Independent Market Access and Reimbursement Risk Assessment.

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Wegovy / semaglutide for managing overweight and obesity

As of September 2023, MARA’s assessment finds Semaglutide’s reimbursement risk concentrated in uncertainty, sensitivity, and broader impacts, with cost effectiveness a strength; the current MARA Rating and full rationale are available in the report.

The assessment also weighs safety and adverse effects: what harms arrive alongside the benefit, which payers set against the gains before funding a treatment. The strength recorded in cost effectiveness carries weight because that domain asks whether the price asked stands in a defensible relationship to the benefit delivered — the core of most European reimbursement decisions.

Obesity

This rating sits within MARA’s Obesity coverage, alongside 8 other independently assessed treatments in the same area.

What payers will ask

Is the clinical benefit the kind payers reward? — Clinical effectiveness

The evidence from the STEP 1 trial indicates that semaglutide leads to significant weight loss compared to placebo, with a mean percentage change in body weight of -12.4% over 68 weeks. Additionally, semaglutide is shown to be more effective than liraglutide, with a weight loss difference of -5.81%. This demonstrates a clear clinical advantage over existing treatments.

Does the economic case hold at the expected price? — Cost effectiveness

The cost-effectiveness estimates for semaglutide are within acceptable thresholds, with the company’s base-case ICER reported at £14,827 per QALY gained. This suggests that semaglutide is a cost-effective option for the target population, particularly when considering the significant health benefits associated with weight loss.

Is there quality-of-life evidence payers weigh? — Quality of life

While the document does not provide extensive HRQoL data, it indicates that semaglutide improves weight management, which is likely to enhance overall well-being and daily functioning. The committee noted the psychological and physical effects of obesity, suggesting that effective weight management could lead to improved quality of life.

Does the safety profile hold up for payers? — Safety and Adverse Effects

The safety profile of semaglutide is acceptable, with the committee noting that adverse events are manageable and primarily mild to moderate. The clinical experts indicated that the treatment is well-tolerated, which supports its use in the recommended population.

Was the drug compared against what payers expect? — Comparator Selection

The comparators selected for the evaluation, including weight management support and liraglutide, are appropriate and reflect current clinical practice. The committee agreed that these comparators are relevant for assessing the effectiveness of semaglutide.

Is the population defined the way payers need it? — Patient Population and Subgroups

The trial population is broadly representative of the intended patient population, although there are some limitations regarding the inclusion of individuals with type 2 diabetes. The committee acknowledged that the target population for semaglutide includes those at higher risk for obesity-related complications.

Does the drug fit how care is delivered and paid for? — Care Pathway Integration

Semaglutide is designed to be integrated into existing specialist weight management services, which are necessary for its effective use. The committee emphasized that these services provide the multidisciplinary support required for successful treatment.

Are the wider system costs understood? — Resource Use and Cost Implications

The resource implications of implementing semaglutide are manageable, particularly given the cost-effectiveness estimates. The committee noted that the treatment is likely to be affordable within the context of Healthcare resources, especially for the target population.

Would the evidence survive payer scrutiny? — Evidence Quality and Robustness

The evidence base is robust, primarily derived from the STEP 1 trial, which is a well-designed RCT. While there are some uncertainties regarding the generalizability of the results, the overall quality of evidence supports the effectiveness of semaglutide.

How exposed is the case to uncertainty? — Uncertainty, Sensitivity, and Broader Impacts

There are notable uncertainties regarding the long-term effects of semaglutide and the assumptions made in the economic model. The committee recognized these uncertainties but concluded that the treatment is still likely to be beneficial for the target population.

Be alerted when this rating changes:

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