Specialty Pharmacy
Many orphan drugs and bio-pharmaceuticals require special handling, distribution, and clinical programs provided by Specialty Pharmacy Operations. VCGBIO has the expertise and a proprietary process around the selection, implementation, and management of specialty distribution networks. VCGBIO will assist your organization in developing a market access and reimbursement strategy via a network of Specialty Pharmacies. Developing a specialty market access strategy, identifying key distribution channels, developing a RFP, identifying potential partners, and negotiating distribution and services agreements are our specialty.
Examples of key areas of focus a manufacturer should consider when choosing a specialty pharmacy/distributor should include:
Hub Services
- Patient Intake and Processing
- Triage Services
- Coordination with Specialty Network
- Coordination with Reimbursement Support Services
Clinical Support Capabilities
- Product Educators
- Nursing Services
- Disease Management
- Adverse Event Reporting
Customer Service and Order Management
- Order management processes
- Customer service policies
- Financial Services
- Manufacturer product reporting
Order Fulfillment and Distribution - General Distribution, Hub vs. Spoke, etc.
- Evaluate process for receiving an order and processing a prescription or order
- Method of tracking order status throughout the delivery cycle
- Shipping materials and validation processes
- Process and SOP for communications to patients and health care providers
- Process and tracking system for resource deployment to patients and health care providers
- Compliance with cGMP guidelines
- Compliance Programs
- Application of Copay and Patient Assistance Programs
Reimbursement Services
- Validate SPS licensure and reimbursement access
- Assist with manufacturer reimbursement services
- Processing and tracking of credits and reversals
- Process to manage assignment of benefits
- Access to patient advocacy groups
- Ability to process claims (drugs, devices, and diagnostics)
Quality Management
- Assess standards for internal audit and quality control
Patient Education, Provider Education and Compliance, and Persistency Services
- Assess programs for patient monitoring of compliance and follow-up
- Assess the need for 24/7 clinical support
- Method for patient education reporting
Information Technology, Data Management and Reporting
- Define requirements for data systems
- Contingency plans and back-up systems in case of system/power outages
- Website, social media, etc.
