It is becoming more difficult to demonstrate that new treatments are cost efficient and should be included in the reimbursement scheme. A pharmaceutical sweden-map-colourcompany’s application to the Dental and Pharmaceutical Benefits Agency (TLV) for a pricing and reimbursement decision regarding a medicinal product with orphan drug status has been rejected. The decision to deny reimbursement for the orphan drug for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) was based on a health technology assessment which took into account off-label use of treatments for pulmonary arterial hypertension (PAH) (for further details please see “Orphan drug denied reimbursement in health technology assessment“).
The Stockholm Administrative Court has since upheld the TLV decision.(1)
After the judgment was given, the TLV published a report proposing amendments to the authority’s recommendations on economic assessments (formally non-binding).(2) The amendments codify the authority’s existing practice and clearly state the possibility for the TLV to take into account off-label use when assessing the cost effectiveness of new treatments.
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For further information on this topic please contact Jonas Löfgren or Annie Kabala at Advokatfirman Lindahl KB by telephone (+46 8 527 70 800) or email ( or The Advokatfirman Lindahl KB website can be accessed at