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Unruffled by ‘outlier’ claims, Vertex CEO upbeat on Orkambi breakthrough

NHS England going public with price makes deal impossible, says Leiden

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Vertex CEO Jeff Leiden

The deadlock between pharma company Vertex and NHS England over cystic fibrosis drug Orkambi was played out today in a parliamentary hearing in London, with the company’s CEO and NHS England and NICE leaders grilled by MPs.

Both sides have thrown accusations via public statements and the media in recent months: NHS England accusing Vertex of being an “extreme outlier” and the US pharma company talking of ‘outrageous’ demands from NHS England - but in person the testimony was far more measured.

The two sides have failed to reach a deal on the drug, which was first launched in Europe three years ago, with both sides blaming the other for inflexibility on the cost and value of the drug, which has a list price of £104,000 ($136,000) per patient per year.

The health and select committee has intervened to try to break the impasse, and perhaps determine if any side might carry more of the blame.

The case has generated frustration and anger from patients, their families and campaign groups, who say some patients have died because they have missed out on receiving Orkambi over the last three years.

They may have taken some heart from the hearings, which seemed to generate a new willingness to return to negotiations with NHS England and NICE – although both sides had accused the other of ‘walking away’ from talks.

“We will negotiate with them [NHS England and NICE] any time or any place," said Leiden. "I think we will reach a reimbursement deal with them. And I will commit that once we have reached [that agreement] we can have the treatment to patients within four weeks.”

Leiden revealed towards the end of his hour-long question and answer session that he has ‘finally’ a meeting with health secretary Matt Hancock next Monday, and expressed confidence that this could open up the chance of a deal being done.

The pressure is on both NHS England and Vertex to come up with a solution, especially as Scotland has recently agreed a pricing and reimbursement deal with the company.

Leiden added: “It could be the same price as Scotland. That’s the quickest way." He said he hoped Hancock’s intervention could be key.

“I am really hopeful that he can get us and the NHS back to the table and we are eager to meet with them and try out some of these new ideas.”

Deciphering the feasibility of this hope was difficult for the MPs, as Scotland’s deal with Vertex remains confidential.

Nevertheless, it’s clear that there will be have to be some movement between the two sides, as Vertex says it already has offered its lowest (confidential) price anywhere in the world to England.

NHS England meanwhile broke the normal protocol when it revealed its offer to Vertex: a total of £500m over the next five years, or £1bn over ten years to include the price of its existing CF treatments Kalydeco and Orkambi, as well as new combination Symkevi, and any subsequent products.

NICE’s chief executive Sir Andrew Dillon and NHS England’s John Stewart, National Director, Specialised Commissioning were both on hand to argue that Vertex had been exceptionally ‘inflexible’ in their approach to negotiations.

However, they were also challenged by the committee, who claimed that NHS England were trying to claw back cost after giving Vertex what the budget holder had since judged to be an overly generous deal on Vertex's first CF drug, Kalydeco, back in 2012.

The committee heard that NHS England’s offer meant that the price per patient for Orkambi under the ‘best and final’ offer was less than £8,000 a year – less than Pulmozyme, a much older drug with more limited benefits.

Jeff Leiden was given a thorough grilling by the MPs about Vertex’s prices, negotiating tactics, and even his own $1.7m annual pay deal, but succeeded in appearing as genial and open to finding a solution as his counterparts at NICE and NHS England.

He says that because NHS England has disclosed it £8,000 per patient price, that would mean all other countries would demand the same if Vertex accepted this deal.

“We have been painted as not willing to take the offer the 90% offer – it’s not that we won’t take it, we can’t take it."

He says this price, if applied to every country, would result in Vertex’s total CF revenues being around £850m a year – nowhere near enough to sustain the company or its future R&D.

“Vertex would go out of business in three to five years, there would be no triple therapy that I have promised patients around the world. There would be no gene therapy that I have promised patients,” he said.

NICE’s Andrew Dillon made particularly eyebrow-raising remarks about Vertex’s negotiating tactics, claiming the company had been “unique in my 20 years working in NICE” because they demonstrated “no flexibility”.

He claimed the company had wanted to “redesign NICE simply to enable the NHS to pay Vertex more money” and said the company wanted societal benefits, such as reduced impact on social security payments and payment of taxes through return to work, to be factored in to Orkambi’s cost effectiveness – something which NICE is unable to do.

By contrast, Leiden claimed Vertex merely wanted NICE to factor in more direct savings to healthcare cost – such as greatly reduced hospitalisation and need for lung transplants.

Leiden also claims the breakthrough in Scotland came when NICE equivalent the SMC agreed to ‘flex’ its methodology – something which he and other industry leaders say is vital if NICE is to capture the full value of specialist medicines for small populations.

The distance between the two sides still seemed great by the end of the three-hour session, though the public airing of the problems may well have given new impetus to a solution.

Speaking from a patient perspective, Oli Rayner said the new generation of drugs have brought great hope to patients, and now wanted to the two sides to stop their bickering.

“I think neither of them come out looking good particularly….it has become a bit of pantomime. That’s a shame because this is really a time of immense hope for our disease.”

The health select committee will continue with its inquiry, and produce its recommendations within the next few months, but all sides will be looking to resolve the dispute if they can before that time.

Watch the evidence session here

7th March 2019

From: Healthcare

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