The National Institute for Health and Care Excellence (NICE), which is Britain’s healthcare cost-effectiveness agency, has determined that abiraterone (Zytiga) was not worth giving to men with castrate resistant metastatic prostate cancer who have yet to had chemotherapy. Unlike the FDA in the United States which rules only on a drug’s efficacy, NICE decides if there is also an economic rational to paying for a treatment.
In the United States Zytiga has been approved in both the pre-chemotherapy and post chemotherapy stage of prostate cancer treatment, but in Britain is only cleared for use in some men after chemotherapy exposure.
“We know how important it is for patients to have the option to delay chemotherapy and its associated side effects, so we are disappointed not to be able to recommend abiraterone for use in this way,” Andrew Dillon, chief executive of the National Institute for Health and Care Excellence (NICE), said in a statement.
Despite this statement he went on to say, “However, the manufacturer’s own economic model showed that the drug would not be cost-effective at this stage – because of this we cannot recommend the drug in this preliminary guidance.”
If history is any indication, NICE’s decision is an economic ploy aimed at the drug’s maker, Johnson and Johnson, to convince them to lower the price of Zytiga in Britain. From the economic standpoint this is a sound strategy, but while the game goes on, too many men will be forced to move to chemotherapy earlier than they might otherwise have needed.
Joel T. Nowak, M.A., M.S.W.
I am about to finish with Provenge at the Mayo Clinic in AZ. The plan is to start the Zytigia by mid June. No chemo yet , only enlargement of 3 lymph nodes. Prostate recurred in 2009 after surgery in 2001. At time of surgery Gleason Score was 22. Ineffective radiation in 2009. Intermittent ADT in 2011. Castrate resistant by late 2013. Current PSA after 1 Provenge treatment 8.2. PSA done inadvertantly while taking Provenge, so not accurate.
I am hoping MY insurance allows the Zyrigia. Hope something changes for the Brits ! Chemo side effects suck !
Charles, Zytiga is an appropriate next step and your insurance company should not balk. Have you considered the Prostvac trial prior to Zytiga? I am on a new kick and feel that this could be a great next step prior to proceeding to Zytiga. If you think you might be interested I could put you in touch with a doctor who is near you and who has been using this strategy with a number of men. Let me know if you might be interested in exploring this possibility. – Joel
Joel, what about Prostvac after receiving the benefits of Zytiga, if and when my PSA stats to rise again?. I am PCa, with four bone met areas, Gl 7 ( 2 cores were 4+3 and 3+4) PSA was 71.4 at Dx in Nov 2012. I am currently on Zytiga ,which has brought my PSA down to undetectable since Sept, 2014 until currently June, 2015. My Drs. at CTCA are not convinced Provenge would have helped,or that my Cigna would cover it, so got on Zytiga first. Could you reference me to any local Drs in So Cal that are using Prostvac( I have not asked My CTCA Dr about it yet), For those in my similar circumstances.
I appreciate all that you do for us, bless you! Hope you are doing well.
Dan, Prostvac is not yet approved by the FDA. They just completed enrolling the phase 3 trial and we will probably not see the actual results for another year or two. Then we will need to wait (assuming the results are positive) for FDA approval which could take another 6 months or more. However, there a two different trials either currently recruiting or getting ready to recruit that you might be able to qualify to join. One is combining enzalutamide (Xtandi) with Prostvac and the other (not yet recruiting) is combining Ipillimumab (another immune therapy drug) with Prostvac. You can find these trials on the clinical trial web page (www.clinicaltrials.gov) and searching for Prostvac. – Joel