Revtorpyk / gedatolisib for HR-Positive/HER2-Negative Advanced Breast Cancer

As of August 2026, MARA’s assessment finds Revtorpyk / gedatolisib’s reimbursement risk concentrated in comparator selection, with clinical effectiveness a strength; the current MARA Rating and full rationale are available in the report.

The assessment also weighs care pathway integration: how the drug fits into the way care is organised today; a treatment that demands new infrastructure or displaces an established pathway faces extra scrutiny. The strength recorded in clinical effectiveness carries weight because that domain asks how much additional benefit the drug demonstrated over the care patients already receive — the first question every payer asks.

Oncology

This rating sits within MARA’s Oncology coverage, alongside 165 other independently assessed treatments in the same area.

What payers will ask

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

The VIKTORIA-1 Study 1 showed a significant improvement in progression-free survival (PFS) with gedatolisib combinations compared to fulvestrant alone, with HRs of 0.24 and 0.33. This represents a clear clinical advantage in a randomized phase III trial.

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

No gedatolisib-specific ICER, QALY gain, or cost-utility model was identified in the evidence reviewed.

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

No HRQoL data or utility values were reported in the pivotal publication or presentations, making it not assessable.

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

Safety data from the phase III trial is well characterized, with common toxicities including stomatitis and neutropenia. FDA-required postmarketing studies indicate ongoing concerns about dose optimization.

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

The trial used fulvestrant monotherapy as the control, which is not the universal second-line standard of care, leading to a gap in comparative evidence against other modern therapies.

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

The trial population was broadly representative of the target population, but there were limitations in subgroup analyses and generalizability to certain demographics, such as Black patients and those with diabetes.

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

The treatment requires significant integration efforts, including repeated IV administration and monitoring for toxicities, and lacks an FDA-authorized companion diagnostic for PIK3CA mutation testing.

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

No budget-impact or resource information is presented, making it not assessable.

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

The evidence is based on a randomized phase III trial with robust PFS results, but lacks mature OS data and HRQoL outcomes, and has ongoing FDA-required studies for dose optimization.

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

There is high uncertainty regarding OS benefit, HRQoL, and cost-effectiveness due to the absence of mature data and economic models.

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