NICE rejects coverage of enzalutamide in men with chemo-naive mCRPC

According to a report on Yahoo!News, the National Institute for Care and Health Excellence (NICE) in the UK has issued draft guidance suggesting that enzalutamide is not sufficiently cost-effective for use in the treatment of men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC). As of 7:00 a.m. Eastern time this morning in the USA, there is no evidence of confirmatory information on NICE’s web site. However, quotes from NICE’s chief executive and others on the Yahoo!News report clearly confirm the accuracy of the report.

This is another setback for at least some men with chemo-naive mCRPC in parts of the UK. The “New” Prostate Cancer InfoLink hopes that further discussions between the manufacturer and NICE can help to resolve this issue.

We note that NICE has also not approved the use of abiraterone acetate (Zytiga) for the treatment of the same group of chemotherapy-naive mCRPC patients. The latest update on this submission (dated last September) suggests that discussions on this decision may still be under review.

2 Responses

  1. That doesn’t seem NICE.

    In comparison, does the FDA approve things based on costs? Or is it strictly if the drug shows benefit. Thanks

  2. Jerry:

    The FDA makes decisions and recommendations about product use exclusively on the basis of the effectiveness and safety of a product in a specific set of patients. The cost of the product is not an issue they deal with.

    Conversely, NICE makes decisions about coverage of products and procedures in England based exclusively on the cost and the “value” of the form of the product’s use or uses. The arguments about NICE’s decisions always revolve around how that “value” is defined. NICE does not make decisions about whether products can or can’t be prescribed or used in England. Their decisions are limited to what the National Health Service should pay for. Decisions about whether a product can be prescribed or not are controlled in Europe by the European Medicines Agency (EMA) and EMA’s Committee for Medicinal Products for Human Use (CMPH), which, like the FDA, are entirely focused on the safety and efficacy of products.

    There is no organization in the US comparable to NICE, but there certainly is in other countries that have nationalized health systems and fixed budgets every year (an example is the Institute for Quality and Efficiency in Health Care or IqWIG in Germany). In the USA, every payer has its own system for deciding what it will or won’t pay for under what type of health insurance plan. So there are probably a hundred or more little NICEs in the USA making their individual decisions in a less than transparent fashion. Even when the FDA says a product is safe and effective in a specific use, that doesn’t necessarily mean a patient will have it covered by their insurance provider; and even if it is covered, that coverage may still include a very significant co-pay for the individual patient.

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