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Press

1May 2026

Rare disease HTA: TLV accepts an ICER above 2 million SEK/QALY

TLV’s recent decision on Fabhalta provides further evidence of how Sweden applies higher acceptable ICERs in very rare conditions.

Fabhalta was assessed for a very rare, severe chronic kidney disease population. Following three-party negotiations, TLV’s base case, including the confidential agreement, resulted in:
➡️ ICER: 2,035,738 SEK/QALY
➡️ QALY gain: 3.91
➡️ Rarity index: 56–85
➡️ Outcome: reimbursement with restriction

You can read the official decision here

And the full HTA report here

Why is […]

29Apr 2026

TLV postpones guideline updates

The Swedish HTA agency TLV has announced changes to the timeline and content of its upcoming guidance on reimbursement and pricing of medicines.

Key points from the update:
📍The previously communicated timeline has been postponed. The revised guidance will enter into force on October 1, 2026
📍The original proposed model for systematic price reductions linked to sales volumes will not be included. Nonetheless, TLV states that sales volumes will be considered in […]

23Apr 2026

🟢Day 2- beyond pharmacoeconomics

Day 2 at SHEA highlighted a broader perspective: health economics extends well beyond traditional pharmacoeconomic frameworks.

Discussions included applications across:
📍social care alongside healthcare
📍the health economic value of green outdoor environments

Closer to our core areas, two themes stood out:
➡️ the continued importance of Nordic registries and their wide applicability
➡️ evolving methods to expand data inputs in health economic evaluations

A presentation by Professor Mikael Svensson also highlighted collaborative research efforts, including contributions […]

23Apr 2026

🔹SHEA Day 1 – Navigating HTA under pressure

Day 1 in Lund highlighted a clear direction: global policy shifts are increasingly shaping local HTA realities.

External changes, including US MFN policy, are already influencing the pharmaceutical landscape beyond their origin.
Less than a year on, the impact feels well embedded.

At the same time, innovation is shifting toward more specialised therapies.
This is adding pressure to value-based pricing frameworks and challenging established standards.

As highlighted by keynote speaker Amanda Cole, innovative payment […]