sweden market access
Insider Insights

What has occurred in the past year in the Swedish market access environment? 


Last week the TLV unveiled its annual report which offered some interesting insights into several trends and projects that have dominated the past year in the Swedish pharmaceutical space.  

The agency noted that applications for new drugs were increasingly complex and associated with higher prices, a trend has also emerged of more companies applying for higher prices for pharmaceuticals that are already included in the drug benefits scheme. To tackle this the TLV has initiated a series of development projects to develop their handling and evaluation methods, especially for rare diseases and for advanced therapy medicinal products (ATMPs). 

Managed entry agreements, known in Sweden as side agreements, played a key role in cost saving for the TLV and generated an estimated €216 million in savings during 2022. They were also an important tool in gaining access to innovative treatments, with one such agreement playing a decisive role in securing reimbursement for the cystic fibrosis treatment Kaftrio.  

The TLV is also investigating several procedures in the HTA process, among them is the question of whether to include the impact on a relatives’ quality of life in a health economic assessment. It was decided that it may be reasonable in special cases, however, the TLV will need to continue to develop criteria for when and how it should be applied. Secondly, the TLV also proposes an investigation into the duration of effect for ATMPs to reduce uncertainties in health economic evaluations. An investigation into the requirements for robust processes for the evaluation, pricing and follow-up of combination medicines in oncology has also been proposed. All these questions will be addressed within a new government assignment that the LV has received.  


  1. Annual Report 2022: Development has characterized the agency’s work – Dental and Pharmaceutical Benefits Agency TLV 
  1. arsredovisning_tlv_2022.pdf 

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