1. Clinical Research and Diagnostic Testing |
Improved access to advanced diagnosticsDeliberate efforts to improve diversity in genetic databasesDeliberate efforts to improve diversity in clinical research
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2. Regulatory Oversight ad Market Authorization |
Coordinated national approach to review and funding
Supplemental process for complex drugs
Pharmacare drug agency to evaluate price and effectiveness
International regulatory collaboration: worksharing, consideration of foreign reviews, etc.
Tailoring valuation to the nature of PMs
Structured value assessments that consider the rarity of conditions, the availability of alternatives, closeness to end of life, novelty, curative nature of treatment, societal impact and severity of illness
Transparency in decision making for predictability
Managing long-term uncertainty
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3. Implementation into the Healthcare System |
Managing healthcare budgets
Additional layer of review: enhanced scrutiny, price negotiations and potential for restricted access for therapies that are expected to exceed a price threshold in annual spending for the first × amount of years
Payment plan options: price caps, volume caps, stepwise, subscriptions
Improving physical accessibilityManaging jurisdictional disparityAlternative provision models
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