Results Imminent From Sweden’s Pilot Of Novel Antibiotic Reimbursement Model
Executive Summary
If successful, a new Swedish model for reimbursing antibiotics that involves guaranteed minimum annual revenues for companies could be tested on other kinds of products.
A Swedish pilot study that has been testing a new reimbursement model intended to encourage the marketing of new antibiotics has been completed and a final report on the results is expected to be submitted to the country’s government next month.
The study, which is funded by the Public Health Agency of Sweden and the Swedish innovation agency Vinnova, is not intended to foster R&D into new antibiotics but rather to test a reimbursement model for specific existing products that involves guaranteed minimum annual revenues in return for supply commitments from the company concerned.
The results of the pilot have been under evaluation by the PHAS and external contracted parties since it was completed in July this year. The evaluation will take account of factors such as the economic consequences for the health care system and pharmaceutical companies and the antibiotic procurement processes.
“Indicators closely monitored throughout the study period are sales data, expenditure and storage status, time from order to hospital delivery, clinical use and patient outcomes of the contracted antibiotics, the PHAS said. Also taken into account is the time from a product's marketing approval by the European Commission to its launch in Sweden.
The PHAS said that if the study outcomes were positive, it would look into whether the model could be applied to different antibiotics or other kinds of products.
Details of the pilot study are contained in a new report on AMR by the International Coalition of Medicines Regulatory Authorities, which was published on 21 November. The report includes case studies on best practices from different countries that were developed in line with the “One Health” approach.
'Special Medical Value' Products
The Swedish pilot study, which began in July 2020, is part of efforts to tackle the growing problem of antimicrobial resistance (AMR). It was prompted by the reluctance of companies to market their new antibiotics in Sweden because of the small market size, low levels of antibiotic resistance and well established antibiotic stewardship policies, according to the agency.
“Patient access to lifesaving antibiotics is crucial in all countries, even those considered as unattractive markets to pharmaceutical companies," the PHAS pointed out. "Therefore, there is an obvious societal need for action to address this gap in access to lifesaving antibiotics in Sweden.”
The design of the pilot took account of legislative aspects such as procurement rules, antitrust rules and state aid. Eligible pharma firms were invited to a meeting to provide input and feedback on the project.
Products chosen had to meet defined requirements for “special medical value” and be at risk of lack of availability in Sweden. Annual sales of each product must not have exceeded SEK4m ($3.8m) in 2019, and the antibiotics must have had an antibacterial spectrum with good activity against multiresistant enterobacterial strains.
The antibiotics must have been approved for treatment as per the World Health Organization’s critical priority pathogen list for at least two of the following indications: complicated intra-abdominal infection, complicated urinary tract infection including acute pyelonephritis, hospital acquired pneumonia, or infections caused by aerobic Gram-negative organisms in patients with limited treatment options.
‘Partially Delinked Model’
The approach used in the pilot is a “partially delinked model” developed by the PHAS that is based on a minimum annual guaranteed revenue for the company on its antibiotic. In return, the company ensures that the product is readily available – ie, it can be delivered to hospitals within 24 hours – and that the company has a “security stock” of the product in Sweden.
During the study, the Swedish regions continued to purchase the new products under contracts signed at national level. “If the revenue from actual sales from the regions is lower than the guaranteed income for a given year, the difference will be paid from the national level at the end of the year to the relevant supplier,” the PHAS said.
“If, on the other hand, revenue from actual sales exceeds the guaranteed level for a given year, the company receives an additional 10% of the value of the guaranteed annual compensation for fulfilling the availability requirements.”
Ideas For Improvement
The PHAS said it conducted follow-up research during the pilot study to gather more information and to “hopefully instil ideas for improvement during the ongoing study.”
Four sub-projects were also pursued. One, involving the Swedish pharmaceutical industry association LIF, was intended to gather information on how the pilot study and the reimbursement model were perceived by the companies involved. The companies were also asked to provide information such as drug prices, stock values and supplies.
Other sub-projects covered topics such as the costs of the reimbursement model, whether the pilot had improved the availability of each antibiotic involved (together with any impact on sales of competing products), and how the products were selected.
Earlier this year it was announced that Shionogi and Pfizer had signed agreements with the National Health Service in England on an innovative subscription model for their respective antibodies, Fetcroja and Zavicefta, which was heralded as a "template for other countries to follow." (Also see "England: Shionogi And Pfizer Ink ‘World First’ Payment Model Deal For Antibiotics" - Pink Sheet, 16 Jun, 2022.)