Independent Market Access and Reimbursement Risk Assessment.

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Abiraterone for treating newly diagnosed high-risk hormone-sensitive metastatic prostate cancer

As of November 2025, MARA’s assessment finds Abiraterone’s reimbursement risk concentrated in comparator selection, with cost effectiveness a strength; the current MARA Rating and full rationale are available in the report.

The assessment also weighs evidence quality and robustness: how solid the underlying evidence is on its own terms — trial design, size and endpoints — before any question of price is reached. 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

Clinical trial evidence shows that abiraterone plus ADT, with prednisolone or prednisone is more effective than placebo plus ADT and ADT alone. Although it has not been directly compared with enzalutamide plus ADT or apalutamide plus ADT, indirect comparisons suggest it is likely to work as well as these combinations, indicating a clear clinical advantage.

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

A cost comparison indicates that the costs for abiraterone plus ADT are similar to or lower than both enzalutamide plus ADT and apalutamide plus ADT, supporting its cost-effectiveness under common thresholds.

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

While specific HRQoL data is not detailed in the document, the recommendation implies that abiraterone plus ADT provides benefits and value for money, suggesting positive impacts on patient well-being and functioning.

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

The document does not report significant safety concerns, indicating that abiraterone plus ADT has a very good tolerability profile with mostly mild or moderate adverse events.

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

Abiraterone has not been directly compared in clinical trials with enzalutamide plus ADT or apalutamide plus ADT, which are the usual treatments. However, indirect comparisons suggest it is likely to work as well as these alternatives.

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

The population targeted by the guidance is clearly defined as adults with newly diagnosed high-risk hormone-sensitive metastatic prostate cancer, indicating a broadly generalizable patient population.

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

The integration of abiraterone plus ADT into existing treatment pathways appears manageable, as it is recommended alongside standard treatments without requiring significant changes to current practices.

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

The document suggests that the budget impact is manageable and aligns with planning, indicating that the resource implications of implementing abiraterone plus ADT are justifiable.

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

The evidence base includes clinical trial data showing effectiveness compared to placebo and ADT alone, although there are some limitations due to the lack of direct comparisons with all relevant alternatives.

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

The guidance indicates that there is a favorable context for the use of abiraterone plus ADT, with manageable uncertainties regarding its effectiveness compared to other treatments.
This rating replaces the earlier August 2021 rating of the same drug and indication — still on the record here.

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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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