Sanofi has received final negative guidance from the National Institute for Health and Clinical Excellence (NICE) saying its cancer drug Jevtana should not be available for routine use by the NHS in England in Wales.
It marks the failure of Sanofi's appeal of the UK healthcare cost-effectiveness watchdog's similarly negative final draft guidance on the drug, which was issued four months ago.
In its final guidance NICE sticks to its verdict that the drug is not suitable for NHS reimbursement at its current median cost of £22,200 per patient as a second line treatment for prostate cancer in combination with prednisone or prednisolone.
The Institute was not swayed by clinical evidence that suggests Jevtana (cabazitaxel) can achieve a mean overall survival of greater than three months in patients with prostate cancer and decided that the drug's cost was still an issue.
“Although cabazitaxel can extend life for some patients,” said NICE's chief executive Sir Andrew Dillon, “its price remains well above what the independent committee appraising this drug considered acceptable, given the benefits it offers.”
Sir Andrew also commented on the number of side effects associated with Jevtana, saying NICE appraisers were concerned about the effect on a patient's quality of life of side effects that include disorders related to bone marrow suppression, such as a reduction in the number of both red and white blood cells, as well as platelets in the blood. Diarrhoea was also described as "major concern".
Dr Jasmin Hussein, oncology medical manager at Sanofi UK, said the decision was a “major setback for these patients who have few treatment options”.
This opinion was backed up by Emma Malcolm, chief executive of research-based charity Prostate Action.
She commented on the limited access men in the UK will have to the drug now that it will only be available on the NHS in England through the Cancer Drugs Fund, which provides £200m a year for local health authorities to purchase cancer drugs that have not been recommended by NICE.
“We know that there are inconsistencies across the country with how this fund is awarded which means some men will only be able to access one of these drugs in some areas,” she said.
NICE is also currently evaluating another prostate cancer treatment, Johnson & Johnson's (J&J) Zytiga (abiraterone), however draft guidance suggests that a recommendation may also prove elusive for this drug.