Kari Amundson, RPH

Fairview Specialty Pharmacy is part of an Integrated Delivery Network which has ownership of the University of Minnesota Hospitals and Clinics. Fairview Specialty Pharmacy set out to design a program to work collaboratively with providers at the University of Minnesota Medical Center (UMMC) to maximize outcomes and decrease waste for patients on therapy for hepatitis C, and apply these learnings to benefit patients seen by providers outside of the health system. The goal of Fairview Specialty Pharmacy’s Hepatitis C Therapy Management program is to help patients remain safely and appropriately compliant on a complex drug regimen, and maximize the return on both financial and personal investment for patients and payers. Based on guidelines and prescribing information, we developed an algorithmic-based therapy management program utilizing targeted questions to identify patients who can benefit from specific resources including side effect management, coaching, and financial support. CaseTrakker is utilized as a case management system to administer scripted algorithms, collect data, and provide reporting.

Prior to approval of the protease inhibitors, our specialty pharmacy team met with the physician assistant at the University of Minnesota Medical Center to gain buy-in for our Hepatitis C Therapy Management program. We described the program and communicated our intent to provide support and monitoring. We assumed this over-stretched provider would welcome help, but were surprised to find this was not the case. She told us that she would be solely following her patients, and had time to see, educate, and spend time on the phone with them. We abided by her request and did not enroll her patients in our program. We continued to provide refill reminder calls, navigate insurance and financial issues, and provide pharmacist counseling. We only offered ongoing nursing support when requested by the patient.

In the spring of 2011, we planned for the potential launch of the protease inhibitors. The trials were indicating considerably improved success rates, yet these products brought a new level of complexity for patients to remain safely and appropriately compliant to the drug regimen. We believed our therapy management program would be instrumental in addressing the challenges for providers and patients to appropriately start and stop these drugs per protocol, manage difficult side effects, and maneuver challenging drug interactions.

We again approached the physician assistant to discuss how we could help manage the new triple therapy regimen. She requested a pharmacist review of patients’ medications for drug interactions before triple therapy was prescribed. She provided 3 questions for our professional staff to ask with refill calls. She also requested notification about every rash, no matter how minor. We agreed to limit our program to these components for her patients.

By doing exactly as we agreed, we began to build trust with this provider. When compliance issues were identified, we alerted the provider and worked together to find individualized solutions. We instructed patients with rashes, fevers, and other serious adverse events to contact this provider. As she began to see value in the additional information we offered and realized we were not trying to duplicate or replace her role, we began to exchange information and dually support these patients. This individual now recognizes the value of specialty pharmacy as part of an integrated care team, and our role has expanded.

Additionally, a culture of collaboration developed through this process. There are ongoing discussions about ways to enhance patient education and discussions about whether to continue individual patients on therapy. The clinic has shared its protocol for managing hepatitis C post liver transplant. Collaboration and communication is even more vital for the transplant population because there is greater potential for drug interactions, inadequate viral load responses, and side effects. Patients benefi t from additional support, improved communication, and consistent messaging. Since language barriers and social issues often impair patients’ ability to adhere to the complicated hepatitis C regimen, interpreters and social workers are also an important part of the team. We are better able to serve patients as an integrated team than as separate silos.

It quickly became clear that integrated, coordinated care and access to the electronic medical record (EMR) provide many unique opportunities to enhance overall care of hepatitis C patients. Prescribers contact Fairview pharmacists via the EMR to review the medications before hepatitis C prescriptions are written. Medications that interact with the hepatitis C therapy protocol (eg, anti-epileptics and statins) are adjusted or held before initiating therapy. Changes are noted in the EMR so all providers have up-to-date and accurate information. Our therapy management team documents information received from patients (eg, compliance and side effects) in the EMR for caregivers to see throughout the course of therapy. We also access the EMR to note previous response history, medical conditions, and intended therapy course to ensure proper duration and counseling. Before sending refills, our professional staff accesses the EMR to review blood counts, check viral loads, and verify that patients are adhering to clinic and laboratory appointments. Access to the EMR also enables monitoring of patients across sites of care. For example, we discovered and addressed a case where pegylated interferon and ribavirin, but not telaprevir, were discontinued in a patient hospitalized due to anemia.

