Focus on Hepatitis C: Bridging the Gap from New Drug Therapy to Successful Treatment

Specialty pharmacists can help patients achieve successful outcomes in the treatment of hepatitis C by providing comprehensive clinical consultations on triple therapies.

Clinical services for patients possess a clear and powerful role in treatment outcomes for complex chronic diseases. Today, many physicians and pharmaceutical manufacturers face continuous challenges of educating patients about new drug therapies and/or indications of drug therapies approved by the FDA. Providers and stakeholders are constantly challenged on how to safely transition patients to begin these new therapies and to assist their patients with completing therapy successfully.

New biologics are an integral part of modern medicine; however, often the side effect profile, coupled with a strict dosage regimen, can interfere with compliance and appropriate utilization of therapy, which may cause a delay in achieving overall positive outcomes. This is where the expertise of a specialty pharmacy can make a significant difference in terms of treatment outcomes.

COMPLIANCE AND PERSISTENCE: TWIN CHALLENGES IN SUCCESSFUL TREATMENT

Physicians are challenged with the ongoing issue of identifying whether a particular medication is effective for a patient, or if the source of the problem may be patient compliance. When reviewing the compliance of a patient on a challenging drug regimen one also has to assess the persistence of a patient to complete therapy. Compliance can be defined by determining whether the patient is taking the medication as directed. On the other hand, persistence can be determined by how long a patient stayed on therapy. Compliance and persistence are equally important for overall adherence to therapy.

Compliance and persistence can both be influenced by “patient activation,” which refers to providing patients with the skills and confidence to be actively engaged in their own health care. In other words, engaged patients are more likely to stay compliant and persist with a medication plan.

A study published earlier this year examined health care costs and patient activation, a metric measured by levels of motivation, knowledge, skills, and confidence, in 33,000 patients.¹ Patient scores in terms of patient activation predicted health care costs, even when differences in age, gender, income, and the severity of a patient’s disease were taken into account. Health care costs of those with the greatest level of patient activation were 8% to 21% lower compared with patients with the lowest levels of motivation, knowledge, skills, and confidence. Even when subsets of patients with the same chronic illness were examined, the pattern held true—those who were more actively engaged saw lower health care costs.

EDUCATION AND PATIENT SUPPORT

For patients who are beginning a therapy that has a new drug indication—or maybe it is a medication that is considered to be a limited distribution drug or a drug that is involved in a risk evaluation and mitigation strategies program—all will require close monitoring and professional drug therapy management. When patients are given prescriptions from their physicians there are many factors to consider including the patient’s:

• Demographics

• Support system

• Intellectual ability to comprehend the regimen

• Individual commitment to monitor personal health

Patient concerns about side effects can have a significant impact on compliance. According to a 2005 survey of 2507 adults conducted by Harris Interactive, nearly half of the respondents (45%) reported that patient concerns about side effects were a driving reason for not taking medications.²

“Here at BioPlus, we understand how difficult it is for patients facing challenging treatment protocols. This is why we’ve expanded the role of our pharmacists in the patient care process. Our pharmacists are the integration piece in the delivery of health care: bridging between the patient and the treating physicians,” explains Nick Maroulis, PharmD, director of pharmacy for BioPlus.

The more informed or educated a patient is regarding treatment, the more motivated that patient will be in terms of adherence. The Agency for Healthcare Research and Quality, which is part of the US Department of Health & Human Services, released a report reviewing evidence from 68 scientific articles about medication noncompliance and concluded that the strongest evidence for improved medication adherence lies with educational and case management interventions, which include reminders and pharmacist-led multi-component interventions.^3,4

Patients benefit from assistance from a multidisciplinary health care team to ensure adherence. The team of health professionals often includes physicians, nurses, pharmacists, and social workers. If the patient treatment plan includes a biologic medication, then a specialty pharmacy will be required to provide drug therapy management, clinical monitoring, compliance programs, shared responsibility, communication, and commitment to assist the patient with successfully completing therapy.

Noncompliance does not just affect treatment outcomes; it also results in additional health care spending. According to the National Council of Patient Information and Education, researchers have calculated that approximately $100 billion has been spent secondarily as a result of non-adherence to medication.⁵ The World Health Organization predicts that this problem will continue to grow as challenges arise with the burden of treating chronic diseases such as the hepatitis C virus (HCV).

