The TLV held a webinar on its new regulations, general advice and updated handbook, providing a timely opportunity to revisit several recent changes.
For those of us supporting reimbursement applications for new medicines in Sweden, several points are particularly worth keeping in mind:
🔹 Incidence and prevalence need greater visibility.
TLV is asking companies to report these for the full indication and, where relevant, for the proposed restricted population.
🔹 Productivity gains may be included in the health economic analysis.
TLV opens for including the value of increased productivity, provided the societal benefit is sufficiently immediate and lasting (“snar och bestående”).
🔹 TLV encourages use of its new health economic analysis template.
The template also reflects areas where TLV is requesting greater clarity from companies, including:
▪️ prevalence and incidence
▪️ the rationale for any proposed reimbursement restriction
▪️ a clear description of the restricted population
▪️ early notice whether a three-party negotiation is requested
The new regulations, general guidelines and the updated company handbook also covers changes relevant to other types of reimbursement cases, including simplified assessment of established active substances and criteria for price increases where generic competition exists.
For market access teams, the direction is clear: assumptions around population, restrictions and process choices need to be explicit early in the submission.
Which of these changes do you expect will have the greatest practical impact on future Swedish reimbursement applications?
