OBJECTIVES: The primary objective was to understand the relative price differential for cancer drugs between the United States and Spain and to develop implications for pricing strategy and patient access.

METHODS: Eleven branded cancer drugs were chosen for the study. Prices for similar doses and packaging were compared between the United States and Spain from the end of 2022 to mid-2024. The time to market access was calculated by subtracting the date of the financing decision from the date of regulatory approval. Key Opinion Leaders (KOLs) and payers were interviewed to understand the current and future implications of the price differential.

RESULTS: The median price discount for the selected cancer drugs in Spain compared to the U.S. was approximately 62% (ranging from 0% to 83%). Oral small molecule drugs had a higher median price discount (73%) compared to biologics (59%). A recent decree further lowered prices in Spain for most branded drugs by 4% to 7.5%. While prices are significantly lower in Spain compared to the U.S., there are several limiting factors for access in Spain: (1) the median time to market access was 647 days, with a range of 104 to 1404 days, (2) for the majority of cancer drugs, there is a maximum ceiling of annual sales, "techo máximo de gasto," (3) some drugs are limited to patients who are expected to live more than 6 months, and (4) approvals are based on a stringent protocol. Interviews with KOLs and payers confirmed significant delays in patient access to new cancer treatments in Spain. In the United States, high cost-sharing for non-Medicare patients was a key concern.

CONCLUSIONS: This analysis shows there is a crucial need for new policy measures to address disparities in drug pricing and patient access in both Spain and the U.S.