Availability of antibiotics
Antibiotics must be used responsibly and the availability of antibiotics of special medical value must be safeguarded. The Government has commissioned the Public Health Agency of Sweden (PHAS) to propose and pilot new models for keeping approved antibiotics available on the Swedish market.
Antibiotic resistance is a major and increasing problem, both globally and in Sweden, and there is a strong correlation between the use of antibiotics and the development of antibiotic resistance. Antibiotics can be considered a finite resource and few new antibiotic classes are being developed. Therefore, existing antibiotics must be used responsibly and the availability of both new and old antibiotics of special medical value must be safeguarded.
Sweden still has a relatively favourable position compared to many other countries, but the number of infection cases with multi-resistant bacteria is increasing. For these patients, the availability of a specific antibiotic may be crucial for the outcome.
Antibiotics are used in a relatively restrictive way in Sweden compared to many other countries. Consequently, some products face such low demand that there is a risk that pharmaceutical companies choose not to make them available on the Swedish market. Availability problems arise when new products are not launched onto the Swedish market and when existing products are withdrawn.
The Government has commissioned the Public Health Agency of Sweden (PHAS) to propose and pilot new models for keeping approved antibiotics available on the Swedish market. Here, we publish information about this project.
Agreements signed for a pilot study of a new reimbursement model
The Swedish Public Health Agency has now entered into an agreement with four pharmaceutical companies to test in a pilot study, whether a new reimbursement model can ensure the availability of particularly medically important antibiotics. In the agreements, the companies undertake, among other things, to guarantee through specified warehousing that Swedish healthcare has good and fast availability of the selected antibiotic products. In return, the company receives a guaranteed annual income per product. The regions prescribes and pay as usual for their use. The four companies that have entered into agreements with the Swedish Public Health Agency are MSD, Shionogi, Pharmaprim and Unimedic Pharma. Five antibiotics are included in the pilot study; Zerbaxa (ceftolozan-tazobactam), Recarbrio (imipenem-cilastatin-relebactam), Fetcroja (cefiderocol), Vaborem (meropenem-vaborbactam) and Fosfomycin infectopharm (fosfomycin).
Pilot study of a new reimbursement model
PHAS was in June 2018 commissioned by the Government to test a new reimbursement model to ensure availability of new antibiotics of special medical value. The aim of the model is to ensure access to antibiotics, so that the Swedish healthcare system will not risk being without active antibiotics for patients with infections that are particularly hard to treat.
The new reimbursement model implies that the state guarantees a minimum annual revenue to the pharmaceutical company. In return, the company delivers a certain amount of antibiotics within specified time limits. In the pilot, we will investigate whether the model is efficient and effective.
The project will run until 2022. The pilot study includes a public procurement process which is planned to be completed in spring 2020. The pilot is partly financed by Vinnova (The Swedish Innovation Agency). The goal of the project is to recommend to the Government whether, and in what way, the model should be implemented in Sweden.
The announcement of the procurement is scheduled for the end of the first quarter of 2020. The procurement will be announced the Swedish Visma TendSign system.
Proposed models for availability
In collaboration with the Dental and Pharmaceutical Benefits Agency (TLV), the PHAS was in June 2016 commissioned by the Government to propose one or several models to ensure the availability of both new antibiotics and old antibiotics, where national availability is insufficient. The suggested models will minimise the risk of resistance development while enabling the best possible care for patients with infections caused by multi-resistant bacteria.
The work focused on both new and old antibiotics of special medical value, where there is a risk of insufficient national availability. The suggested models include for example economic compensation, identification of antibiotics of special medical value or storage and distribution methods.
The commission was reported to the Ministry of Health and Social Affairs on 1 December 2017. Please see report: Availability of antibiotics. This report is a short summary of four in-depth interim reports which are published in Swedish.
Complementary Commission – Analysis of conditions for a pilot study of a model presented by the LIF
The Swedish Association of the Pharmaceutical Industry (LIF) has presented a new economic business model with the purpose of safeguarding access to new antibiotics in Sweden. The Public Health Agency of Sweden (PHAS) and The Dental and Pharmaceutical Benefits Agency (TLV) have been commissioned to evaluate the model, and they are also to evaluate the preconditions for a pilot study of the model proposed by the LIF. The primary focus of the commission will be on accessibility and not on incentives for research in order to develop new antibiotics.
The analysis is presented in a report (in Swedish) with a summary in English: Analys av förutsättningar för att testa en ny ersättningsmodell för antibiotika