Cambridge biotech Genzyme said that a British panel has approved reimbursement payments for one of Genzyme’s multiple sclerosis drugs in the UK.
The drug, Lemtrada, was approved last year by European regulators. But because a two-year Lemtrada treatment for a European patient can cost nearly $77,000, it is crucial that a drug be approved by panels in individual countries that determine what treatments qualify for reimbursement by that country’s health plan.
Lemtrada has already received reimbursement approval in some European countries including Germany, a company spokeswoman said.
(US regulators rejected Lemtrada in December, and Genzyme is in the process of resubmitting its Lemtrada application.)
In its press release, Genzyme said that Lemtrada has just been approved for reimbursement by the National Institute for Health and Care Excellence, or NICE, the panel that makes reimbursement decisions for the UK. The NICE panel approved Lemtrada for the treatment of adults with relapsing remitting multiple sclerosis, or RRMS.
A press release issued by NICE included a statement from Professor Carole Longson, the director of the NICE Health Technology Evaluation Centre.
“Evidence has shown that alemtuzumab is more effective and less expensive than current similar treatments for those with severe relapsing-remitting MS,” Longson said.
Lemtrada is the marketing name for alemtuzumab.
“We are pleased that NICE has recommended Lemtrada as being both clinically effective and cost effective for people with relapsing remitting MS,” Genzyme president and chief executive David Meeker said in a statement. “There are approximately 100,000 people in the UK diagnosed with the disease, and Lemtrada can be a potentially transformative treatment for appropriate patients.”
Lemtrada is administered by infusion. At the start of the treatment, a patient gets an infusion on five consecutive days. Twelve months later, the patient receives infusions on three consecutive days. Each infusion costs an estimated 7,045 euros, Genzyme said. At the current exchange rate, that works out to nearly $9,600 per infusion.
Lemtrada is an important drug for Genzyme, which has a heritage in rare genetic disorders and has expanded in recent years to develop MS drugs.
The potential for Lemtrada was among the reasons why French drug maker Sanofi SA acquired Genzyme in 2011 for $20.1 billion.
As part of that deal, Sanofi agreed to reward former Genzyme stockholders if the drug achieved certain milestones in the US market regarding approval and sales.
But in December, Genzyme had a setback when Lemtrada was formally rejected by the US Food and Drug Administration. Even though the drug has now been approved by regulators in the European Union, Australia, Brazil, Canada, Mexico, and Guatemala, the FDA questioned the integrity of Lemtrada’s clinical trials and cited the risk of potentially serious side effects.
In April, Genzyme said it planned to file an updated application for Lemtrada that would address the issues raised by the FDA.
In its Wednesday release, Genzyme reiterated its plan to resubmit a Lemtrada application to the FDA some time in the second quarter of this year.