In Europe, just because it’s approved doesn’t mean you can get it …

The complexity of access to new agents for the treatment of prostate cancer in countries around the world is not necessarily evident to all our readers, so, just as an example, here is the situation as of today regarding access to abiraterone acetate in the UK alone:

  • In July 2011, the European Medicines Agency (EMEA) recommended approval for the marketing of abiraterone acetate (Zytiga™) for the treatment of metastatic, castration-resistant prostate cancer in men who have already progressed after treatment with docetaxel-based chemotherapy.
  • In September 2011, European regulators approved abiraterone for prescription and clinical use in all countries that belong to the European Union several months ago. However, …
  • In the UK, the National Institute for Clinical Excellence or NICE issued a draft opinion that the cost of the drug — at a nominal price of £3,000 a month (equivalent to about US$4,700) — was higher than they felt to be appropriate. As a consequence, abiraterone has not been approved for widespread prescription in England, but …
  • It has, in fact, been possible to obtain a prescription for abiraterone acetate in England through the Cancer Drugs Fund, an initiative designed to increase access to drugs for treatment of cancer in England. As of February 1, nearly 500 men had successfully applied for treatment with abiraterone in the 9 months up through February 1 this year.

The regional nature of government in many European countries means that this type of coverage decision process plays out across many member countries in the European Union.

The complexity and costs associated with access to innovative drug therapy in the USA can look complex to us here at home, but despite supposedly “nationalized” health care systems in many European countries, obtaining access there can be just as Byzantine (and sometimes more so). By comparison with the UK, the situation in nations like Italy and Spain is even more complex!

5 Responses

  1. In France, it’s possible to get abiraterone through a hospital oncologist or urologist. And, in this situation, it’s free for the patient … but possible only for selected patients.


  2. As a follow-up to the item above, shortly after noon today, Eastern Daylight Savings Time in the USA, the Scottish Medicines Consortium (SMC) issued a statement saying that abiraterone acetate “has been deemed too expensive for use on the NHS in Scotland.”

  3. In the Netherlands secret “caps” have been placed on the total amount of certain medications that a patient is allowed to receive. If one needs more than is allowed for a specific illness under specified conditions, well, too bad. And the patient knows nothing. The doctors do though. These caps are determined by a quango of private insurers in collusion with the current health minister. It works like this. First a total financial framework is set up each year or so, again by this quango. Then each proposed medication is evaluated, with average total cost being the decisive criterion. If that exceeds a certain part of the framework dedicated to medications for this specific illness at such-and-such stage or degree of severity, the medication is rejected for that use. The only medication that I know about that was subjected to this, is lapatinib, in one of its two current applications for breast cancer. I have seen the documents online.

    I am speculating now, but it is possible that the potential good effect of lapatinib for some parameters of prostate cancer was an unstated consideration. I consider the secrecy to be disgusting, especially since the Dutch government refuses to consider a progressive raise of taxation. I was the first public person to learn about such things, because I was asked to investigate the nation’s near-total private insurance system. As soon as I got prostate cancer and determined — by a secret second opinion in another country — that, given my parameters, my life might well be at stake, I left for the country where I got that second opinion. I got a proper treatment; it will end in June, and my chances are pretty good. That doctors collaborate with this should sicken anyone. I think that, at this moment, the Netherlands is the only EU country where private insurance is obligatory. Perhaps Belgium (Flemish and Wallonian parts) is another, but I’m not sure.

  4. Just so that we are very clear, lapatinib has never been submitted for approval by the manufacturer for any prostate cancer indication, and the results currently available from Phase II trials of lapatinib in advanced forms of prostate cancer are varied. There are four ongoing trials of lapatinib in the treatment of prostate cancer, but none of these are Phase III trials, and it seems highly unlikely that the manufacturer intends to seek an approval for the use of lapatinib in the treatment of prostate cancer.

  5. Thanks, Sitemaster. That brings me up to date. I was thinking about a report on this site, some time ago. I noticed it because when that article appeared here, the use I mentioned had just been rejected by the Health Minister, who accepted the advice of the quango. Right after that, the main Dutch researcher on lapatinib was said to be furious at this decision. He remarked that residents of the Netherlands who feel they need lapatinib for breast cancer have no choice except to fight the decision in court. I’ve no idea what if anything has happened since then. My hunch about prostate cancer was a mere educated guess. There’s not one word about it in the Dutch documents that I have seen.

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