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A pioneering new breast cancer treatment will not be routinely available in England, the NHS drugs advisory body NICE is proposing.
The drug - Kadcyla - adds six months of life on average to women dying with an aggressive form of breast cancer.
NICE criticised makers Roche for not setting an affordable price, in its updated draft guidance.
The drug costs £90,000 per patient but Roche said it had offered a lower - undisclosed - price in recent talks.
The two organisations have been in negotiations since the first draft guidance from NICE (the National Institute for Health and Care Excellence), rejecting the drug, was published in April.
While this latest guidance is only the final draft version, there tends not be any major changes when the official recommendations are published - normally a few months after this stage.
The original cost of Kadcyla worked out at £90,000 per patient - that is based on the standard 14 months of treatment.
Roche said it had offered to lower the price "substantially", but NICE said the new price - which is not being disclosed - made little difference.
'Huge blow'
Kadcyla is used to treat people with HER2-positive breast cancer that has spread to other parts of the body and cannot be surgically removed.
About a fifth of breast cancer cases are HER2-positive, and it is thought this drug could benefit 1,500 women a year.
It works by seeking out and destroying cancerous cells, attacking them from within.
Its novel action means it is unlikely to cause the side-effects, such as hair loss, seen with many other types of chemotherapy.
For advanced cancer, the aim is remission rather than cure
NICE chief executive Sir Andrew Dillon said: "We are really disappointed that Roche were not able to demonstrate more flexibility.
"The company is well aware that we could not have recommended Kadcyla at the price it proposed."
Dr Jayson Dallas, of Roche, said: "NICE's rejection of Kadcyla demonstrates quite simply that their current system is broken, not fit for purpose and in need of a complete overhaul when it comes to advanced cancer."
Mia Rosenblatt, head of policy and campaigns at Breast Cancer Campaign, said the news was a "huge blow".
"It is vital that this is not the end of the line for Kadcyla in respect of NICE approval, and we ask NICE and Roche to urgently revisit their negotiations to find a solution."
It means the only way women will be able to get access to the treatment is through the Cancer Drugs Fund, for which their doctors would have to make special requests.
Since April more than 200 women have been given Kadcyla in this way, but the Cancer Drugs Fund is due to end in 2016.
While the guidance applies only to England, officials in Northern Ireland, Wales and Scotland do consider NICE recommendations. None of them currently fund the drug.
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