What NHS England isn’t telling you, and more indispensable insight for commissioners. This week by HSJ commissioning correspondent Sharon Brennan.

For two years NHS England and pharma company Vertex have been in heated negotiations over a price to make the specialist Cystic Fibrosis drug Orkambi available on the NHS.

The drug, which targets the underlying genetic cause of some mutations of CF, was licensed for use in the UK in 2015, and is being adopted elsewhere across the globe. But the National Institute for Health and Care Excellence rejected the drug on grounds of value – clinical benefit versus cost.

The blockage on the treatment is despite NHS England having said in 2016 it wants the NHS to “become the first health service in the world to truly embrace personalised medicine”.

As NHS England explains, personalisation in medicine means using “new approaches to better manage patients’ health and target therapies”, as per Orkambi, which is tailored to genetic makeup and aims to treat underlying cause rather than manage symptoms.

Orkambi is designed to slow decline in lung function, which is the main cause of death among people with cystic fibrosis. The latest evidence about its effectiveness at doing so was not available at the time of NICE assessment.

This week NHS England published what it said was its “final offer” to Vertex. It said it would pay £100m annually for five years for three CF drugs manufactured by the company: Ivacaftor (already funded on the NHS), Orkambi and a third drug that is likely to come onto the market in 2018. All three target different mutations of the CF gene.

While pricing of Ivacaftor, also known as Kalydeco, remains commercially sensitive, but the NHS is known to have spent £55m on it in 2015-16, which was likely to rise. This drug treats just 5 per cent of the 8,000 strong CF population in England, half of who are likely to die before they are 47.

Details are uncertain, but the numbers suggest NHS England is effectively offering in the region of £45m a year to fund medicines effective for at least half the CF population.

In response to the offer Vertex said: “This proposal fails to adequately reflect the value of our current and future medicines.”

While NHS England has been successful in driving down prices for other medicines, with Orkambi there is a real possibility that perceived unaffordability means England will offer second rate care for CF compared to European counterparts.

It raises two related questions: What is NHS England’s offer and message, as commissioner of specialised services, to people who can benefit from expensive new treatments? The other is whether the health system is doing enough to adopt and encourage these kind of cutting edge innovations.

There have been successive strategies directed at these conundrums.

Former life sciences minister George Freeman, who commissioned one of these – The Accelerated Access Review – during his time in government, has joined the row over Orkambi, declaring that failure to reach a deal was “very disappointing”. He said the purpose of policies he backed on accelerated access were “precisely for the benefit of rare disease patients like CF. He added: “I’m afraid NHS England/DH machine still thinks innovation = cost.”

Pharma has consistently argued the NHS needs to purchase more new products if the UK is to hold onto the sector’s research and development investment. But with Brexit looming, these threats have a greater chance of becoming real.

In a letter to the prime minister leaked to the Daily Mail, the Vertex chief executive said that without major changes to drugs assessment “any future biotech investment in the UK is at significant risk”. It is more than ironic that the company was specifically identified in the government’s life science sector deal in December as the type of business it wanted to attract.

Some of these concerns may be partly resolved under new pharmaceutical price regulation scheme negotiations (the current scheme runs out at the end of this year). There is talk it might include a new medicines fund to mirror the cancer drugs fund.

But beyond that, it is unclear what NHS England’s wider strategy is for commissioning specialised medicines. I’ve been told there were plans to consult this summer on a new vision for specialised commissioning, but that this was delayed to make way for drawing up the NHS 10 year plan.

If the NHS is to keep up with European neighbours in providing the best treatments available, it will need a more sophisticated strategy that goes beyond driving down medicines costs.