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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?