Ten Long-term Impacts of COVID-19 on Biopharma
- COVID-19 has presented an abundance of short-term implications and challenges for biopharma companies; however, it is useful to understand and prepare for the longer-term impacts as the acute disruptions to regulatory processes and healthcare delivery begin to subside
- CBPartners’ Take: To proactively prepare for a post-COVID-19 world, biopharma leaders should develop strategies to integrate technology across the value chain and increase focus on patient centricity in terms of process flows and treatment administration
The Short-term Trends and Implications of COVID-19
As the COVID-19 pandemic swept across the globe, unprecedented delays and widespread disruptions were felt across the biopharma industry. Global healthcare systems shunted resources away from non-essential treatments and reallocated efforts towards COVID-19-related activities, resulting in shifts in healthcare delivery (e.g., deferred or cancelled medical procedures and preventative care) and research efforts. Biopharma companies were faced with several immediate challenges with implications across business units and commercial functions, including:
- Postponement of regulatory approvals, reimbursement decisions, and pricing negotiations
- Disruptions to clinical research programs (e.g., enrollment challenges and protocol adjustments)
- Reduced face-to-face interaction with payers and physicians
- Decreased demand for non-essential medical devices and therapeutics
- Drug production and supply chain management disruptions
While the pandemic brought about several acute impacts across the healthcare sector, a number key trends have been accelerated or enhanced in the wake of the pandemic and will likely have lasting commercial implications for biopharma companies.
Long-term Trends and Implications of COVID-19
1. Accelerated adoption of telehealth / telemedicine
While telemedicine had been steadily gaining traction among patients and physicians, its widespread implementation has been accelerated by nearly a decade in a reaction to the COVID-19 pandemic. To decrease the risk of infection and reduce hospital capacity constraints, the site of healthcare delivery was shifted away from hospitals, encouraging healthcare professionals (HCPs) to innovate their practices to be compatible with virtual platforms. In parallel, payers in certain markets (e.g., USA Medicare) implemented permanent changes to reimbursement policies to expand their coverage for virtual care delivery. While this trend is most relevant to primary care, telemedicine is becoming increasingly applicable for specialists and with new systems now in place, there is endorsement to continue exercising a virtual component of healthcare even after it is safe to resume face-to-face practice.
The long-lasting adoption of a blended healthcare model, combining digital and face-to-face healthcare across the patient journey from pre-diagnosis to post-treatment selection, will remain relevant to reduce hospital resource constraints and potentially improve patient experience. This accelerated acceptance of telehealth solutions presents biopharma companies with an opportunity to leverage momentum towards home-based care and strategical position their business models to support integrated care to reduce the burden on clinics and health systems. Manufacturers that are able to better align their products with the telehealth process in terms of patient journey, product features, as well as practice and patient support services will be clear winners.
2. Increased treatment selection emphasis on home-administered products
To support the continuity of care for patients during the pandemic, physician prescribing patterns have shifted to prefer oral or subcutaneous therapies which can be self-administered in the home setting, rather than IV treatments which are reliant on hospital systems. This shift away from hospital-administered drugs and lab monitoring has been supported by the acceptance of digital solutions to consult, prescribe to and monitor patients.
Financial reports have highlighted increased sales of self-administered products, such as psoriasis drug OTZELA®. In a recent report, Amgen attributed the reported 14% sales growth relative to the same period last year, to the oral route of administration of OTEZLA® in a therapeutic area otherwise dominated by injectables. Given the potential to reduce costs at the health systems level, the value of subcutaneous products will remain relevant beyond the pandemic and may influence pipeline optimization and launch strategies of biopharma companies in the long-term.
3. Increased pressure to demonstrate treatment value given COVID-19 impact on healthcare budgets
Significant public health spending in response to the COVID-19 pandemic has far exceeded allocated healthcare budgets of many governments and the negative economic impacts are expected to endure long-term. While certain markets that experienced a substantial disease burden are expected to be hardest hit, payers across global healthcare systems will demonstrate a decreased willingness to fund high-cost therapies and the focus of many governments will be turned toward cost-containment initiatives and efforts to ensure efficient resource utilization at a health systems level. Pressure on already stretched healthcare budgets will likely result in a higher level of evidence requirement for reimbursement, triggering manufacturers to re-evaluate their value propositions and align treatment positioning with changing payer needs. However, in certain markets this may mean biopharma companies will have more latitude to explore value-based contracts and other health technology assessment (HTA) process shaping activities as a longer-term mechanism to mitigate financial risk for health systems.
4. Increased scope of conventional partnerships between manufacturers and government
The economic downturn and pressure on healthcare and life sciences budgets resulting from the pandemic has increased the need to foster partnerships between academia, government, and industry to decrease financial risk and increase R&D efficiencies. While partnership models across the board are common in the biopharma industry, the pressure to bring COVID-19 tests and therapeutics to market at an unprecedented speed fueled a new wave of collaboration between big pharma competitors (e.g., REGN and ROCHE partnership). In parallel, the pandemic brought about an increased drive to work collaboratively with regulators and governmental health agencies and these interactions are likely to shape relationships moving forward. A prime example is the current contracting environment for COVID-19 vaccines between governments and manufacturers in order to share risk for vaccine development. Beyond infectious disease, this increased scope of partnerships and willingness to cross pollinate research would be beneficial to drive the same sense of urgency in other therapeutic areas (e.g., Alzheimer’s disease, cancer, autoimmune diseases) to lead to faster innovation; however, whether this behavioral shift will remain beyond the pandemic is yet to be seen.
