Introduction to Speciality Pharmacy Flashcards

1
Q

Speciality Pharmacy Stats

A
  • > 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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Top 3 Clinical Areas for Speciality Medications

A
  1. Oncology
  2. Bleeding/Blood Disorders
  3. HIV/AIDS
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Speciality Pharmacy Today

A

3200+ active speciality Rx in US

Market Value:
- 68.3 billion to 1.5 trillion

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Characteristics of Speciality Medications

A
  • small populations
  • rare diseases
  • high cost
  • special handling requirements
  • not just injectables (oral too)
  • reimbursement challenges
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Evolution of Speciality Pharmacy

A

Historically:
- fill service gaps
- increase level of care
- control costs
- stakeholder ease

Now:
- enhanced data
- REMS
- inventory management
- coordination of care
- testing management

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Speciality Pharmacy Supply Chain

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

INDEPENDENTS WERE A GROWING AREA OF SPECIALITY PHARMACY

A

THEY ARE BEING PURCHASES BY PBMs AND LARGE ENTITIES

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Fasting growing area of Speciality Pharmacy?

A

hospital speciality Rx

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

How do patients receive their speciality medications?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Speciality Pharmacy is more than dispensing

A
  • QOL screening
  • Medication Adherence
  • ADR screening
  • clinical interventions
  • education
  • follow-up
  • REMS
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Speciality Pharmacy Focus Areas

A
  • 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)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Speciality Pharmacy Marketplace

A
  • PBM owned
  • Retail owned
  • Wholesaler owned
  • Managed Care Hybrid
  • Hospital Hybrid
  • Manufacturer focus

CHANGES FREQUENTLY DUE TO ACQUISITIONS

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Types of Speciality Pharmacy Models

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

HUB

A
  • 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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

KNOW DIFFERENCE / SIMILARITIES BETWEEN HUB AND SPECIALITY PHARMACY

A

KNOW DIFFERENCE / SIMILARITIES BETWEEN HUB AND SPECIALITY PHARMACY

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

HUBS AT AS REMS GATEKEEPERS

A

HUBS AT AS REMS GATEKEEPERS

17
Q

Importance of Speciality Pharmacy Accreditation

A
  • drug manufacturers and payers want to work with the best speciality pharmacies
  • provides competitive advantage
  • fosters continual improvement
  • compliance with the law
18
Q

Speciality Pharmacy Accreditation

A
  • 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
19
Q

Gold Standard Speciality Pharmacy Accreditation

A

URAC

20
Q

Other Speciality Pharmacy Accreditation

A

Joint Commission
National Committee for Quality Assurance (NCQA)

21
Q

URAC

A
  • 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)

22
Q

REMS

A

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

23
Q

Levels of REMS

A
  1. Professional labeling/package insert
  2. Medication guide
  3. Communication Plan
  4. ETASU
24
Q

ETASU Requirements

A
  • 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