SL Insight Newsletter #7

According to a recent article, the supply of new therapies is stagnating: fewer SL listings, longer negotiations, tighter limitations. Individual case reimbursements (Art. 71 KVV) are filling the gap. Next topic on the horizon: cost-consequence model (ex-post return on high sales).

What does that mean specifically?

• Availability: Only 47% of new EMA approvals (2020–2023) will be regularly available in the SL as of January 2025 (2018: 64%). Orphan drugs are particularly affected.
• Timeline: 6% reach SL within 60 days; oncology ~278 days until reimbursement decision.
• TQV practice: Old/generic therapies often serve as price anchors → high discounts, tighter limitation texts as control.
• Art. 71 KVV: Around 27% of new active ingredients are covered on an interim basis via individual case reimbursement – pragmatic, but administratively cumbersome.
• Cost follow-up model: Planned payback/revenue cap increases forecast complexity (list price vs. ex-post return).

What does this mean for market access?

Plan time-to-SL conservatively (oncology realistically ≥ 9 months); anticipate limitations early on and justify them clinically; consider Art. 71 processes (medical/insurance companies) from the outset; take payback effects into account in the CH P&L and in the forecasts.