NCPE Director Opposes Early Drug Access, Citing Cost and Efficacy Concerns
NCPE Director Professor Michael Barry opposes early access to unassessed high-cost drugs, particularly for rare diseases, citing concerns about efficacy and budget impact. He estimates early access could add billions to the drug budget, emphasizing that most delays stem from the pharmaceutical industry. A review of Ireland's drug approval process is expected by year-end.
Professor Michael Barry, Director of the National Centre for Pharmacoeconomics (NCPE), opposes early access to medicines, especially for rare diseases, if they are not first assessed for value. He argues that high-cost drugs with significant budget impact, like those for rare diseases, must be evaluated for cost-effectiveness.
Barry noted that assessments of drugs for rare illnesses this year showed none improved overall survival, with only a 16% improvement in quality of life. He estimates early access could add €1 billion to the drugs budget in five years and €2 billion in eight years. For cancer drugs, early access could increase the budget by €1 billion by year three, €2 billion by year four, and €3.5 billion by year five.
He clarified that early access means immediate availability upon pricing and reimbursement application. Barry would only support early access for drugs with proven overall survival benefits. He also stated that most delays in drug access are due to the pharmaceutical industry, citing data where 706 of 871 days for rare disease drug determination related to pharma companies, versus 151 days for assessment.
Minister for Health Jennifer Carroll MacNeill expects a comprehensive review of Ireland's drug approval process by year-end. Barry believes pharmaceutical companies need to present drugs sooner and be more agile. Regarding Mounjaro, a drug for overweight individuals or diabetics, Barry expects it to be deemed cost-effective due to a significant price reduction, but still anticipates a €2 billion-€3 billion expenditure over five years.