As reported by the Center for Biosimilars, CVS Caremark has announced their 2024 formulary changes. Some of which, especially in the ophthalmology area, are particularly interesting and may shake up the category for wet, age-related macular degeneration.
The large PBM decided to exclude from coverage the reference product for aflibercept (Eylea®) despite aflibercept biosimilars having not yet been approved by the Food and Drug Administration (FDA). The decision to eliminate aflibercept coverage, though unusual, can be justified on a number of levels: Outcome differences have not been demonstrated between aflibercept and ranibizumab, they are both administered via intravitreal injections, and the ranibizumab biosimilars are less expensive than Eylea (and the reference product for ranibizumab, Lucentis®). For good measure, CVS Caremark de-listed Lucentis®, leaving its biosimilars, Byooviz® and Cimerli®, as the only formulary options for either category.
It is likely that upcoming aflibercept biosimilar approvals did not play a role in the PBM’s decision. The initial launches for Eylea biosimilars are expected in the second half of 2024, and these include Coherus/Formycon’s FYB203 and Celltrion’s CT-P42, both of which were submitted for FDA approval in June 2023. At least seven prospective biosimilar makers are completing or have completed phase 3 trials for aflibercept products.
Although Regeneron’s exclusivity on Eylea expires May 18, 2024, Regeneron filed a patent infringement suit on November 7 to forestall Celltrion’s entry into the market. The timing of the legal action seems a bit strange. According to Venable LLP, which follows biosimilar-related patent litigation, “To our knowledge, this case presents the first [time the patent holder] brought suit after receiving the biosimilar applicant’s abbreviated BLA and responsively providing a list of patents without waiting for the ‘patent dance’ to proceed beyond the patent list stage.”
One other thing to consider: ranibizumab and aflibercept are not usually covered by PBMs, as they are provider-administered and covered under the medical benefit as buy-and-bill drugs. However, keep in mind that CVS is part of the CVS Health-Aetna integrated organization. Could this decision have some implications for the health plan’s coverage? Not for Aetna’s Medicare Advantage customers apparently: Its Part B formulary lists two preferred products: bevacizumab and Byooviz (the latter only after a trial and failure of bevacizumab).
In related news, Outlook Therapeutics, the company seeking to introduce a manufactured bevacizumab formulation for the same ophthalmologic indications as ranibizumab and aflibercept, announced that it is moving forward with a new clinical trial, as required by the FDA in its complete response letter of August 23, 2023. It has stated that, with its proposed trial design, the noninferiority study versus ranibizumab could be completed in 2024, and a new BLA submitted “by the end of calendar year 2024.” This timeline suggests that a launch of ONS-5010 would be possible no earlier than the second quarter of 2025.
