Merck KGaA's Mavenclad, Roche's Perjeta win 'innovative' coverage deals with NHS

Cost watchdogs in England and pharma don't always see eye to eye, but the sides are celebrating two new deals that will allow certain multiple sclerosis or breast cancer patients access to Merck KGaA's Mavenclad or Roche's Perjeta, respectively. 

NHS England head Simon Steven announced the deals Thursday, calling the agreements "concrete examples" of the agency's efforts to work "with the life sciences industry to make treatments available for patients, while securing fair value for taxpayers."

The Mavenclad agreement is an outcomes-based deal for patients with highly active relapsing remitting MS, one of several such agreements NHS England has entered recently on innovative and expensive new drugs, according to a statement. 

Mavenclad won European approval in August, six years after regulators in both Europe and the U.S. said they wouldn't sign off on the drug. Back in 2011, a late-stage study showed a possible link to cancer, and regulators said the drug's risks weren't worth the benefits.  

The company responded by closing its Swiss organization and laying off thousands of employees. But four years later, the drugmaker announced it would seek approval based on new data and analysis. Merck KGaA is looking for peak sales of €700 million ($816 million) for the drug and will decide this year whether to seek U.S. approval, Reuters reported back in September. 

For Perjeta's, NHS England and Roche agreed to a "confidential arrangement" to ensure routine access, according to NHS England. Previously, Perjeta was available through the Cancer Drugs Fund.  

England's NICE recommended the drug earlier this year for early-stage neoadjuvant use in HER2-positive breast cancer, according to a spokesperson, and now NHS England has agreed to cover Perjeta in cases where cancer has spread to other parts of the body, cannot be surgically removed and has stopped responding to other treatments. 

In a statement, Roche's general manager in the U.K., Richard Erwin, said the company is "extremely pleased that due to the collaborative approach Roche, NHSE and NICE have taken, we have been able to come to an agreement on Perjeta that we believe meets the conditions and criteria required to enable NICE to recommend it for routine funding for eligible patients." 

The deal follows a contentious past for the parties and previous rejections for the drug dating back to 2013. Roche has also had issues winning coverage for some of its other new cancer drugs in the U.K., such as Tecentriq and Kadcyla.