The Dental and Pharmaceutical Benefits Agency (TLV) has indicated that it will implement measures to “strengthen the price dynamics in the pharmaceutical market” with the aim of generating savings of at least SEK800 million over four years (calculated from 1 January 2021).
According to the TLV, “The prices of medicines that have been on the market between 5 and 15 years are high compared to other European countries and are also relatively static and do not change over time. TLV believes that the savings can best be achieved through strengthened price dynamics for medicines and wants to contribute to creating favourable conditions for price competition. The authority therefore wants to further develop and strengthen collaboration with both regions and companies, including through tripartite discussions”.
To bolster “price dynamics”, the TLV is proposing to:
- “Further develop […] follow-up of drugs and reconsiderations for different groups of drugs” to ensure greater transparency and predictability in the assessments and measures pursued by the TLV.
- Clarify for the regions and pharmaceutical companies the pharmaceutical areas where TLV sees that there is the potential for more effective competition and improved price dynamics.
- Strengthen the incentives for the regions to carry out tripartite consultations (between the TLV, regions and manufacturer) and sign side agreements (the collective name for rebate agreements – the TLV notes that there are 47 side agreements in place for medicines as at 1 January 2022).
- Review the possibility of reforming the current system of price reductions for medicines older than 15 years.
The TLV goes on to note that outcome-based payment models should be tested for ATMPs, and that it sees a need to find ways to promote use of biosimilars, including by introducing a requirement for a specific price differential between biosimilars and the original reference biological drug at the time of admission to reimbursement and via substitution by pharmacists.
www.tlv.se, “TLV genomför och föreslår nya åtgärder för ökad prisdynamik på läkemedelsmarknaden”, 16th June 2022
www.tlv.se, “Uppföljning av läkemedelskostnader”, June 2022
www.tlv.se, “Långsiktigt hållbar finansiering av läkemedel”, June 2022