Purpose: To evaluate effects of reimbursement policy change on visual outcomes of patients with diabetic macular edema treated with ranibizumab.
Methods: In this retrospective comparative cohort study, we included 78 treatment-naïve patients with diabetic macular edema (107 eyes) insured under Taiwan's National Health Insurance from July 2013 to January 2015 (Group A) and April 2016 to June 2017 (Group B), or before and after the major reimbursement policy change, respectively. Best-corrected visual acuity (BCVA), optical coherence tomography findings, and injection numbers at baseline and postinjection Months 3, 6, and 12 were collected. Mean BCVA change and predictive factors for enhanced BCVA improvement at Month 12 were analyzed.
Results: The mean improvement in BCVA at 1 year was 5.8 ETDRS letters (Group A) before and 14.8 letters (Group B) after the policy change (P = 0.009), and the mean numbers of injections were 4.6 ± 2.0 and 6.5 ± 2.3 in Group A and B (P < 0.001), respectively. Linear regression revealed that greater visual improvement at Month 12 was significantly associated with worse baseline BCVA, greater visual gain at Month 3, new reimbursement policy (Group B), and the presence of subretinal fluid in baseline optical coherence tomography, but not with total injection number. Compared with Group A, Group B had enhanced BCVA improvement when baseline subretinal fluid was present (P = 0.001), but not when subretinal fluid was absent (P = 0.656).
Conclusion: Health care policy change significantly affected the visual outcomes of patients with diabetic macular edema in a clinical practice setting, with superior final BCVA and BCVA improvement after increased reimbursement. Presence of subretinal fluid at baseline predicted enhanced post-policy change visual improvement.