Product information and disease description Place of product in therapy Approaches to treatment

Care management intervention strategies

12 evidence topics · 11 sources

Anti-VEGF dosing regimens: fixed, as-needed, treat-and-extend, and personalized intervals

“There are numerous protocols: monthly or bimonthly injections, treat-and-extend, PRN, or personalized treatment interval.” (opens the source at this quote in a new tab)
“There is no consensus about the ideal treatment intervals with anti-VEGF agents, and the physician can tailor treatment on an individual patient basis.” (opens the source at this quote in a new tab)
“A continuous, variable dosing regimen that attempts to individualize therapy, commonly referred to as treat-and-extend, is frequently used in clinical practice as an alternative to the two treatment approaches above.” (opens the source at this quote in a new tab)

NICE: agent selection by cost and switching

“Given the guideline committee's view that there is equivalent clinical effectiveness and safety of different anti-VEGF agents (aflibercept, bevacizumab and ranibizumab), comparable regimens will be more cost effective if the agent has lower net acquisition, administration and monitoring costs.” (opens the source at this quote in a new tab)
“Consider switching anti-VEGF treatment for people with late AMD (wet active) if there are practical reasons for doing so (for example, if a different medicine can be given in a regimen the person prefers), but be aware that clinical benefits are likely to be limited.” (opens the source at this quote in a new tab)

Payer coverage restrictions and step therapy prevalence

“Descriptive assessment showed that approximately 65% of commercial coverage decisions and approximately 52% of MA decisions included restrictions beyond the FDA label.” (opens the source at this quote in a new tab)
“Coverage decisions for originator products were more likely to include restrictions compared with those for biosimilar products.” (opens the source at this quote in a new tab)
“Step therapy protocols were found in up to 75% of plans but were variable by drug, with most requiring a first-line trial of bevacizumab.” (opens the source at this quote in a new tab)

Medicare Advantage step therapy and prescribing of bevacizumab

“The difference-in-differences regressions found a 7.8% (95% CI, 4.9%-10.7%; P < .001) greater probability of being prescribed bevacizumab for the first administration due to step therapy.” (opens the source at this quote in a new tab)
“Step therapy was not significantly associated with an increased rate of medication switching (hazard ratio, 0.86; 95% CI, 0.71-1.06; P = .15).” (opens the source at this quote in a new tab)

Medicare Part B anti-VEGF use after step therapy

“After step therapy implementation, relative usage of aflibercept increased by 32.0%, while there was a decrease in relative usage of bevacizumab by 33.2% and ranibizumab by 4.3%.” (opens the source at this quote in a new tab)
“Step therapy has not significantly increased bevacizumab usage on an aggregate level.” (opens the source at this quote in a new tab)

Bevacizumab-first step therapy outcomes at an academic center

“After 1 year, mean ΔVA was +8.4 letters (95% CI: +6.1 to +10.6 letters). 86% had treatment success, and 6% of eyes had switched to aflibercept.” (opens the source at this quote in a new tab)
“11% (n = 38) of eyes were switched to aflibercept.” (opens the source at this quote in a new tab)

Prior authorization for anti-VEGF agents in retina practices

“Overall, 2140 (96.2%) requests were approved.” (opens the source at this quote in a new tab)
“Overall, PA denial for step therapy was 2.9% (65 of 2225) of requests and uncovered diagnoses was 0.9% (20 of 2225) of requests.” (opens the source at this quote in a new tab)

Step therapy policy review

“Following the 2019 Centers for Medicare and Medicaid Services decision permitting Medicare Advantage plans to impose step therapy for Part B drugs, many insurers adopted a bevacizumab (Avastin, Genentech/Roche)-first approach to intravitreal anti-VEGF therapy.” (opens the source at this quote in a new tab)
“However, CMS maintained that FDA-approved biosimilars could be used in step therapy programs.” (opens the source at this quote in a new tab)

Patient monitoring during intravitreal therapy

“Treated patients should be instructed to report symptoms of endophthalmitis, retinal detachment, or decreased vision, and they should be re-examined promptly.” (opens the source at this quote in a new tab)

PULSAR: criteria for shortening the dosing interval and the limit on extension in year 1

“Beginning at week 16, patients receiving aflibercept 8 mg were assessed and the dosing interval was shortened if the following DRM criteria were met: BCVA loss of more than 5 letters from week 12 and either a more than 25 μm increase in central retinal thickness (CRT) from week 12 or new foveal haemorrhage or neovascularisation” (opens the source at this quote in a new tab)
“Patients in the aflibercept 8q12 and 8q16 groups who met the DRM criteria at week 16 or week 20 had their interval shortened and subsequently received aflibercept 8 mg every 8 weeks.” (opens the source at this quote in a new tab)
“The minimum interval for all patients was 8 weeks, and dosing intervals could not be extended within the first year of treatment.” (opens the source at this quote in a new tab)

TENAYA and LUCERNE: disease activity assessment for interval assignment and the personalised treatment interval regimen

“After the first four monthly doses (day 1, and weeks 4, 8, and 12), patients in the faricimab group were assessed at weeks 20 and 24 for protocol-defined disease activity based on structural and functional criteria and treating physician clinical assessment” (opens the source at this quote in a new tab)
“Patients in the faricimab group who did not have active disease at weeks 20 and 24 received faricimab at week 28 and continued a 16-week regimen up to week 60.” (opens the source at this quote in a new tab)
“In the PTI regimen, dosing intervals can be extended in 4-week increments or reduced in 4-week or 8-week increments to a minimum of every 8 weeks, a maximum of every 16 weeks, or maintained based on disease activity assessments at study drug dosing visits.” (opens the source at this quote in a new tab)

Archway: monthly monitoring during 24-week refill intervals

“Patients treated with the PDS Q24W were monitored monthly through trial completion to maintain visual acuity examiner masking, and additional safety visits were performed at days 2 and 7 after implantation.” (opens the source at this quote in a new tab)
“Archway required monthly monitoring for PDS-treated patients to align with the visit schedule of the monthly ranibizumab comparator arm.” (opens the source at this quote in a new tab)
“the Archway trial was not designed to evaluate the number of visits required for monitoring PDS-treated patients” (opens the source at this quote in a new tab)