The evolution of pharmacotherapy for hepatitis C virus (HCV) infection, which hit a peak over the last 5 years, has made a cure feasible. The ProvenCare hepatitis C program at Geisinger Clinic incorporated these therapies to provide comprehensive, cost-efficient, and streamlined care by reducing barriers to access, resulting in enhanced cure rates.
Teamwork: A multidisciplinary team and their ongoing input is critical. Early collaboration with our health plan and informatics partners, leveraging the skills and abilities of team members, and allowing them to practice to the extent of their licenses were key to the development of this program.
Investment in data infrastructure: Creating a data infrastructure is the key to allowing the team to function most efficiently. However, if this step is cost prohibitive, a general spreadsheet may suffice to closely track patients. Regardless of whether the medical records system is electronic or paper-based, the development and implementation of standardized note templates are crucial and not arduous.
Frequent follow-up and access to care throughout treatment: The development of a method to closely track and monitor all patients at each step in the treatment process is imperative in order to achieve remarkable clinical results. Providing patients with access to clinical staff throughout treatment allows for open communication, improves adherence, and facilitates the effective management of adverse effects.
Continual change: Recognizing that health care is dynamic and is continuously changing based on emerging evidence. Regular meetings allow the team to proactively address challenges and incorporate new evidence, such as updates in the treatment guidelines (www.hcvguidelines.org) or new insurance mandates.
Hepatitis C is associated with substantial morbidity. Although new direct-acting antivirals have transformed hepatitis C from a chronic disease to a curable infection, these treatments are expensive and require strict adherence in order to achieve a sustained virologic response (that is, a cure) and to prevent the development of drug resistance.
The Geisinger Clinic provides services in counties with some of the highest rates of HCV infection in Pennsylvania. Many of these counties are located in rural settings where access to health care is limited. Hence, the challenge was to provide anti-HCV therapy to the patients in central Pennsylvania to achieve maximum sustained virologic response rates. To meet this challenge, we developed a comprehensive approach by marshaling resources across the health care system.
Our goal was to provide evidence-based, efficient care, tailored to patient needs, that would provide the maximum chance of cure from chronic HCV infection.
As the first step toward our goal, we established a team who met regularly to create a standard treatment algorithm. A key mandate of our approach was a collaborative practice agreement that allowed clinical pharmacists to order laboratory studies and medications and to monitor care.
Staffing and Tools
To implement our approach, we hired additional clinical pharmacists and nurse coordinators to adequately manage the patients and to assist in the development of the care pathway. Our clinical and informatics team members created smart tools to standardize documentation; the development of these tools allowed care to be tracked at the individual and population levels and reduced the administrative burden by capturing the data necessary for prior authorizations. To minimize the number of patients lost to follow-up, we created a list of all patients at various stages of care and made this list accessible to the entire team through our electronic health records system.
Patient Access and Adherence to Therapy
Our approach includes a number of actionable steps designed to maximize patient access and to ensure adherence to therapy. Once referred, the patient is contacted by a nurse coordinator or a pharmacist, who explains the flow and structure of the program. Next, the patient undergoes blood testing, after which an in-person office clinic visit is scheduled. Completing the blood work prior to the clinic visit ensures the availability of the information needed to make treatment decisions and avoids additional clinic visits.
Only one in-person clinic visit is required, during which the clinical provider and staff explain the treatment regimen in detail and emphasize the importance of adherence to treatment and subsequent monitoring (i.e., blood work). Follow-up evaluations are conducted via telephone calls scheduled at the patient’s convenience as well as via secure messaging through our patient portal (MyGeisinger).
This approach allows improved access, efficient treatment decision planning, and enhanced patient engagement; the latter is paramount to a successful program as direct observation therapy is neither available nor feasible. Therefore, our program requires an additional outreach to the patient before prior authorization is initiated to ensure that the patient is “on board” with the plan and the lines of communication are open.
Coordination of Therapy
Upon receiving medication, the patient is instructed to contact the office before initiating therapy. During this telephone encounter, the patient is again provided with instructions regarding drug administration, with an emphasis on the importance of taking the medication as prescribed as well as on pertinent drug interactions and their management.
