A version of this article was previously published in the Journal of mHealth.
The field of oncology is rapidly growing and evolving. In 2022, global spending on cancer medicines was approximately 196 billion USD, and this number is forecasted to reach $375 billion by 2027. In fact, for the past five years, the number of treated patients with cancer has seen an average annual increase of 5% globally (1). However, with rapid growth comes growing pains.
Specific challenges facing the oncology field
1. Increased competition and evolving standard of care
New competitors are entering the market at a rapid pace, and competition is intensifying. There are currently more than 2,000 oncology products under development. Emerging biopharma companies are responsible for over 70% of these products (up 20 percentage points from 2017) while Big Pharma has seen a declining share of the oncology pipeline, at only around 20% of products currently under development (down 15 percentage points from 2017). This competitive intensity tends to focus on smaller patient populations with multiple treatment options (1,2).
With a larger number of treatable patients, improving survival rates, more clinical trials, and increased focus on real-world evidence, the definition of ‘standard of care’ is continuously changing. As a result, treatment algorithms are becoming more complex, leading to variable uptake and use of new treatments across regions, clinics, and prescribers (2).
Further, the time advantage traditionally afforded to new cancer therapies has been substantially reduced due to advances in our understanding of the underlying tumor biology and the emergence of novel treatment modalities. Occasionally, the advantage dissappears well before the period of exclusivity ends (2).
2. Delayed diagnoses and later-stage cancers
With early-stage cancer diagnoses decreasing by nearly 20% in the first year of the COVID-19 pandemic, and—as a result—late-stage cancer diagnoses now increasing, healthcare costs and patient deaths are expected to increase substantially (3). Even now (as of November 2023), only about 65% of patients with cancer received their diagnosis and started their first treatment within 2 months of an urgent referral in England (4).
In addition, the global population is getting older, and more cancers of all stages will be diagnosed as a result, putting even more pressure on the healthcare system. Compared to 2015, the proportion of the world’s population aged > 60 years is estimated to increase by nearly 50% by 2050 (5).
3. Long, expensive, and suboptimally designed clinical trials
While new oncology trials have reached historically high levels (up 22% in 2022 compared to 2018) (1), they remain riddled with issues. These include high complexity, high costs, poor awareness, long recruitment times, high burdens on participants, poor retention, and a lack of diversity among both participants and investigators/clinical trial site staff (6).
The above obstacles are largely interconnected. For example, the lack of awareness of clinical trials impacts recruitment and enrollment times. Typically, oncology trials are conducted at Centers of Excellence; for patients seen and treated in other settings, there is no standard mechanism for recruitment (6).
The poor diversity among clinical trial participants and its impact on the applicability of the trial outcomes on the real-world patient population has been well-established (1). However, a lack of diversity among clinical trial site staff and investigators can also impact both trial recruitment and retention. When there is no consideration of potential language barriers or cultural differences, patients may not be aware of or feel comfortable enrolling in clinical trials.
4. Access and reimbursement challenges
With a growing number of new, increasingly expensive oncology products entering the market, many OECD countries have expressed concerns about their ability to balance access to these oncology treatments with spending efficiency. In addition, access to oncology medicines remains unequal across different countries (7).
At a national level, there is high variability in the regulatory review period and the time between application and granting of coverage; the average total time from application for marketing authorization to coverage reportedly ranges from as little as 9 months to a staggering 52 months (7).
In terms of reimbursement, the costs of some oncology drugs are prohibitively high for patients without private insurance, reducing their accessibility. Patients’ out-of-pocket costs for these medications are increasing, indicating a need for customized co-pay assistance programs and innovative financial solutions to help offset the high cost of treatment (8).
Helping patients, healthcare providers, and investigators to navigate (or overcome) these challenges
In light of these many challenges, how can pharmaceutical teams help their most important stakeholders navigate the rapidly changing field of oncology? As the title alluded to, digital tools could play an important part.
In addition to its roles in accelerating drug discovery and development, AI could be leveraged to sift through clinical and real-world data to find patterns in treatment sequences globally and regionally. Alternatively, using virtual collaboration tools, insights on changing standards of care and treatment algorithms can be collected from key opinion leaders. In turn, these insights can be used as a basis for digital education initiatives for other healthcare providers and patients on the currently available treatment choices and therapies in development.
When it comes to overcoming the many issues facing oncology clinical trials, digital technologies such as eConsent, eDiaries, telemedicine, wearables, and smartphone apps are already on the radar of most trial sponsors. However, these technologies will not be suitable for all studies and all patient populations. Seeking feedback from patients, patient advocates, and caregivers on their unique needs and the specific gaps of the planned clinical trial can help co-design the most appropriate and effective digital solutions for that study (6).
Personalized support
Pharma can also help by developing tech-enabled patient support programs and other personalized support and education solutions. However, considering the distrust that many patients harbor against Big Pharma, a transparent, collaborative approach should be taken, involving both healthcare providers and patients in the process (9).
Further, having clinical trial explainers and other materials in the participants’ native languages is critical for recruiting and retaining diverse study participants. It is important to have someone review these materials from the participant’s point of view to ensure that they are culturally appropriate (6). Virtual activities such as asynchronous annotation by patient advocates can facilitate this review and ensure that all materials are appropriate and inclusive.
What’s next?
This is by no means a comprehensive list of the many obstacles facing the oncology field or of the digital solutions that could help overcome them. Clearly, these challenges will not be solved overnight, but Pharma has the power to move the needle forward, and digital tools could play a major role. If unsure of where to start, try asking the people affected directly by cancer what matters to them.
References:
- https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-oncology-trends-2023
- https://www.bcg.com/publications/2021/navigating-evolving-oncology-treatment-landscape
- https://www.statnews.com/2023/08/04/pandemic-cancer-diagnoses-late-stage/
- https://news.cancerresearchuk.org/2024/01/11/cancer-waiting-times-latest-updates-and-analysis/
- https://www.who.int/news-room/fact-sheets/detail/ageing-and-health
- https://www.pharmaceutical-technology.com/interviews/qa-exploring-the-challenges-behind-oncology-trials/?cf-view
- https://www.oecd.org/health/health-systems/Addressing-Challenges-in-Access-to-Oncology-Medicines-Analytical-Report.pdf
- https://www.pharmacytimes.com/view/trends-in-oncology-pharmacy-will-drive-the-market-beyond-2022
- https://www.zs.com/insights/pharmas-role-in-bringing-the-future-of-health-to-oncology
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