Podnet na vytvorenie PP pre liečivo esketamín

Organisation: Psychofarmakologická sekcia SPsS SLS

Created at: 28.03.2025

Processed at: 07.04.2026

Question

The drug esketamine is covered by public health insurance from 1.10.2023. The drug has been evaluated by the National Institute for Health Value and Technology and has met the legislative conditions for cost-effectiveness. The drug esketamine has also signed a reimbursement conditions agreement with the Ministry of Health, which includes a condition on the amount of reimbursement. Esketamine is currently not included in the DRG-List of medical procedures or in the List of Allowable Items. Despite the fact that the medicine is preferentially intended for administration in outpatient care, in some cases, in particular at the start of treatment and for patients hospitalised for other reasons, esketamine may be administered in the context of inpatient care.

Inclusion of the drug esketamine in the List of Creditable Items in the same breakdown as we are proposing to include in the List of Medical Procedures: administration of the drug esketamine, nasal: up to less than 56 mg administration of the drug esketamine, nasal: from 56 mg to less than 84 mg administration of the drug esketamine, nasal: from 84 mg to less than 112 mg administration of the drug esketamine, nasal: from 112 mg to less than 140 mg administration of the drug esketamine, nasal: 140 mg to less than 168 mg Administration of esketamine, nasally: 168 mg to less than 196 mg Administration of esketamine, nasally: 196 mg to less than 224 mg Administration of esketamine, nasally: 224 mg to less than 252 mg Administration of esketamine, nasally: 252 mg to less than 280 mg Administration of esketamine, nasally: 280 mg to less than 308 mg Administration of esketamine, nasally: 308 mg to less than 336 mg Administration of esketamine, nasally: 336 mg to less than 364 mg Administration of esketamine, nasally: 364 mg to less than 392 mg Administration of esketamine, nasally: 392 mg to less than 420 mg Administration of esketamine, nasally: 420 mg to less than 448 mg Administration of esketamine, nasally: 448 mg to less than 476 mg Administration of esketamine, nasally: 476 mg to less than 504 mg Administration of esketamine, nasal: 504 mg to less than 532 mg Administration of esketamine, nasal: 532 mg to less than 560 mg Administration of esketamine, nasal: 560 mg to less than 588 mg Administration of esketamine, nasal: 588 mg to less than 616 mg Administration of esketamine, nasal: 616 mg to less than 644 mg Administration of esketamine, nasal: 644 mg or more

Esketamine is indicated for patients with treatment-resistant depressive disorder 3+L (based on SPC) or 4+L (based on I.O.) [ICD-10-SK-2024 code: F32.1, F32.2, F33.1, F33.2]. In clinical practice, patients with an inadequate therapeutic response to previous treatment may result in hospitalization of the patient. In such patients, the indication for Spravato may be initiated as part of the provision of inpatient care. Likewise, in patients who are set up for long-term treatment with esketamine, when hospitalized for other reasons, this treatment cannot be discontinued. The inclusion of the drug in the list of creditable items would ensure special reimbursement for the drug administered over and above the cost of the inpatient case and in accordance with the contract on the terms of reimbursement. The number of patients who would be affected by the use of PP is approximately 50 for the whole Slovak Republic per year and the annual cost would be approximately 220 000 € per year for all patients treated in the Slovak Republic. Officially determined price and price in an institutional pharmacy: Spravato 28 mg: ÚUC 177,52 €; price in an institutional pharmacy 191,71 € The holder of the registration has signed a contract with the Ministry of Health of the Slovak Republic on the conditions of reimbursement according to § 7a (1) of Act No 363/2011 Coll., the cost of the drug at the start of treatment during the first 28 days of treatment (average dosage according to the tolerability of the treatment): 1. day 1: dose 56 mg, consumption of 2 x Spravato 28 mg, cost of medicine 383,42 € Day 4: dose 56 mg, consumption of 2 x Spravato 28 mg, cost of medicine 383,42 € ... Day 25: dose 56 mg, consumption of 2 x Spravato 28 mg, cost of medicine 383,42 € Total cost of the medicine for the first 28 days of treatment, 8 administrations: 3 067,36 €. When hospitalized for reasons other than depressive disorder, but this is a concomitant comorbidity treated with esketamine, the cost of the drug alone for a 10-12 day hospitalization is €1,533.68. The cost of the provision of this medicine is not and cannot be taken into account in the relative weighting of hospitalisation cases, as they are exceptional, occur only in a small number of patients and in different DRG groups according to the underlying disease (reason for hospitalisation). The reimbursement per hospitalisation case in similar situations is not sufficient to cover the financial cost of the provision of the medicine.

Answer

For the opinion, see feedback number 789.