Market Access Challenges for Oncology Combination Therapies in Europe: A Review of Regulatory Approvals HTA Outcomes and Pricing Dynamics
Author(s)
Farah Moalla, BioE1, Hend Jedidi, MD1, Meriem Fadhel, BioE1, Ines Abdelghani, PharmaD1, Lylia Chachoua, PhD, PharmD2, Imen Soussi, BioE1, Aleksandra Caban, Head of PRMA department3, Mondher Toumi, Sr., MSc, PhD, MD4.
1Clever-Access, Tunis, Tunisia, 2Clever-Access, Paris, France, 3Clever-Access, Cracow, Poland, 4University Aix-Marseille /Creativ-Ceutical, Paris, France.
1Clever-Access, Tunis, Tunisia, 2Clever-Access, Paris, France, 3Clever-Access, Cracow, Poland, 4University Aix-Marseille /Creativ-Ceutical, Paris, France.
OBJECTIVES: Oncology combination therapies are increasingly used to improve outcomes in cancer care. However, they face unique market access challenges in Europe where health technology assessments (HTAs) and pricing vary significantly. This study provides a comprehensive review of the European regulatory, pricing and market access landscape for these therapies.
METHODS: On 30/12/2024, the European Medicines Agency (EMA) database was searched to identify oncology therapies approved in Europe in combination according to their label. Combinations involving radiotherapy, chemotherapy, vaccines, hormonal products, or generics/biosimilars were excluded. HTA reports from France, England, Germany and Scotland were reviewed to assess national recommendations. Pricing dynamics were analysed using PoliData database™ to identify price changes based on list prices for constituent products after indication assessment.
RESULTS: Twenty-six combinations were approved by the EMA across 35 oncology indications. Among these, 20 combinations were approved in a single indication, 2 in 2 indications, 2 in 3 indications, and 1 in 5 indications. Thirteen combinations paired 2 existing monotherapies, 10 involved an add-on to existing monotherapies, 2 were entirely novel combinations and 1 was a fixed-combination. In 40% of indications, at least one product had prior monotherapy approval in the same disease. England had the highest proportion of recommended therapies (59%), followed by Scotland (47%), France (45%), and Germany (37%). Only 43% of combinations were recommended by all four HTA bodies. Price erosions post-combination indication assessment based on list price were frequent in Germany (26% of combinations experiencing a price change for both constituent products), while no price changes in any of the combination's constituents were observed in England or Scotland. Changes were rare in France.
CONCLUSIONS: The findings highlight inconsistencies in patient access to oncology combination therapies across Europe. Divergent HTA and pricing decisions contribute to variable access, underscoring the need for more harmonized processes ensuring equitable patient benefit from innovative therapies.
METHODS: On 30/12/2024, the European Medicines Agency (EMA) database was searched to identify oncology therapies approved in Europe in combination according to their label. Combinations involving radiotherapy, chemotherapy, vaccines, hormonal products, or generics/biosimilars were excluded. HTA reports from France, England, Germany and Scotland were reviewed to assess national recommendations. Pricing dynamics were analysed using PoliData database™ to identify price changes based on list prices for constituent products after indication assessment.
RESULTS: Twenty-six combinations were approved by the EMA across 35 oncology indications. Among these, 20 combinations were approved in a single indication, 2 in 2 indications, 2 in 3 indications, and 1 in 5 indications. Thirteen combinations paired 2 existing monotherapies, 10 involved an add-on to existing monotherapies, 2 were entirely novel combinations and 1 was a fixed-combination. In 40% of indications, at least one product had prior monotherapy approval in the same disease. England had the highest proportion of recommended therapies (59%), followed by Scotland (47%), France (45%), and Germany (37%). Only 43% of combinations were recommended by all four HTA bodies. Price erosions post-combination indication assessment based on list price were frequent in Germany (26% of combinations experiencing a price change for both constituent products), while no price changes in any of the combination's constituents were observed in England or Scotland. Changes were rare in France.
CONCLUSIONS: The findings highlight inconsistencies in patient access to oncology combination therapies across Europe. Divergent HTA and pricing decisions contribute to variable access, underscoring the need for more harmonized processes ensuring equitable patient benefit from innovative therapies.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR138
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Approval & Labeling, Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
Oncology