DETERMINATION: MEDICALLY NECESSARY
Avastin (bevacizumab) is medically necessary for this patient with type 2 diabetes mellitus, proliferative diabetic retinopathy with high-risk characteristics, and clinically significant macular edema, particularly given the documented history of vitreous hemorrhage, persistent neovascularization, and prior treatment with other anti-VEGF agents and corticosteroids. 1, 2
Rationale for Medical Necessity
Clinical Appropriateness Based on Guidelines
The American Diabetes Association 2025 guidelines explicitly state that intravitreal anti-VEGF agents (including bevacizumab, ranibizumab, and aflibercept) are appropriate first-line treatment for center-involved diabetic macular edema with vision impairment. 1 The International Council of Ophthalmology guidelines confirm that for center-involving DME with vision loss (6/9 or 20/30 or worse), intravitreal anti-VEGF treatment with bevacizumab 1.25 mg can be considered. 1
For proliferative diabetic retinopathy, the American Academy of Ophthalmology recommends prompt treatment within less than 1 month of diagnosis, and anti-VEGF therapy is non-inferior to traditional panretinal laser photocoagulation for reducing vision loss risk. 2 This patient meets urgent treatment criteria with PDR with high-risk characteristics bilaterally. 1
Disease Severity Meets Treatment Thresholds
This patient demonstrates multiple high-risk features warranting anti-VEGF therapy:
Proliferative diabetic retinopathy with high-risk characteristics bilaterally including persistent neovascularization elsewhere with preretinal hemorrhage, requiring follow-up at less than 1-month intervals per guidelines. 1
Clinically significant macular edema documented on OCT with tractional striae and epiretinal membrane in the right eye, and mild cystic changes in the left eye. 1
History of vitreous hemorrhage (documented through prior authorization), which bevacizumab has demonstrated efficacy in rapidly resolving while promoting regression of retinal neovascularization. 3, 4, 5
Persistent retinal hemorrhages and neovascularization despite previous treatments, indicating active disease requiring ongoing anti-VEGF therapy. 1, 2
Prior Treatment History Supports Continued Anti-VEGF Therapy
The patient has previously received Eylea (aflibercept) and dexamethasone treatments, demonstrating that anti-VEGF therapy is the established treatment approach for this patient. 1 Switching to bevacizumab is medically appropriate as:
All three major anti-VEGF agents (bevacizumab, ranibizumab, aflibercept) are recognized as effective treatments for diabetic macular edema and proliferative diabetic retinopathy. 1
Bevacizumab provides similar visual outcomes to other anti-VEGF agents in eyes with mild to moderate visual impairment, though it may be slightly less effective at reducing retinal thickening compared to aflibercept or ranibizumab. 1
The 2025 ADA guidelines state that eyes with persistent diabetic macular edema despite anti-VEGF treatment may benefit from alternative approaches, but switching between anti-VEGF agents is a reasonable strategy before considering corticosteroids or laser. 1
Evidence Supporting Bevacizumab Efficacy
Multiple studies demonstrate bevacizumab's effectiveness specifically for proliferative diabetic retinopathy with complications:
Bevacizumab results in marked regression of retinal neovascularization, with 61-75% of eyes showing total regression and 34% showing partial regression at 6 months follow-up. 5
For vitreous hemorrhage complicating PDR, bevacizumab produces rapid resolution with partial clearing at 1 week and nearly complete regression at 1 month. 3, 4
In patients with PDR and prior complete panretinal photocoagulation who develop new vitreous hemorrhage, bevacizumab injection cleared hemorrhage completely in 72% of eyes at 12 months. 4
Bevacizumab is an established anti-VEGF agent used for treating PDR and has demonstrated efficacy in regressing retinal neovascularization. 2
Treatment Protocol Requirements
Standard anti-VEGF protocols for PDR typically require intensive initial treatment with near-monthly injections during the first year, followed by maintenance dosing. 2 For this patient:
Initial intensive phase should include monthly bevacizumab injections (1.25 mg) for at least 4-6 months with close monitoring. 2
Maintenance phase requires extended interval dosing (every 6-8 weeks) based on clinical response and OCT findings. 2
Monitoring schedule must occur every 1-3 months to assess neovascularization regression and need for continued therapy. 1, 2
Most patients require administration every 4-8 weeks during the first 12 months of treatment, with fewer injections needed in subsequent years. 1
Critical Caveats and Monitoring
A critical consideration is that anti-VEGF therapy for proliferative disease requires greater number of visits and treatments than panretinal laser, and individuals with nonintentional lapses in treatment are at risk for worse visual acuity and anatomic outcomes. 1 This patient must maintain scheduled follow-up.
The presence of tractional changes (fibrotic proliferans with localized traction and retinal hole superotemporal in the right eye) requires careful monitoring, as tractional retinal detachment may occur or progress after bevacizumab injection. 6 If vitrectomy becomes necessary, surgery should be performed within 4 days after bevacizumab injection. 6
The epiretinal membrane with tractional striae in the right eye may affect treatment response and should be monitored, as persistent macular edema despite anti-VEGF therapy may ultimately require macular laser photocoagulation or consideration of vitrectomy. 1
Criteria Met for Authorization
Based on the provided criteria source, bevacizumab is indicated when ALL of the following are present:
- Age 18 years or older - Patient meets this criterion
- Intravitreal administration needed - Confirmed by clinical presentation
- Eye condition appropriate for bevacizumab treatment - Patient has diabetic macular edema, which is explicitly listed as an appropriate indication
This patient fully satisfies all required criteria for bevacizumab authorization. The clinical documentation demonstrates proliferative diabetic retinopathy with high-risk characteristics, clinically significant macular edema, persistent neovascularization, and history of vitreous hemorrhage - all conditions for which bevacizumab has established efficacy and guideline support. 1, 2