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The VA National Formulary and Veterans Health Care
Pages 183-200

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From page 183...
... Implementation of this contract was begun with the appointment of staff and a committee of independent experts to carry out the necessary work. This committee consisted of representatives of two veterans service organizations, health professionals knowledgeable in clinical pharmacology, pharmacy and therapeutics activities, and clinical medicine and geriatrics, and pharmacists and others with experience in managed care and pharmacy benefits management.
From page 184...
... At the simplest level, formularies may be open that is, they list many drugs and place few limits on access or coverage, they may be closed, in which case, they list a limited number of drugs and place more limits on access or coverage, or they may be partially closed. Aside from listing or not listing a drug in the formulary itself, the limits or controls that characterize a formulary and formulary system include generic prescribing, generic substitution, therapeutic interchange, use of step protocols, restrictions by certain specialties or clinical settings or conditions, nonformulary exceptions and prior approval or authorization processes, prescription copayments that vary in amounts and differ for generics and brands covered or not covered in the formulary, specific exclusions of drugs or drug classes, or closure of drug classes and designation of drugs or drug classes as preferred, among others.
From page 185...
... These bodies issue drug class reviews and treatment guidelines, and make decisions on drug additions to and deletions from the formulary and the designation of closed and preferred classes. VISN formularies differ among themselves and from the National Formulary, but local formularies are usually the same as the VISN formulary.
From page 186...
... National Formulary elements of restrictiveness include formulary size, number of classes closed and number of drugs in closed classes, timeliness of addition of newly approved drugs, appropriateness and responsiveness of the nonformulary exceptions process, sensitivity of therapeutic interchange policies to patient risks, coverage of over-the-counter (OTC) drugs, and generic substitution.
From page 187...
... A nonformulary exceptions process should involve procedures for obtaining nonformulary drugs that are simple, fair, and reasonable and do not involve needless delays and complicated technicalities. In 1999, the VHA reported that 3.45% of total prescriptions, and 4 to 6% of prescriptions in closed classes, were filled with nonformulary drugs.
From page 188...
... Therapeutic interchange is common in hospitals, generally also in the same drug classes. Since hospital medical staffs agree in advance to interchanges, individual prescriber permission at the time of dispensing is usually not sought.
From page 189...
... offer OTC coverage as a specific pharmacy benefit, and the number of OTC drugs or drug classes covered in managed care is limited mostly to insulin and diabetic supplies with lesser coverage of antihistamines, histamines receptor (H2R) blockers, nonsteroidal anti-inflammatory drugs (NSAIDs)
From page 190...
... Because only drugs selected through drug class reviews by the National Formulary in a closed class are available throughout the VHA unless a nonformulary exception is approved, class closure exerts strong effects on prescribing behavior. Prescribing of preferred drugs in preferred classes is encouraged by drug usage criteria, information about the preferred drugs, and other administrative directives.
From page 191...
... Many of these depend on being able to convert data into defined daily doses and to use detailed management information to predict purchasing patterns absent Formulary changes. For example, some large private-sector health centers multiply total annual spending on a particular Formulary agent by the percentage price decrease negotiated at the time of Formulary selection and take this as a cost avoidance or savings for the year, unadjusted for possible coinciding factors affecting drug usage.
From page 192...
... Costs not captured in this estimate would include time spent by VISN leaders and personnel in implementing and managing the National Formulary at that level, time spent by the NAC on National Formulary contract work, procurement costs for the formulary's closed classes, and time spent administering National Formulary exceptions and therapeutic interchanges at the local level, among others. The committee had no information that would allow an assessment of these costs or an overall estimate of VA National Formulary operational expenditures.
From page 193...
... The committee looked predominantly at clinical pharmacy services, local facility pharmacy and therapeutics committees, VISN formulary committees, the VA PBM and MAP, the quality and availability of existing and new FDAapproved drugs on the National Formulary, drug class reviews and therapeutic guidelines, the nonformulary process, therapeutic interchange policy, and drug utilization review (DUR)
From page 194...
... Formulary committees appear to be highly variable in membership, and the presence of no or very few physicians on some of them may have implications for physician acceptance of the VISN or National Formulary. The VHA reorganization that authorized 22 VISNs also led to the creation of a Pharmacy Benefits Management Strategic Healthcare Group located in Washington, D.C., and Chicago, a Medical Advisory Panel made up of 1 DOD and 11 VA field physicians, and a VISN Formulary Leaders Committee, as described earlier.
From page 195...
... Class closure, committed-use contracts, preferred drug designations, drug usage criteria, and separate negotiations for drug prices, such as blanket purchase agreements, all may affect the utilization of drugs in certain classes. Dramatic changes in utilization may follow class closure, National Formulary selection, and contracting for drugs.
From page 196...
... Concerns exist in a number of areas, such as the addition of drugs, the nonformulary process, therapeutic interchange, and patient and physician acceptance. The absence of good data on quality effects is a particular concern, as is the need for better data to enable prudent management of the National Formulary.
From page 197...
... Other Formulary management strategies in managed care include generic substitution, therapeutic interchange, DUR, exclusion of certain specific drugs or drug classes, and prior approval. The committee reviewed a number of publicly available managed care or PBM formularies and described some classes that are closed in these formularies and also in the VA National Formulary.
From page 198...
... The National Formulary provides fewer choices in some drug classes, particularly closed classes, although Medicaid prior approval in some of these classes may limit access. The committee reviewed 15 studies of Formulary system controls in Medicaid fee-for-service programs.
From page 199...
... The committee observed that the present DOD Basic Core Formulary, mail order formulary, and multiple treatment facility formularies are not comparable counterparts to the VA National Formulary and Formulary system. They are in earlier stages of development.
From page 200...
... 200 DESCRIPTIONAND ANALYSIS OF THE VA NATIONAL FORMULARY Other controls, such as generic substitution and therapeutic interchange, are in common use in many systems. The important element for quality and restrictiveness is timely availability of a safe and effective, medically necessary drug, if not listed, through an exceptions process.


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