pSivida Corp, a global medical device manufacturer, received a blow after regulators in the United Kingdom decided that the company’s treatment technologies for diabetic macular edema were too expensive. The Illuvian macular edema treatment system was licensed from pSivida to Alimera Sciences.
The National Institute for Health and Clinical Excellence is a regulatory body in the United Kingdom that regulates different treatment options available to patients under the government’s nationalized healthcare system. Since healthcare under the NIH is subsidized by taxpayers, regulators in the U.K. actively look for ways to minimize healthcare treatment costs.
According to the decision by the NIH, the benefits of pSivida’s Illuvien macular edema treatment technology do not justify the cost. However, pSivida and Alimera, the license-holder for the Illuvien technology, are working on an updated pricing scheme for the United Kingdom. The new “Patient Access Scheme” will provide specialized pricing agreements to reduce government healthcare costs. In a press release, Alimera stated, "[The Patient Access Scheme] being developed, if accepted, will make Iluvien available to all chronic DME patients in the United Kingdom considered insufficiently responsive to available therapies,"
Both companies have experienced issues with the Illuvien brand. In 2011, the United States Food and Drug Administration rejected the medical device / drug combo for the treatment of diabetic macular edema. According to the U.S. regulatory agency, Alimera failed to show that the benefits of the technology outweighed its potential risks.