Men with advanced prostate cancer have been betrayed by “Orwellian” manoeuvring by NICE to deny them the life-saving drug, Enzalutamide.
Enzalutamide is one of two drugs used to control the cancer when, as invariably happens, conventional hormone therapy and chemotherapy cease to work. The other is Abiraterone, which was approved by NICE in mid-2012 (after protests by patients when it was initially denied them) and many men are doing well on it. However, one of its drawbacks is that it can cause liver damage, particularly in patients who have previously had chemotherapy. For such patients, the only hope is Enzalutamide, which has been undergoing the NICE appraisal process for the last 14 months.
All the signs were that that it would be approved. Indeed, the last draft of the consultation document, released in November, approved the use of the drug for any patient who had had chemotherapy. Based on this a number of clinicians have led those of their patients who are not doing well on Abiraterone to expect imminent approval of Enzalutamide.
Earlier this year however, in a cruel move that dashed these patients’ hopes, NICE issued to consultees a document, in which, to patients’ and clinicians’ dismay, with no prior discussion, a caveat had been introduced that use of Enzalutamide was not approved where the patient had previously been given Abiraterone, the very class of patient for whom it might be said that Enzalutamide was developed. We in Tackle immediately sent a strong letter of protest, pointing out that this was an abuse of NICE’s process, and represented a cavalier treatment of men with advanced prostate cancer, who are ill-placed to fight for their rights. Apart from the procedural failings, the caveat was unjustified as there is no evidence to support it.
This revised aassessment will be discussed and finalised in March. Not only has this delayed the process of approval, for which many men are waiting, hoping that they don’t die first, but if this unjustified restriction is not removed, many hundreds of men will be denied their last chance of a greatly extended life. At the very least we want an explanation of the reasons behind this caveat.
We say: Patients are outraged by this cruel betrayal by NICE. NICE have broken their own appraisal procedures in order to introduce, based on no evidence, a significant change that will be the death knell for many patients. They cannot be allowed to get away it. We call on clinicians, some of whom have reported “spectacular” results with this drug, to put their weight behind a patients’ call for fairness.
We encourage everyone who cares about this gross injustice to sign the petition set up by Prostate Cancer UK and supported by Tackle.