Celgene rebuffed by NICE over cancer drug
pharmafile | September 9, 2014 | News story | Sales and Marketing | Abraxane, Cancer, Celgene, Gemzar, NICE, gemcitabine, nab-paclitaxel
In new draft guidance NICE says that Celgene’s Abraxane (nab-paclitaxel) taken with Lilly’s Gemzar (gemcitabine) should not be funded by the NHS for previously untreated metastatic pancreatic cancer.
This is because it has “limited benefits compared to current treatments and it is more costly”, according to the watchdog.
In its early stages pancreatic cancer does not overtly lead to a display of any symptoms which makes it difficult to recognise, and also means many people are not diagnosed until the cancer is very advanced.
Without treatment survival may be only two to six months. Some patients may be offered a combination chemotherapy treatment called Folfirinox (fluorouracil, leucovorin, irinotecan and oxaliplatin), which is the current standard of care for people who are not too ill to receive it.
The drug is available in Wales and is under consideration in Scotland (although Wales may have to fall in line with NICE, should it say ‘no’ in final guidance).
But this treatment has serious side effects, which means it is not always an appropriate option, according to NICE. When this is the case Gemzar (which was recommended by NICE in 2001) is generally used, or alternatively, Lilly’s drug in combination with Roche’s cancer treatment Xeloda (capecitabine) can also be employed.
Sir Andrew Dillon, NICE chief executive, says: “Unfortunately the development of new treatments for pancreatic cancer has been very limited in recent years.
“Although a number of newer treatments including Abraxane have been introduced, we are disappointed that, when considering the impact of side effects as well as how effective the treatment is the evidence fails to show that it works any better for patients than other treatments already provided by the NHS. It is also more expensive.”
Information provided by Celgene showed that Folfirinox was in fact more clinically effective than its drug with Gemzar. It also showed that although this combination was more effective than Gemzar alone, it resulted in more serious side effects.
Clinical experts told NICE’s expert committee that the side effects for Abraxane and Gemzar were more manageable compared to those associated with Folfirinox, but both Celgene and the clinical specialists agreed that Abraxane and Gemzar would not be suitable for people who had become very ill because of their condition.
The list price of Abraxane is £246 per 100mg vial, with the average cost of a 28-day course of treatment expected to be just under £1,500. This price means that when used with Gemzar, NICE says, Celgene’s drug costs a substantial £78,500 per QALY gained, when compared to Gemzar alone.
NICE will not usually recommend a medicine that has a QALY above £30,000, or £50,000 in certain extreme cases, meaning this is well above its accepted level.
Abraxane works as a formulation of paclitaxel, a chemotherapy which works by blocking cell division and promoting cell death. The drug was originally licensed for breast cancer.
Cancer Drugs Fund
The drug is currently available via the Cancer Drugs Fund, but this could soon come under cost-effective scrutiny itself under new rules introduced by the government last month.
The CDF had been a carte blanche for new oncology medicines not recommended by NICE since its creation in 2010, but it could soon fall under the auspices of the watchdog as the Fund’s extended £280 million budget is not enough to pay for all new cancer drugs.
Ben Adams
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