Bayer feels sting of mixed decision from NICE for Eylea's use in diabetics

Bayer has won an approval from England's National Institute for Health and Care Excellence (NICE) for its popular eye drug Eylea. But it was a mixed result. The drugmaker offered a discount to get the approval and then NICE granted it for some, but not all, patients with diabetic macular edema (DME).

In preliminary guidance, NICE greenlighted Eylea to treat the majority of DME patients but gave a thumbs-down to the drug for individuals with early stages of the disease. The cost-effectiveness gatekeeper doled out its recommendation partly because Bayer agreed to a patient-access scheme, reducing the drug's financial burden on the U.K.'s NHS, said Carole Longson, director of NICE's health technology evaluation center (as quoted by PharmaTimes).

Bayer said it is "disappointed that a core group of patients diagnosed with early stage [DME] would be denied treatment until their disease has progressed to a stage where permanent damage to the eye has already begun." But Sobha Sivaprasad of Moorfields Eye Hospital was more pointed. She called the decision "frustrating" because if those patients were treated earlier, it would help them maintain their vision. She was quoted in the Bayer release as also saying that the alternative treatment of laser surgery "is not very effective and can even lead to deterioration of vision, meaning the decision is often made to leave patients and monitor them for disease progression until they can receive alternative treatment options."

Bayer said it will work with NICE throughout Eylea's appraisal process to ensure that all DME patients have access to the drug by the time the U.K. body finalizes its decision. A final word from NICE is expected in June 2015.

The decision comes amid promising results for Eylea, as the drug topped Roche ($RHHBY) and Novartis' ($NVS) Lucentis and Avastin in treating moderate to severe vision loss in patients with DME in the first head-to-head study comparing the meds.

This is not the first time Bayer has hit a payer speed bump for Eylea. In December, Germany's cost-effectiveness gatekeeper, the German Institute for Quality and Efficiency in Health Care (IQWiG), said Eylea does not perform any better than Lucentis as a treatment for DME. IQWiG had previously said that it could not assess the drug as a treatment for age-related macular degeneration because Bayer did not provide enough relevant data.

NICE chief Sir Andrew Dillon

Meanwhile, NICE continues to battle it out with the industry over its payment thresholds. Drugmakers often criticize the watchdog for being unreasonable in its demand for discounts, and patient groups have grilled the U.K. body for not approving new and promising treatments. NICE CEO Sir Andrew Dillon defended NICE's stance, saying the U.K. "can't just say yes to anything and everything. ... We don't have enough money--and anyway, not everything is worth having." 

But drugmakers and NICE enjoyed a moment of solidarity this week, as they banded together in defending against a study claiming NICE is paying companies too much for new treatments. The study, conducted by the University of York, said the measure the U.K. body uses to evaluate drugs should be capped at around £13,000. But Dillon dismissed the findings, saying researchers are fooling themselves if they think drugmakers would provide their products in England at that rate.

- read Bayer's release
- here's the PharmaTimes story

Special Reports: Top 15 Drug Launch Superstars - Eylea | The 25 most influential people in biopharma today - Sir Andrew Dillon

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