3. Oral Anticancer Drugs: Recommended
Dispensing and Monitoring
4. Chemotherapy Review Committee Process
5. Determining Clinical Benefit of High Cost
The Oncology FAC approved these guidance documents
with subsequent review under the national PBM approval
process. They are not mandatory for decision making but
are encouraged for use at the facility or VISN level and
can be found at the PBM website.
Prostate cancer is one of the common malignancies that
afflicts veterans. It is a disease with treatments involving
multiple high-cost oncology drugs and as such is an ideal
therapeutic area for possible intervention. Prostate cancer provides an opportunity for the second step of this
project. As there are multiple therapies available for the
treatment of metastatic castrate-resistant prostate cancer
(mCRPC) that have been evaluated in the clinical trial
setting for similar indications among
comparable patient populations and
are high cost items, providers find it
difficult to choose among them.
A clinical pathway (CP) is a visual
care map that provides direction for
treatment options.6-8 Brief annotations
are provided throughout the map to
help provide rationale along with a
rating of the clinical evidence that
supports that decision. The ultimate
goal of the CP is to improve patient
outcomes by providing uniformity of
care. Uniformity can lead to increased
efficiencies, reduced chance of medication errors, and
proactive management of expected toxicities. Clinical
pathway development is an extensive process.
The oncology-focused NPBM-CPPMs serve as facilitators for the development of the prostate cancer pathway. This involved the creation of a database of pertinent
prostate cancer literature, including national consensus
guidelines (ie, National Comprehensive Cancer Network,
American Urology Association). This database is available for reference and discussion throughout the process. Key VA oncologists with expertise in prostate cancer
management were identified to serve as stakeholders and
critically review the literature, providing input regarding
each step throughout the pathway process.
Similar to previously described documents, the CP
for mCRPC (CP-mCRPC) will undergo peer review by
the Oncology FAC with subsequent review under the
national PBM approval process. The intent of the CP-mCRPC is not to mandate decision making regarding
treatment but to encourage consistent treatment and ultimately to minimize variance in practice and optimize patient outcomes. Clinical pathways are dependent on the
current evidence and, therefore, are documents that require evaluation and regular updates.
The CP process for prostate cancer
will serve as a model for the development of subsequent pathways for
Many commercial insurers use prior
authorization (PA) solely for drug
coverage decision making. The PBM
has recently adopted an expanded
variation of the PA process for a few
select medications at both the national and VISN level. The VA PBM
PA is a thorough review process to ensure that select patients are appropriate for a particular therapy in an attempt to optimize outcomes. In the process, providing
drug therapy to those veterans most likely to benefit will
minimize the impact of drug cost.
Drugs selected for PA review are those that meet the
following characteristics: (1) Drug has demonstrated limited clinical benefit in a select subpopulation of patients;
(2) Drug has a high potential for off-label use; and (3)
Drug is considered a high-cost item. The potential benefits of this process are not limited just to ensuring that
the appropriate patient receives the appropriate therapy.
Prior authorization at the national and VISN levels promotes consistent health care delivery throughout the VA.
F DA approval of an
oncology drug means that
a National PBM Clinical
Manager needs to first
determine the role and
value of this drug to the
Table. Top 5 Cancer Diagnoses in VHA for
Fiscal Year 2013
1. Prostate Cancer
2. Lung Cancer NOS/Small cell (combined)
3. Colorectal cancer (combined)
4. Bladder cancer
Source: 2014. VHA Support Service Center (VSSC): Cancer Care Cube.
NOS = not otherwise specified.