Wednesday, February 20, 2013

Hepatitis C Model Delivers Great Care Anywhere

Hepatitis C Model Delivers Great Care Anywhere
Articles from the February issue of Gastroenterology & Endoscopy News are now online. Click here to see all of the stories from the February issue.

Karine Rozenberg-Ben-Dror, PharmD
VISN 12 HCV Task Force Manager Department of Veterans Affairs (VA)
Clinical Pharmacy Specialist/Informatics
Jesse Brown VA Medical Center
Chicago, Illinois
James Duvel, PharmD
VISN 12 Pharmacoeconomic Advisor
Department of Veterans Affairs
Donna Leslie, PharmD
VISN 12 Pharmacy Executive
Department of Veterans Affairs
Michael Bonner, MD
Associate Chief of Staff for Informatics
Milwaukee VA Medical Center
Milwaukee, Wisconsin
In May 2011, the FDA approved the use of boceprevir (Victrelis, Schering-Plough) or telaprevir (Incivek, Vertex) in combination with pegylated interferon and ribavirin for the treatment of genotype 1 hepatitis C. These new protease inhibitors (PIs) promise to alter the landscape of hepatitis C treatments and outcomes.
New treatment algorithms for the treatment of hepatitis C virus (HCV) infection, termed response-guided therapy, require providers to conduct thorough reviews of prior treatments to determine eligibility for new triple regimens incorporating a PI, as well as to guide duration of therapy. Guided therapy involves knowledge of the degree of liver disease and prior treatment response at specified time points, depending on variables such as week of treatment and viral load. Viral loads that decline rapidly identify patients who are highly responsive to therapy, as opposed to unresponsive patients who may need to stop treatment to avoid developing viral resistance.

Another factor to consider with triple therapy is adverse drug events (ADEs). ADEs are common with PI-containing regimens and may be serious or life-threatening. Frequently, providers need to adjust treatment or respond to these reactions to avoid termination of therapy and optimize treatment success. To further complicate management, more than 300 drug interactions with PIs have been identified; these include interactions with commonly prescribed agents for lowering blood pressure and cholesterol.

Optimal HCV treatment for patients in a comprehensive health system requires an efficient and effective process. Ideally, the established structure would support rural as well as urban settings and allow for sharing of information, education of providers, and metrics to monitor treatments. Such a process was established successfully within the Department of VA.

VA Task Force
The VA hospitals and clinics are geographically clustered into groups called Veterans Integrated System Networks (VISN). There are 22 VISNs in the VA system. Facilities located in the states of Illinois, Wisconsin, and Michigan comprise VISN 12, which includes 7 unique urban and rural hospitals as well as satellite clinics that provide integrated care to approximately 200,000 veterans. Of these, approximately 3,000 patients have HCV genotype 1 and may be candidates for response-guided therapy.

Table 1. Role of the Task Force Managera
Generate discussion to identify goals and objectives, and barriers to treatment.
Seek expert opinion to aid consensus development.
Attend national VA meeting(s) and communicate topics of pertinence or interest.
Identify and provide criteria for use, electronic tools (eg, monitoring guides, drug-drug interaction tool).
Coordinate resolution of problems related to laboratory and pathology, and reporting and management of ADEs.
Review electronic records for ADEs and cases of interest for discussion at task force meetings.
Discuss or review the appropriate use of protease inhibitors, erythropoietin, and G-CSF.
Encourage discussion about local best practice solutions and interesting/unusual patients.
aAt meetings, via email, or one on one with providers
ADEs, adverse drug events;
G-CSF, granulocyte colony-stimulating factor
The VISN pharmacy executive identified an HCV-experienced clinical pharmacy specialist to lead an HCV task force (TF) and queried each facility to identify a multidisciplinary group consisting of nurse practitioners, physicians (internal medicine, infectious disease, and gastroenterology/​hepatology), and clinical pharmacy specialists. The role of the TF manager was to optimize access to and treatment with PI-containing regimens (Table 1). The manager organized meetings, prepared reports, and encouraged members to share expertise and experiences.

The TF had to identify and resolve unique and common barriers, standardize the approach to therapy, and familiarize providers with complexities of the new HCV regimens. The TF conducted biweekly one-hour teleconferences.

Through agendas and meeting minutes, the group tracked progress of the TF and provided communication to those unable to join the conferences. Meetings were held monthly or as needed, depending on the issues that were unresolved via the teleconferences.

The TF focused on identifying barriers to optimizing care and establishing goals to address such barriers as well as solutions to any problems related to HCV therapy (Table 2). These barriers included lack of manpower, insufficient clinic space, and suboptimal laboratory HCV RNA quantification. In several facilities, clinics with one clinician evolved to include the aid of a clinical pharmacist to review previous treatment history, reconcile medications, evaluate for potential drug-drug interactions, and recommend or initiate formulary agents to manage side effects. Identification of potential drug interactions occurred before HCV treatment was initiated, allowing timely use of alternative agents. The time that TF members spent in the clinic was optimized by having nurses, rather than nurse practitioners or clinical pharmacists, measure blood pressure and train patients on injections. Through service agreements, some facilities were able to expedite referral to psychiatry or infusion clinics, thereby enhancing access to care and reducing hospitalizations for blood transfusions. If needed, TF members from a sister facility could provide support by email.

