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NICE’s evidence review of esketamine for treatment-resistant depression

Discussion in 'Research methodology news and research' started by cassava7, Dec 17, 2022.

  1. cassava7

    cassava7 Senior Member (Voting Rights)

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    After an appeal by Janssen (the pharmaceutical company that manufactures esketamine) in July, NICE reviewed the evidence they submitted again in a technology appraisal guidance (TAG) and recommended against its use for treatment-resistant depression.

    The TAG committee’s discussion is an interesting read, albeit long and technical, because it lays out all of the limitations with the evidence (two phase 3 trials + two open-label study for long term follow-up).

    It shows how the design of the trials made evaluating the efficacy of esketamine difficult, in particular how it differs from clinical practice and the heterogeneity of the treatment-resistant population (with regards to the treatments they have received). Also included is a discussion on the placebo effect from increased clinical contact.

    Overall, I find that NICE conducted a thorough review of the evidence and I think it is worth highlighting their work.

    https://www.nice.org.uk/guidance/ta854/chapter/3-Committee-discussion
     
  2. Hutan

    Hutan Moderator Staff Member

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    Aotearoa New Zealand
    Some good news, thanks cassava. If NICE is functioning well, it can help solve a lot of problems in medicine.
     
  3. Hutan

    Hutan Moderator Staff Member

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    Aotearoa New Zealand
    Having skimmed through, I just want to add my applause to NICE. The committee making the decision made good use of patient and clinician experts. They listened when patients said that trying another course of treatment that, in reality, is unlikely to work isn't, in the words we hear so often, 'better than nothing'. Actually, it's worse than nothing because of the hopelessness it causes when it eventually becomes clear that the treatment doesn't work and because of the effort and time that it takes to try it. But the committee clearly understood that there is a need for new, more effective treatments.

    And the committee listened when a patient expert who had recovered explained how the illness can make people feel helpless and, I assume, not feel able to be proactive when a treatment isn't working. The committee listened when a clinical expert said that a lot of people keep taking medication for depression for a long time after it is clear that it isn't helping.

    I think a lot of these things apply to any significant chronic illness and certainly to ME/CFS.

    I thought this was notable too. Results from two studies the company provided were dismissed on the grounds that the studies were too small and were observational (i.e. not blinded with a comparison treatment). Too small was 160 people and 32 people.
    Perhaps it was relatively easy for the committee to reject the drug, as it sounds as though its administration is costly and burdensome, involving hospital visits. But still, for as far as I got in reading the report, I thought the committee (and the NICE staff supporting them) did a good job. I wish that they would review the chronic primary pain guideline.
     
    Simbindi, cassava7, John Mac and 4 others like this.
  4. CRG

    CRG Senior Member (Voting Rights)

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