An overview of how different payers prioritize safety and tolerability profiles when assessing new therapies.
MARA Rating Insight Since 2020, assets averaging a 3.3 Safety score cleared HTA hurdles more often than those at 3.2, whose marginal uptick in adverse-event risks led to additional data requests and slower decisions. That 0.1-point gulf can tip the balance between rapid approval and prolonged review.
Did you know? At MARA Rating, we convert the safety and tolerability criteria of NICE (UK), G-BA/IQWiG (Germany) and ICER (US) into a transparent A++ to C score—across 350+ assets. A strong safety profile isn’t just “nice to have”; it’s often the linchpin of payer confidence.
What Is Safety & Tolerability? This domain quantifies risks versus benefits and how they compare to the current standard of care:
- Short-Term Adverse Events: Frequency and severity of side effects during initial exposure.
- Long-Term Risks & Complications: Chronic toxicity or late-emerging safety issues.
- Frequency/Severity of AEs: Overall burden—from mild nuisances to life-threatening events.
- Safety Profile vs. Comparator: Does your therapy reduce risks, or introduce new ones? MARA Scoring Framework
Strong vs. Marginal Scores
- A++ / A+ / A (“Strong or above”): These assets averaged ≥3.3 in Safety—minimal, manageable side effects and a tolerability profile that eases payers’ risk concerns.
- B++ to C (“Marginal or below”): Assets at ≤3.2 saw slower reviews, stringent monitoring requirements or even coverage with risk-sharing schemes.
Even a 0.1-point safety boost can accelerate market access by reducing the need for post-launch surveillance.
Actionable Tips by Role
- Market Access Professionals: Build comprehensive safety follow-up programs—capture both trial and real-world adverse-event data to preempt payer questions.
- Venture Investors & Acquirers: Scrutinize long-term safety datasets—assets with few late-arising risks lower portfolio volatility.
- Drug Developers: Invest in proactive risk-mitigation: design trials with clear monitoring plans, adopt companion diagnostics for high-risk subgroups, and publish safety narratives early.
See Your Edge Our anonymized score distributions across 350+ assets highlight exactly where your Safety & Tolerability evidence shines—and where you may need to shore up risk management.
Do you know how your product scores? Visit mararating.com or send us a line.
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