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. 2024 Sep 14;8(6):658-663.
doi: 10.1177/24741264241275283. eCollection 2024 Nov-Dec.

Bevacizumab First in DRCR Protocol AC vs Real-World Physician Treatment Choice for Diabetic Macular Edema: Two-Year Cost Analysis

Dilraj S Grewal  1 , Ella Leung  2 , Miguel Busquets  3 , Philip Niles  4 , Dan A Gong  5 , Anton M Kolomeyer  6 , Nitika Aggarwal  7 , Nick Boucher  7 , Jill Blim  8 , Judy E Kim  9 , Reginald Sanders  10 , Paul Hahn  6 ; ASRS Health Economics Committee
Affiliations

Bevacizumab First in DRCR Protocol AC vs Real-World Physician Treatment Choice for Diabetic Macular Edema: Two-Year Cost Analysis

Dilraj S Grewal et al. J Vitreoretin Dis. .

Abstract

Purpose: To compare the modeled costs of the Protocol AC bevacizumab-first treatment protocol (with a switch to aflibercept for sub-responders) with real-world costs for treatment-naïve patients with diabetic macular edema (DME) over a 2-year period. Methods: Published data from the Diabetic Retinopathy Clinical Research Network (DRCR) Protocol AC bevacizumab-first arm (154 eyes) were used to model 2-year treatment costs. Real-world costs were modeled using data from the Vestrum Health electronic medical records database from a 2016 to 2018 cohort of treatment-naïve eyes with DME (n = 1062) treated with antivascular endothelial growth factor monotherapy. The visual acuity (VA) before treatment in the real-world cohort was matched to Protocol AC. A secondary cost analysis further matched VA gains after treatment in the real-world cohort (n = 346) to Protocol AC. Results: In Protocol AC, the modeled 2-year DME treatment cost in the bevacizumab-first arm was $18,952, with a mean of 16.1 injections over 22.5 visits and 70% of eyes being switched to aflibercept by year 2. (Within 2 years, 57% of injections were bevacizumab and 43% were aflibercept.) Over the same period, the modeled 2-year real-world cost ($11,459) was 40% lower, with a mean of 8.6 injections over 13.8 visits (42% bevacizumab, 45% aflibercept, 13% ranibizumab). Even when matched for baseline VA and a 14-letter VA gain over 2 years, the real-world cost ($15,394) was still 19% lower than the modeled cost in the Protocol AC bevacizumab-first arm. Conclusions: The real-world cost of treating DME over 2 years was significantly lower than the DRCR Protocol AC bevacizumab-first cost. Application of Protocol AC findings into real-world utilization, as with step therapy mandates, should only be considered if the same intensive protocol could be followed. These data suggest that existing real-world costs that reflect physician choice are already significantly lower than protocol-mandated step therapy, even when controlling for similar VA outcomes.

Keywords: DRCR Protocol AC; aflibercept; bevacizumab-first; cost analysis; diabetic macular edema; real-world costs; step therapy.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr. Grewal: Genentech (consultant); Regeneron (consultant). Dr. Niles: Regeneron (consultant). Dr. Kolomeyer: Alimera (consultant); Apellis (consultant); Biogen (speaker, consultant); Genentech (speaker, consultant); IvericBio/Astellas (speaker); Regeneron (speaker, consultant). Dr. Kim: Genentech/Roche (advisory board); Outlook Therapeutics (advisory board); Regeneron (advisory board). Dr. Hahn: Adverum (consultant, advisory board); Alimera (advisory board); EyePoint (speaker, consultant, advisory board); Genentech (speaker, consultant, advisory board). None of the other authors declared potential conflicts of interest with respect to the research, authorship, and/or publication of the article.

References

    1. Lenahan KL, Nichols DE, Gertler RM, Chambers JD. Variation in use and content of prescription drug step therapy protocols, within and across health plans. Health Aff (Millwood). 2021;40(11):1749-1757. - PubMed
    1. Sachs RE, Kyle MA. Step therapy’s balancing act—protecting patients while addressing high drug prices. New Engl J Med. 2022;386(10):901. - PMC - PubMed
    1. Nayak RK, Pearson SD. The ethics of ‘fail first’: guidelines and practical scenarios for step therapy coverage policies. Health Aff. 2014;33(10):1779-1785. doi: 10.1377/hlthaff.2014.0516 - DOI - PubMed
    1. Wells JA, Glassman AR, Ayala AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema: two-year results from a comparative effectiveness randomized clinical trial. Ophthalmology. 2016;123(6):1351-1359. - PMC - PubMed
    1. Bressler NM, Beaulieu WT, Glassman AR, et al. Persistent macular thickening following intravitreous aflibercept, bevacizumab, or ranibizumab for central-involved diabetic macular edema with vision impairment: a secondary analysis of a randomized clinical trial. JAMA Ophthalmol. 2018;136(3):257-269. doi: 10.1001/jamaophthalmol.2017.6565 - DOI - PMC - PubMed

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