Table 2. Barriers To Optimizing Hepatitis C Therapy
BarrierInitial CircumstancesGoals
Suboptimal HCV RNA testing methodsQuantification <43 IU/mL Quantification <10-15 IU/mL
Excessive laboratory turnaround time>2 weeks at some facilities<2 weeks for all facilities
Inadequate manpower or insufficient spaceLack of hepatology service providers Lack of manpower and dedicated clinic space Admission to hospital for side effect management (psychiatry, blood transfusion)Provide access to expert opinion in difficult-to-treat cases Shared responsibilities and offsite support Service agreements: mental health provider to see patients presenting with depression or anxiety while on HCV therapy, infusion clinic to provide blood transfusion during routine hours
Inadequate knowledge baseNew, inexperienced clinicians and variable use of electronic tools Enhance knowledge base by highlighting the availability of VA Criteria for Use of HCV agents, VA website, and electronic tools that contain Word documents and website links with tutorials
Inadequate reporting of ADEs Low reporting ratesStandardize or improve electronic reporting in the medical record using group consensus
ADE, adverse drug event; HCV, hepatitis C virus

Laboratory issues were universal to all the facilities—the HCV RNA limit was not low enough for response-guided therapy, and electronic reporting of the results was delayed. Support from the VISN pharmacy executive and the chief medical officer empowered the TF manager to collaborate with the VISN chief of laboratory and pathology to uniformly reduce the HCV RNA to the desired range and reduce the time for the results to be entered into the electronic medical record (EMR) at all the facilities. The ability to report HCV RNA in less than 2 weeks allows providers to identify quickly patients in whom treatment should be stopped. The reduction in the quantification limits of HCV RNA to less than 10 to 15 IU/mL assures the provider and patient that the treatment decision was evidence-based and supported by criteria for use of PIs.

The TF identified a lack of uniform ADE reporting throughout the VISN 12 facilities. After consulting an expert at the VA’s national Pharmacy Benefit Management group for guidance, the TF identified realistic and achievable parameters to standardize ADE reporting. The number of reports increased from a baseline of 9 events in quarter 1, to 41 in quarter 2; the increase was maintained in quarter 3, making VISN 12 one of the highest-reporting VISNs in the country. A shared responsibility for increased reporting developed at several sites, when additional reactions were noted during medical record reviews.

To enhance knowledge and communication about the HCV therapy initiative, the TF manager encouraged clinicians to use available electronic knowledge-based tools ( website; “ask the expert,” a live VA website that allows experts in the field to respond to questions; criteria for use of specific drugs; a drug-drug interaction tool). These standardized, evidence-based tools are updated nationally to maximize patient care throughout the VA system. Additionally, electronic consults allow providers to request PIs such as boceprevir using the EMR. This consult highlights appropriate criteria for use and helps identify candidates for treatment. For difficult-to-treat patients, clinicians coordinate with the TF manager to query experts outside the VISN, who offer data supporting decisions and/or expert opinions.

Models of Care
In the VA system, facilities are supported by national groups such as Pharmacy Benefit Management, the Hepatitis C Resource Center, and the Office of Public Health, which provide evidence-based guidance for disease management. Providers work locally at their individual sites and network periodically when attending meetings and speaking with colleagues.
Coordination of information within a single VISN as well as with other networks and national groups is paramount in reaching providers and patients who are far from expert care and to allow optimized care using complex regimens. The “Ferris wheel” model highlights the flow of information within a large network to provide an efficient method to improve and enhance delivery of information (Figure).

Figure. VISN Ferris wheel model.a
a The Ferris wheel model is supported by national groups. The momentum is driven by the task force manager and facility providers who network and may seek expert guidance on a national level to resolve issues. As the wheel turns, providers may interact at national meetings to share and gather new information that can be redistributed by the task force to various facilities.
CMO, chief medical officer; HCV, hepatitis C virus; TF, task force; VISN, Veterans Integrated System Networks

The complex care of patients embarking on PI-containing regimens can be standardized with regard to laboratory monitoring, ADE reporting, and access to treatment tools. Disease state management is enhanced when clinicians have access to experts who can lend support and share experiences, providing clinicians with a much larger set of information from which to draw new ideas and solve problems. Clinical pharmacy subject experts are excellent conduits to bring clinicians and patients together to provide the best care anywhere, irrespective of clinic makeup or location.
Source -

Dr. Bonner was formerly VISN 12 Chief Medical Officer.

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