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In contrast, the VA National Formulary now offers a uniform pharmacy benefit to all veterans by reducing variation in access to drugs. In addition, using preferred agents in each drug class provides VA with additional leverage when contracting with drug suppliers to reduce prices across the entire VA system.
Many oncology agents are not included on the VA National Formulary due to cost and the potential for off-label use. However, the formulary status of oncology agents in no way limits access or the availability of any oncology drug for appropriate patients. In fact, nonformulary approval requests work as a mechanism for review to ensure that these agents are used properly in the subset of patients who are most likely to benefit.
The PBM assesses all new oncology drugs for value and potential use within the VA, as well as cost impact. Following this assessment, various clinical guidance documents may be developed that are intended to guide clinicians in the proper use of medications for veterans. All documents prepared by the PBM undergo an extensive peer review by the Medical Advisory Panel and other experts in the field.
Drug Monographs
A drug monograph is a comprehensive, evidence-based drug review that summarizes efficacy and safety based on clinical trial data published in peer-reviewed journals, abstracts, and/or FDA Medical Review transcripts. Cost-effectiveness analysis is included if available.
Criteria for Use
Criteria for Use (CFU) are developed for drugs considered to be at high risk for inappropriate use or with safety concerns. The purpose of the CFU is to select patients most likely to benefit from these agents by using clinical criteria, which may qualify or eliminate a patient for treatment. National CFUs are available on the national PBM website. Local CFUs are often written and shared among oncology pharmacists via the VA oncology pharmacist listserv.
Abbreviated Reviews
Similar to drug monographs, abbreviated reviews are much shorter and focus on the relevant clinical sections of the drug monograph necessary for clinical or formulary decision making.
National Acquisition Center
The National Acquisition Center (NAC) is the pharmaceutical contracting mechanism for the VA and works closely with the PBM.5 The NAC pursues significant drug price reductions for the VA based on many strategies. Public Law 102-585 ensures that certain government agencies, including the VA, receive special discounts on pharmaceuticals, which is at least a 24% discount from the nonfederal Average Manufacturer Price. This is known as the Federal Supply Schedule (FSS) and/or Big 4 pricing. In addition, bulk purchases and performance-based incentive agreements can lead to substantial local discounts. By working with specific drug distribution and warehouse contractors, the NAC assures ready access to drugs for VA patients. The NAC also allows for an efficient drug inventory process, thus reducing inventory management costs.
Guidance Documents
In 2012, the VA Oncology Field Advisory Committee (FAC) created the High Cost Oncology Drug Work Group to address the impact of high-cost oncology drugs within the VA.11 This work group was composed of VA oncologists and pharmacists whose efforts resulted in 5 guidance documents designed to reduce drug costs by optimizing therapy and reducing waste: (1) Dose Rounding in Oncology; (2) Oral Anticancer Drugs Dispensing and Monitoring; (3) Oncology Drug Table: Recommended Dispensing and Monitoring; (4) Chemotherapy Review Committee Process; and (5) Determining Clinical Benefit of High Cost Oncology Drugs. Reviews of 2 of these documents follows.
Determining Clinical Benefit of High Cost Oncology Drugs provides a decision tool to aid members of the oncology health care team in optimizing patient outcomes while attempting to obtain the greatest value from innovative therapies. When a high-cost or off-label request is made for a particular patient, using this process encourages thoughtful and evidence-based use of the drug by considering all clinical evidence in addition to the FDA-approved indication. Finally, a drug’s safety profile in relation to the indication, therapeutic goal, and specific patient characteristics and desires are integrated into a final decision to determine the appropriateness of the therapeutic intervention for the patient.
Oncology Drug Table: Recommended Dispensing and Monitoring contains a list of oral oncology drugs and includes recommendations for dispensing amount, adverse effects, laboratory monitoring, formulary status, approval requirements, and monthly cost of each agent based on the current NAC pricing.5 Cost awareness is critical when comparing alternative treatment options to minimize cost when treatments with similar benefits are considered. Most VA oncologists do not have easy access to the cost of various treatments and can be surprised about how expensive many common regimens cost. The costs listed in this document are updated about every 3 months.
