Aqneursa (levacetylleucine)

No published budget impact model, cost-effectiveness analysis, or health technology assessment of levacetylleucine in A-T has been identified, and no source states a wholesale acquisition cost (WAC) announced with the A-T approval of 18 September 2026. The prices identified are for the 1 gram packet introduced in September 2024. IntraBio reported to California a WAC of $13,450 per carton of 28 packets at introduction on 24 September 2024. An Oklahoma Medicaid review dated February 2025 listed $480.36 per packet, $57,643.20 per 30 days, and $691,718.40 per year at the maximum labeled dose of 4 g per day. Federal prices per carton of 28 packets that started on 1 January 2026 are $13,339.54 on the Federal Supply Schedule and $10,206.02 for the Big Four, and the New York Medicaid list effective 29 September 2026 carries a maximum reimbursable amount of $555.7142800 per packet. A September 2026 news report states a cost of $15,000 every one to two weeks.

The labeled dose is 2 g per day at 15 kg to less than 25 kg, 3 g per day at 25 kg to less than 35 kg, and 4 g per day at 35 kg or more. In the pivotal trial, 18 of 73 participants (25%), 17 (23%), and 38 (52%) were in those weight bands. For the eligible population, IntraBio states that A-T affects an estimated 1 in 40,000 people, and Quince Therapeutics cites approximately 4,600 diagnosed people with A-T in the United States from IQVIA claims data; IntraBio estimated 200 people in the United States with Niemann-Pick disease type C (NPC) in its California filing for the 2024 introduction. National Medicaid data for the first quarter of 2026, which precedes the A-T approval, record 7,728 units and $4,017,756.66 reimbursed under fee-for-service and 6,076 units and $3,160,527.34 under managed care. An Oregon Medicaid evaluation in NPC dated December 2025 listed levacetylleucine among medications proposed for a carve-out of products with an estimated acquisition cost of more than $500,000 per member over 12 months.