5. Opportunity for new partnerships with tech players
Similarly, opportunities to explore partnerships with private entities that have traditionally been far-removed from the biopharma industry have emerged as the healthcare ecosystem has undergone structural changes in response to COVID-19. A new role for tech companies to partner with biopharma has become increasingly relevant with the more recent emphasis on telemedicine. Such relationships may be leveraged to develop value-added patient services, collect patient data, and optimize the R&D cycle to further reduce biopharma costs in a world where pricing pressure is likely to persist. The accelerated trend for biopharma to collaborate with external tech partners to develop innovative solutions and enhance the patient treatment journey may continue to be explored long-term; however, the importance of compliance within the healthcare sector and alignment of company goals with patient needs must not be overlooked as a key challenge.
6. Acceleration of clinical trial efficiencies and tech-integration
Disruptions to traditional models of care delivery and clinical trials have accelerated pressures to make trials simpler, decentralized, and more patient centric. Slowdown in patient recruitment and interruptions to ongoing trials led some biopharma companies to adapt new solutions such as direct shipping of investigational products to patients, home infusions of IV drugs to avoid hospital visits, site shifts from academic institutions to smaller private practices, patient assessments through telemedicine, and virtual site visits. Consequently, patient reported outcomes (PROs) and home monitoring may become increasingly important aspects of tech-enabled trials. While the shift to a virtual clinical trial platform has been discussed by organizers several years prior to the pandemic, it was not yet fully embraced by many medical centers until the recent climate proved it necessary. With the required technologies and guiding policies now put in place, decentralized tech-enabled clinical trials may set a new precedent for the future.
7. A new benchmark has been set for vaccine & drug development
The record timelines to develop COVID-19-related therapies, driven by intensified public pressures, may set a new benchmark for drug development moving forward. In the US, the fast-track process for VEKLURY® (remdesivir) may accelerate the trend of expediting approvals and monitoring safety in the real world. Regulators have reviewed COVID-19-related therapies, such as VEKLURY® (remdesivir), in real-time as they have read out to decrease the time from clinical research programs to approval and ultimately patient access. While synthetic control arms were employed in COVID-19 trials, a higher standard for synthetic control arms will likely be required in the future to allow real-world evidence (RWE) to effectively power trials with low incidence and small population sizes (e.g., tumor-agnostic therapies). Although the use of RWE will not apply to all products and its impact on regulatory processes remains to be seen fully, pathways have been established for lightning fast approvals under special circumstances. This sheds light into the role of RWE and how it may be used as well as some of the challenges associated with data quality and consistency which showcase hurdles manufacturers will need to overcome in the future to adopt RWE as a more consistent part of the traditional drug development process.
8. Investment in therapies with strong societal impact (anti-infectives and vaccines)
The rapid onset of the public health crisis has demonstrated how vulnerable society is to novel infectious diseases. While funding for R&D in infectious disease treatments has typically come from government entities, there is an increased interest among biopharma and capital markets to invest in therapies with a strong societal impact (e.g., vaccines, anti-viral, anti-microbials). Although therapeutic areas like oncology and other chronic diseases will continue to generate greater incentives for investment, there may be more long-term commitment to infectious diseases and public health more globally in the future. We have already seen evidence of this movement with the reinvigorated support of antibiotic development, given the increasing global concerns around drug resistance. While prior lessons on the importance of societal investment in vaccines and anti-infectives have been lost (e.g., post-SARS investments were eventually re-directed), the COVID-19 pandemic is a lesson that healthcare systems will remember in the long-term and thus has a real chance to impact how research spending is allocated.
9. Shifts in digital sales force strategy and HCP engagement
Whilst facing the challenges of treating patients during the pandemic and adapting to the rapidly changing care delivery environment, HCP engagement with sales reps sharply plummeted and face-to-face interactions were at a standstill. Many pharma companies partially or completely removed their sales presence from the field given the low priority of non-COVID-19-related activities. Although most HCPs expect in-person interactions with sales reps to resume following the crisis, many others expect a lasting impact on their willingness to engage in live meetings and anticipate remote interactions will play a larger role in the mix. Post-pandemic, there is an opportunity to leverage digital engagement strategies that have been more widely applied. As the acute impacts for the pandemic subside, biopharma must find new ways to reengage HCPs and commercialization models may be reevaluated to embrace omnichannel strategies and customer-centric digital solutions that leverage a wealth of HCP data and machine learning to steer digital interactions.
10. Manufacturer support systems may be redeveloped to be compatible with remote care
The acceleration of telehealth brought on by the COVID-19 crisis will push manufacturers to redevelop patient support systems in the long-term. For example, in the US, patient co-pay card systems and patient education were not developed to cope with telemedicine and new administrative processes that are compatible with remote care will have to be implemented to reduce the burden on patients. Additionally, the pandemic has triggered accelerated change to put in place support services for patients in the home setting such as home drug delivery and nursing support. To maintain competitiveness in the rapidly changing healthcare ecosystem, patient programs to support integrated at-home care may become increasingly important considerations for biopharma. A delicate balance will need to be struck between the need to deliver flexible, decentralized solutions while navigating the compliance risk associated with innovation in this space.
CBPartners will continue to monitor these trends and any subsequent biopharma impacts that may emerge as the dynamic healthcare environment continues to evolve in a post-COVID-19 world.