SKY-0515

No price, SKY-0515-specific sales forecast, cost-effectiveness analysis, budget impact model, or health technology assessment has been published. The company has stated that launch could occur as early as 2027. The only market estimate that names SKY-0515 is a market research announcement that estimates the seven-major-market HD market at approximately USD 320 million in 2025, with a projected 14% compound annual growth rate from 2026 to 2036, and lists SKY-0515 among pipeline candidates; the announcement does not report product-level forecasts.

The available cost evidence is disease-level. In U.S. Medicare fee-for-service claims (3,688 beneficiaries with Huntington's disease), mean annual total healthcare costs were $20,475 in early-stage, $29,733 in middle-stage, and $56,657 in late-stage disease; in U.S. Medicaid claims (595 beneficiaries), the corresponding means were $22,797, $55,294, and $95,251. In the Huntington's Disease Burden of Illness study (five European countries and the United States), mean annual direct medical costs were €12,663 (n = 2,094) and mean annual indirect costs were €47,576 (n = 436); mean annual total costs were €42,477 in early-stage, €64,688 in mid-stage, and €86,177 in advanced-stage disease, and in a subsample of 307 participants indirect costs accounted for 84%, 80%, and 66% of total costs by stage.

Modeling evidence exists for other investigational huntingtin-lowering therapies. A U.S. Markov model from a modified societal perspective estimated incremental cost-effectiveness ratios of $2.28 million per QALY gained for tominersen and $285,703 per QALY gained for AMT-130 versus standard of care. Because no established cost data exist for either product, the model assumed drug costs by analogy with spinal muscular atrophy therapies (an annual tominersen cost of $318,750 and a one-time AMT-130 cost of $1,806,250), and the probability that tominersen was cost-effective was 0% throughout the acceptability curve. A separate decision-modeling framework found that hypothetical disease-modifying treatments reduced lifetime costs in a prefunctional decline population but increased costs in populations with active functional decline, and its authors stated that differences in mechanism, route (including oral), and dosing frequency made it difficult to assign a treatment price. In August 2026, the Institute for Clinical and Economic Review announced an assessment of AMT-130 that is planned to include a five-year health care system budget impact analysis; SKY-0515 is not an intervention in that draft scope. Budget impact for SKY-0515 therefore cannot be estimated from public data as of September 2026.