Market Access Flashcards
What is Market Access in pharma?
Bridge between regulatory approval and patient access, ensuring medicines are funded and delivered appropriately.
What does Market Access encompass?
HTA, Pricing & Reimbursement, Stakeholder engagement, Evidence generation.
What is the W.A.I.T. Indicator 2023?
Survey showing disparities in drug availability across EU countries.
Why is access to orphan drugs lower?
Due to budget constraints, smaller markets, and infrastructure limitations.
What is HTA?
National-level assessment of clinical and economic value of drugs for reimbursement.
Difference between Regulatory and HTA evaluation?
Regulatory focuses on safety/efficacy; HTA evaluates value including cost-effectiveness.
What are the 4 value pillars in HTA?
Disease Burden, Unmet Need, Clinical Value, Economic Value.
Key ICER characteristic in US HTA?
Non-binding and advisory.
Why is Germany a priority launch country?
Largest EU market, fast HTA, free pricing for 6 months, early access programs.
What is AMNOG?
Germany’s HTA pathway for benefit assessment and pricing negotiation.
What are IQWiG’s benefit ratings?
Major, Considerable, Minor, Unquantifiable, No Benefit, Negative.
How are orphan drugs rated in Germany?
Automatically given at least ‘Unquantifiable’ rating (4).
Germany pricing outcomes based on benefit rating?
Higher rating = premium; lower rating = discounts.
What are Risk-Sharing Agreements?
Agreements like Outcome-Based, Value-Based, Cost/Volume Sharing, Subscription models.
What is Roctavian?
Gene therapy for Hemophilia A with major clinical benefits but market access challenges.
Why did Roctavian face reimbursement issues?
Low perceived unmet need, long-term efficacy doubts, poor patient buy-in.
Final key lesson of Market Access?
Success needs data, communication, stakeholder engagement, and country-specific strategies.
