Sweden closes drug subsidy gap for children with rare swelling disorder

Children under 12 who need the 300 mg strength of Takhzyro for hereditary angioedema can now qualify for Sweden’s prescription subsidy, after the regulator removed an age cut-off that blocked access.

The TLV decision, announced on Tuesday, takes effect on 27 October. Hereditary angioedema is a rare inherited condition causing recurrent, often painful swelling that can also affect the airways.

The subsidy remains limited to patients with severe disease and at least four attacks a month. Takhzyro is approved from age two; the subsidy change does not alter that approval.

The medicine’s 150 mg strength was already subsidised without an age restriction. But the 300 mg strength remained restricted to patients aged 12 and over.

TLV says that mismatch excluded some younger patients whose recommended treatment required 300 mg. The product information mainly bases dosing on body weight, making age an inappropriate subsidy boundary, the regulator concluded.

Manufacturer Takeda asked for the change after identifying children under 12 whose weight meant they needed the higher strength. TLV also found that the differing conditions could complicate prescribing.

Both strengths have the same medicine cost per dose. TLV therefore considered the cost of extending the 300 mg subsidy reasonable under the existing disease-severity conditions.

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