Two health economic assessments released in Sweden

On November 07, 2023, the Dental and Pharmaceutical Benefits Agency (TLV) accomplished its work on health economic assessments of Intellis and WaveWriter Alpha – spinal cord stimulation systems used for the treatment of long-term, intractable pain with the following key conclusions provided:

Intellis:

• The TLV evaluated that Intellis treatment in combination with conventional medical treatment leads to the development of clinical efficacy, but the long-term effect vs conventional treatment remains uncertain;
• The company's health economic analysis is based on the fact that Intellis treatment effect provides greater pain relief and thus the increased quality of life as well as a reduced number of healthcare visits, but at a higher price vs conventional medical treatment;
• The TLV has identified a number of uncertainties in the company's analysis, the biggest of which are the treatment effect, battery life, and resource utilization for standard care. In TLV's analysis, among other things, the treatment effect for sample stimulation and costs for healthcare visits have been adjusted;
• Despite TLV adjusting several assumptions in the health economic analysis, the level of uncertainties in the results remained very high;

WaveWriter Alpha:

• The TLV evaluated that WaveWriter Alpha treatment in combination with conventional medical treatment leads to the development of clinical efficacy, but the effect size vs conventional treatment remains uncertain;
• The company's health economic analysis is based on the fact that WaveWriter Alpha treatment effect provides greater pain relief and thus the increased quality of life as well as a reduced number of healthcare visits, but at a higher price vs conventional medical treatment;
• The TLV has identified a number of uncertainties in the company's analysis, the biggest of which is the treatment effect. Since the company's analyzes are associated with uncertainties, TLV did not present only sensitivity analyzes with varied assumptions;
• Overall, TLV assesses that the results uncertainty level is high and considers primarily the lack of clinical evidence for the effect size, as well as the other evidence regarding quality of life and care resources.

The full details in Swedish can be found here.

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