NO FROM NICE TO ABRAXANE FOR PANCREATIC CANCER

The benefits of nab-paclitaxel (Abraxane, Celgene) plusgemcitabine do not outweigh its high costs as therapy for previously untreated metastatic pancreatic cancer, according to new draft guidance issued by the National Institute for Health and Care Excellence (NICE) in the United Kingdom.

Thus, the advisory agency recommended that the combination should not receive funding from the National Health Service (NHS).

"The cost of nab-paclitaxel is not justified by its limited benefit," according to a press release issued by NICE on September 8.

The draft document was based on NICE committee recommendations and relied on results from past clinical trials, data provided by Celgene, and clinical expert opinion. NICE is the British drug evaluation agency that provides guidance to the NHS about the cost-effectiveness of drugs.

"Unfortunately, the development of new treatments for pancreatic cancer has been very limited in recent years," commented Sir Andrew Dillon, NICE chief executive.

"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," "he added.

The New York Times has reported that nab-paclitaxel therapy costs between $6000 to $8000 a month.

The current standard of care — for patients who can tolerate it — is FOLFIRINOX (a combination offluorouracil, leucovorin, irinotecan, and oxaliplatin), according to NICE press materials. The adverse effects of the combination, though, can limit its use.

In such cases, the go-to drug is often gemcitabine alone or in combination with other agents, such ascapecitabine. NICE has recommended gemcitabine since 2001, and it is often considered the reference for advanced pancreatic cancer.

Nab-paclitaxel is a new formulation of paclitaxel bound to albumen, which facilitates transport through blood vessel walls. It is also marketed for the treatment of metastatic breast cancer.

Past studies have suggested that nab-paclitaxel combined with gemcitabine can extend life in treatment-naive patients with advanced pancreatic cancer. According to results from the phase 3 MPACT trialpresented in January 2013 at the Gastrointestinal Cancers Symposium in San Francisco, California, nab-paclitaxel plus gemcitabine improved overall survival by about 2 months compared with gemcitabine alone. The new combination therapy, however, was associated with more grade 3/4 treatment-related adverse events.

According to Celgene data reviewed by the NICE committee, FOLFIRINOX is "more clinically effective" in terms of overall and progression-free survival than is nab-paclitaxel plus gemcitabine.

Clinical experts who advised the NICE committee said that adverse effects associated with nab-paclitaxel plus gemcitabine were "more manageable" than those for FOLFIRINOX. Specialists and company data both agreed, however, that nab-paclitaxel is not "suitable" for those who are doing "too poorly."

Going forward, local healthcare agencies in the United Kingdom will still need to wait for final guidance from NICE. Until then, "NHS bodies should make decisions locally on the funding of specific treatments," the press release advised. Patients in the United Kingdom who are receiving nab-paclitaxel with gemcitabine can continue their therapy, with the option to continue until deemed appropriate to stop by themselves and their healthcare providers.