OBJECTIVES:

Daclizumab beta is a humanized monoclonal antibody recently approved for the treatment of adults with relapsing forms of multiple sclerosis (MS). The objective of this budget impact analysis is to estimate the economic consequences of the introduction and use of daclizumab beta in Italy, for the treatment of patients with relapsing remitting MS (RRMS), eligible to second line therapies.

METHODS:

The analysis evaluates the economic impact of the first three years of daclizumab commercialization, from the perspective of the Italian National Healthcare Service (NHS). Direct healthcare costs (drugs, administration, monitoring, relapse and adverse event management) were calculated comparing two scenarios: i) current scenario, where second line treatments (fingolimod, natalizumab, alemtuzumab), currently available in Italy, are used to treat RRMS patients, ii) alternative scenario, where daclizumab beta is introduced as an alternative. Target population was estimated in 9,950, 11,480 and 13,080 patients at years 1, 2 and 3 respectively, based on Italian prevalence, incidence and market data. Impact of relapses was estimated using results from recently published mixed treatment comparison. Unit costs were based on national prices, tariffs, and published literature (in euros 2017). One-way sensitivity analysis was conducted.

RESULTS:

According to negotiated price and reimbursement conditions, the introduction and use of daclizumab beta would decrease total costs, compared to the current scenario. In the current scenario, estimated costs were approximately 170.2, 196.4 and 223.8 million euros in years 1, 2, and 3 respectively. In the alternative scenario estimated costs were approximately 168.9, 192.4 and 217.9 million euros. The cumulative budget impact over three years was a saving of approximately 11.2 million euros for the Italian NHS. All scenarios tested in sensitivity analysis were favorable to the alternative scenario.

CONCLUSIONS:

The adoption of daclizumab beta for the treatment of RRMS patients eligible to second line therapies is economically favorable (budget-saving) for the Italian NHS.