Management of Drug Formulary

1
Management of Drug Formulary

• Dimitry Gotlinsky
• Western University
• Managed Care Clerkship
• ProPharma Pharmaceutical Consultants, Inc.
• 06/16/06

2
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

3
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

4
Techniques of Formulary System Management

• 3 general categories
• a) Drug use evaluation
• b) Formulary maintenance
• c) Drug product selection

5
Drug Use Evaluation

• Diagnosis criteria
• Prescriber criteria
• Drug-specific criteria

6
Formulary Maintenance

• Therapeutic drug class review
• Formulary addition or deletion
• Use of non-formulary drugs

7
Drug Product Selection

• Generic substitution
• Therapeutic Interchange

8
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

9
Members of P T Committee

• Physicians
• Pharmacists
• Nurses
• Administrators
• Quality assurance coordinators
• Epidemiologists/specialists
• Ethicists

10
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
  non-formulary drugs

11
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

12
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

13
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
  non-formulary drugs

14
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

15
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

16
AMCP Format

• Allow a health system and its PT committee to
  determine
• a) clinical benefits
• b) risks
• c) evaluate value
• d) determine overall cost
  consequences
• to their health system
  

17
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 PT committees

18
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

19
In Conclusion

• American public is unwilling to accept limits on
  the use of health care services
• Major factor contributing to resistance of
  cost-effectiveness 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

20

• Questions?