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Transcript
Management of Drug Formulary
Dimitry Gotlinsky
Western University
Managed Care Clerkship
ProPharma Pharmaceutical Consultants, Inc.
06/16/06
Drug Formulary

A drug formulary is a preferred list of
medications developed by health care
professionals

Promotes high quality medical care that is
affordable for patients

Features a continually revised list of prescription
medications
The Formulary System
 Provides
drug product selection and
formulary maintenance
 Drug utilization review
 Periodic evaluation and analysis of
treatment protocols and procedures
 Monitoring, reporting, and analysis of
adverse results of drug therapy
Techniques of Formulary System
Management
3
general categories
a) Drug use evaluation
b) Formulary maintenance
c) Drug product selection
Drug Use Evaluation
Diagnosis
criteria
Prescriber criteria
Drug-specific criteria
Formulary Maintenance
Therapeutic
Formulary

drug class review
addition or deletion
Use of non-formulary drugs
Drug Product Selection
Generic
substitution
Therapeutic
Interchange
How are Formularies Chosen?
 Not
all drugs are created equal

Safety and efficacy are the 2 most
important aspects of choosing a formulary

Based on recommendations of Pharmacy
& Therapeutics Committee
Members of P & T Committee







Physicians
Pharmacists
Nurses
Administrators
Quality assurance coordinators
Epidemiologists/specialists
Ethicists
P & T Committee Duties





Appraises, evaluates, and selects drugs for the
formulary
Meets as frequently as is necessary to review and update
the formulary
Oversees quality improvement programs that employ
drug use evaluation
Implement generic substitution and therapeutic
interchange
Develops protocols and procedures for the use of nonformulary drugs
Types of Formularies

Open
-greatest level of flexibility
- typically 2-tiered benefit design

Multi-tier
-provides for a high level of flexibility
-most of the time utilizes 3-tier benefit design, but can
more

Closed
-least level of flexibility
-involves use of NDC blocks and prior authorizations
Cost of Medications
Cost is just one of many factors that plays
a role
 Basing formulary system decisions on cost
factors is secondary
 First priority is to establish safety, efficacy,
and therapeutic need
 Lower cost drug for the same condition
does not get automatically picked

Non-Formularies
The formulary system should:
a) enable individual patients needs to be met
with non-formulary drug products
b) provide access to a formal appeal process if a
request for a non-formulary drug is denied
c) institute an efficient process for the timely
obtaining of non-formulary drug products
d) include policies that state that practitioners
should not be penalized for prescribing nonformulary drugs

Good Formulary System
Informative
 Proactively inform practitioners about
changes to the formulary
 Disclose the existence of formularies
 Provide rationale for specific formulary
decisions when requested
 Provide patient education programs

AMCP



Health care systems frequently conduct
formulary decision-making under uncertain
conditions
Needed a standardized approach to support
product evaluation and selection with clinical
outcomes as the most important consideration
Approved a set of guidelines for MCOs to use
when considering drugs for inclusion in
formularies
AMCP Format

Allow a health system and its P&T committee to
determine:
a) clinical benefits
b) risks
c) evaluate value
d) determine overall cost consequences
to their health system
AMCP Guideline Goals



Establish a comprehensive, standardized,
evidence-based process for evaluation of clinical
and economic data
Provide manufacturers with a consistent format
for providing necessary information
Improve the timeliness, quality and relevance of
information available to P&T committees
AMCP “Dossier” Content







Approved and off-label indications
PK and PD
Dose and Duration
Safety Information
Key economic study results
Economic evaluation support data
Demographics
In Conclusion




American public is unwilling to accept limits on
the use of health care services
Major factor contributing to resistance of costeffectiveness analysis
AMCP format will help health systems establish
a rational evidence-based decision making
As a result will gain the confidence and trust of
patients as well as clinicians, payers and
members
Questions?