Preparing for new therapies & step therapy challenges: Q3 pipeline watch for retina practices

Biosimilar expansion and its influence on ASP trends and step-therapy requirements

The biosimilar market is the most immediate source of change. Several new products are expected to launch in the second half of this year and into 2027. What distinguishes this wave is not only the number of new products that will be available, but the differences between them. Some biosimilars will launch with prefilled syringes, while others will transition to prefilled formats after they launch. For practices that have long relied on a predictable set of reference products, this shift introduces new considerations around storage, handling, and workflow. Inventory systems that once managed a smaller number of products, will soon need to accommodate a broader mix, and the decision about what to stock will increasingly depend on payer mandates, regional coverage patterns, and the pace at which practices can turn inventory without overextending capital. 

As more biosimilars enter the market, average sales price (ASP) stability and predictability will influence how the market evolves. Launch strategies – particularly whether a product enters the market with or without a Q-code – will influence early adoption and rebate timing. Practices will need to watch ASP behavior closely, not only to understand margin implications, but also to anticipate how payers may adjust coverage as the market evolves. Thus, the coming quarter will bring more variability and practices that are monitoring these shifts will be better positioned to make informed decisions about product selection and patient access.

Additionally, step therapy edits are intensifying. What was once a single “try and fail” requirement is increasingly becoming a double step edit, with many patients required to step through repackaged Bevacizumab before moving to a branded reference product. Not only can these requirements delay optimal care, but they can also create confusion for patients who don’t understand why they must switch therapies or fail multiple products first before they can move on to their doctor’s recommended treatment. These requirements also create administrative burden on practices as they have to contend with more denials, more appeals, and more documentation to secure coverage. Further, communication gaps between payers and patients often leave practices responsible for educating patients on these mandates – adding another layer to staff and time workflows that practices need to address. 

Preparing for the cell and gene therapy shift in retina care

In addition to adjusting to the biosimilars market, retina practices should begin to consider the financial and operational complexities that will arise from the introduction of cell and gene therapies (CGT). Currently, the number of products available for retina are limited and confined mostly to rare diseases where there aren’t any other treatments available. But as the field evolves over the next several years, the therapies will bring with them a fundamentally different care model than what today’s retina practices are used to. 

The economic implications for CGTs alone will be challenging, from five- to six-figure therapies and long reimbursement timelines to reliance on single-case agreements. These issues will create financial issues practices are not used to navigating. For indications without an existing standard of care, the financial disruption will be modest. However, for indications such as wet-AMD, where practices are used to generating substantial recurring revenue, “one-and-done” gene therapy treatments will impact patient turnover and revenue stability. 

Operationally, gene therapies will introduce storage issues as they generally must be kept frozen or ultra frozen. Thus, the ability to store product will be an operational lift or barrier for most retina practices as freezers are costly and relying on a center of excellence can create another set of barriers. The route of administration also matters greatly and since many of these therapies will be subretinal and require an ambulatory surgical center (ASC), this will create a new set of issues as many retina practices do not have a stake in an ASC nor do they have one on site.

Though there currently is no one-size-fits-all solution, manufacturers are aware of the challenges surrounding the storing and administration of cell and gene therapies for retina diseases and are working to find solutions to help ease barriers and improve access to treatments when they become available. Though no additional CGT approvals are expected this year, providers are currently being approached about a new, approved therapy for MacTel, which will provide a window into what’s to come. Though MacTel is a rare disease, the implementation of the new therapy will serve as an example of why retina practices should start thinking about the impact of expanded availability of CGTs. Conversations and planning should begin now as additional therapies begin to move from rare disease exceptions to more mainstream treatment options.

TKIs

Three emerging mechanisms of action are poised to expand the retinal treatment landscape beyond traditional anti-VEGF therapies. These include tyrosine kinase inhibitors (TKIs), Wnt pathway agonists, and dual-target Anti-VEGF/Tie2 therapies, each designed to improve durability, vascular health, and overall patient outcomes while potentially reducing treatment burden. The benefits of each include: 

TKIS

• May provide longer-lasting treatment effects by targeting multiple disease pathways
• Offer broader biological activity compared with therapies focused on a single target
• Could reduce treatment burden by decreasing the frequency of injections 

 Wnt Agonists

• Promote vascular stability and support tissue repair within the retina
• May provide neuroprotective benefits that help preserve retinal function
• Could work synergistically with anti-VEGF therapies to improve outcomes and potentially extend treatment intervals 

 Anti-VEGF/Tie2 Therapies

•  Use a dual-target approach by inhibiting VEGF while activating the Tie2 pathway
• Designed to enhance vascular stability and reduce leakage and inflammation 
• May deliver greater treatment durability, helping reduce the need for frequent injections

Partnering with Cencora 

In the face of these challenges, retina practices are trying to navigate these changes while trying to maintain stability for patients already on therapy. Retina specialists are understandably cautious about switching stable patients to a new therapy, especially when vision outcomes are at stake. Yet payer mandates will eventually force movement, and practices will need to prepare for transitions that may not align with clinical preference. Other specialties, particularly oncology, have already navigated similar biosimilar adoption challenges, and retina practices can draw on those lessons – especially around workflow redesign, staff education, and patient communication. The right partner can also make a difference.

For nearly 20 years, Cencora has provided strategic support to retina practices of all sizes – from large aggregators to small, mid-sized, and independent groups – and is well-positioned to continue advancing its leadership within the specialty. With Cencora, retina practices gain the clarity, tools, and partnership needed to integrate biosimilars with confidence and begin to prepare for a future with CGTs.