OBJECTIVES: To estimate the budget impact of introducing low-dose methoxyflurane (LDM) as an alternative for emergency relief of moderate-to-severe pain in conscious adult patients with trauma and associated pain from the perspective of the Spanish NHS.

METHODS: A budget impact model was developed over a 3-year time horizon following ISPOR guidelines. The target population was estimated based on epidemiological data. The therapeutic alternatives evaluated were: fast-acting analgesics, according to the World Health Organization analgesic ladder and Spanish emergency protocols, and nitrous oxide. The following direct health costs (€ 2018) were included: drug acquisition, staff time, resource use (consumables and physiological saline), adverse events (nausea, vomiting, hypoventilation, oxygen desaturation, hypercapnia and need for naloxone), and complications management (phlebitis and extravasation). The modelling approach and assumptions were validated by a group of experts specialized in hospital emergencies. The robustness of the model was evaluated by a deterministic sensitivity analysis.

RESULTS: The model estimated that 1,250,644; 1,276,275 and 1,301,905 patients with moderate trauma pain and 1,013,440, 1,034,209 and 1,054,978 with severe trauma pain would be eligible for treatment in 2019, 2020 and 2021, respectively. The results showed that LDM could have a modest budget impact for the Spanish NHS of € 12,669 in the first year, € 53,622 in the second year and € 97,723 in the third year, leading to a cumulative budget of € 164,015 in three years. The usage of this new drug could generate a substantial saving in time for the healthcare staff, valued at € 3.2 million.

CONCLUSIONS: The introduction of LDM for the emergency relief of moderate-to-severe pain in adult patients with trauma could have a very limited budget impact for the Spanish NHS (€ 164,015), during the first three years of its introduction, while providing fast and effective analgesia.

Study funded by Mundipharma Pharmaceuticals, S.L.