Five years since securing European approval on their lupus drug, Benlysta, GlaxoSmithKline plc (NYSE:GSK) will now finally be able to introduce it to England after they got the approval from the country’s price watchdogs.
NICE, England’s National Institute of Health and Care Excellence have finally given its approval to the drug. Previously, the organization rejected the sale of the drug in the country, saying that the price was not justified. NICE released a guidance that Benlysta be adopted by the National Health Service.
Certain conditions were drawn up though. GSK is mandated to offer the drug at a discounted price. Also, NICE recommended that more clinical data should be gathered about Benlysta should be carried out to ease the apprehensions about the efficacy of the product. However, according to Erik van Snippenberg, General Manager of GSK UK, though they got NICE’s approval, they will still be challenged by the restrictions.
Lupus is a chronic autoimmune disease and affects more than 20,000 people in England and Wales. It has to be controlled. Otherwise, it can be debilitating and can lead to long term-term organ damage and premature death.
Benlysta belongs to a new class of drugs called BLys-specific inhibitors and is the first one to be launched. These new drugs work by attacking a natural protein that produces the antibodies that destroy the body’s own healthy tissues.
It was a promising drug, being the first new lupus drug to be approved in 50 years. It was acquired by GSK when they did a hostile takeover of Human Genome Sciences for $3 billion. In 2012, when it was first introduced, NICE appealed that there should be a price review on the drug since it costed $3,700 for the first four weeks and $1,227 every four weeks. However, the new price for the drug has not yet been disclosed.
Other European authorities have been very reluctant to approve expensive new meds because of debt problems in the region. Germany also turned down Benlysta because of its high price. It has already been approved by the FDA but has not been prescribed that much because of its $35,000 a year price tag.