“Our team approach and motto for clinical monitoring of patients and assisting patients as they begin new drug therapy or an indication is very simple; it all starts and ends with, ‘How may we help you?’,” notes Dr. Stephen Vogt, president and chief executive officer of BioPlus. The pharmacy is willing to make every effort to help a patient transition to a new medication with a new indication when it comes to market. Its clinical team is committed to counseling and educating every patient about compliance, adherence, and providing drug therapy interventions if necessary. BioPlus is committed to helping to bridge the gap between beginning therapy, adhering to therapy, and completing therapy successfully.

THE PATIENT EXPERIENCE

One of the essential functions as a specialty pharmacy is to provide a voice for patients and to listen intently to patient concerns. BioPlus is deliberate in providing advocacy for our patients so that they may experience a seamless process from when a prescription is ordered by a physician, given to a patient to take to a pharmacy for dispense, filling the prescription, adhering to the prescription, and completing the treatment successfully.

The BioPlus team of patient care coordinators is the foundation for a solid structure of clinical assessments for patients. They coordinate patient care by providing courtesy calls to patients, scheduling shipments, and reporting noncompliance of treatment to our pharmacists who then can intervene, counsel, and report to the physician. Patient care coordinators are responsible for logging activities for patients who begin service and documenting a current response to therapy—especially if it pertains to an adverse reaction and/or adherence—by utilizing a pharmacist internally designed software program called “BioAssessments.” This guides the patient care coordinators through assessment questions that help to document patient progress and response.

Patient care coordinators request labs for patients, notify the prescribing physician of labs, and forward this information to a clinician for appropriate assessment. They gather pertinent information from patients to ensure compliance, which is priceless for patients who are on more challenging drug regimens, such as triple therapy for hepatitis C.

Data is collected via the BioAssessments program and then e-mailed to a pharmacist for review. The pharmacist then intervenes, as needed, with a patient consultation or physician interaction.

Patient care coordinators connect patients to a clinical pharmacist by asking a series of questions, including:

• How well are you tolerating treatment?

• Have you missed any doses?

• Have you started any new medications?

• What is your most recent weight?

• How many doses do you have on hand?

• Would you like to speak with a clinical pharmacist for a consultation?

TECHNOLOGY LINKS KEY PLAYERS

BioPlus leverages technology to foster fast, easy connections among the key health care players. The Therapy Access Portal (TAP App), an application for prescribers to use on tablets and laptops, incorporates and applies data to improve health outcomes for patients. Prescribers can use the TAP App to connect with a patient’s entire medical pharmacy care team, giving them full visibility to their patients while they are being serviced by Bio-Plus. Prescribers can submit and manage e-scripts, as well as view real-time information about patient compliance, see when refills are needed, review drug profiles, and view interventions by BioPlus’ clinical pharmacists.

NEW HOPES AND NEW CHALLENGES

Approximately 4 million Americans are infected with the HCV, yet an estimated 1.6 million remain undiagnosed. The virus can remain asymptomatic for up to 20 years, but eventually is associated with serious health problems, including cirrhosis, liver failure, and liver cancer. The new gold standard for treating hepatitis C—triple therapy of pegylated interferon, ribavirin, and a protease inhibitor—is very effective in clearing the virus and reducing mortality.^6,7 In fact, it is more effective than any prior treatment, offering the potential of a meaningful cure for up to 70% of HCV infections. However, it is associated with side effects for the majority of patients. As an additional challenge, there are also numerous drug interactions with this triple therapy.

Since the approval of protease inhibitors as adjunct therapy for HCV in April 2012, manufacturers realized that patients would need strong education and support to manage the drug interactions and side effects in order to maintain adherence and treatment completion with this therapy.

The clinical support team at BioPlus works diligently to overcome patient barriers to achieve optimal patient compliance. The clinical team is available to help all patients who begin protease inhibitors with the standard HCV regimen, with a special focus on identifying the major concerns for which patients may need consultations and provide education on those issues.

After a thorough review of the new protease inhibitors indication and addition to the standard of care for hepatitis C, the clinical team at BioPlus provides drug therapy management for patients starting protease inhibitors with ribavirin and pegylated interferon (peginterferon), and provides approximately 100% of the triple therapy hepatitis C patients’ consultations for the reasons shown in Tables 1 and 2.

