OBJECTIVES Explore the methodology used to establish the Ricarte Soto Law (RSL) reimbursement cap for products that have faced generic competition at time of evaluation.

METHODS Published RSL decision outcomes were reviewed to analyze the price-setting methodology used to define the RSL reimbursement cap of therapies that had faced generic competition at the time of being evaluated. Analysis focused on comparing the number of brands registered, number of bids received, alternative contracting solutions, prices referenced and final reimbursement cap.

RESULTS 13 molecules were identified that faced generic competition at the time of assessment for RSL inclusion. In 92% of assessments, the price-setting methodology used to define the RSL reimbursement cap was the lowest of (1) the international reference price, (2) the lowest tender award identified in MERCADO PUBLICO in the prior year, or (3) the average of bids submitted by manufacturers to RSL. An exceptional methodology was used to define the reimbursement cap of fulvestrant, given the price was defined as the average of the MERCADO PUBLICO tender price and the bids submitted by the manufacturer. Analysis also identified that different presentations of a given molecule were assessed independently, with different price-setting methodologies being used used to set the RSL reimbursement cap (e.g., immunoglobulin 10g & immunoglobulin 2g). For products with multiple indications, each indication was evaluated separately and only brands that have the indication under evaluation listed in their local label indication were allowed to submit a bid (e.g., FRENSIUS KABI´s immunoglobulin 10g was allowed to participate in the assessment for primary immunodeficiency, but not immune thrombocytopenia purpura (ITP) because the ITP indication was not listed in their label).

CONCLUSIONS The most common methodology for determining the RSL reimbursement cap for genericized products is lowest of (1) the international reference price, (2) the lowest tender award, or (3) the average of bids.