Rare Disease Pharmacy: REMS, Hubs, and Single-Source Risk

flowchart LR
 P[Patient and caregiver] --> C[Clinic and prescriber]
 C --> H[Hub services]
 H --> SP[Specialty pharmacy]
 SP --> P
 M[Manufacturer] --> H
 M --> SP
 C --> SP
 SP --> Pay[Payer]
 H --> Pay

flowchart TD
 A[Referral received] --> B{Prescriber certified?}
 B -- No --> C[Clinic certification outreach]
 B -- Yes --> D{Patient enrolled?}
 D -- No --> E[Enrollment support]
 D -- Yes --> F{Monitoring current?}
 F -- No --> G[Lab or assessment follow-up]
 F -- Yes --> H[Dispense authorization]
 H --> I[Ship and schedule next check]

flowchart LR
 C[Clinic referral] --> H[Hub intake]
 H --> BI[Benefit investigation]
 BI --> PA[PA or appeal support]
 H --> EN[Patient enrollment]
 PA --> SP[Specialty pharmacy]
 EN --> SP
 SP --> SH[First dispense]
 SP --> C
 H --> P[Patient communication]

flowchart TD
 A[Define patient and product risks] --> B{High REMS or clinical complexity?}
 B -- Yes --> C[Need tight training and oversight]
 B -- No --> D[Assess reach and payer fit]
 C --> E{Need redundancy?}
 D --> E
 E -- Low --> F[Exclusive or narrow model]
 E -- High --> G[Two-SP or limited network]
 G --> H[Set data, SLA, and escalation rules]
 F --> H

flowchart TD
 A[Exception detected] --> B{Blocks current therapy?}
 B -- No --> C[Standard owner resolves]
 B -- Yes --> D{Clinical timing risk?}
 D -- Yes --> E[Clinical escalation and patient plan]
 D -- No --> F[Access or supply escalation]
 E --> G[Communicate next step]
 F --> G
 G --> H[Document root cause and prevention]