Introduction to Speciality Pharmacy Flashcards
Speciality Pharmacy Stats
- > 90% of us will encounter speciality medications within our career
- > 50% of late stage pipeline drugs are speciality medications
- > 70% of applications for new indications are speciality medications
- less than 2% of the population use speciality medications but they account for 51% of total pharmacy spending
PAYERS WANT TO USE SPECIALITY PHARMACY’S
Top 3 Clinical Areas for Speciality Medications
- Oncology
- Bleeding/Blood Disorders
- HIV/AIDS
Speciality Pharmacy Today
3200+ active speciality Rx in US
Market Value:
- 68.3 billion to 1.5 trillion
Characteristics of Speciality Medications
- small populations
- rare diseases
- high cost
- special handling requirements
- not just injectables (oral too)
- reimbursement challenges
Evolution of Speciality Pharmacy
Historically:
- fill service gaps
- increase level of care
- control costs
- stakeholder ease
Now:
- enhanced data
- REMS
- inventory management
- coordination of care
- testing management
Speciality Pharmacy Supply Chain
Manufacturer –> Packager –> Warehouse –> Distributor –> Patients
Distributors:
- hospitals
- speciality Rx
- mail order
- physician offices/clinics
3PL ALLOWS MANUFACTURERE TO BYPASS THE WHOLESALERS AND GO DIRECTLY TO DISTRIBUTOR OR PATIENT
INDEPENDENTS WERE A GROWING AREA OF SPECIALITY PHARMACY
THEY ARE BEING PURCHASES BY PBMs AND LARGE ENTITIES
Fasting growing area of Speciality Pharmacy?
hospital speciality Rx
How do patients receive their speciality medications?
Most Common:
- MD writes Rx –> Fax to speciality –> speciality ships/mails to patient
Hub:
- MD writes Rx –> Fax to HUB –> HUB review & triage –> Fax Rx to Network Speciality –> speciality ships/mails to patient
Speciality Pharmacy is more than dispensing
- QOL screening
- Medication Adherence
- ADR screening
- clinical interventions
- education
- follow-up
- REMS
Speciality Pharmacy Focus Areas
- servicing parent PBM patient
- orphan products
- high volume of products
- unique diseases
- national services
- smaller programs/products
- solutions tied to other services (infusion, home health, retail)
Speciality Pharmacy Marketplace
- PBM owned
- Retail owned
- Wholesaler owned
- Managed Care Hybrid
- Hospital Hybrid
- Manufacturer focus
CHANGES FREQUENTLY DUE TO ACQUISITIONS
Types of Speciality Pharmacy Models
Open Distribution
- Pros:
* access
* MD/Payer/Patient choices
* vendors happy
- Cons:
* inconsistency
* worst data
* worst compliance
* expensive infrastructure cost
* most returns
* low control
* lack of interest by SP
* lowest financial assistance
* highest overall cost
Controlled Distribution
- Pros:
* consistency
* best data
* best compliance
* low infrastructure cost
* least returns
* flexible
* high interest by SP
* high financial assistance
- Cons:
* less choice
* consistent with marketplace access
CONTROLLED AND SET BY THE MANUFACTURER
HUB
- smooth the movement of a drug from the manufacturer to the patient
- consider the hub a central point for data collection to provide the manufacturer with insights that further enhance and develop a detailed patient engagement strategy –> support patients long term
KNOW DIFFERENCE / SIMILARITIES BETWEEN HUB AND SPECIALITY PHARMACY
KNOW DIFFERENCE / SIMILARITIES BETWEEN HUB AND SPECIALITY PHARMACY
HUBS AT AS REMS GATEKEEPERS
HUBS AT AS REMS GATEKEEPERS
Importance of Speciality Pharmacy Accreditation
- drug manufacturers and payers want to work with the best speciality pharmacies
- provides competitive advantage
- fosters continual improvement
- compliance with the law
Speciality Pharmacy Accreditation
- evaluative, rigorous, transparent, and comprehensive process in which healthcare organizations undergo examination of its systems, processes, and performance by an IMPARTIAL EXTERNAL ORGANIZATION to ensure it is CONSISTENT WITH NATIONAL STANDARDS
- accreditation has become an integral and mandatory part of operational excellence
Gold Standard Speciality Pharmacy Accreditation
URAC
Other Speciality Pharmacy Accreditation
Joint Commission
National Committee for Quality Assurance (NCQA)
URAC
- standards focused on protection and quality improvement with less emphasis on care coordination and population health like NCQA
often will see them combined (dual accreditation)
REMS
Risk Evaluation and Mitigation Strategy
- drug safety program by FDA that can require certain medications with serious safety concerns to help ensure the benefit > risk
- REMS are designed to reinforce medication use behaviors that support safe use
Levels of REMS
- Professional labeling/package insert
- Medication guide
- Communication Plan
- ETASU
ETASU Requirements
- provider requirements (trained/certified on drug)
- pharmacy/pharmacist certification
- restricted distribution in certain HC settings
- patients may need lab tests with frequent monitoring
- drug only dispensed to patient with evidence of safe use
- patient enrolled in registry
