National lupus organizations in more than 28 countries, and individuals with lupus and their families around the world, are rallying to protect access to new treatments and the development of future therapies to treat lupus. Recently, the United Kingdom's (UK) National Institute for Health and Clinical Excellence (NICE) released its preliminary recommendation not to cover the cost of Benlysta®, the first drug developed and approved in more than 50 years for use in people with lupus. NICE's preliminary recommendation would, in essence, deny physicians and patients a new treatment option for this complex and underserved disease.
The advent of Benlysta® represents several significant firsts for lupus, a life threatening and disabling disease with few approved treatments. Benlysta® is the first therapy specifically developed for lupus since the disease was first recognized in the mid 1800's. It is the first to specifically address an important underlying pathology of this disease - current treatments for lupus only manage the symptoms and mitigate the consequences of the disease. It is the first to successfully complete two international Phase III clinical studies, which are the largest ever conducted for lupus.
Current treatments used in lupus, include chemotherapies, glucocorticoids, and anti-virals. Side effects for these treatments include bone loss and osteoporosis leading to joint replacements, loss of fertility, cardiovascular complications, vision loss, infections, and more. In addition, many of the commonly used lupus treatments were developed for and borrowed from other diseases and conditions, and never properly tested or approved for lupus.
"We urge NICE to consider the unique medical needs of people with lupus, and the impact of existing therapies used to manage lupus, as they prepare their final decision," stated Sandra C. Raymond, President and CEO of the Lupus Foundation of America. "When evaluating the cost-benefit of Benlysta®, NICE must not ignore the lifetime costs of the disease related to the use of current therapies, including the costs for joint replacements, hospitalizations, rehabilitation, long term home care, physician visits, and additional medications resulting from the consequences of existing treatments."
Patient advocates from 28 nations have banded together and sent a letter, spearheaded by LUPUS EUROPE, Lupus Foundation of America, and the St. Thomas' Lupus Trust (UK), urging NICE to reverse its preliminary decision and recommend Benlysta® for coverage when they issue their final recommendation.
To bolster this effort, a worldwide petition has been launched and individuals with lupus, their families, and friends are urged to sign the petition (http://www.thepetitionsite.com/1/cover-Benlysta/). In less than two weeks, nearly 4,000 signatures have been garnered. The petition will remain online until a final NICE decision has been reached.
"We urge everyone touched by this disease to sign the petition and make their voices heard," said Yvonne Norton, Chair of LUPUS EUROPE. "It is through personal experiences shared by people affected by lupus that we can further demonstrate the need for new, approved lupus treatment options for physicians and their patients."
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