NICE rejects Provenge as a treatment for mCRPC based on cost

The National Institute for Health and Clinical Excellence (NICE) in the UK has issued a statement that, according to preliminary draft guidelines, it has rejected the use of sipuleucel-T (Provenge) to treat patients with metastatic prostate cancer before they have received chemotherapy.

According to the media release on the NICE web site,

The available evidence showed that the price the NHS is being asked to pay for the drug is too high for the benefit it may provide to patients.

There appears to be a good deal of difference between the various opinions about the cost of sipuleucel-T per quality-adjusted life year or QALY under specifically defined circumstances.  However, The “New” Prostate Cancer InfoLink is not surprised by NICE’s preliminary conclusion. If sipuleucel-T is to become an available treatment in England on a standard basis, then the manufacturer is going to need to find a way to either lower the price or provide some more compelling evidence of its value for men with chemotherapy-naive, metastatic, castration-resistant prostate cancer.

3 Responses

  1. Does NICE take into consideration a treatment’s side effects? I don’t know what Provenge side effects are like, but chemotherapy is often difficult to endure. If, in contrast, Provenge side effects were minimal, would that be a factor in the NICE equation?

  2. NICE takes under consideration all aspects of the clinical use of every treatment they assess: effectiveness, safety, utility, cost, you name it. The assessment of the overall value of any particular treatment is extremely complicated, however. And for an organization like NICE, it is also important to understand that they also have to assess the relative value of approving treatment X with the consequent outcome that they won’t have the resources to approve treatment Y if they do approve treatment X.

    Perhaps one way that it would be helpful for you to think about this is, if you only had the financial resources available to approve and pay for either enzalutamide (Xtandi) or sipuleucel-T (Provenge) for the treatment of mCRPC for all Medicare patients in America, which would you approve?

  3. Dear Sitemaster:

    NICE might not have much to say about cancer medications in future. Please read this. This free trade agreement or FTA and another (the Transatlantic Trade and Investment Partnership or TTIP, between the EU as a whole and the USA) will be linked to other FTAs by a deal being negotiated now, in secret. It is the Trade in Services Agreement (TISA).

    More importantly, TTIP will probably contain provisions for so-called “investor-state dispute settlement” (ISDS) mechanisms. ISDS will allow any company to sue any Member State of the EU. Cases will be decided in secret courts in third countries, by a panel of three judges from industry. One test case for ISDS is taking place now, between Vermont and some firm (I forget), over Vermont’s right to manage its own water.

    ISDS will help any firm to get its way in the EU, in any dispute, as a Member State can most often not meet the firm’s financial demands. These include compensation for “expected future losses”, if the firm cannot invest as it desires. This power will make decisions all but irreversible. As a first step, the NHS was effectively privatised by the Health and Social Care Act, of 2013. When TTIP cuts in, the provisions of that Act will be near-irreversible. Many NHS facilities have been sold off already, and there is now talk of outsourcing some cancer care facilities. This is permitted by the Act. Similar tricks have been pulled in the Netherlands and Sweden.

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