The focus of the monograph is on efficacy and safety of the product and its potential impact on the veteran population. Cost-effective analyses are considered when available, although they are not commonplace at the time
of product launch. 5 Authoritative reviews from other national public health providers (eg, National Institute for Health and Care Excellence) are sought to provide a perspective on a drug therapy’s impact on other health care systems.
Criteria for Use documents are tools to help direct therapy to the appropriate veterans, emphasizing the considerations for safe and optimal use. Criteria for Use are not developed for every drug under review. Instead, CFUs are focused on only those drugs that may be considered a high risk for inappropriate use or may raise safety concerns. The documents developed by the NPBM-CPPM, whether they are monographs for formulary consideration or CFUs, undergo peer review by the Medical Advisory Panel (MAP), VISN VPEs, and fieldbased experts that include Field Advisory Committees (FACs) and other field practitioners.
Cost Issues
The stimulus to develop clinical guidance is not solely based on FDA approval of a new molecular entity. Many times, there are drug-related issues, identified by practitioners in the field, that call for resolution. Some of these issues are not exclusive to VA practice but impact VA practitioners just as they would impact non-VA practitioners. It is the role of the PBM to help address those drugrelated issues.
The high cost of oncology drugs is one such issue that impacts clinicians and patients both inside and outside the VA system. The Oncology FAC recognizes the impact of high-cost drugs on the VA system as a whole. They had been tasked with the goal of providing guidance to the field on the use of high-cost oncology drugs. The oncology-focused NPBM-CPPMs has helped the Oncology FAC address this issue. The plan was to develop guidance documents that focus on minimizing the cost to both veterans and VA facilities. The strategy was to first develop
general, broad-based guidance documents that can be used by any site or VISN, especially those sites without oncology-trained pharmacists, to aid in making decisions about high-cost oncology drugs. The second step was to focus on the nuances of select drugs or diseases and provide drug-specific or disease-specific guidance to help manage cost issues within the identified areas.
Under the auspices of the Oncology FAC, the oncology-focused NPBM-CPPMs convened the High Cost Oncology Drug Workgroup to help tackle this concern. The workgroup included oncology-specialized VA physicians and pharmacists who were divided into subgroups to address areas where recognition and subsequent intervention had the greatest potential to reduce facility drug expenditures.
These interventions previously have been identified as best practices within the VA and were thought to be applicable as broad-based guidance to serve as the first step of the cost control strategy. The work of the subgroups resulted in the following guidance documents:
- Dose Rounding in Oncology
- Oral Anticancer Drugs Dispensing and Monitoring
- Oral Anticancer Drugs: Recommended Dispensing and Monitoring
- Chemotherapy Review Committee Process
- Determining Clinical Benefit of High Cost Oncology Drugs
