Another NICE no for Dendreon cancer drug
pharmafile | January 13, 2015 | News story | Sales and Marketing | Cancer, Dendreon, FDA, NHS, NICE, Provenge, sipuleucel-T
Dendreon has seen its prostate cancer treatment for people whose disease has spread and who are not yet suitable for chemotherapy, rejected by NICE for the second time in less than a year.
The healthcare guidance body decided not to recommend Provenge (sipuleucel-T) as the price the NHS is being asked to pay for the drug is deemed too high, at around £50,000 per patient.
Sir Andrew Dillon, NICE chief executive, comments: “Sipuleucel-T is a new and innovative way of treating prostate cancer, using the patient’s own immune system to attack the cells. But Dendreon has so far been unable to show that it works better than other treatments currently available.
“Based on the evidence presented, NICE is unable to recommend the NHS provide funding for this drug, as it costs too much for the extra benefit it may provide.”
Aside from price, the drug was also not proven to delay the progression of the disease, unlike current treatments. It is still uncertain how well it works compared with other existing medicines.
In October last year the UK body issued preliminary draft guidance not recommending the treatment for patients under the NHS.
It was revealed that because the administration of the drug is complex and there is currently no experience in the UK of using it, NICE said it was unclear if the NHS would incur additional costs using the medicine.
Approved by the FDA in April 2010, Provenge is the first remedy for metastatic hormone-resistant prostate cancer that is not cytotoxic or based on hormone-related therapy.
The vaccine is a cell-based therapy which stimulates the immune cells to identify and attack cancerous cells. The treatment involves collecting white blood cells from the patient (a process called leukapheresis).
Over 40,000 men are diagnosed with the disease in the UK every year, with around 250,000 currently living with it according to Prostate Cancer UK.
NICE has come under fire in recent years over its rejection of new medicines like Provenge, sparking the creation of the Cancer Drugs Fund (CDF) in 2010.
But now with this second rejection from the UK body confirmed, the controversial CDF could possibly be the only way this treatment could see the light of day in the UK.
So far the annual fund has paid for treatment for an estimated 55,000 people. Since March 2011, the CDF has injected an extra £200 million a year into the NHS to pay for new oncology products not recommended by NICE.
Announced yesterday now its budget is to continue from £280 million in 2014/15 to an estimated £340 million from April 2015, in a review which will also create projected savings of around £80 million.
These reserves will be made available through a combination of negotiated price reductions and improved clinical effectiveness.
But being included in the CDF drugs list doesn’t guarantee a treatment will stay. Only last week Pharmafile revealed that Novartis’ Afinitor (everolimus) is to be removed from the CDF in a move a source described as ‘devastating for patients’.
Furthermore AstraZeneca withdrew its own application for its ovarian cancer drug Lynparza (olaparib) yesterday, believing it would be ‘caught up’ in the current process of re-views affecting drugs already on the list.
Tom Robinson
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