability of Antineoplastic Medicines) 2.0 survey.
ESMO’s Economic Model Project: Understanding health technology assessment decisions
ESMO’s Economic Model Project is a collaboration between ESMO and the London School of Economics. The initiative aims to understand how health technology assessment (HTA) agencies with well-established processes make decisions regarding new oncology products. HTA assessments from decision bodies in Australia, Canada, England, France and Scotland were analyzed to understand factors that affect:
- Time to coverage/reimbursement of oncology treatments
- Outcomes of HTA deliberations
The study found that there was considerable variation in time to reimbursement across markets. In particular, in instances where there is parallel regulatory and HTA review (e.g., Australia and Canada), the time to reimbursement is reduced. An interesting observation was that HTA assessments of treatments approved under accelerated regulatory pathways take longer than assessments of treatments that have received standard marketing authorization. This discrepancy may be due to there being a smaller body of supporting evidence available for products that have undergone accelerated approval, and therefore more uncertainty in the clinical and economic benefits. This highlights that although a treatment may receive fast-tracked regulatory approval, this does not necessarily mean rapid widespread access for patients.
Clinical benefit, as reflected by a high ESMO Magnitude of Clinical Benefit Score (ESMO-MCBS), was associated with positive HTA outcome and a shorter time to reimbursement. Other factors associated with positive reimbursement decisions were innovation and unmet need. However, evidence uncertainty—both in clinical (e.g., uncertainty in magnitude of clinical benefit) and economic (e.g., uncertainty related to health economic model inputs) terms—was found to be negatively associated with positive decisions. The outcomes of the analysis reinforce the importance of manufacturers establishing a robust evidence base to support their HTA submissions.
ESMO ANMS 2.0 survey: Examining access to cancer medicines
The ESMO ANMS 2.0 survey spans 173 countries and is an ongoing study that is a follow-up to a survey reported in 2017. The purpose of the survey is to understand limitations in formularies, the availability of medicines, and barriers to access. Preliminary data from 106 countries were shared at the congress and demonstrated wide global variation, with clear disparities between higher and lower income countries in access to both inexpensive and innovative cancer medicines.
Analysis of reimbursement for basic chemotherapy agents—inexpensive agents used across a broad spectrum of disease and on the World Health Organization’s list of essential medicines—found that they were available at no cost to patients in the vast majority of high-income and upper-middle income countries. However, in many low and low-middle income countries, patients have to pay the costs of treatment in full. Considering more expensive agents—specifically, innovative medications such as immunotherapies considered to have substantial clinical benefit—the overall trend remains the same as for basic agents, although even in upper-middle income countries (as well as low and low-middle income countries) patients are more likely to have to pay higher out-of-pocket costs than patients in high-income countries.
Across all medicine types, procurement chains demonstrated more reliability in higher income countries, with intermediate or unreliable availability of drugs in lower income countries. The overarching message from the data was that in the lowest income countries, access to basic chemotherapy agents and innovative medications is most limited, and patients—who may be poorly placed to do so—have to pay the most to access treatment.
Looking ahead to address healthcare inequities
The field of oncology is characterized by innovation and research. Currently, there are over 25,000 recruiting or active trials registered on clinicaltrials.gov. While manufacturers endeavor to develop new and effective cancer treatments and regimens, we need to consider how access for those therapies will be secured and what evidence will support this.
In the opening session of this year’s ESMO congress, the president of the organization—Solange Peters—stated, “what could be more frustrating than not being able to secure the treatment you know to be the most beneficial for your patient?”
For patients, nothing is more important than receiving the right treatment at the right time. However, it is apparent that there is still a way to go at a health-system level to support rapid patient access to treatment and address the current inequities observed across markets.