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Biopharma must step up amidst growing oncology market.
Decades of research led to significant breakthroughs in oncology drug development, and it has created much hope for cancer patients with lifesaving or life-enhancing medicines. Today, a few cancers are curative, and some are turned into chronic diseases; however, significant unmet needs remain across most cancers. More than 19M new cancer cases are diagnosed each year, and the oncology market valued at more than a hundred billion dollars in the US alone continues to grow. Today, almost one-third of the industry pipeline is concentrated in oncology which is exciting for patients and caregivers. This article shares our perspectives on key trends shaping the oncology marketplace and how biopharma must adapt to stay focused on bringing personalized solutions to cancer patients.
The unmet patient needs exist in virtually every 164+ recognized cancer type. These unmet needs range from finding more efficacious and tolerable therapies to improve the quality of life for patients to seeking curative treatments. Though there is a higher concentration of clinical trials in common tumors, biopharma companies target a wide range of rare cancers, given that the same drugs or technology platforms often have applications across tumors.
Significant progress has been made in critical areas, such as immuno-oncology and targeted therapies. The use of combination treatments has increased with 2% of patients receiving combined therapy regimens in 2000 to 44% of cancer patients in 2018, according to Avalere Health. R&D focus is shifting towards targeted therapies, including gene and cell therapies. Over 300 CAR-T clinical trials are ongoing, and gene therapies are also entering clinical trials. If successful, these novel therapies will radically change the treatment paradigm in many cancers.
Precision medicines are increasingly being used to offer personalized treatment solutions. Almost two-thirds of the oncology patients receive a biomarker test, and the payers are increasingly covering these tests. However, the pathway for adoption and access of new testing mechanisms is still lengthy, and regional disparities often pose many challenges. In the case of next-generation sequencing (NGS) testing, it is only available across a few health systems, and broader use is warranted. In 2020, the CMS expanded its scope to cover NGS testing and introduced 16 ongoing strategic initiatives to provide better patient value and results through competition and innovation.
FDA's fast track, breakthrough, and accelerated approval pathways allow biopharma companies to bring medicines faster to patients. In 2020, Seattle Genetics' Tukysa (tucainib) was approved via real-time oncology review four months after NDA submission. The FDA acknowledges the critical unmet needs in oncology and has shown increasing flexibility in supporting cancer development programs with the real-time evaluation of clinical data. However, biopharma must exert caution to ensure faster decisions don't compromise on the quality of clinical outcomes.
Given the speed of oncology drug approvals and limitations with randomized clinical trials (RCTs), it's critical to leverage RWE to understand better the long-term treatment effectiveness and durability of response across patient types. The RWE studies assimilate data from disparate sources with varied previous lines of treatment and other concurrent treatments, which is not generally feasible during clinical trials. However, the systems used to capture RWE are not mature enough to make real-time decisions as concerns linger about data quality. Both providers and payers will continue to invest in RWE systems to optimize patient performance with timely interventions.
The cost concerns persist across the healthcare system, and a healthy debate is taking place on how best to align value-based pricing in a resource-constrained environment.According to ASCO, the average cost of a newly approved treatment in 2020 was $225K+ per year. Stakeholders continue to worry about budget impact, uncertain therapeutic durability, inadequate reimbursement, and burden on patients/caregivers. Given the increasing cost of medical treatments and care management, CMS and private health systems are experimenting with new models such as Merit-based Incentive Payment Systems (MIPS) and Oncology Care Model (OCM).
The performance-based contracts often linked to clinical, quality, utilization, and financial outcomes have been widely discussed but continue to be challenging to implement in a protected class like oncology. However, a definite trend shows that 24% of payers executing outcomes-based contracts in 2017 vs. 59% in 2019, according to Avalere Health. Given the expensive nature of gene and cell therapies, these performance-based contracts are becoming commonplace for manufacturers to show value and de0risk larger payments.
The goal of offering quality care at an affordable cost continues to be an uphill battle, given the fragmented nature of the healthcare system and the misalignment of stakeholder incentives. However, novel technologies and care delivery models profoundly impact all aspects of healthcare delivery. For example, artificial intelligence and machine learning tools allow better diagnosis by minimizing human errors in some areas. The AI-based predictive platforms are helping patients in reducing recurrence and improving the standard of care. Insurance companies leverage these AI platforms to develop algorithms for timely intervention and ultimately reduce healthcare costs.Leading biopharma companies are leveraging the power of AI in clinical trials and cancer care management to stay at the forefront.
The patient advocacy groups continue to play a prominent role in all facets of cancer care by fundraising to support R&D initiatives, assisting with clinical trial recruitment, and helping patients with socio-economic support. For example, the Living Beyond Breast cancer organization offers educational and support programs, which help breast cancer patients and caregivers. Many of these non-profits provide testing, diagnosis, treatment advice; prescription advice; distress management; financial aid; age-related support, and caregiver support. The patient advocates and influencers often profoundly impact patients' quality of life going through a challenging journey. The social media platforms enable better patient engagement within a closed ecosystem—even KOLs acknowledge the importance of social media in engaging patients. Biopharma must partner with these organizations to stay closer to the patient community to address unmet needs.
During the pandemic, the healthcare system has been under duress, leading to suboptimal care for cancer patients. According to Lancet's estimation, the delayed diagnosis leading to delayed treatments and cancer stage shifts have led to an increased mortality rate between 5 and 9%. Many clinical trials have experienced setbacks due to slower patient enrollment. The providers, patients, and caregivers have relied on a combination of live and remote care management. Telehealth platforms and patient HUB systems provide much-needed connectivity between providers and patients. The maturity of these platforms is vital to increase provider-patient connectivity to optimize care management.
Biopharma takes a lead role in shaping many aspects of the oncology marketplace. Biopharma must continue to collaborate with the scientific, payer, and patient communities to better understand the patient's unmet needs. The goal is to translate these unmet needs into personalized medical treatments while ensuring optimal care management beyond therapeutic interventions. This holistic approach to patient care management inevitably leads to better clinical, economic, and quality of life outcomes. There is incremental and radical innovation taking place in many areas of oncology for us to be hopeful for a better future. Biopharma companies must play a more meaningful role in ensuring that patients who benefit from these novel treatments have timely access to diagnostics and treatment interventions.
Subbarao Jayanthi, Managing Partner, RxC International, William Smith, Management Consultant, RxC International