Managed Access Programs (MAP)
However you define managed access in your company, Early Access Care will customize a program that is suitable for your innovative medicine at any phase of drug development. These days terminology for early access programs is expansive.
Traditionally, a Managed Access Programs (MAP) is an early access program once a manufacturer has secured a first regulatory approval, allowing the supply of the medicine to patients and physicians in countries where it is not yet approved
Early access is a continuum throughout the life-cycle of a medicine.
Early Access Care will customize a program that is suitable for your innovative medicine at any phase of development.
Early planning enables a company to approach early access with a holistic plan spanning early development through commercialization. Considerations include:
- Phase of development (Phase 2,3, filing, launch)
- Planning for early and effective engagement with Health Technology Assessment
- Country specific factors can impact the feasibility of providing early access and drive prioritization
- Inclusive of countries with centralized approval and pending pricing and reimbursement decisions
Company stakeholders need to prepare effectively for downstream demand to ensure uninterrupted patient treatment and management of new requests.
In all cases, it is necessary that all requirements are met before the medication is distributed for use:
- Specific requirements of the Managed Access program are fulfilled (e.g. filing, submission to Health Authority (HA)
- Physician attestation that medical condition is life-threatening, seriously debilitating, or chronic
- Licensed therapeutic treatment option is not available
- The anticipated positive risk-benefit ratio for the treatment of a patient participating
- Patients undergo informed consent procedure that meets the local requirements
End of Map
Commercialization within a local market, and in some cases reimbursement, are the end milestones for a MAP. Planning the phasing-out on a country by country basis means that local country stakeholders and company licensing partners are informed and decision makers on the phase-out plan in a given market.
Contact Early Access Care to assist you with your strategic planning, operational management, and transition to launched product.
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