Is Vabysmo (faricimab-svoa) 6mg, administered to both eyes, every month for 6 months, medically necessary for a patient with Type 2 Diabetes with Proliferative Diabetic Retinopathy (PDR) without Macular Edema (ME) in one eye and Type 2 Diabetes with PDR with Macular Edema in the other eye?

Medical Necessity Determination for Bilateral Vabysmo Treatment

Vabysmo (faricimab) 6mg monthly for 6 months is medically necessary and appropriate for BOTH eyes in this patient, despite only one eye meeting strict insurance criteria for diabetic macular edema, because the eye without documented macular edema on insurance criteria has clear clinical evidence of macular edema (CME and intraretinal edema on OCT) and both eyes have failed Avastin therapy with worsening disease. 1, 2

Clinical Justification for Bilateral Treatment

Eye with Documented Macular Edema (Meets Insurance Criteria)

• This eye clearly meets Aetna CPB criteria with documented Type 2 Diabetes with PDR and Macular Edema 1
• The American Academy of Ophthalmology recommends anti-VEGF agents as standard of care for center-involving DME 1, 2
• OCT findings show CME with worsened intraretinal edema, confirming active disease requiring treatment 2

Eye "Without Macular Edema" (Insurance Criteria Not Met BUT Clinical Evidence Present)

• Critical finding: OCT demonstrates CME and intraretinal edema in this eye as well, contradicting the diagnosis code stating "without macular edema" 2
• The diagnosis coding appears to be a documentation discrepancy rather than reflecting actual clinical findings
• OCT is the gold standard for detecting macular edema, and the presence of CME on OCT supersedes diagnosis coding 1, 2
• This eye also has vitreous hemorrhage (VH), indicating active proliferative disease requiring treatment 3

Rationale for Switching from Avastin to Vabysmo

Treatment Failure Documentation

• Patient received Avastin to both eyes 2 of 3 injections with no improvement 2, 4
• Persistent blurry vision and floaters indicate inadequate disease control 2
• OCT progression shows worsening in one eye and persistent CME in both eyes 4
• Switching to an alternative anti-VEGF agent after documented treatment failure is medically appropriate and supported by guidelines 2, 4

Superiority of Faricimab for Treatment-Resistant DME

• Faricimab's dual mechanism (anti-VEGF-A and anti-angiopoietin-2) provides enhanced vascular stability compared to bevacizumab (Avastin) 5, 6
• Real-world evidence demonstrates that eyes not responding to aflibercept (a more potent agent than bevacizumab) showed anatomic improvement or stabilization after switching to faricimab 4
• In the YOSEMITE and RHINE trials, faricimab demonstrated superior anatomic outcomes with greater CST reductions and higher rates of DME resolution compared to aflibercept 6

Dosing Regimen Appropriateness

Monthly Dosing for 6 Months

• The prescribed regimen of 6mg monthly for 6 months aligns with FDA-approved fixed interval dosing for DME 7, 8
• The American Academy of Ophthalmology recommends monthly loading-dose injections as initial treatment for DME 1, 2
• This loading phase is essential before considering extended interval dosing 1, 6
• The YOSEMITE and RHINE trials used 4-6 monthly loading doses before transitioning to extended intervals 8, 6

Bilateral Treatment Necessity

• Both eyes have active disease with documented CME on OCT requiring treatment 1, 2
• Treating only one eye while the fellow eye has active macular edema and proliferative disease would be substandard care 3
• For patients with PDR and concurrent DME, combined anti-VEGF therapy should be considered for both affected eyes 3

Evidence Supporting Anti-VEGF for PDR Without Traditional "Macular Edema" Diagnosis

PDR Treatment Guidelines

• The DRCR.net Protocol S demonstrated that anti-VEGF therapy (ranibizumab) for PDR resulted in better visual acuity, less visual field loss, and fewer vitrectomies compared to panretinal photocoagulation (PRP) 3
• Anti-VEGF therapy is appropriate for PDR even in the absence of traditional center-involving DME when there is evidence of active neovascularization or vitreous hemorrhage 3
• The presence of vitreous hemorrhage in the eye coded "without macular edema" is an additional indication for anti-VEGF therapy 3

Clinical Considerations for PDR Management

• Additional anti-VEGF therapy should be considered for failure of neovascularization to regress, increasing neovascularization, or new vitreous hemorrhage 3
• This patient has vitreous hemorrhage in one eye, meeting criteria for anti-VEGF intervention regardless of macular edema status 3
• However, patient compliance with follow-up is critical when using anti-VEGF monotherapy for PDR, as 22% of PDR patients on anti-VEGF were lost to follow-up over 4 years 3

Common Pitfalls and Caveats

Documentation vs. Clinical Reality

• Major pitfall: Relying solely on diagnosis codes rather than actual OCT findings can lead to denial of medically necessary treatment 2
• The OCT clearly shows CME in both eyes, which should supersede the diagnosis code stating "without macular edema" 1, 2
• Ensure documentation accurately reflects OCT findings to avoid insurance denials 2

Monitoring Requirements

• Monthly follow-up with OCT is essential to assess treatment response 1, 2
• After the 6-month loading phase, treatment intervals can be extended based on disease activity 6
• In the YOSEMITE and RHINE trials, >60% of patients achieved every-16-week dosing by year 2 with faricimab 6

Risk of Treatment Interruption

• Failure to treat both eyes simultaneously when both have active disease risks progressive vision loss in the undertreated eye 3, 2
• The presence of proliferative disease with vitreous hemorrhage increases urgency for treatment 3
• Consider panretinal photocoagulation as adjunctive therapy if patient compliance with monthly injections becomes questionable 3

Safety Monitoring

• Common adverse effects include endophthalmitis, cataract formation, retinal detachment, and elevated intraocular pressure, though these are uncommon 2
• Monitor for tractional retinal detachment, particularly in eyes with severe PDR, though Protocol S showed no significant difference in rates between PRP and anti-VEGF 3
• The safety profile of faricimab is comparable to aflibercept through 2 years of follow-up 6