Monday, July 15, 2024

Antibiotics Research Revolutionized by UK’s Groundbreaking Subscription Funding Model

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The UK has introduced a groundbreaking subscription-style funding model for antibiotics, aiming to solve the research funding crisis for new antimicrobials. This model, based on the inherent value of next-generation antimicrobial candidates to the healthcare system rather than sales volume, has the potential to revolutionize the field. On 8 May 2024, the UK became the first country to implement this novel funding approach formally.

Antimicrobial resistance (AMR) presents a significant global health threat, making the development of new antibiotics crucial. However, the high costs and limited financial returns due to rapid resistance development have stymied research efforts. The UK’s subscription model, inspired by a “Netflix-style” payment system, addresses these challenges by paying developers based on the value their drugs bring to the National Health Service (NHS), independent of sales volume. This approach is under consideration in Sweden and the US, with potential for global adoption.

The UK’s model was piloted from 2019 to 2024, focusing on sustainable development and funding for novel antimicrobial candidates against priority pathogens. Payments are made based on the product’s potential value to the NHS, ensuring continuous support for essential drugs even if their market demand fluctuates. This model is designed to stimulate innovation and ensure the availability of effective treatments for serious infections.

UK Government and NHS Launch Pilot for Subscription-Style Antibiotics Funding Model

The UK Government, the National Institute of Health and Care Excellence (NICE), and NHS England launched a pilot trial to evaluate the subscription-style scheme. The trial aimed to fund promising antimicrobial candidates tailored for last-line use against priority pathogens. The first two candidates, chosen through a tendering process, were Fetcroja (cefiderocol) from Shionogi and Zavicefta (avibactam + ceftazidime) from Pfizer. These drugs were selected based on their novelty, supply assurance, and stewardship commitments.

Following modified health technology assessments by NICE, focusing on clinical and economic value, these drugs were recommended for treating severe Gram-negative bacterial infections. NHS England secured three-year contracts for these products, with options to extend up to ten years. Each product was assigned a preliminary maximum contract value of £10 million per year, ensuring developers receive consistent payments regardless of the volume supplied.

The UK Government approved the permanent implementation of the subscription-style funding model for antibiotics. The scheme now includes more than two drugs per year and provides flexibility for drugs already on the market or expected to be approved within 12 months. Contracts will last three years, with possible extensions of up to 15 years, covering the product’s exclusivity period. Products are assigned value bands initially, which can change based on periodic reviews of their continued value to the NHS.

Antibiotics

Sweden and US Explore Subscription Models to Boost Antibiotic R&D, Inspired by UK’s Success

Sweden and the US are also exploring similar models. Sweden’s incentivized payment model, initiated in 2020, focuses on existing at-risk antibiotics and plans to expand to new products. The US’s Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act is still under evaluation but aims to create subscription contracts for new antibiotics from a dedicated funding pool. These international efforts are closely watched, as their success could lead to broader global adoption.

The UK’s subscription model has been welcomed by the pharmaceutical industry, although there have been criticisms regarding funding levels. The Association for the British Pharmaceutical Industry (ABPI) expressed hope that this model will incentivize antimicrobial R&D by reducing financial risks and improving economic sustainability. However, a single-country model will have a limited impact on global antibiotic R&D and the AMR problem if it remains isolated. Therefore, the success of parallel schemes in Sweden and the US will be critical.

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The UK’s initiative represents a significant step towards sustainable antibiotic development. By decoupling revenue from sales volume, the model encourages the development of essential antimicrobials and ensures their availability. This approach can potentially address the global challenge of AMR by fostering innovation and providing a stable financial environment for developers.

Global Adoption Needed for UK’s Revolutionary Subscription Model to Combat Antimicrobial Resistance

For the subscription model to have a significant global impact, other countries must adopt similar schemes. The collaborative efforts in Sweden and the US are promising, but a broader international adoption is necessary. The success of the UK’s model could serve as a blueprint for other nations, promoting a coordinated effort to combat AMR and support antimicrobial innovation.

The potential for this model to become standard practice in the pharmaceutical industry is significant. By demonstrating the feasibility and benefits of the subscription approach, the UK is leading the way in rethinking how antibiotics are funded and developed. The model’s expansion and adaptation in different countries will be crucial in addressing the global AMR crisis.

The UK’s subscription model for antibiotic funding represents a revolutionary approach to addressing the challenges of antimicrobial development. By focusing on the value to the healthcare system rather than sales volume, this model incentivizes innovation and ensures the availability of essential treatments. The ongoing trials and potential global adoption of similar models could mark a turning point in the fight against AMR, providing a sustainable path forward for antibiotic research and development.

 

Resource: Pharmaceutical Technology, July 01, 2024

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