Independent Market Access and Reimbursement Risk Assessment.

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Durvalumab for untreated extensive-stage small-cell lung cancer

As of February 2025, MARA’s assessment finds Durvalumab’s reimbursement risk concentrated in quality of life, with cost effectiveness a strength; the current MARA Rating and full rationale are available in the report.

The assessment also weighs clinical effectiveness: how much additional benefit the drug demonstrated over the care patients already receive — the first question every payer asks. 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.

Oncology

This rating sits within MARA’s Oncology coverage, alongside 153 other independently assessed treatments in the same area.

What payers will ask

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

The evidence suggests that durvalumab has comparable efficacy to atezolizumab, which is the standard treatment for extensive-stage small-cell lung cancer. However, there is no direct clinical trial evidence comparing durvalumab with atezolizumab, and the evidence is based on indirect comparisons. This limits the strength of the claim regarding its effectiveness.

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

The document indicates that durvalumab has similar or lower costs compared to atezolizumab when considering all relevant costs, including commercial arrangements. This suggests a strong cost-effectiveness profile under common thresholds.

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

There is no specific data provided in the document regarding HRQoL outcomes for patients treated with durvalumab. The absence of patient-reported outcomes or validated tools to measure quality of life impacts the assessment, leading to a rating of no demonstrated benefit.

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

The safety profile of durvalumab is not explicitly detailed in the document, but it is implied to be comparable to atezolizumab, which is known to have a manageable safety profile. This leads to an acceptable safety rating.

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

The document notes that durvalumab has not been directly compared with atezolizumab in clinical trials. While indirect comparisons suggest similar efficacy, the lack of direct evidence raises concerns about the robustness of the comparator selection.

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

The recommendations specify that durvalumab is indicated for adults with an ECOG performance status of 0 or 1, which is a relevant and representative patient population for this treatment. However, there are no subgroup analyses mentioned.

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

The integration of durvalumab into existing treatment pathways appears manageable, as it is recommended alongside standard treatments like atezolizumab. Minor adjustments may be needed, but no significant barriers to integration are noted.

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

The document suggests that the budget impact of durvalumab is manageable and aligns with planning, indicating that it is not expected to impose a significant resource burden on the healthcare system.

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

The evidence base relies on indirect comparisons and lacks direct Phase III trial data. While the evidence is somewhat robust, the absence of high-quality, direct comparative studies introduces uncertainty.

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

The document indicates a favorable context for the use of durvalumab, with manageable uncertainties regarding its effectiveness and cost. However, the lack of direct evidence does introduce some residual uncertainty.

Be alerted when this rating changes:

Sample two-page MARA Rating report for the fictional drug Samplinib: the rating with its decision record, and the ten graded payer questions with the reasoning behind each
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