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MPs threaten to publish Vertex’s Orkambi price if no deal struck

Gives deadline of 30 November for long-running row to end

Orkambi

MPs are threatening to make public Vertex’s confidential price offer for its cystic fibrosis (CF) drug Orkambi, in order to break a deadlock over access to the drug in England.

Vertex has been attempting to gain reimbursement for its combination treatment Orkambi since 2016, but saw the drug rejected by cost effectiveness watchdog NICE that year.

There are around 10,000 patients with CF in the UK - the second highest total population of patients anywhere in the world, making it a key market for the company.

It has become locked in an increasingly ill-tempered and public spat with NHS England throughout 2018, with both sides claiming that the other’s pricing demands are unreasonable. The company's CEO Jeff Leiden even wrote to Prime Minister Theresa May in July to protest against the impasse, but negotiations have remained stalled since then.

The House of Commons health and social care select committee is looking to break the deadlock, and is threatening to reveal all details of negotiations between Vertex, NICE and NHS England if no deal is reached by 30 November.

As the UK is used as a reference pricing market by many other countries, revealing its actual price offer would damage its negotiating position around the world.

Confidential price discounts have become a routine part of the NICE and NHS England processes of granting market access in the country, and the committee’s move could undermine the wider system.

However this unprecedented involvement of the committee in the drug’s pricing suggests the MPs believes the negotiating process has broken down on both sides.

NHS England has made an offer covering its wider portfolio of CF drugs. This “provides the potential” for Vertex to secure revenues of £1bn over the next 10 years from Orkambi, Kalydeco and newly EU-approved combination Symkevi without having to gain NICE approval.

However, the company has rejected this offer. Vertex says NHS England’s demand represents an average of all of Vertex’s CF medicines, and is equivalent to a near 90% discount on what Germany pays for one of Vertex’s medicines.

The committee has now requested papers including formal submissions and offers made by Vertex to NICE and NHS England, including those made throughout the negotiation period to date.

It is demanding to see NHS England’s formal response to Vertex’s original offer and any formal updates to subsequent proposals, and also wants NICE to provide an unredacted assessment of the clinical and cost effectiveness of the drugs presented to the NICE appraisal committee.

The committee has also requested that NICE provides it with a memorandum to put Orkambi in context with other drugs whose pricing has not been considered cost-effective.

Woollaston

Committee chair Sarah Woollaston MP

Chaired by Conservative MP Sarah Woollaston, the committee issued a statement on Friday:

“The Committee hopes that negotiations are successful and that a deal can be reached which will ensure that Orkambi can be made available to NHS patients. It looks forward to hearing that agreement has been reached by the end of the month, in which case it has indicated that it would not be likely to progress its inquiry any further at the present time. If no agreement is reached by that date, it will consider further how to proceed.”

Meanwhile, a group of clinicians led by Prof Stuart Elborn of the Royal Brompton Hospital and Imperial College, has written to the BMJ, calling for an agreement to be reached.

“Clinicians in the UK want to use these therapies and people with CF wish to be treated with these drugs. It is therefore incumbent that Vertex work with NICE and UK commissioners to strike a fair deal based on the robust health technology assessment undertaken, to enable us to deliver the best care possible for people with CF in the UK.”

Vertex has confirmed to PMLiVE that it is aware of the committee’s requests. While the company’s leaders will almost certainly be outraged by the threats to reveal the confidential price, it has refused to comment directly.

The company simply says that it “welcomes the Committee's interest in access to cystic fibrosis medicines in England” and looks forward to “supporting its inquiry into this important issue”.

Finally, patients activists #OrkambiNow and patient association the CF Trust have played a big role, and continue to demand urgent access to the drug, which was first approved in Europe nearly three years ago.

Article by
Andrew McConaghie

12th November 2018

From: Regulatory

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