Demand for pharmaceuticals is growing in Sweden and healthcare expenditure is increasing, with GlobalData expecting 2.9% growth in 2023 and a 4.4% rise the following year, reaching SEK684.9 billion by 2024.
Further analysis reveals the demographic profile to be “rapidly ageing”, with one of the largest elderly populations in Europe. In addition, its high urbanisation and general economic success, boasting one of the highest GDPs in Europe, make Sweden a strong market for pharmaceuticals.
A quick look at sales confirms this. According to forecasts published by the Swedish National Board of Health and Welfare (Socialstyrelsen) in June, average annual sales for reimbursed medicines in the country are expected to rise by 5.65% a year between 2023 and 2026. According to Socialstyrelsen, hospital medicines will witness particularly steep growth, with sales rising 9.3% by 2026.
Commercialising medicines in Sweden is not without its challenges for marketing authorisation holders. While based on universal coverage, the healthcare system is highly decentralised. It is managed by 21 county councils, which have a high degree of autonomy over the hospitals and primary care centres, including pricing and reimbursement decisions for new health technologies.
The Swedish Dental and Pharmaceutical Benefits Agency (TLV) performs health technology assessments to evaluate the benefits of new medicines against requested prices and determine whether the products should be reimbursed. However, a successful result from the TLV does not guarantee a reimbursement from a council.
Moreover, the TLV’s requirements are becoming increasingly stringent and have been motivated by cost-saving efforts for many years. In 2002, Sweden overhauled its entire pricing and reimbursement system, abandoning the reference price scheme it had been using since 1993 and introducing a value-based system based on cost-effectiveness analysis. Automatic substitution for the lowest-cost generic equivalent also became mandatory.
A ceiling-price system has been in place since 2011 for all substitutable medicines, with caps usually set at 35% of the highest price in the substitution group. In addition, price reductions of 7.5% are in place for medicines that have been on the market for 15 years.
Meanwhile, managed entry agreements have become an increasingly important part of the government’s strategy for lowering the budgetary impact of new medicines.
In focus: Managed entry agreements
Managed entry agreements (MEA), also known as risk-sharing schemes or patient access schemes, are made between marketing authorisation holders and payers to reduce uncertainty surrounding innovative new treatments. MEAs can be both financially based and outcomes based.
According to Pontus Johansson, senior economist at the TLV, “managed entry agreements provide the opportunity to cope with uncertainties when bringing new, innovative and effective pharmaceuticals to patients faster and more equally”.
Sweden introduced finance-based MEAs, based on rebates, as a tool for facilitating access to high-cost medicines and managing uncertainty in 2014. Recent years have seen the government scale up the implementation of these measures. As of June, a total of 57 medicines were subject to risk-sharing agreements in Sweden, scooping 10% of market sales. These include oncology drugs as well as many PCSK9 inhibitors, JAK inhibitors, hepatitis C and haemophilia A and B treatments.
In a recent report, the TLV forecasts repayment obligations for outpatient medicines to total SEK3.15 billion ($289 million) in 2023, representing a 27% increase on the previous year. Should this prove true, the annual savings from MEAs will overtake the previous peak of SEK3.08 billion in 2019.
While the refunds generated from MEAs have resulted in significant cost savings for Sweden’s county councils, they have also been advantageous for marketing authorisation holders by enabling the reimbursement of medicines that may otherwise have been rejected due to evidentiary uncertainties. Orphan medicines, for example, are natural candidates for risk-sharing agreements due to target population demographics.
So, what’s next for market access in Sweden? In 2023, a key focus is the creation of new frameworks for advanced therapy medicinal products such as cell and gene therapies.
In June, GlobalData reported that the government had appointed the TLV to develop a new outcomes-based system for conducting health economic evaluations of these medicines. The agency’s work will involve the use of simulation modelling to investigate how various methods could address the risks and uncertainties posed by advanced therapy medicinal products in order to determine whether the cost is reasonable against the claimed benefits.
Separately, the government is investigating the possibility of including the impact that a new medicine can have on the quality of life of a patient’s relatives within its health economic evaluations.
Gaining entry to the market
To access the Swedish market and launch a commercially successful medicine, it is essential to gain a thorough understanding of the country’s value-based pricing models.
Working with a dedicated service provider who can demonstrate in-depth expertise of the market access landscape in the Nordics and who has the ability to provide a wide range of complementary solutions to ensure your drug’s success – including commercial strategy, medical affairs, supply chain management, quality and technical compliance – can be instrumental.
By forging true partnerships with pharmaceutical companies, Copenhagen-based Abacus Medicine Pharma Services delivers innovative and unique end-to-end solutions to support the launch of speciality medicines in Europe. The company has a particularly strong track record with commercialising and distributing drugs in the Nordics and Benelux markets.
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