ANTICIPATING THE VALUE- AND PRICE-DETERMINATION CHALLENGE OF GLP-1 RA INDICATION EXPANSION ACROSS HETEROGENEOUS THERAPEUTIC AREAS: LESSONS FROM PD-1/PD-L1 AND TNF-α INHIBITORS INDICATION EXPANSION
Author(s)
Chiraz Hicheri, BioE1, Hend Jedidi, DMD1, Aurélie Millier, PhD2, Aleksandra Caban, PharmD3, Mondher Toumi, MSc, PhD, MD4, Lylia Chachoua, PharmD, PhD2.
1Clever-Access, Tunis, Tunisia, 2Clever-Access, Paris, France, 3Clever-Access, Cracow, Poland, 4Aix-Marseille University, Marseille, France.
1Clever-Access, Tunis, Tunisia, 2Clever-Access, Paris, France, 3Clever-Access, Cracow, Poland, 4Aix-Marseille University, Marseille, France.
OBJECTIVES: GLP-1 receptor agonists (GLP-1RAs) are expanding beyond diabetes and obesity into new diseases (CVD, CKD, MASH, OSA, and possibly brain, mental-health and addiction disorders) with very different, hard-to-compare outcomes. Using PD-1/PD-L1 inhibitors and TNF-α Inhibitors (adalimumab) as past examples, we examined the value and pricing challenges multi-indication GLP-1RAs may face, including after patent expiry (loss of exclusivity, LoE).
METHODS: We reviewed how HTA bodies in France (HAS), Germany (G-BA/IQWiG) and England (NICE) assessed each new indication of PD-1/PD-L1 inhibitors (pembrolizumab, nivolumab), whose cancer indications share one outcome (survival), and adalimumab, used across four specialties with very different outcomes and biosimilar competition after patent loss.
RESULTS: HTA bodies assessed each new indication separately, without carrying over earlier ratings. Clinically-rated systems (France, Germany) score value per indication, while England's QALY-based system can place all indications on one cost-per-QALY scale. The same drug often received different ratings across indications, and even across patient subgroups: under Germany's AMNOG, pembrolizumab was rated 'major added benefit' in one cancer type but 'not proven' in another, and nivolumab was 'considerable' in one tumour subgroup but 'not proven' in another. Adalimumab was judged on a different outcome in each disease (PASI for psoriasis, CDAI for Crohn's, ACR for arthritis, Mayo for colitis), so its indications could not be compared on a single scale. Official list prices changed little; value was managed through confidential discounts. After patent loss, adalimumab biosimilars cut net prices by up to about 80%.
CONCLUSIONS: Even with one shared outcome (survival), value was judged per indication; for GLP-1RAs, which lack one and rely on surrogate measures, the problem will likely be greater. After patent loss, a cheaper older GLP-1 should replace a costly new one only if it works as well in that disease; otherwise publicly funded head-to-head trials (as with bevacizumab/ranibizumab) and biosimilar competition will cut prices.
METHODS: We reviewed how HTA bodies in France (HAS), Germany (G-BA/IQWiG) and England (NICE) assessed each new indication of PD-1/PD-L1 inhibitors (pembrolizumab, nivolumab), whose cancer indications share one outcome (survival), and adalimumab, used across four specialties with very different outcomes and biosimilar competition after patent loss.
RESULTS: HTA bodies assessed each new indication separately, without carrying over earlier ratings. Clinically-rated systems (France, Germany) score value per indication, while England's QALY-based system can place all indications on one cost-per-QALY scale. The same drug often received different ratings across indications, and even across patient subgroups: under Germany's AMNOG, pembrolizumab was rated 'major added benefit' in one cancer type but 'not proven' in another, and nivolumab was 'considerable' in one tumour subgroup but 'not proven' in another. Adalimumab was judged on a different outcome in each disease (PASI for psoriasis, CDAI for Crohn's, ACR for arthritis, Mayo for colitis), so its indications could not be compared on a single scale. Official list prices changed little; value was managed through confidential discounts. After patent loss, adalimumab biosimilars cut net prices by up to about 80%.
CONCLUSIONS: Even with one shared outcome (survival), value was judged per indication; for GLP-1RAs, which lack one and rely on surrogate measures, the problem will likely be greater. After patent loss, a cheaper older GLP-1 should replace a costly new one only if it works as well in that disease; otherwise publicly funded head-to-head trials (as with bevacizumab/ranibizumab) and biosimilar competition will cut prices.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA3
Topic
Clinical Outcomes, Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), Diabetes/Endocrine/Metabolic Disorders (including obesity), Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)