Sweden’s pricing and reimbursement body has responded to the EFPIA WAIT Indicator debate by setting out why access to effective medicines cannot be judged by national reimbursement status alone.
Sweden’s Dental and Pharmaceutical Benefits Agency has used the latest debate around the EFPIA WAIT Indicator to explain how it interprets access to effective medicines. The agency presents access as a combination of national reimbursement decisions, time to first patient use, real-world uptake and regional reimbursement routes, rather than as a single measure based on whether a medicine is included in the national pharmaceutical benefits scheme.
The Dental and Pharmaceutical Benefits Agency (Tandvårds- och läkemedelsförmånsverket, TLV) published TLV fördjupar: Hur säkrar vi tillgång till effektiva läkemedel? (TLV in depth: How do we secure access to effective medicines?) on 20 May. Anna Alassaad, TLV’s chief strategist, has commented that international comparisons give different results depending on the methodology used.
According to TLV, Sweden is around the EU average and broadly in line with other Nordic countries when access is measured by whether new medicines are included in the national pharmaceutical benefits scheme. The agency also points to other analyses showing high use in Sweden of medicines that represent major medical advances.
However, TLV says national reimbursement status captures only part of access. The agency is therefore widening how it follows availability by looking at real-world uptake, time to first patient use, and other routes beyond the national decision by which products reach patients, including regional reimbursement decisions. It also wants to understand more about medicines that are not submitted for national reimbursement.
The commentary places the access debate within TLV’s value-based framework. TLV says newness is not enough: a medicine must add medical value compared with existing treatment, and its cost must be weighed against other healthcare activity. The agency also links difficult access decisions to rising prices and clinical uncertainty, particularly for some cancer medicines.
TLV’s commentary adds a useful national HTA perspective to the broader European access debate. It treats access as a sequence from reimbursement assessment to clinical uptake, rather than as a single listing event. That framing makes room for questions that availability rankings cannot easily answer: how quickly medicines reach patients, whether uptake varies by region, and why some products do not enter the Swedish access pathway at all.
Source: Dental and Pharmaceutical Benefits Agency (TLV)
Link: TLV fördjupar: Hur säkrar vi tillgång till effektiva läkemedel? (TLV in depth: How do we secure access to effective medicines)
Date: 20 May 2026
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