Twenty years after its founding, England’s National Institute for Health and Care Excellence (NICE) has established itself as perhaps the world’s preeminent drug cost watchdog. Now, the only leader it has ever known will step down from his post.

Sir Andrew Dillon, NICE’s chief executive since its founding by the Tony Blair administration in 1999, will vacate his seat in March 2020. NICE’s board is expected to advertise the position in the fall. Sir David Haslam, NICE’s current chair, will also step down from his seat.

The departures come as NICE faces renewed calls to revamp its drug appraisal process—particularly for new technologies such as gene and cell therapies—and prepares to review its methods beginning next year.

Dillon has helmed the institute through the rough seas of its founding days and hasn’t been afraid to court controversy. The career executive, for instance, has led the agency through some very unpopular cancer drug rejections. He's also been front and center amid NICE’s public deadlockwith Vertex over pricing for cystic fibrosis (CF) drug Orkambi.

The yearslong struggle between the CF drugmaker and NICE has led to a very public spat that eventually roped in the U.K. Parliament after a public petition garnered 10,000 signatures.  

During the March hearing, Dillon raised eyebrows by saying Vertex had indicated "no flexibility" during negotiations over Orkambi’s $136,000 per year price, a unique case in his 20 years at NICE.

Vertex CEO Jeffrey Leiden said the drugmaker had already offered NICE its lowest confidential price in the world and was open to negotiating access. Months later, there has still been no agreement signed.

A similar—if less public—standoff played out over the past year between NICE and BioMarin over pricing of its Batten disease drug Brineura. After a year of negotiations, NICE blamed BioMarin for the hang-up in February, saying the drugmaker had been given "ample opportunity to come up with a workable solution."

Another head of a major drugmaker, Roche CEO Severin Schwan, castigated NICE back in 2015 after the institute's Cancer Drug Fund dropped its breast cancer drug Kadcyla. Schwan called the move "stupid from a cost point of view," but NICE agreed almost two years later to recommend the drug for the general population use. 

NICE’s flexibility in its value assessment—known as quality-adjusted life-years—has come under fire from both drugmakers and U.K. patients eager for novel drugs.

Richard Torbett, executive director of the Association of the British Pharmaceutical Industry (ABPI), said in June that NICE’s value metrics needed to evolve with the times and didn’t offer the flexibility necessary to introduce novel treatments.

"We don’t always agree with the approach taken by NICE to assess the value of medicines," Torbett wrote in a blog post. "We believe that its methods need to evolve over time as new technologies present new challenges."

Thursday, Mike Thompson, ABPI's chief executive, said Dillon had a "laser focus" on getting the best price for U.K. patients. 

"He has played a central role in building the credibility of the organisation, insisting on transparent processes, and a continuous dialogue with all stakeholders, recognising that as the science evolves, NICE needs to evolve too," Thompson said in a statement. "As a result of this leadership, there is a consensus across industry about the central role of NICE in assessing all medicines, ensuring that patients have a right to access the treatments they need."

Only recently has NICE shown some interest in revising its methodology. The institute is preparing a full-scale review of its value assessments that is expected to begin in 2020, after Dillon’s departure.

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