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 Availability problems arise when new products are not launched onto the Swedish market and when existing products are withdrawn.
Preliminary study on a reimbursement model to strengthen access to prioritised older antibiotics
At the end of June 2023, the Public Health Agency of Sweden was commissioned by the Government to carry out a preliminary study of a new reimbursement model where pharmaceutical companies receive compensation for providing a buffer stock of certain prioritised off-patent antibiotics. The assignment was reported to the Government at the turn of the year.
The agency has drawn up criteria and guidelines for the reimbursement model and identified prioritised off-patent antibiotics that are proposed to be covered by the model. The methodology for selection is based on a priority list of medically important antibiotics with a risk of insufficient availability that the agency previously published. From this list, a number of delineations were made, where, for example, older antibiotics that are recommended as first line treatment and are not interchangeable were prioritised.
According to this model, a compensation is offered to the pharmaceutical companies, on condition that they meet certain requirements such as the storage of a central buffer stock. The purpose is to give the companies a financial incentive to keep the products on the Swedish market and to prevent shortage situations. The Public Health Agency of Swedens’ recommendation is that the proposed reimbursement model should be tested and implemented in a pilot study as soon as possible.
Read the report (in Swedish with English summary): En förstudie om en ny ersättningsmodell för att tillhandahålla ett buffertlager av vissa antibiotikaprodukter (folkhalsomyndigheten.se)
Commissions aimed at increasing availability to new medically important antibiotics through the previously pilot-tested reimbursement model
At the end of May 2023, the Public Health Agency of Sweden was comissioned by the government to continue to strengthen the availability of certain antibiotics of particular medical value, to ensure access to treatment alternatives for critically ill patients with difficult-to-treat bacterial infections. The assignment was finalised at the end of the year.
The work was based on the experiences from the new model for guaranteed compensation that was previously developed and pilot tested by the agency.
The reimbursement model for new antibiotics was developed prior to a procurement within this assignment based on experiences and conclusions from the previously completed pilot study.
The model for guaranteed reimbursement was selectively updated based on experiences from the previous pilot study.
The procurement process resulted in agreements with two pharmaceutical companies for two antibiotic products that met the set requirements: Recarbrio (imipenem, cilastatin and relebactam) and Zavicefta (avibactam and ceftazidime). The agreements have now been extended until 31 December 2024.
On January 22, 2024, the agency received another assignment to continue the work of strengthening the availability of certain antibiotics of particular medical value. The final report is to be submitted to the Swedish government by January 31, 2025.
Read the report (in Swedish with English summary): Tillgänglighet till vissa antibiotika – Fortsatta erfarenheter från en tidigare pilottestad ersättningsmodell (folkhalsomyndigheten.se)
Results from the pilot study
The Government commissioned the Public Health Agency of Sweden (PHAS) in 2018 to propose and pilot a new model for keeping approved antibiotics of special medical value available on the Swedish market. The aim of the model was 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 reimbursement model implies that the state guarantees a minimum annual revenue to the pharmaceutical company. In return, the company should stock-pile and deliver a certain amount of antibiotics within specified time limits.
The pilot study ran from 15 July 2020 to 31 December 2022. The reimbursement was partially decoupled from sales revenue. The regions paid for the medicines they used and deliveries of purchased products through customary distribution routes as usual. The evaluation of the study showed that the reimbursement model was appropriate and effective to ensure the availability of certain antibiotics. Through it, Sweden gained access to several new antibiotics, also earlier than other European countries.
The Public Health Agency of Sweden considers that a model with partially de-linked compensation, similar to the one tested in the pilot study, can ensure the availability of particularly medically important antibiotics in an effective and efficient manner and that model should be made permanent to ensure the availability of antibiotics of particular medical importance. This should be combined with regular auditing of medical needs and with surveillance to ensure responsible use of these products.
For sustainable access to antibiotics, measures along the entire chain are needed, from models to stimulate research and early development to models to launch and maintain products in markets.
On May 31, 2023, the final results from the pilot study were reported to the Swedish government.
Read the final reports (in two parts, in Swedish with English summaries):
The information sheet, "Availability to antibiotics of particular importance" presents a brief final report for the government assignment to evaluate a reimbursement model that can be used in procurement of availability of certain antibiotics.
Proposals for measures to strengthen access to off-patent antibiotics
In September 2021, the Public Health Agency, the Dental and Pharmaceutical Benefits Agency, TLV, and the Medical Products Agency received a joint assignment from the government to map the market and identify efforts to strengthen access to off-patent antibiotics. The aim was that the healthcare system should have continued access to a wide range of effective older antibiotics to treat infections, while maintaining a low resistance development. In the final report of the assignment, the three authorities propose measures in various areas to strengthen access to off-patent antibiotics such as increased ceiling prices, an in-depth investigation and pilot testing of a new compensation model where pharmaceutical companies receive a fixed annual compensation for providing a buffer stock of identified antibiotics, as well as removal of the annual fee for antibiotics and further investigation of the possibility of common packaging in the Nordic countries.
The assignment was reported to the government on November 11, 2022.
Final report of the governmental assignment (In Swedish):
The sheet "Strengthening access to off-patent antibiotics" briefly presents the final report from three Swedish agencies of the government assignment Strengthening availability to off-patent antibiotics.
Updated priority list for off-patent medically important antibiotics at risk of insufficient availability
The Public Health Agency has published a new priority list within the framework of the government's mission To strengthen access to off-patent antibiotics, in collaboration with PLATINEA and an advisory reference group. A list of antibiotic products that were judged to be at risk for having a lack of availability in Sweden was evaluated with regard to clinical value and the estimated size of consequences for healthcare if the product were not available. This list includes currently marketed off-patent antibiotic products that in 2021 sold for less than SEK 3 million or that have had repeated longer shortages. In contrast to previous corresponding priority lists from 2017 and 2021, antibiotic products that are not marketed in Sweden but are often prescribed under license, or are widely used in Europe have also been valued and prioritized.
- Priority list of off-patent antibiotic products at risk for lack of availability in Sweden
- PLATINEA (platinea.se)
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.
More information:
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.
Availability of antibiotics - Reporting of Government commission (folkhalsomyndigheten.se)
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.