Celgene's Abraxane rejected on cost grounds
Abraxane has been rejected by NICE for use in previously untreated metastatic pancreatic cancer.
England's cost effectiveness watchdog says Celgene's Abraxane (nab-paclitaxel), which is taken with gemcitabine, has limited benefits compared to current treatments and is more costly.
In its draft guidance, NICE says the data provided by Celgene was less than compelling - it says the data showed that FOLFIRINOX was more clinically effective than nab-paclitaxel with gemcitabine. It also showed that although nab-paclitaxel with gemcitabine was more effective than gemcitabine alone, but that it resulted in more serious side effects. Nab-paclitaxel with gemcitabine was similar in effectiveness to gemcitabine with capecitabine but may have more side effects.
Abraxane a novel formulation of paclitaxel, a chemotherapy which works by blocking cell division and promoting cell death. In this formulation, paclitaxel is attached to albumin which helps it move through the walls of blood vessels.
In the early stages, pancreatic cancer doesn't usually cause any symptoms, which can make it difficult to recognise and means that many people are not diagnosed until the cancer is very advanced. Without treatment, survival may be only two to six months. Some people may be offered a FOLFIRINOX chemotherapy (a combination of fluorouracil, leucovorin, irinotecan and oxaliplatin), which is the current standard of care. However this treatment has serious side effects which means it is not always an appropriate option. When this is the case gemcitabine (recommended by NICE in 2001) is generally used, or gemcitabine taken with capecitabine.
Clinical experts told the committee that the side effects for nab-paclitaxel with gemcitabine were more manageable compared to those associated with FOLFIRINOX, but both Celgene and the clinical specialists agreed that nab-paclitaxel with gemcitabine would not be suitable for people who are too ill for chemotherapy treatment.
The list price of nab-paclitaxel is £246 per 100 mg vial (excluding VAT). The company's submission also states that a 250 mg vial will be available from September 2014 at a price of £615 (excluding VAT). The company estimated the average cost of a 28-day course of treatment to be £1,481 (excluding VAT).
NICE says the most plausible cost per QALY (Quality Adjusted Life Year) gained for nab-paclitaxel plus gemcitabine compared with gemcitabine alone was £78,500 per QALY gained. The company's analyses showed that nab-paclitaxel plus gemcitabine was dominated by FOLFIRINOX (that is, nab-paclitaxel was less effective and more costly) and had cost per QALY of £87,100 compared with gemcitabine plus capecitabine.
Sir Andrew Dillon, NICE chief executive, said: "Unfortunately the development of new treatments for pancreatic cancer has been very limited in recent years. Although a number of newer treatments including nab-paclitaxel 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."
Stakeholders, including Celgene, healthcare professionals and members of the public are now able to comment on the preliminary recommendations, available here, which are available for public consultation.
Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Abraxane is currently available via the Cancer Drugs Fund.