A case management system is used to document results, which are presented to payers to help them develop effective and effi cient benefi t strategies.

Viral loads are reviewed and documented to verify that patients should remain on therapy and report therapy outcomes. The majority of patients complete therapy. No patients have stopped without the knowledge of the provider, and all discontinuations have been appropriate (eg, significant side effects or inadequate viral loads).

Medication Possession Ratios are above 90%. In addition to managing drug interactions, side effects, and adherence issues, Fairview Specialty Pharmacy staff have made other important interventions. Examples include:

• Preventing ordered, but unneeded, refills of telaprevir beyond the FDA-approved duration of 12 weeks. By preventing this 28-day refill, $21,000 (AWP) per month per patient in wasted medication was avoided.

• Keeping patients on track by ensuring the correct dose and duration of each medication. In one case, our nurse corrected a patient who was planning to discontinue all 3 medications at 12 weeks (instead of just telaprevir) because his viral load was undetectable at week 4. In another case, we intervened after identifying a patient who was taking ribavirin 3 times a day to “catch up” with missed doses.

• Identifying and alerting prescribers to cases where only 24 weeks versus 48 weeks of therapy are necessary.

• Contacting prescribers to obtain timely refi ll authorizations and expediting orders to ensure the appropriate duration of therapy is completed without interruption.

• Coaching patients to safely remain on therapy when experiencing mild to moderate side effects.

• Working with patients to fi nd grants, foundation support, and other sources of funding to help them afford therapy for the duration.

• Providing additional injection training when patients change health plans while on therapy, requiring a switch to an alternative pegylated interferon product.

After observing the complexity of hepatitis C therapy and seeing where patients can slip between the cracks, it is evident that a specialty pharmacy functioning in a silo does not work. Providing optimal care of patients on hepatitis C therapy demands that specialty pharmacies work closely with providers and payers.

A multi-disciplinary team approach that includes the specialty pharmacy best addresses the complex needs of this patient population. Ideally, timely information should be available to all members of the care team via the medical record. Obtaining provider buy-in is essential, but trust must be established first. We believe professional staff (nurses, pharmacists) should be managing refills in the specialty pharmacy, as these regimens are complicated and professional judgment is required to act on information gathered to triage patients appropriately.

Learnings garnered from data collected in our therapy management program are presented quarterly to payers for ongoing evaluation of utilization management strategies. With the significant expense of the hepatitis C triple therapy regimen, we believe utilization management strategies that ensure proper utilization and decrease waste are warranted. However, these strategies cannot interfere with patient compliance by preventing access to timely refills. In order to prevent interruptions, payers should proactively work with the specialty pharmacy to facilitate strategies that deliver results. Examples of strategies that make sense include:

• Utilizing a split-fill program (provide 2 weeks at a time) for telaprevir and possibly boceprevir. Telaprevir makes most sense, as it is more expensive per fill. Due to the logistics of lab appointments and lab results, we observe patients stopping therapy at week 6 versus week 4 or week 14 versus week 12.

• Allow only 12 weeks of telaprevir. Physicians may continue therapy for longer than 12 weeks in unique cases; however, there is no evidence to support additional benefit. In some cases, extra refills are accidentally indicated for telaprevir along with the other drugs. We alert the prescriber and cancel refills, although some pharmacies may miss this.

• Requiring labs before the next refill authorization is difficult due to logistical realities and may put undue stress on a clinic. By the time the lab results are available, the refill needs to be sent out. Ideally, the specialty pharmacy has access to the EMR and can monitor labs to ensure appropriate continuation.

• Preferring 1 pegylated interferon is an option, but payers should evaluate the fi nancial benefi t versus the risk of interruption. It may be acceptable to prefer 1 protease inhibitor to decrease costs, but know there needs to be a mechanism for appropriate exceptions for comorbid conditions and concomitant medications.

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Integrated, coordinated care and access to the electronic medical record provide many unique opportunities to enhance overall care and decrease costs associated with hepatitis C therapy.