The National Institute for Health and Care Excellence (NICE) has issued final approval for coverage of treatment with enzalutamide (Xtandi) for men with metastatic, castrated-resistant prostate cancer (mCRPC) who have already received prior treatment with docetaxel-based chemotherapy.
Of course data presented earlier this year has clearly demonstrated the clinical effectiveness of enzalutamide in men with mCRPC who have not received chemotherapy too, but neither the US Food and Drug Administration (FDA) nor the European Medicines Agency (EMA) has actually approved enzalutamide for use in such patients (as yet).
The approval of coverage of enzalutamide by NICE — albeit limited at this time — still represents an important opportunity for men in the UK who have late-stage progressive disease, giving them a further, active opportunity for treatment in addition to other drugs such as abiraterone acetate and cabazitaxel. It also suggests that NICE will be willing to cover use of enzalutamide in appropriate, pre-chemotherapy patients with mCRPC once the EMA recommends approval of enzalutamide for that use too.
Since other European nations tend to watch NICE’s recommendations for coverage of cancer drugs with care, it is likely that NICE’s action may influence some other countries to also cover the costs of this drug within national health systems.
Filed under: Drugs in development, Management, Treatment | Tagged: coverage, enzalutamide, NICE, UK |
THE "NEW" PROSTATE CANCER INFOLINK 
And the FDA gets flack for being “slow” to approve drugs?
It’s not proper to blame NICE for being slow to approve. I contacted them once, to compare their procedure for one drug, with Sweden’s. The nice person I spoke with told me that NICE would wait at least 6 more months before deciding, as they wanted more information from the producer. In this case I think they were right, I know nothing about others. Similar variations might characterise the FDA.
George:
I think Tony’s only point is that here is America there is a constant whine about how long it takes the FDA to approve new drugs or new indications for approved drugs. The truth is that the vast majority of that whining comes from people who have no real idea what the FDA (or the EMA in Europe for that matter) is actually required to do by law.
Dear Sitemaster,
That is why I called NICE. I don’t like whining in general, and whining without knowledge is pretty bad, in my book. It is even worse if you neglect any opportunity to find out if your whining is legally and/or medically justified. After contacting NICE I called the manufacturer of the drug, and spoke with an information division. I asked if it was safe to take, as the drug was so new that NICE was concerned. The man answered, “[do] you want to be a human guinea pig?” I replied with “No,” and forgot about it.
One moral is, that this doctor was willing to prescribe the stuff for me, without knowing much about it. He meant well, might have heard about it indirectly from colleagues, and took their approval on faith. I told him all this, visited a doctor who works with that drug every day, got a test and was told that I did not need to take the stuff and probably never will. Doing all this was not hierarchically proper, but I did gain the respect of both doctors, who have been helping me wonderfully since then.
Mike – have you heard anything more about enz. being approved by NICE pre-chemo??
Tx, rd
Rick:
Enzalutamide has not yet been formally approved for use pre-chemo in the EU. It was recommended for such approval just last week (see this morning’s new post) and so it will be a while before its use pre-chemo is formally assessed by NICE.
Many thanks Mike and timely given your current post — I am helping a caregiver in the UK.