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Alecensa / alectinib for adjuvant treatment of ALK-positive non-small-cell lung cancer

As of November 2024, MARA’s assessment finds Alecensa / Alectinib’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 clinical trial evidence suggests that alectinib reduces the likelihood of cancer recurrence compared to chemotherapy, indicating comparable efficacy. However, the trial duration is insufficient to determine long-term survival benefits, which limits the strength of the evidence.

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

The cost-effectiveness estimates for alectinib are within the acceptable range for Healthcare resources, indicating a clear economic value. The presence of a commercial arrangement further supports its cost-effectiveness.

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

There is no specific data provided on HRQoL improvements associated with alectinib. The absence of validated tools or significant patient-reported outcomes means that the impact on quality of life remains uncertain.

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

Alectinib is reported to have a good safety profile, with manageable adverse effects. However, specific adverse event data is not detailed, which could raise concerns about the overall tolerability.

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

The treatment was compared against standard adjuvant therapies, specifically chemotherapy, which is appropriate for the patient population. This provides a relevant context for evaluating alectinib’s effectiveness.

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

The trial population is well-defined, focusing on adults with resected ALK-positive NSCLC, which aligns with the intended use of alectinib. However, subgroup analyses are not extensively detailed.

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

Alectinib can be integrated into existing treatment pathways for NSCLC without significant changes to current practices, as it serves as an adjuvant therapy following surgery.

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

The budget impact is manageable, and the commercial arrangement suggests that the financial implications for the Healthcare are considered acceptable, indicating a reasonable resource use.

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

The evidence is based on clinical trials that are well-structured, although the duration of follow-up raises some concerns about long-term outcomes. Overall, the evidence is credible.

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

There are uncertainties regarding long-term survival benefits due to the trial’s duration. While the context is favorable, the lack of long-term data introduces significant 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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