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2 Information about esketamine

Marketing authorisation indication

2.1 Esketamine (Spravato, Janssen) in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI), is indicated for adults with treatment-resistant major depressive disorder who have not responded to at least 2 different treatments with antidepressants in the current moderate to severe depressive episode.

Dosage in the marketing authorisation

2.2 Esketamine is administered from a nasal spray device by the patient under the direct supervision of a healthcare professional. For adults under 65, the starting dose is 56 mg on day 1 with subsequent doses at 56 mg or 84 mg twice a week for the first 4 weeks. In weeks 5 to 8 the drug's summary of product characteristics (SPC) recommends maintaining the dose from week 4 at once weekly intervals. From week 9, 56 mg or 84 mg is recommended in the SPC every 2 weeks or once weekly. Dose adjustments should be made based on efficacy and tolerability to the previous dose. After depressive symptoms improve, the SPC recommends continuing treatment for at least 6 months. The SPC dose recommendations also apply to adults who are 65 and over and for people of Japanese family origin, with the exception that the starting dose on day 1 should be 28 mg, and any dose changes should be in 28 mg increments.


2.3 The device is single use and delivers 28 mg of esketamine in 2 sprays; one 14 mg spray per nostril. Costs per dose are:

  • £163 for a 28 mg dose (one 28 mg device)

  • £326 for a 56 mg dose (two 28 mg devices)

  • £489 for an 84 mg dose (three 28 mg devices).

    Based on the company's economic model, an average course of therapy costs £10,554.25. Costs may vary in different settings because of negotiated procurement discounts.