Evolution of National Price Negotiations for Pharmacy/Retail Medicines (Triparty Negotiations) in Sweden and Implications for Access
Author(s)
Anja Wikström, MSc1, Achmet Ali Tsaous, MSc2, Thomas Johansson, Sr., Other1, Ebba Gregory, MSc, PhD1.
1Bristol Myers Squibb (BMS), Solna, Sweden, 2Bristol Myers Squibb (BMS), Helsinki, Finland.
1Bristol Myers Squibb (BMS), Solna, Sweden, 2Bristol Myers Squibb (BMS), Helsinki, Finland.
OBJECTIVES: Sweden has two routes to reimbursement which rely on a health economic evaluation by TLV, one for pharmacy/retail medicines and the other for hospital medicines. According to the latest WAIT report, 50% of new treatments are available in Sweden compared with 46% in the EU. With global price strategies, net prices are often required to reach cost-effectiveness. Negotiations for a confidential net price are an exception for new pharmacy/retail medicines, and standard for hospital medicines. We aimed to investigate how triparty negotiations have evolved from 2014-2024.
METHODS: Information on agreements, number of assessments, type of decision (restriction, rejection, withdrawal, general reimbursement) and time to TLV decision from marketing authorization was extracted from annual, prognostic and assessment reports from TLV (2014-2024).
RESULTS: The first negotiations were initiated in 2014. Initially, the number of agreements increased rapidly following reviews of already reimbursed medicines aiming at reducing costs. In 2017, 22 agreements were effective, which doubled by the end of 2018. An increasing number of agreements have expired, often requiring renegotiations. In 2020 alone, since several agreements were soon to expire, reviews were initiated for three therapy areas including 23 treatments. During 2019-2024, TLV initiated 48, 38, 85, 87, 78 and 53 assessments of new products (or formulations), for which 15(31%), 7(18%), 11(13%), 9(10%), 4(5%) and 9(17%) negotiations were initiated and 8(17%), 1(3%), 5(6%), 6(7%), 3(4%) and 0(0%) reached an agreement. Each year 29-55% of the submissions were withdrawn. For medicines with marketing authorization 2021-2023, and a positive TLV decision by January 2025, the time to decision was 4 months longer (median) for medicines with a triparty agreement.
CONCLUSIONS: Dependence on triparty negotiations presents a bottleneck to access while increasing the workload for the regions. A simplified process to incorporate net prices might solve this challenge and initiatives by TLV, the regions and LIF are ongoing.
METHODS: Information on agreements, number of assessments, type of decision (restriction, rejection, withdrawal, general reimbursement) and time to TLV decision from marketing authorization was extracted from annual, prognostic and assessment reports from TLV (2014-2024).
RESULTS: The first negotiations were initiated in 2014. Initially, the number of agreements increased rapidly following reviews of already reimbursed medicines aiming at reducing costs. In 2017, 22 agreements were effective, which doubled by the end of 2018. An increasing number of agreements have expired, often requiring renegotiations. In 2020 alone, since several agreements were soon to expire, reviews were initiated for three therapy areas including 23 treatments. During 2019-2024, TLV initiated 48, 38, 85, 87, 78 and 53 assessments of new products (or formulations), for which 15(31%), 7(18%), 11(13%), 9(10%), 4(5%) and 9(17%) negotiations were initiated and 8(17%), 1(3%), 5(6%), 6(7%), 3(4%) and 0(0%) reached an agreement. Each year 29-55% of the submissions were withdrawn. For medicines with marketing authorization 2021-2023, and a positive TLV decision by January 2025, the time to decision was 4 months longer (median) for medicines with a triparty agreement.
CONCLUSIONS: Dependence on triparty negotiations presents a bottleneck to access while increasing the workload for the regions. A simplified process to incorporate net prices might solve this challenge and initiatives by TLV, the regions and LIF are ongoing.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR81
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Procurement Systems, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas