OBJECTIVES:

A new coverage system for high-cost drugs is operating in Chile. The system covers the treatment with Traztuzumab (TZ) for metastasic and early HER2 (+) breast cancer (mBC and eBC). Pertuzumab (PT) in mBC is a complementary technology that can be considered for coverage. Among criteria for the evaluation, Risk-Sharing Agreements (RSA) have been added as requisite. The following work aims to present a model of RSA for HER2 (+) mBC breast cancer suitable for the Chilean context.

METHODS:

Epidemiological data was analyzed to model demand side (mBC and eBC cases). Additionally, clinical trials were studied in terms of inclusion and exclusion criteria, treatment protocols, outcomes (Progression-Free Survival - PFS), horizons and persistent uncertainties. Supply-side was described with the aim to the estimation of direct costs of treatment. Key variables for the RSA were identified and finally, scenarios were identified and proper comparisons were conducted.

RESULTS:

The proposed RSA “Discount conditional to global treatment” entails a price decrease in TZ in eBC, which is the main expenditure component. This discount is conditional on the adoption of PT for mBC. When the payer accepts the incorporation of PT, the manufacturer activates a discount in TZ for mBC as well.

If the payer incorporates PT without a RSA, its adoption would imply an increased expenditure for the system (+7.73%). Nonetheless, if the payer incorporates PT with this RSA, the system would experience savings (-10.22%).

CONCLUSIONS:

Recommendations for RSAs proposals were properly followed. These results were submitted to the authority, and expectations on the acceptance of the model are high, based on a wide national experience with the disease, increase in PFS, minimal transaction-costs associated and important expected savings.