Focus on Patient Centricity
In traditional drug development, limited engagement—or engagement too late in the development program—between sponsors, regulators, and payers can result in unacceptable delays of patient access to life-saving medicines. While alternative approaches such as Adaptive Licensing, which includes staggered approval, managed entry, and progressive authorization have expedited the process, it addresses only one part of the challenge and does not include the payer. A coordinated and cohesive effort from a systems perspective is still lacking.
What is Pharmacology to Payer?
Pharmacology to Payer (P2P) is an innovative systematic patient-centric strategy that overcomes silo-based thinking and facilitates a common decision-making platform for collaboration by sponsors, regulators, and payers to use across the development lifecycle. P2P evaluates the socio-economic impact of new drugs through the integration of quantitative pharmacology, PK/PD, disease progression, epidemiology, healthcare utilization, and the pharmacoeconomics of a compound for a disease of interest. By modeling all these various elements we are able to link early drug development to disease progression and the patient journey.
Approaches to the Drug Development Lifecycle
Benefits of P2P
P2P will create a transparent dialogue and practical decision-making framework for all stakeholders, providing significant benefits:
- Sponsors will obtain an earlier estimation of market value and business case, certainty of a path to market, and earlier revenue through ‘provisional pricing’
- Regulators will achieve earlier alignment with regulatory requirements
- Payers gain earlier alignment with reimbursement requirements, and opportunities to risk/cost share
- Patients will gain earlier access to medicines for patients
Applications of P2P in Product Development
- Pandemic planning
- Profile diagnostic opportunities
- Evaluate high-cost and debilitating diseases impacting a patient, their carers, and the community, including infectious diseases, medical countermeasures, oncology, chronic inflammatory, neurodegenerative diseases including Alzheimers and multiple sclerosis, and PK/PD to health economics
Pharmacology to Payer for Influenza