Cost of Abraxane not justified, says NICE in draft guidance for use in pancreatic cancer

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has published new draft guidance which recommends that US biotech major Celgene’s (Nasdaq: CELG) Abraxane (nab-paclitaxel) taken with gemcitabine should not be funded by the National Health Service for previously untreated metastatic pancreatic cancer, because it has limited benefits compared to current treatments and it is more costly.

Nab-paclitaxel is 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. NICE is currently looking at how well nab-paclitaxel, taken with gemcitabine, works for people whose pancreatic cancer has spread and who have not received any other treatments.

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 chemotherapy treatment called FOLFIRINOX (a combination of fluorouracil, leucovorin, irinotecan and oxaliplatin), which is the current standard of care for people who are not too poorly to receive it, but 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.

NICE chief executive Sir Andrew Dillon 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.”

Information provided by Celgene 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, 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.

Concerns expressed by Celgene and Pancreatic Cancer UK

Expressing concern at the preliminary recommendation, Celgene urges NICE to re-consider its preliminary recommendation so that metastatic pancreatic cancer patients in England will have the same access to Abraxane as patients in Wales, where the treatment is currently recommended for use.