Age-related macular degeneration and diabetic macular edema are the leading causes of blindness and visual impairment in the United States, affecting a combined 1.8 million people. Ophthalmic vascular endothelial growth factor inhibitors (OVEGFIs) are first-line treatments for retinal diseases and are injected into the affected eye(s) to improve visual acuity. OVEGFIs are a top 10 medical drug spend category for both commercial and Medicare, with annual single-eye treatment costs ranging from $1,000 to more than $20,000, depending on the drug and dosing frequency. 

In January 2022, the U.S. Food and Drug Administration (FDA) approved faricimab-svoa (Vabysmo^®), which allowed extended dosing up to every 16 weeks after four monthly loading doses. However, faricimab-svoa is more costly than most competitor products when not used at an extended dose beyond every eight weeks. 

This study assessed extended faricimab-svoa therapy, analyzing medical drug claim data and assigning eye sidedness (e.g., left, right or both eyes) to claims using billed units, procedure modifier codes and International Classification of Diseases, Tenth Revision (ICD-10) codes. The research found that fewer than 2 out of 3 eyes newly initiating faricimab-svoa therapy reached maintenance phase, and approximately 1 out of 5 received extended dosing during the first year of treatment.  

The low proportion of extended dosing identified in the study provides insight into faricimab-svoa’s competitiveness in this drug category, which may influence its position and importance in management strategies such as step therapy.  What’s more, the study calls attention to value-based contracts and how their use may improve faricimab-svoa’s proposition in this competitive category while meeting the varying treatment needs of patients. 

David Eckwright, senior director of clinical project and program management at Prime Therapeutics (Prime), was the lead author on this study, and he shared some additional insights on this striking research.

Alex Cook: You cite how OVEGFIs are a top 10 medical drug spend category for both commercial and Medicare. What are some of the other drugs in this category?
David Eckwright: This category is 20 years old, with the first FDA approval dating back to 2004 when pegaptanib (Macugen^®)was approved. Since then, additional therapies have come out, including ranibizumab (Lucentis^®) in 2006 and aflibercept (Eylea^®) in 2011. There has been significant action in this category within the last few years with ranibizumab biosimilars entering the market (ranibizumab-eqrn [Cimerli^®] and ranibizumab-nuna [Byooviz^®]) and the introduction of products having the potential for dose extension, such as faricimab-svoa (Vabysmo^®).

This is a fascinating study because the therapy you and your fellow researchers examined is both newer to the market and can potentially lead to a dramatic outcome: improving visual acuity. What inspired you and the team to research this topic?
Faricimab-svoa was approved with a wide range of potential maintenance dosing frequencies, from every 4 to 16 weeks. This four-fold difference in dosing leads to a four-fold variation in annual therapy cost, with more frequent doses (every 4 weeks) being four times as expensive as the less frequent (every 16 weeks). Therefore, we wanted to understand how often members are receiving the lower-cost extended dose, defined as dosing beyond the typical every 8-week dosing of existing therapies, using our real-world data. This information is vital for understanding how often members are benefiting from this innovative extended dosing regimen of this otherwise more costly therapy.

The study also notes that value-based contracts may improve faricimab-svoa’s proposition in this competitive category while meeting the varying treatment needs of patients. Tell us a little bit more about that.
Drugs with varying dosing (i.e. consumption) based on patient need is not new, and these variations can lead to fluctuations in therapy costs. Sometimes therapy cost fluctuations for a drug can be dramatic, and it becomes crucial to have mechanisms in place to promote cost predictability and consistency for payers. One effective solution is value-based contracts. Prime is a leader in value-based contracts and having a construct based on dosing (i.e. consumption) is not new to us and could be a useful tool applied to drugs, promising the potential for extended dosing in this category.

In a broader sense, how does managed care research help improve access and reduced costs for high-cost therapies such as this?
Managed care research involves the development and deployment of innovative analytic methodologies to better understand real-world drug therapy utilization and cost, to understand its impacts on health care utilization (e.g. total cost of care) and to identify cost-optimized usage (e.g. dose consolidation, dispensing optimization, vial management). The foundational insights from this type of work are vital for making informed therapy management decisions to promote cost-effective therapies and reduce the total cost of care.

Specialty drugs are a booming segment of the health care industry. As a researcher, how do you keep up with the rapid developments in this space? How does it inform your work on a day-to-day basis?
I lean a lot on our internal expertise here at Prime. I learn from our amazing team of specialty drug and pipeline experts who also share their insights publicly as well through various publications such as the High-Cost Therapy Profile, Clinical Highlights, Drug Approvals, FDA Decisions Expected and our annual Medical Pharmacy Trend Report that we will release later this month. Our collaboration is crucial in directing our research efforts to fill important industry knowledge gaps, which in turn informs our decision-making and managed care strategies.

Stay tuned for more AMCP Nexus 2024 in focus content throughout the week in the Prime newsroom. For more information on this research, check out the research poster.