NICE tells J&J … the price just ain’t right!

The National Institute for Health and Clinical Excellence (NICE) in the UK has issued draft guidance and a media release stating that it can not justify recommending the use of abiraterone acetate for the treatment of men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC).

According to NICE’s media release, this decision is based entirely on cost grounds. Even the chief executive of NICE, Sir Andrew Dillon, is quoted as saying,

We know how important it is for patients to have the option to delay chemotherapy and its associated side effects, so we are disappointed not to be able to recommend abiraterone for use in this way. However, the manufacturer’s own economic model showed that the drug would not be cost-effective at this stage …

The pressure is obviously being placed on Johnson & Johnson to provide abiraterone acetate at a lower price if the company wants to see this product being recommended for treatment of chemotherapy-naive patients with mCRPC in the UK. There is also a clear message here for Astellas Pharma, who will be hoping to see enzalutamide approved for a similar indication in Europe in the near future.

Efficacy alone is no longer enough; the price has to be right!

13 Responses

  1. … It is about time … There are so many drugs for prostate cancer … that this is the standard that should be used. … FDA? Are you listening

  2. Hopefully the Brits will bring about the break in cost that will have to be passed on to benefit users everywhere.

  3. Dear Robert:

    The FDA in the USA has no authority or responsibility for the setting of prices of new drugs, nor does the equivalent organization in Europe (the European Medicines Agency or EMA). If you want an organization in the USA like NICE in the UK, with the power to negotiate with drug companies on the pricing of new drugs, then you are going to need to talk to your Congresspersons. Here in the USA the only organizations with the power to negotiate pricing with drug companies are health insurance companies and those acting on their behalf like large pharmacy provider organizations.

  4. Dear Chuck:

    At present, what happens in the UK has little significant impact in most other countries — because most other countries (with a few exceptions like Australia, New Zealand, and some other European nations) don’t have truly nationalized health care systems.

  5. @robert moore … I am not sure what standard you are referring to — that the FDA should consider cost effectiveness when approving drugs for prostate cancer (and other diseases)?

    Before I respond further, please clarify.

  6. Again … The FDA has no remit to consider cost in its decision to approve new drugs (or to expand the approved list of indications for drugs that hava already been approved). What is more, they absolutely do not want to have to deal with that factor. There are two very different questions here: (a) Is a drug effective and safe to use for a specific indication? (b) Is a specific use of a drug cost-effective? It is absolutely essential that these two questions be addressed by separate regulatory processes. You really don’t want the FDA to get into the cost-effectiveness issue. And that is exactly why NICE in England operates independently of the European Medicines Agency (the European equivalent of the FDA).

  7. I absolutely agree Mike – I’m just trying to understand the earlier comment.

    NICE is essential in a national health system. I frankly believe it is inappropriate in a privatized system. I guess the question is whether a comparable independent body has a role in Medicare, Medicaid, the VA and such like.

  8. Dear Rick:

    The key issue here in America is Medicare. Both the VA and the individual states are already able to make decisions about what they will or won’t pay for when it comes to drug therapy. Indeed, the VA is widely recognized to be an extremely tough negotiator when it comes to what they will pay for any and all drugs. In many states, Medicaid simply won’t cover the costs of anything beyond the most basic types of care.

    Medicare is a whole other issue because CMS is legally required to cover the costs of many categories of drug (specifically including drugs for the treatment of cancer) under a highly defined set of formulae — whether the use of a specific drug is economically “reasonable” or not. This has been a very contentious issue for years, with little common ground between industry, patient groups, physician groups, and the legal community. It’s coming to a head. And it’s not just about the drug costs. They are only a relatively small part of the problem. Look at the issue of the costs associated with proton beam radiation therapy vs. IMRT or the costs of maintaining elderly and very sick patients in ICUs for weeks or months at a time, when there is no good reason to believe they are going to be able to recover.

    Sooner or later we are going to have to face up to the fact that just because we can often extend life does not necessarily imply that it is right to do so if there is no definable value to so doing (beyond the purely emotional). And this is going to have legal ramifications when it comes to tort law and the size of the awards that one often sees law firms and plaintiffs seeking for certain types of “wrongful death” or other medical problems.

  9. Dear Rick D. and Mike (Sitemaster),

    I was talking about cost-effectiveness and Mike was right on about talking about the inability of Medicare to do the tough negotiating on costs that Medicaid does. I am not familiar with the VA so I defer to Mike on his knowledge about that system. I know that I did not like the passage of Medicare Part D because the Bush administration and drug lobbyists would not let Medicare do the same things in terms of negotiating that Medicaid does and I am reluctant to be a member of AARP because they supported that boondoggle.

    I know of no credible studies that show restriction of awards reduces malpractice rates long-term

  10. Medicare, Medicaid, and the VA are nationalized, not private. Maybe issues of cost and cost-effectiveness should be left to those national systems that have demonstrated independence in those issues like Medicaid and the VA.

  11. Would NICE’s decision affect Canada or Germany or Sweden?

  12. While I am sure that Canada, Sweden, and Germany keep a close eye on NICE’s decisions, the degree to which they might actually be affected by those decisions is unknown, and in Canada decisions about what to pay for are made on a province level, not a national level.

  13. Here is a link to how NICE and other such organisations calculate cost-effectiveness. This method is controversial in the EU right now. I suppose because the notion of “cost” has concealed ethical and political dimensions. For example, is it morally responsible to raise taxes in a steeply progressive fashion, so as to cover the costs of certain medications? (I am simplifying.)

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