The cost of nab-paclitaxel is not justified by its limited benefit, says NICE in draft guidance
NICE has published draft guidance which recommends that nab-paclitaxel given with gemcitabine should not be funded by the NHS for previously untreated metastatic pancreatic cancer, because its limited benefits compared to current treatments do not justify its cost.
Nab-paclitaxel, which is given in combination with gemcitabine, is also known as Abraxane and is marketed by Celgene. It 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, given with gemcitabine, works for people whose pancreatic cancer has spread and who have not received any other treatments.
People with newly diagnosed pancreatic cancer are usually offered a combination treatment called FOLFIRINOX, but it can be associated with serious side effects and therefore can't be given to everyone. When this is the case, other options include gemcitabine alone or with capecitabine.
Information provided by Celgene showed that FOLFIRINOX is likely to be more effective than nab-paclitaxel with gemcitabine. Although nab-paclitaxel with gemcitabine was more effective than gemcitabine alone, it resulted in more serious side effects. It also resulted in more side effects than gemcitabine with capecitabine, but was shown to have similar effectiveness.
Commenting on the draft guidance, Sir Andrew Dillon, NICE chief executive, said: "In the early stages, pancreatic cancer doesn't usually cause any symptoms, which can make it difficult to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 2 to 6 months. Unfortunately the development of new treatments for pancreatic cancer has been very limited in recent years."
Sir Andrew continued: "Although nab-paclitaxel is more effective than one of the treatment options currently available, is associated with more side effects and is also more expensive."
Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country. This draft guidance does not mean that people currently taking nab-paclitaxel with gemcitabine will stop receiving it. They have the option to continue treatment until they and their clinicians consider it appropriate to stop.
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Notes to Editors
Explanation of terms
Paclitaxel formulated as albumin-bound nanoparticles (referred to in this document as nab-paclitaxel; Abraxane, Celgene) has a UK marketing authorisation in combination with gemcitabine for the first-line treatment of adults with metastatic adenocarcinoma of the pancreas.
Side effects of nab-paclitaxel with gemcitabine include a drop in the number of blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness, numbness or tingling in fingers and toes (peripheral neuropathy), gastrointestinal problems; aching joints and muscles, tiredness, feeling sick and hair loss.
About the guidance
The draft guidance will be available at /guidance/indevelopment/GID-TAG453 from Tuesday 30 December 2014.
The marketer of the drug submitted data from Study CA046 which showed that nab-paclitaxel plus gemcitabine compared with gemcitabine alone had statistically significantly longer overall survival (median gain of 2.1 months) and progression-free survival (median gain of 1.8 months), and higher response rates (relative risk of 3.19 to 3.81). The mixed treatment comparison showed that nab paclitaxel plus gemcitabine was associated with a shorter overall survival and progression-free survival compared with FOLFIRINOX, and with a similar overall survival and progression-free survival compared with gemcitabine plus capecitabine.
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).
The Committee agreed that the most plausible cost per QALY (Quality Adjusted Life Year) for nab-paclitaxel plus gemcitabine compared with gemcitabine alone, would lie somewhere between £72,500 and the £78,500.
Nab-paclitaxel plus gemcitabine did not meet the extension-to-life criterion when compared with FOLFIRINOX or gemcitabine plus capecitabine.
For the comparison of nab-paclitaxel plus gemcitabine compared with gemcitabine alone, the Committee accepted that the end-of-life criteria could be applied when taking into consideration both the relative magnitude of the overall survival gain, and the impact of giving proportionally greater weight to QALYs gained in this condition. The Committee agreed that this was an unusual circumstance and that applying the maximum weighting would not be appropriate. In addition, it noted that this would apply only to those people for whom FOLFIRINOX and gemcitabine plus capecitabine are not suitable treatment options. Although the end-of-life criteria were met, the Committee agreed that the magnitude of additional weight that would need to be assigned to the QALY benefit would be too great for nab-paclitaxel to be considered cost effective compared with gemcitabine. Therefore nab-paclitaxel plus gemcitabine could not be considered a cost-effective use of NHS resources compared with gemcitabine.
The SMC is currently considering the use of nab-paclitaxel in combination with gemcitabine for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas - http://www.scottishmedicines.org.uk/SMC_Advice/Forthcoming_Submissions/nab_paclitaxel_Abraxane
Nab-paclitaxel is currently available via the Cancer Drugs Fund.
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