How can pharma achieve earlier biologic intervention?
Before breath is lost: Earlier introduction of biologics and inflammatory control preserve patient tissue health and long-term outcomes across respiratory conditions.
Hurdle: Not only do current bio-eligibility criteria limit use, earlier biologic initiation is economically challenging without price reform: Patients must “fail” multiple therapies or accumulate exacerbations before qualifying for biologics use, despite biomarker and clinical trajectory indicating impending irreversible tissue loss.
Solution: Prehab instead of rehab: shift toward biomarker-driven risk stratification over retrospective exacerbation counts, leveraging earlier identification of high-risk inflammatory signatures to align high-risk patients with earlier biologic treatment.
Current Landscape:
- GOLD 2026 COPD treatment guidelines advise introduction of biologics after 2 moderate or 1 severe exacerbation, yet at this intervention point, typical patients are operating at 60% lung function [GOLD Grade 2].
- Recent discussions at the GOLD 2025 Conference pushed for biologic introduction after only 1 moderate exacerbation; patients with shorter disease duration and preserved lung function at the time of biologic initiation respond better, exhibiting improved symptom control, enhanced lung function, fewer exacerbations, and higher chance of achieving remission.
- The majority of COPD patients experience <1 moderate exacerbation, and are successfully and cost effectively controlled with cheaper bronchodilators and LAMA/LABA therapies, lowering the economic burden of COPD care at a population level.
- In the US, a typical COPD patient costs payers $10k–$15k per year on standard inhaled therapy and exacerbation management, by contrast, a biologic could cost $50k+ per year.
- Even if biologics reduced exacerbations by ~30%, this would only save $1,500–$2,000 annually in hospital costs, falling far short of the $40k+ price gap; at today’s prices, a biologic would need to prevent multiple hospitalizations every year to break even, a bar no COPD drug has yet met.
Paradigm shift:
- Despite supportive biology and HCP consensus, adoption of first-line biologics is constrained by the absence of validated biomarkers that reliably predict patient risk independently of adherence and comorbidities; paediatric data, composite biomarker panels and disease stability endpoints can move the needle in patient risk stratification.
- Most patients are managed cheaply but decline steadily, as total lifetime cost continues to rise despite “cost-effective” short-term decisions: Step-down-early-intervention payment frameworks would enable payers to test early value without committing to population-wide first-line use.
Until respiratory care moves from retrospective eligibility to prospective risk management, biologics will continue to be evaluated on costs incurred too late to reflect their true preventive value.
Words by Jessica Chadwick