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Medicare Turns Gimlet Eye on DME Drugs

MedPageToday, 2012

At that meeting, the RIDE and RISE trials showed that the VEGF inhibitor ranibizumab (Lucentis) improved vision in DME patients compared with placebo.
However, clinicians there told MedPage Today that another anti-VEGF agent, the cancer drug bevacizumab (Avastin), was equally as effective at a much lower price tag.
Though both drugs are manufactured by Genentech, ranibizumab injections can run $1,950 each while bevacizumab costs only $50 per shot.
The National Eye Institute sponsored a 1,161-patient study called , which found that both agents appeared to have similar clinical efficacy in wet age-related macular degeneration -- a condition for which ranibizumab is now approved, and for which bevacizumab is frequently prescribed off-label.
The CATT study results figured heavily into technology assessment reports created for MedCAC, written by researchers at the University of Alberta and Massachusetts General Hospital under contract with the Agency for Healthcare Research and Quality.
Aside from ranibizumab and bevacizumab, two other treatments -- pegaptanib (Macugen) and aflibercept (Eylea) -- are FDA-approved for other indications and have been used off-label in DME.
The review of 15 randomized controlled trials and eight observational studies totaling more than 4,000 patients noted, however, that the side effect profile of bevacizumab relative to ranibizumab and the other agents remains the "greatest element of uncertainty" because it may be linked with more systemic side effects.
Head-to-head trials of VEGF inhibitors in DME are just one type needed for the CMS decision, panelists said.
Another key need is appropriate measures of patient outcomes, particularly improvements in quality of life, that are related to gains in visual acuity.
Goodman said that while better visual acuity doesn't inevitably translate to an improvement in quality of life, it does track it closely.
There's also a need for more safety data and longer follow-up on the potential for adverse events, panelists said.