Introduction to Specialty Pharmacy

Specialty Pharmacy Introduction

• Specialty pharmacy manages rare, chronic, and complex medical conditions
• It dispenses high-cost, limited distribution drugs (LDDs)
• Medications needing special handling and monitoring are dispensed
• There's no universal definition of specialty pharmacy

Learning Objectives

• Define specialty pharmacy practice settings
• Understand specialty pharmacy workflows
• Identify key stakeholders in a specialty pharmacy
• Discuss the roles of a specialty pharmacist
• List patient assistance programs
• Identify strategies to become a specialty pharmacist

Why Specialty Pharmacy?

• Treats complex, chronic, and rare conditions
• Medications require specialized dosage, handling, administration, or storage
• Medications are not commonly stocked in community pharmacies
• High cost of some medications
• Monitoring requirements for some medications

Medical Conditions

• Inflammatory diseases (e.g., RA, Psoriasis, PsA, AS, UC, Crohn's, AD, eosinophilic asthma)
• Oncology
• Infertility
• Growth deficiency
• Infectious diseases (e.g., HIV, AIDS, HCV, HBV)
• Multiple sclerosis
• Hyperlipidemia
• Cystic fibrosis
• Transplant
• Rare genetic conditions

Specialty Process Flow

• The process flow varies based on the specific specialty pharmacy
• Includes incoming referral, intake process, benefit verification, and insurance investigation
• Involves contact with providers, verification of medical benefits, and claims submission to pharmacy benefit managers (PBMs)
• Involves steps like medication shipping and clinical counseling

Path of a Specialty Pharmacy Rx

• Referral management
• Delivery of medication
• Specialty therapy management
• Data and analysis

Referral Management

• Onboarding
• Benefit investigation
• Prior authorization
• Financial assistance

Dispensing System

• Prescription filling
• Delivery of medication

Specialty Therapy Management

• Patient education
• New-therapy-start
• Clinical interventions (e.g., adverse drug events management, drug-drug interactions)
• Refill administration
• Adherence/compliance

Data and Analysis

• Patient-reported outcomes (e.g., RAPID-3, SVR)
• Adherence/compliance
• Pharmacovigilance

The 4 P's of Specialty Pharmacy

• Patient
• Prescriber
• Pharma
• Payor

Patient

• Educate patients about their medication to reduce stress
• Provide therapy experts for patient questions/concerns
• Offer financial assistance programs

Prescriber

• Provide doctors visibility into their patients' status
• Investigate health plan coverage
• Follow up with patients and document treatment outcomes

Pharma

• Improve medication compliance and therapy success
• Prevent therapy disruptions
• Reduce medication errors

Payor

• Support population health improvement
• Reduce unnecessary fulfillment costs
• Usually the lowest cost of care setting
• Enhance risk avoidance

Specialty Pharmacist

• Operational responsibilities
• Clinical responsibilities
• Fulfillment responsibilities
• Pharmacovigilance
• Industry relations
• Pharmacy liaison
• Health Economics and Outcomes Research (HEOR)

Financial Assistance Programs

• Patient Assistance Programs (PAPs)
• Copay assistance programs

Patient Assistance Programs (PAPs)

• Provide free or low-cost medication to uninsured and underinsured patients
• Managed by pharmaceutical companies, non-profits, and government agencies
• Each agency has specific criteria and eligibility requirements

Copay Cards

• Also known as copay savings programs or copay coupons
• Help insured patients afford expensive medications
• Cover patient's deductible and copay
• Managed by pharmaceutical companies

Who's Eligible for Programs?

• Anyone with private insurance
• Program restrictions vary
• Patients must not be insured by Medicare, Medicaid, or Tricare
• No need to prove financial hardship

How to Prepare for a Career in Specialty Pharmacy

• Get involved with student organizations (e.g., NASP, AMCP)
• Complete a specialty pharmacy APPE
• Consider pursuing a PGY-1 pharmacy residency

Post-graduation

• Complete a PGY-1 pharmacy residency
• Publish articles related to specialty diseases

Becoming a Specialty Pharmacist

• Become a board-certified specialty pharmacist (CSP)
• Become a subject-matter expert (e.g., oncology, HIV, MS)

Overall Spend and Volume Trend

• Specialty medications have seen significant growth in spending over the last decade
• Projections show continued growth in the specialty medication market segment