TRIPLE THERAPY CONSULTATIONS

The majority of patients receiving consultations with a pharmacist during HCV triple therapy are genotype 1 patients. All patients admitted to service for telaprevir or boceprevir in combination with peginterferon and ribavirin are provided a general overview of the warnings and precautions associated with these protease inhibitors. Both females and males are educated regarding the risk of pregnancy while on protease inhibitors and the appropriate contraception to use, if needed. Patients receive a thorough education about the common adverse reactions with protease inhibitors and are instructed on how to manage mild side effects with OTC medications. Moderate and severe side effects are also discussed.

Dosing and administration are key areas of concern for patients. Instructions are provided for proper injection techniques for peginterferon. Dosing schedules are established for patients administering both ribavirin and telaprevir or those administering ribavirin and boceprevir. Information regarding nutritional considerations is provided for patients in order for patients to take the protease inhibitors according to the manufacturer’s food intake recommendation. Patients receive a review on the importance of compliance and how to resume therapy if a dose is missed. Patients are warned and educated about the potential drug interactions of the treatment with their other medications, and a complete drug utilization review is provided for all patients.

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OVERCOMING FINANCIAL BARRIERS

In addition to providing clinical consultations, BioPlus works tirelessly to guide patients toward financial assistance, if required. It’s not uncommon for patients to discover serious shortfalls between their insurance coverage and ability to pay. In some cases, patients can’t start treatment because they are unable to financially bridge the difference of a very high deductible.

This is where the patient foundation assistance program at BioPlus steps in. “Last year our program successfully connected BioPlus patients with $5.1 million in foundation grants and co-pay assistance,” notes Dr. Vogt. “We’re proud of the patient funding we facilitated for patients last year and we’ll continue our work with patient foundations and copay assistance this year and beyond,” he adds.

By some estimates, 1 in 8 oncology patients cannot afford the copay for their specialty medications.⁸ Similarly, a literature review last year noted that over the past few years, the increase in the patient share of medication costs has been negatively impacting patient adherence.⁹

The patient foundation assistance program at BioPlus is a unique program with dedicated staff who actually process the funding foundation paperwork for patients, rather than simply pass along telephone numbers for the patients to investigate themselves, and provide direct copay assistance. The comprehensive clinical services provided by BioPlus ensure successful treatment outcomes for the greatest number of our patients. This is the core value of the unique approach at BioPlus Specialty Pharmacy. SPT

References:

1. Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff. 2013;32(2):207-214.

2. Harris Interactive medication adherence online survey. The Wall Street Journal Online’s Health Industry Edition. Published 2005.

3. Closing the quality gap: revisiting the state of the science series: medication adherence interventions. Comparative effectiveness. Structured abstract, September 2012. Rockville, MD: Agency for Healthcare Research and Quality.

4. Executive summary. Closing the quality gap series: medication adherence interventions: comparative effectiveness. Evidence Report/Technology Assessment number 208. Sept. 11, 2012.

5. Enhancing prescription medication adherence: a national action plan. National Council on Patient Information and Education. Published 2007.

6. Kim JJ, Culley CM, Mohammad RA. Telaprevir: an oral protease inhibitor for hepatitis C virus infection. Am J Health Sys Pharm. 2012;69(1):19-33.

7. Zaman A. Successful clearance of hepatitis C virus is associated with lower all-cause mortality. JW Gastroenterology. Published January 11, 2013.

8. Rajurkar SP, Presant CA, Bosserman LD, McNatt WJ. A copay foundation assistance support program for patients receiving intravenous cancer therapy. J Oncol Pract. 2011;7(2):100-102.

9. Eaddy MT, Cook CL, O’Day K, Burch SP, Cantrell CR. How patient cost-sharing trends affect adherence and outcomes: a literature review. P T. 2012;37(1):45-55.

About the Author

Kimberly Hicks, PharmD, MHA, is the clinical pharmacy specialist at BioPlus Specialty Pharmacy. She specializes in disease and drug therapy management of patients on biotech medications, with a special emphasis on hepatitis C management. She is a licensed pharmacy consultant with the state of Florida and an active community health educator.

BioPlus is a pharmacist-owned, URACaccredited, national specialty pharmacy providing high-touch services and specialty pharmaceuticals for patients with chronic diseases, such as hepatitis, bleeding disorders, immune deficiencies, neuromuscular disorders, cancer, and other conditions. Licensed in all 50 states, BioPlus is one of the nation’s largest independent specialty pharmacies.It is accredited by Verified Internet Pharmacy Practice Sites (VIPPS) and the Accreditation Commission for HealthCare (ACHC). Patients can contact the pharmacy toll free at (888) 514-8082.