Independent Market Access and Reimbursement Risk Assessment.

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Atezolizumab for untreated metastatic non-small-cell lung cancer (NSCLC)

As of June 2021, MARA’s assessment finds Atezolizumab’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 indicates that atezolizumab has comparable efficacy to pembrolizumab based on an indirect comparison, but there is no direct evidence from head-to-head trials. The IMpower110 trial showed that atezolizumab improves overall survival and progression-free survival compared to chemotherapy, but the lack of direct comparison with pembrolizumab introduces uncertainty. Therefore, it meets non-inferiority but does not demonstrate a clear edge.

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

The cost-effectiveness analysis indicates that atezolizumab is cost-saving compared to pembrolizumab, with positive incremental net health benefits at NICE’s acceptable thresholds. The committee concluded that the likelihood of atezolizumab being cost-effective is high, supporting its use within Healthcare resources.

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

The document does not provide specific data on HRQoL improvements associated with atezolizumab compared to pembrolizumab. While the treatment is expected to improve quality of life due to its mechanism, the absence of validated tools or significant domain-specific improvements leads to a rating of no demonstrated benefit.

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

Atezolizumab is reported to have a good safety profile with no robust differences in toxicity compared to pembrolizumab. The absence of significant adverse events undermining the treatment’s benefits supports a rating of acceptable safety with some concerns.

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

The main comparator for atezolizumab is pembrolizumab monotherapy, which is appropriate given the treatment landscape for untreated high PD-L1-expression metastatic NSCLC. The committee recognized that pembrolizumab is the standard of care, and the selection aligns with current clinical practice.

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

The trial population for atezolizumab is representative of the intended patient population with untreated high PD-L1-expression metastatic NSCLC. The focus on TC3 and IC3 subpopulations aligns with the marketing authorization, although some subgroup gaps exist.

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

Atezolizumab can be integrated into existing care pathways with minor adjustments, as it does not require new infrastructure or significant changes in clinical practice. The committee noted that the approval of atezolizumab would not necessitate changes in the use of PD-L1 assays in clinical practice.

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

The budget impact analysis indicates that atezolizumab has a manageable budget impact aligned with planning, as it is associated with cost savings compared to pembrolizumab. The committee concluded that the resource implications are justifiable given the treatment’s benefits.

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

The evidence base is primarily derived from the IMpower110 trial, a Phase 3 RCT, which is robust but has some limitations due to the lack of direct comparisons with pembrolizumab. The committee acknowledged the potential biases in the indirect comparisons but considered the overall evidence acceptable.

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

There are notable uncertainties regarding the duration of treatment effects and the comparability of PD-L1 assays used in different studies. While the committee recognized these uncertainties, they concluded that the overall context supports the use of atezolizumab, albeit with caution.

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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