July 15 (Bloomberg) -- Novartis AG, Europe’s second-largest drugmaker, failed to win approval from the U.K.’s health-cost agency for its drug Lucentis in diabetics who suffer an eye condition.
Lucentis wasn’t cost effective in patients with macular edema, the National Institute for Health and Clinical Excellence said today in a statement. The medicine costs 742 pounds ($1,200) for a monthly injection, NICE said. The agency advises the U.K.’s state-run National Health Service on which treatments represent value for money.
Novartis’s estimates for the cost of the treatment were based on “implausible assumptions” and if more realistic estimates had been made, the cost would have exceeded limits that NICE sets, the agency said. It was unable to recommend the medicine over an existing treatment for diabetics with macular edema, laser therapy.
“Laser therapy has provided stabilization of vision in many patients, but generally does not improve vision, and despite treatment many patients continue to lose vision,” the Basel, Switzerland-based company said in a statement. “Lucentis has been shown to double the likelihood of gaining vision and reduce the chance of losing vision by up to three-fold compared to laser” therapy.
One study found that patients required a median of eight to nine injections of Lucentis in the first year of treatment and two to three in the second year, according to the company.
Novartis said it plans to appeal NICE’s draft recommendations. The agency said it expects to publish a final decision next month.
Diabetic macular edema is caused by leaky blood vessels in the eye. Laser therapy cauterizes the vessels and seals them off, minimizing the leakage. NICE already recommends Lucentis for a separate eye condition, wet age-related macular degeneration.
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