NICE initially refuses to cover cost of abiraterone acetate for mCRPC

In an utterly unsurprising announcement from the UK, the National Institute for Clincial Excellence (NICE) has issued draft guidance in which it refuses to cover the proposed cost of abiraterone actetate.

This draft guidance looks suspiciously like the first round in a negotiating process with the manufacturer of abiraterone acetate. Why? Because Andrew Dillon, NICE’s chief executive has indicated that the draft ruling could be reconsidered and that the manufacturer might want “to further reduce the acquisition cost to the NHS of the drug by proposing a revised patient access scheme.”

According to the manufacturer, the proposed cost of abiraterone acetate in the UK was £2,930 (US$4,638) for a 30-day supply. The company has already stated that it would “be actively participating in this consultation as we strive for a positive outcome for patients.”

Dillon is also quoted at saying that abiraterone acetate “could potentially extend life by more than 3 months, compared with placebo,” but that NICE’s advisory committee “did not feel [it] provided enough benefit to patients to justify the price the NHS is being asked to pay, even with the discount that the manufacturer has offered.”

The agency also determined that the treatment did not meet its criteria to be considered under special arrangements for drugs treating people at the end of their life, as “the population for which it is licensed cannot be considered to be small.”

One of the upsides of nationalized health care systems is that health care is provided to all. One of the downsides is that every new drug and treatment may not be available through such a system until this type of financial negotiation can be completed, which just takes time.

Abiraterone acetate was approved in Europe last September as a treatment for men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on or after receiving docetaxel-based chemotherapy. It must be given in combination with prednisone or prednisolone.

6 Responses

  1. The high cost of abiraterone at £3,000 per month is based on the high dosage of 4 tablets per day. This high dosage is only needed for the first month and can be decreased to 1 tablet per day, giving a long-term cost of only £750 per month. The same scientists have also developed salvestrol platinum which has been shown to be powerful against all forms of cancer, including prostate cancer, and is available in the UK for £60 per month.

  2. Dear Dr. Potter:

    Are you able to provide references for the clinical use of abiraterone acetate at 750 mg/d and for the use of salvestrol platinum in the management of prostate cancer? I am not familiar with such data.

  3. I found it interesting that a circular looking for men to support a petition to persuade NICE to reverse the decision contains this statement to justify the cost:

    The potential to increase life by years. Not just 4 months. On the 9 month trial, nobody on the drug died. Men on the placebo arm of the trial started to die after 5 months. Hence 4 months of extra life.

    I thought the median survival was about 14 months and understood that to mean that half the men died before that period?

  4. Terry:

    Alas, some people have minimal appreciation of the science of clinical trials!

  5. An influential, intellectual, and politically important British newspaper, The Guardian, published an article entitled “Cancer drug ‘too expensive for NHS’” about this issue online today. … Well worth reading for its detail and information on the initial reactions.

  6. Abiraterone is an exceedingly potent drug, active at the nanomolar level. The high dose of 4 tablets (1 gram) per day was arrived at from the Phase 1 clinical study, which showed this to be the maximum effective dose. The minimum effective dose was 250 mg, which is equivalent to 1 tablet per day. The high dose of 1 gram per day is needed to adjust the body to total androgen deprivation. After a month the LHRH signals have subsided and so a lower maintenance dose can be given. This and other aspects are being investigated in over 34 different ongoing clinical trials on abiraterone.

    The use of Salvestrol Platinum in the managment of prostate cancer has been published in a series of case studies in the Journal of Orthomolecular Medicine which can be found by searching on Salvestrol Case Studies. An example of one of these case studies is added below:

    Case #3. Prostate Cancer

    A 74-year-old gentleman was diagnosed with prostate cancer. Subsequently this gentleman spoke with his cousin, a university lecturer, who told him that one of his students was diagnosed with a terminal brain cancer who had recovered after taking Salvestrols. He decided to begin a course of Salvestrol supplementation taking two (350 point) Salvestrol Shield capsules per day. Six months after receiving his diagnosis his PSA level had dropped from 11 to below 1 ng/mL. The patient moved to another country which necessitated a change of doctors. At this point the patient switched Salvestrol products and began taking one (2,000 point) Salvestrol Platinum capsule three times per day after meals, to give a total supplementation of 6000 points per day. Twelve months after receiving his diagnosis his PSA level had dropped to 0.2 ng/mL. The new doctor continued with the PSA monitoring and upon receiving a subsequent PSA test result the physician said that the PSA level received was as low as it could be and asked if the patient was sure that he had not had surgery. Given the physician’s surprise that such a result could be achieved the patient confessed to taking Salvestrols. The physician then stated that he had other patients he would like to start on Salvestrols. This patient continues to receive PSA test results at the 0.2 ng/ml level and has continues to take one (350 point) Salvestrol Shield capsule per day as a preventive measure, and has now embarked on a fitness program and change in diet.

    Dr Potter

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