NICE not recommending Dendreon cancer vaccine
pharmafile | October 16, 2014 | News story | Sales and Marketing | Dendreon, NHS, NICE, Provenge, sipuleucel-T, therapeutic cancer vaccine
NICE has issued preliminary draft guidance not recommending Dendreon’s therapeutic cancer vaccine Provenge for prostate cancer in people whose disease has spread, and have few symptoms prior to chemotherapy.
The UK pricing watchdog says evidence showed that the price the NHS is being asked to pay for Provenge (sipuleucel-T) is too high for any benefit it may provide to patients.
NICE chief executive Sir Andrew Dillon says of the decision: “Sipuleucel-T is a new and innovative way of treating prostate cancer, using the patient’s own immune system to attack the cancer cells – but based on the evidence presented so far, it costs too much for the benefit it provides.
“It was shown to prolong overall survival compared with a placebo treatment, but there were uncertainties in the evidence about how well sipuleucel-T works compared with some other existing treatments. It was also not proven to delay the progression of the disease unlike current treatments, and this can potentially affect a person’s quality of life.”
In addition to the doubts circling the clinical effectiveness of Provenge, there were also uncertainties around the amount of money the NHS might have to pay for the treatment.
Because the administration of the drug is complex and there is currently no experience in the UK of using it, NICE says it is unclear if the NHS would incur additional costs using the medicine.
Additionally, Dendreon only plans to offer Provenge in a limited number of treatment centres initially, which would make it difficult for all patients in England to gain access – resulting in high travel costs for the individual or the NHS.
The cost of Provenge is £16,141.33 per dose excluding VAT. The recommended course of treatment is three doses at approximately 2 week intervals, so a course totals £47,132.68 based on a mean of 2.92 doses per patient.
Sir Andrew adds: “Dendreon, which markets sipuleucel-T, now has the opportunity to respond to this preliminary guidance and offer clarification where needed.”
Hard times for Dendreon
This latest news arrives at a turbulent time for the Seattle-based firm, as just two months ago its chief executive John Johnson jumped ship amid falling sales of the company’s key cancer vaccine.
Thomas Amick took his place at the helm but this has not prevented further woes, which include its shares hitting a new low recently according to analyst Bill Maurer, who adds: “The company basically stated that it would not have enough cash to pay back its 2016 notes, something I’ve been warning investors about for a few years.”
Provenge was approved by the FDA in April 2010 but its US breakthrough did not open the floodgates: and its slow uptake was in large part the reason for the Seattle-based biotech slashing 600 jobs and closing its manufacturing facility in New Jersey last year as part of its restructuring plans.
Its high cost and an unusual mechanism of action – plus competition from big rivals such as Johnson & Johnson’s Zytiga and Astellas and Medivation’s Xtandi – have been key reasons for Provenge’s failure to gain the market foothold its manufacturer expected.
Whilst it was the first immuno-oncology treatment of its type to be approved anywhere in the world, it sits in a crowded marketplace and was closely followed by Bristol-Myers Squibb’s blockbuster melanoma treatment Yervoy (ipilimumab).
In September Merck also became the first pharma firm to gain approval for the next generation of immuno-oncology treatments known as PD-1 inhibitors, after its melanoma treatment Keytruda (pembrolizumab) gained the FDA’s backing.
Bristol-Myers Squibb has also just been granted a speedy review for its new cancer immunotherapy drug Opdivo by the FDA, for patients with the deadliest form of skin cancer.
As for Provenge, NICE says Dendreon, consultees, healthcare professionals, patient groups and members of the public are now able to comment on the preliminary recommendations which are available for public consultation.
Brett Wells
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