This year’s Academy of Managed Care Pharmacy (AMCP) conference in Chicago was the first in-person AMCP meeting in three years and brought together almost 3,000 representatives spanning drug manufacturers, health plans, pharmacy benefit managers, and market access professionals across the US health industry. It is exciting to see in-person conferences returning, which allow for engagement and networking opportunities that we have missed over the last few years! We thoroughly enjoyed attending AMCP 2022 and have summarized our key takeaways below, spanning three major themes:
Current Market Trends & the Future Drug Pipeline
Impact of Upcoming Generics and Biosimilars
Generic and biosimilar drugs are some of the most anticipated approvals and launches of 2022 due to the potential cost savings and improved access that they will offer, which may provide a new gap in the market for expensive, yet innovative treatments, such as gene therapies. Biosimilar drugs started gaining momentum in the US market in 2021 with the notable approval of the first biosimilar for Humira, an anti-inflammatory drug with a wide range of indications that accounts for approximately $20 billion per year in spending. Development of biosimilars for other anti-inflammatory agents, and drugs for respiratory disease, diabetes, multiple sclerosis, and ophthalmology is also currently underway, with possible launches as early as the second half of 2022.
While these biosimilar launches are heavily anticipated by a range of stakeholders, speakers at AMCP also emphasized that managing the introduction of biosimilars will be a challenge for payers over the next several years, starting with Humira. One management strategy may be to exclusively include biosimilars in formularies, however, payers expect that the price difference between biosimilars and branded Humira may not be significantly different in early years, minimizing the attractiveness of this approach. In addition, securing rebates from biosimilar manufacturers may be difficult when multiple biosimilars from different manufacturers begin to emerge. Additionally, speakers emphasized that some patients and prescribers may still prefer Humira over biosimilars, particularly due to convenience with the proprietary Humira injection pen. Payers may therefore utilize a Humira/biosimilar parity strategy, including both in their formularies, however it is unclear if AbbVie, Humira’s manufacturer, would maintain current rebate levels with this strategy. As such, a third strategy for payers may be to continue exclusively with Humira in their formularies, taking advantage of large rebates and avoiding the administrative work required to switch all patients to biosimilars. However, the sustainability of this method is unclear as newer biosimilars enter the market and prices of biosimilars decrease. While many unknowns remain, it will be exciting to follow the evolution of biosimilar coverage and payer decision-making when the first Humira biosimilars launch in the next year, as similar dynamics will follow across many relevant high-profile indications in upcoming years.
FDA Approval Trends
Several notable trends emerged regarding drug approvals in the US from 2021 and early 2022. Notably, speakers at AMCP highlighted that the FDA may be adopting more stringent approaches in its assessment of new drugs and increasing its scrutiny of data, trial designs, and endpoints before granting approvals. This was highlighted by the number of complete response letters (CRL) received by manufacturers before gaining approval. In addition, in early 2022, the FDA voted to reject a novel drug application for an amyotrophic lateral sclerosis drug, despite this being a disease area with an immense unmet need, noting uncertainties in the presented evidence. Additional trends showed that novel approvals in 2021 were predominantly for later line medications. Further, many approvals in 2021 were for products developed by small companies, highlighting the importance of biotechnology start-ups in driving innovation in healthcare.
Data-Driven Trends and Changes in Practice
The use and analysis of real-world evidence (RWE) were well-discussed topics at AMCP 2022; speakers reported on observed healthcare trends throughout the COVID-19 pandemic, sharing key learnings and interesting uses that could be incorporated within wider medical systems moving forward.
Hospital Visits and Healthcare Access
It was expected that COVID-19 would cause substantial disruption to medical care, and multi-year data confirmed this. There were nearly 1 billion fewer diagnostic visits than expected in the US in 2020, a drop of nearly 20%, with the largest gaps occurring in endocrinology, rheumatology, and primary care visits. As a leading indicator of long-term impact, the effects are continuing to be felt as subsequent COVID-19 surges put pressure on healthcare systems and problems that could have been avoided by regular check-ups begin to surface.
How patients receive care has also changed considerably across the COVID-19 pandemic; payers and manufacturers will have to keep these changing factors in mind when considering pricing and reimbursement over the coming years. When examining growth of sales, hospitals and long-term care facilities had negative growth in 2020, as expected, and have begun to recover in 2021 and 2022. However, home health care services continued to have robust growth of ~10% in both 2020 and 2021, suggesting they may play a larger role post-pandemic. It will be important for payers and manufacturers to consider the implications of these trends, particularly for therapies that could be administered in a variety of settings. Administration in a hospital or traditional healthcare setting may be associated with lost productivity and costs associated with hospitalization and other related resource use; however, the convenience of a home setting may not always lead to cost savings, as the initial development costs of setting up home administration might not offset the cost burden of having patients come into a hospital.
Interestingly, telemedicine has not had a major impact on total medical claims through 2021, suggesting that individuals are utilizing this option less frequently than anticipated compared to the spike in use in the early stages of the pandemic. At the beginning of 2021, telemedicine made up nearly 13% of all total claims made, dropping down and stabilizing near 7% by the end of the year.
RWE in the Field
Finally, RWE was utilized in the care of COVID-19 patients. The treatment care algorithm for COVID-19 continues to evolve, and (inter)national guidelines are often updated too infrequently to keep up with the latest evidence. With the sheer number of guidelines and papers published, healthcare workers were often overwhelmed with information, leading to the risk that patients received suboptimal care. At AMCP, there were first-hand accounts detailing the use of RWE in the optimization of COVID-19 patient care. With the constant inflow of patients, particularly in larger healthcare systems, there was also a large amount of RWE that could be used to inform clinical practice. By examining records to see how patients responded to various treatment options, local guidelines were refined and developed at a system level, allowing for more frequent updates that could quickly respond to real-world results. This approach could be expanded to a variety of medical conditions beyond COVID-19, such as other fast-moving infectious diseases or conditions without well-defined guidance, where individual treatments and outcomes are particularly informative and impactful.
Diversity, Equity, and Inclusion at AMCP
AMCP emphasized the need for diversity, inclusion, and equitable access across the healthcare sector, particularly focusing on the role managed care pharmacy could play, aligned with the aims of Costello Medical’s equality and inclusion taskforce. These goals are important and laudable, and several speakers touched upon inequalities that currently exist; for example, outside research has shown that minorities were more likely to be impacted by a lack of medical access compared to White populations in the US. However, whilst diversity, inclusion, and equitable access issues are apparent, there were few direct solutions presented during the meeting and only one education session that directly discussed ethnic and racial disparities within the US.
We look forward to hearing about the steps AMCP will take towards these goals in the years ahead.
About Costello Medical
Costello Medical provides scientific support to the healthcare industry in the analysis, interpretation and communication of clinical and health economic data. Our team of over 300 people are based in Cambridge, London, Manchester, Boston, Singapore and Shanghai. Alongside our evolving technical and creative capabilities, we remain committed to our core values of high-quality scientific work coupled with exceptional customer service. Our core areas of expertise are Medical Communications, Market Access and Health Economics and Evidence Development. For more information on our services, please visit our website at www.costellomedical.cn.