BIM-IOL System

No cost-effectiveness analysis, budget impact model, health technology assessment, or published price was identified for the BIM-IOL System, which is in Phase 3 development with a planned 505(b)(2) NDA submission in 2028. The sponsor's Form 10-K estimates a U.S. total addressable market of approximately $13 billion, based on approximately 1 million U.S. cataract surgeries per year in patients with glaucoma or OHT (of approximately 5 million total), the proportion of glaucoma that is open-angle (approximately 90%), and the wholesale acquisition cost of iDose TR. Glaukos set the iDose TR wholesale acquisition cost at $13,950 per implant in December 2023. The sponsor also estimates 5.4 million cataract surgeries in glaucoma and OHT patients outside the United States in 2025. The sponsor expects Medicare Part B coverage with billing under a temporary and then a permanent product-specific J-code, reimbursed at ASP plus 6%, as for Durysta (J7351) and iDose TR (J7355). In May 2026 the AMA CPT Editorial Panel approved an add-on Category III CPT code for attachment and insertion of an IOL-mounted drug-eluting implant (placeholder +X659T; released as +1090T on July 1, 2026), used with Category I cataract surgery codes such as 66984 and 66991. Medicare Part B payment limits for July to September 2026 were $213.756 per 1 mcg for J7351 (bimatoprost intracameral implant) and $196.746 per 1 mcg for J7355 (travoprost intracameral implant).

No published cost-effectiveness or budget impact analysis of a sustained-release prostaglandin implant (Durysta or iDose TR) was identified in PubMed or web searches. The nearest published economic evaluations assess MIGS devices implanted during cataract surgery. A U.S. Medicare Markov model found Hydrus with cataract surgery to be cost-effective versus cataract surgery alone over 2 years (incremental cost-utility ratio USD 38,346.43 in mild and USD 42,895.38 in moderate glaucoma). A 35-year U.S. societal model found that Hydrus or iStent inject with cataract surgery dominated or was cost-effective versus cataract surgery alone. A 2-year budget impact model of the OMNI surgical system in a hypothetical U.S. plan with 1 million Medicare lives estimated a total cost decrease of $35,362. For the topical comparator, Medicare Part D spending on prostaglandin analogs was $733 million in 2013 and $1.09 billion in 2017, of which 86% was spent on branded products.