A treatment calendar is created for each patient to serve as a visual reminder of lab-work dates and medication refills. Follow-up lab tests are ordered and scheduled to provide a timeline for the patient; in addition, a nurse coordinator calls to remind the patient of any upcoming lab work. Subsequently, the clinical pharmacist contacts the patient to review the results, assess adherence, and manage adverse effects. This process continues until the patient is cured.
Affordability of Treatment
For patients who are not able to afford treatment, we utilize manufacturer-based copay assistance programs and grant money from public foundations. At Geisinger Clinic, no patient has ever been denied treatment because of financial difficulties.
This effective operation was not created overnight. Throughout the 2 years of development, we faced and overcame a number of implementation challenges:
- Achieving consensus regarding treatment candidacy and choice of medications (protease inhibitor vs. non-protease inhibitor-based therapy) required several meetings with clinical providers.
- To ease the workflow for the clinical staff and to provide practice structure, it was necessary to establish strategies and guidelines for the management of patients who were actively using illicit substances or alcohol and patients with cirrhosis who were candidates for transplantation.
- The techniques to assess liver fibrosis have changed over time. Although liver biopsy is the gold standard, it is not mandatory. Previously, we had used screening blood tests; however, as mandated by various health insurances, this practice was abandoned in favor of ultrasound elastography, which led to changes in patient scheduling and in the work flow of various team members. These changes were frequently communicated to Geisinger Health Plan liaisons, which improved efficient treatment authorization.
Our multidisciplinary team included physicians (gastroenterologists/hepatologists), pharmacists, nurse coordinators, nurse practitioners, data analysts, system leadership, research, and representatives from the Geisinger Health Plan.
Sustained Virologic Response Rates
Among patients treated with the ProvenCare model at Geisinger, the sustained virologic response rate at 12 weeks after the completion of therapy was 94%, with only 3.6% of patients lost to follow-up (as determined on the basis of insurance claims data and manual chart review).
In comparison, the cure rate among Geisinger Health Plan-insured patients who were treated at non-Geisinger facilities was 56%, with 44% of patients lost to follow-up. These findings indicate that the ProvenCare model ensures a very high rate of patient follow-up and adherence to treatment; we believe that it also provides an effective method to track patient status in real time through close follow-up and documentation.
Patient and Clinician Satisfaction with Program
Although we did not measure patient satisfaction objectively, patients appeared to be very appreciative of the respect for their time and close follow-up throughout treatment, as often verbalized during telephone encounters (especially when we provided them with the news that they had been cured). Moreover, in an internal survey of 12 clinical providers using a 5-point scale, 10 rated their satisfaction as 5 (very good) and 2 rated it as 4 (good).
The primary goals of the ProvenCare program are to reduce the HCV burden and to remove unwarranted variation in clinical delivery. Therefore, we are currently assessing the impact of the model on the reduction in HCV-induced cirrhosis and associated morbidity as well as on health care costs. Implementation of this model has led to pointed contracting and may have led to discounted drug pricing with some vendors, although this is only speculation.
Where to Start
To implement similar approaches to the care of patients with HCV, an organization must:
- Understand current care processes, including gaps and barriers to care.
- Organize a multidisciplinary team of all relevant stakeholders.
- Develop a clinical care vision and take actions that are both evidence-based and sensitive to patient needs.
- Implement a data infrastructure to monitor the impact of the program. At Geisinger, we used the Tableau-based Hep C dashboard, which pulled data from our EMR system to track sustained virologic response rates (both overall and by genotype), fibrosis, therapy used, and so on. This step may require upfront investment to create the necessary programs or could be as simple as using formatted spreadsheets to track each patient’s status along with a universal documentation method.
- Incentivize the clinical staff involvement and designate a clinical champion who drives implementation. At Geisinger, the Gastroenterology and Pharmacy departments were incentivized to hire additional nurse coordinators and clinical pharmacists, respectively. Initially, the program was steered by physicians, but once the process was developed, the clinical pharmacists (e.g., Sara Gaines, PharmD, at the main Geisinger Campus and Julienne Hanley, PharmD, at Geisinger Wyoming Valley) became the champions to maintain and direct the process and day-to-day practice.
Contributors: We thank Kristi Clarke, Julienne Hanley, Jeremy Vilcheck, Mike Evans, Bret Yarczower, John Bulger, Joe Chronowski, Eric Wright, and Michael Gionfriddo for their contribution to the development of the ProvenCare Hepatitis C program and dissemination.