PRICE DIFFERENTIALS AND TIME-TO-FINANCING FOR NEW ONCOLOGY MEDICINES IN SPAIN VERSUS THE UNITED STATES: IMPLICATIONS OF US MOST-FAVORED-NATION PRICING AND SPAIN'S PRICING REFORM
Author(s)
Saurabh Aggarwal, BS, MS, PhD1, Sushil Kumar, BS2, Ozlem Topaloglu, PhD, MPH2.
1NOVEL Health Strategies, Chevy Chase, MD, USA, 2NOVEL Health Strategies, Bethesda, MD, USA.
1NOVEL Health Strategies, Chevy Chase, MD, USA, 2NOVEL Health Strategies, Bethesda, MD, USA.
OBJECTIVES: To quantify the gap between Spanish ex-factory prices and US list prices for recently financed cancer medicines, and the delay from EU marketing authorisation (MA) to Spanish financing, and to interpret both against the US Most-Favored-Nation (MFN) reference-pricing policy and Spain's draft pricing-and-financing Royal Decree.
METHODS: We identified every oncology medicine granted a financed price by Spain's Interministerial Commission on the Pricing of Medicines (CIPM), sessions 246-269 (April 2024-April 2026), taking the maximum ex-factory price (PVL) from the official acuerdos. US prices were the publicly listed price (drugs.com cash price; manufacturer WAC for CAR-T and radioligand therapies). Prices were compared on a like-for-like unit (per vial; per tablet/capsule at matched strength; per mg) and converted EUR→USD at 1.138. Access lag was measured from EU MA to CIPM financing.
RESULTS: Twenty-seven medicines were financed; 25 had a US comparator. The median Spanish price was 54.0% below the US (mean 41.9%; 49.5% excluding streptozocin, an old generic priced higher in Spain), ranging from ~83% lower (fruquintinib) to near-parity for selected cell and older therapies. Findings matched a prior 12-medicine cohort (median 62%). Median time from EU MA to Spanish financing was 20.4 months (mean 26.1; range 4-76).
CONCLUSIONS: Spanish prices for new cancer medicines are ~50% below US list prices but reach patients a median ~1.7 years after EU approval. Under US MFN (Executive Order, May 2025; CMS GLOBE/GUARD models, late 2026), the US price would reference the lowest price among wealthier OECD countries, including Spain, so low Spanish prices could pull US prices down. Conversely, Spain's draft Royal Decree introduces statutory six-month timelines and adaptive financing to compress these delays. Low price and slow access remain in tension.
METHODS: We identified every oncology medicine granted a financed price by Spain's Interministerial Commission on the Pricing of Medicines (CIPM), sessions 246-269 (April 2024-April 2026), taking the maximum ex-factory price (PVL) from the official acuerdos. US prices were the publicly listed price (drugs.com cash price; manufacturer WAC for CAR-T and radioligand therapies). Prices were compared on a like-for-like unit (per vial; per tablet/capsule at matched strength; per mg) and converted EUR→USD at 1.138. Access lag was measured from EU MA to CIPM financing.
RESULTS: Twenty-seven medicines were financed; 25 had a US comparator. The median Spanish price was 54.0% below the US (mean 41.9%; 49.5% excluding streptozocin, an old generic priced higher in Spain), ranging from ~83% lower (fruquintinib) to near-parity for selected cell and older therapies. Findings matched a prior 12-medicine cohort (median 62%). Median time from EU MA to Spanish financing was 20.4 months (mean 26.1; range 4-76).
CONCLUSIONS: Spanish prices for new cancer medicines are ~50% below US list prices but reach patients a median ~1.7 years after EU approval. Under US MFN (Executive Order, May 2025; CMS GLOBE/GUARD models, late 2026), the US price would reference the lowest price among wealthier OECD countries, including Spain, so low Spanish prices could pull US prices down. Conversely, Spain's draft Royal Decree introduces statutory six-month timelines and adaptive financing to compress these delays. Low price and slow access remain in tension.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR186
Topic
Health Policy & Regulatory, Health Technology Assessment, Real World Data & Information Systems
Topic Subcategory
Pricing Policy & Schemes
Disease
Oncology