Bringing any new drug to market is a time consuming, costly and high-risk endeavour that typically takes 10 years, at an average development cost of about $1.3 billion U.S.
Even then, only one in five drugs tested in people is approved and reaches the market. For antibiotics, the economic considerations are more challenging than for many other medical areas. In addition to the unique scientific and regulatory challenges in antibiotic development, pricing and reimbursement do not reflect the true value of these life-saving drugs.
As a consequence, a small minority of innovative pharmaceutical companies have maintained their R&D investment and today’s antibiotic pipeline is insufficient to meet the global need.
In my view, there are several approaches that will help attract greater investment in antibiotic innovation and deliver new treatments to patients:
Multiple but targeted policies:
A combination of “push” (e.g., early research subsidies) and “pull” incentives (market or value-based rewards) will be required to mobilise investment and stimulate sustainable levels of antibiotic innovation. These approaches should prioritise development of medicines targeting serious or life-threatening infections that cannot be treated reliably with existing medicines.
Development and regulatory:
There is a need for legislation and regulation to enable regulatory authorities to streamline, accelerate and cover the cost of clinical trials required for regulatory review and approval of antibiotics, and for new indications for existing antibiotics to address serious infections. Harmonising clinical trial guidance across regulatory agencies would make registration trials both faster and more feasible.
Market and value-based approaches serve as powerful and predictable incentives for companies. There is advocacy for policies to ensure antibiotic reimbursement better reflects the life-saving and societal value of antibiotics targeting serious infections. Reimbursement changes would need to be coupled with stewardship measures that ensure that patients receive the optimal treatment for their individual situations while helping manage antibiotic resistance. There are efforts to reimburse antibiotics separately from bundled hospital payments based on patient diagnoses as a way to ensure that their use is driven only by clinical considerations, not economic considerations.
Addressing antibiotic resistance requires a comprehensive, global approach, including multi-sector incentives and efforts. Governments need to address challenges that limit the development of new antibiotics, and also need to ensure reimbursement for appropriate antibiotic use through strategies that recognise the diversity of national regulatory systems and specific patient circumstances. Additionally, strong, locally-driven stewardship, which considers the factors impeding appropriate use of antibiotics in different settings, is essential to slow resistance and extend the useful lifespan of these critical medicines.