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.
- Meanwhile, the Wesh regional government did approve prescription of abiraterone acetate in late February (on an interim basis), although the actual price negotiated is unknown, and …
- The Scottish regional government is still expected to make a decision about coverage of abiraterone at some time in the near future.
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!
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