6:24 PM
 | 
Mar 08, 2019
 |  BioCentury  |  Politics, Policy & Law

Top-down solution to the U.K. Orkambi debacle

How a meeting between Vertex and U.K. Health Secretary could break the Orkambi impasse

Cystic fibrosis patients hope that a meeting on Monday between Vertex and the U.K. Health Secretary will break the deadlock that has prevented reimbursement of Orkambi by NHS.

If it works out, patients in England will gain access to the drug while the parties continue to hammer out an agreement on pricing -- a major step forward for one of the largest CF populations in the world, which has been locked out of the most promising treatment yet for the disease.

The reimbursement fight has been going on for over three years, since Orkambi lumacaftor/ivacaftor received European approval in November 2015.

In that time, Vertex Pharmaceuticals Inc. reached pricing agreements for Orkambi in eight European countries (see Figure: “Orkambi European Reimbursement”).

At a House of Commons Health and Social Care Committee hearing on March 7, neither party showed willingness to budge. NHS England stuck to a previous offer many consider lowball, and Vertex refused to change its counter-proposal offered last summer, which it characterized as the best price for Orkambi anywhere in the world.

Patients’ glimmer of hope from the hearing came with the disclosure of the Monday meeting between Vertex Chairman, President and CEO Jeffrey Leiden and U.K. Health Secretary Matthew Hancock. Leiden said he plans to present Hancock with a proposal that would give patients immediate access to Orkambi while negotiations continue. Vertex signed a similar deal with the Scottish government in December.

“We welcome anything where there is quick access,” Anna Evans, policy and evidence manager at patient group Cystic Fibrosis Trust, told BioCentury.

Providing immediate access to therapy would both be good for patients and take political pressure off the negotiations, said Evans.

Given the entrenched positions of both sides, and Parliament’s dismissal at the meeting of other workarounds, a top-down solution from the Secretary may be the only option left to break the impasse.

Based on comments at the hearing, pressure from top government leaders may have been required to push through deals with Vertex in other countries as well.

The only remaining option may be for Hancock to broker a deal with Vertex and then force NHS England to accept it.

But while patient groups embrace the short-term solution, they hope NICE and NHS learn a bigger lesson from the Orkambi debacle, and restructure the way the organizations assess Orphan drugs to prevent similar pricing battles in the future.

Loggerheads

Testimony at the hearing from senior executives at NHS England, the National Institute for Health and Care...

Read the full 2062 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury

Article Purchase

$150 USD
More Info >