BLOG: ‘Exciting’ discoveries at oncology conferences not always accessible to everyone
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I am a medical oncologist from Mexico City and my main practice is at an academic institution where we mostly focus on patients with breast cancer. However, like many oncologists in Mexico, I also have some private practice where I see patients with all cancer types.
Since becoming an oncologist, every time I attend a conference and witness a new positive study about a novel treatment that everyone gets excited about, I get a bittersweet feeling.
‘Left out’
I recently attended the 2023 San Antonio Breast Cancer Symposium, and this time was no exception. Among all the excitement and hope of groundbreaking and innovative treatments, I — and most importantly, my patients — are left out. My first thoughts are: When will I be able to use these new treatments and in whom will I be able to use them?
Unfortunately, the answers to those questions tend to be complicated at best, as the time from the approval of a drug by the U.S. FDA until approval by regulatory authorities in other countries, including Mexico, can be quite long.
For example, the FDA approved trastuzumab deruxtecan (Enhertu; AstraZeneca, Daiichi Sankyo) in December 2019 for HER2-positive advanced breast cancer, and later in August 2022 for HER2-low advanced breast cancer. I still remember the standing ovation at its presentation at ASCO 2022.
In Mexico, however, this drug was only approved for these indications by the national drug agency, COFEPRIS, in March 2023 — more than 2 years after its initial U.S. approval.
Other barriers
Timing is not the only barrier to widespread access. Even when a drug is eventually approved, initial access is limited for patients in private care, mainly due to cost.
Most of my practice is in a public hospital, where approval and acquisition of medications through the public system must be obtained in advance, further delaying treatment.
For example, trastuzumab deruxtecan was only recently added on Jan. 16 to the Medication Book of the National Compendium of Healthcare Supplies, which lists medications that can be prescribed at public health care institutions.
After a medication is listed, institutions then need to acquire the drugs, which may entail facing additional bureaucratic and budgetary hurdles.
Currently, many FDA-approved treatments for breast cancer are at different points of this situation in Mexico. Among eight drugs approved by the FDA for advanced breast cancer since 2018, as of January 2024, only five are approved by COFEPRIS in Mexico, and a single drug is listed in the Medication Book and, therefore, available to be prescribed at public institutions in Mexico.
These delays affect antibody-drug conjugates like trastuzumab deruxtecan, targeted therapies and selective estrogen receptor degraders, and is, therefore, a common issue for advanced breast cancer treatments across all subtypes.
Given my primary work at a public institution, costs of treatment are also always on my mind. Costs have been steadily increasing in the last few decades, including the above-mentioned recently approved breast cancer medications.
This impacts patients across the world, but patients in low- and middle-income countries may be especially affected by rising drug costs. Mean quarterly household income in Mexico was 63,695 Mexican pesos in 2022 (about $1,230 USD per month), with 90% of households having a mean monthly income of less than $2,000 USD (below the poverty level for a family of three). This means that most patients are at significant risk for financial toxicity; many face catastrophic out-of-pocket expenses from cancer care, leaving most expensive new cancer treatments out of reach.
For all of these reasons, results from research presented at SABCS aren’t results that I will immediately be able to share with my patients — I sadly know that these new treatments won’t be benefiting them any time soon.
‘A positive aspect’
Ironically, there is one positive aspect of the ‘wait time’ I have before I can prescribe a new treatment. It allows me time to reflect on the true value of these new interventions and to carefully review the available evidence, which is usually greater by the time of widespread access.
In resource-limited settings, the value of treatments also becomes even more important: are we really getting a good bang for our buck with these new treatments, or should we ensure first that basic resources are provided with a limited budget?
If I have a limited quantity of “X” drug, who are the patients who would benefit the most from it? Are the presented results I’m seeing right now with this new treatment what my patients will experience? As an oncologist interested in the care of older adults, do I have enough information to prescribe this new treatment safely to my older patients? And the same question can be asked of many other patient characteristics for groups underrepresented in clinical trials. Do these presented results reflect what I will see in situations I commonly encounter, such as patients with advanced breast cancer with extensive tumor burden due to systematic delays in diagnosis and referrals?
Ways to improve
What can we do to improve timely access to innovative drugs that allow us to provide meaningful benefit to our patients, such as prolonging survival and/or improving quality of life?
Solutions include pharmacy-expanded access programs that facilitate drug availability to oncologists in low- and middle-income countries, while also encouraging them to collect their own experiences and evidence in their unique patient populations.
Patient savings programs, although limited in low- and middle-income countries, can also assist qualifying patients with out-of-pocket costs. National regulatory processes can be optimized and streamlined to ensure access to new therapies that provide meaningful value as soon as possible.
Sadly, the specific strategies that could contribute to improve access and affordability of new treatments may differ between regions. What works in one low- and middle-income country may not work in another part of the world. Differences in drug approval systems and health technology assessment evaluations across the world attest to that.
Currently available value frameworks have been primarily developed from a first-world perspective; are they truly applicable in settings where even basic resources are limited?
It is also worthwhile to ask if it is adequate or even ethical to measure “value” differently across different settings.
I don’t have a clear answer for these questions, unfortunately.
The oncology community needs to be mindful of the global benefits of new cancer research and how long they take to occur. I look forward to the day when I can go to an oncology conference and know that it won’t be long before I can share what I learn with my patients in my country.
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Haydeé Verduzco-Aguirre, MD, oncologist at Instituto Nacional de Ciencias Médicas y Nutricion Salvador Zubirán, Mexico City, Mexico, and oncology fellow at Costs of Care. She can be reached at: haydee.verduzcoa@incmnsz.mx or on X (formerly known as Twitter) @hafaydeefe. She wrote this blog post with guidance from Fumiko Chino, MD, radiation oncologist at Memorial Sloan Kettering Cancer Center and Director at Costs of Care.
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