Hepatitis C Case Study -Adherence to targeted therapies

Hepatitis C Case Study at Prosperity Specialty Pharmacy
Published Online: Monday, September 12th, 2011 Stephanie S. Holliday, PharmD, and Rosemary Kerwin, PharmD

Adherence for targeted therapies is even more essential now than it ever has been. This case case studies of services offered at a specialty pharmacy illustrates the impact of hepatitis C patients.

As the delivery of pharmaceutical agents evolves, patients will appreciate an increase in autonomy regarding medication administration. Historically, many medications required administration in an infusion suite. However, more and more medications are being formulated or reformulated for oral administration at home. There are even opportunities to increase dosing intervals from daily to weekly.

Targeted therapies allow for improved medication side effect profiles, affording patients the opportunity to receive once-debilitating treatment regimens for a reduced duration. With this autonomy, however, comes a greater need for patients to maintain medication adherence. In the case of hepatitis C (HCV), adherence is more essential now than it has ever been.

In May 2011, 2 specialty agents within a new class of medications for hepatitis C (HCV) were approved and quickly adopted as the current standard of care when used in combination with pegylated interferon and ribavirin. This new regimen allows for a shortened course of therapy for patients with HCV genotype 1. Patients expecting 48 weeks of therapy now have an option to be treated for 24 or 28 weeks.

Despite the allure of the shorter treatment duration, these protease inhibitors are particularly prone to HCV viral resistance when not taken as directed. As little as a single missed dose of the 3-times-daily protease inhibitors can lead to viral resistance and ultimate regimen futility. This is in significant contrast to previous therapies for HCV that have proven reliance on adherence for positive outcomes, as reported in several studies which have shown an improvement in cure rates when patients take more than 80% of their doses for at least 80% of the prescribed duration.

Preventing Barriers
While patients are realizing more autonomy with medication administration, providers must focus on preventing barriers to medication adherence. These barriers are present for most, if not all, self-administered medication regimens. The potential influence of acute and chronic side effects on therapeutic outcomes establishes a need for patient education before and during therapy with specialty medications.

These side effects can be debilitating, ranging from flu-like symptoms to kidney failure. Most specialty medications will carry black-box warnings related to their toxicities and they require frequent laboratory visits and trips to provider offices to monitor the unwanted physical and mental effects of some treatments. The effects on a patient’s quality of life are significant with specialty medications as well. Many patients may alter their work schedule due to fatigue and insomnia, become self-conscious due to hair loss, or seek assisting devices to cope with muscle weakness and bone pain.

In addition to medication side effect profiles, cost ranks as a significant barrier to adherence. The financial impact on a patient’s life as they initiate a specialty medication regimen can be quite significant. For this reason, many patients will delay treatment until they are financially able to maintain the prescribed duration of therapy. Medicare Part D and private insurances include most specialty pharmaceuticals in their formularies; however, prior authorizations tend to slow medication delivery and the resulting copayments may still prove to be a financial burden.
Finally, although patients appreciate the option for autonomy when it comes to medication administration, this task can be both challenging and complex for those with physical and emotional barriers, as well as those with deficiencies in health literacy that may interfere with medication administration.

Hepatitis C Case Study
At Prosperity Specialty Pharmacy, a Community Specialty Pharmacy Network (CSPN) member located in Fairfax, Virginia, services include medication therapy management, drug–drug interaction checks, a refill reminder program, injection trainings, and providing patients access to disease-specific financial assistance. These services have translated into cost-saving outcomes for patients, providers, and the pharmacy.

With the help of a clinical pharmacy specialist, a pharmacy resident, student pharmacists, and clinically trained pharmacy technicians, the services at Prosperity Specialty Pharmacy have increased adherence rates for many patients. In an observational study conducted by the pharmacy’s community practice resident, entitled “Impact of a Specialty Pharmacy Refill Reminder Program on Hepatitis C Patient Adherence and Incidence of Early Virologic Response,” the impact of the pharmacy’s refill reminder program on rates of HCV patient adherence was assessed.

The study also aimed to determine the impact of adherence on early virologic response (EVR), an HCV viral load measure predictive of treatment success assessed at the end of the first 12 weeks of therapy with pegylated interferon and ribavirin. The study reported an 81% adherence rate to pegylated interferon and ribavirin over the initial 12 weeks of therapy. This outcome was compared with data from a study by Vincent et al (2009), which concluded that EVR was most common among patients with adherence rates to HCV therapy greater than or equal to 85%. Despite a less than optimal overall adherence rate for patients enrolled in the Prosperity Specialty Pharmacy study, 40% of study participants achieved EVR, while 29% of study participants in the Vincent et al study achieved EVR with an adherence rate of less than 85%. 1 Additional studies at Prosperity Specialty Pharmacy are underway and aim to further examine adherence rates and incidence of EVR and sustained viral load among the HCV patient population in hopes of defining the influence that specialty pharmacy can have on therapeutic outcomes.

Case Study: Step by Step
The refill reminder program at Prosperity Specialty Pharmacy is just one of the services provided to patients to ensure optimal treatment outcomes. The following case highlights many of the services available at Prosperity Specialty Pharmacy and other specialty pharmacies like it.
Day 1: Receipt of Order
Patient name: John Smith
Date of birth: 10/19/1954
Diagnosis: Hepatitis C
HCV genotype: 1a
HCV viral load: 5,123,345 IU/mL
Rx
1. pegylated interferon alpha-2a 180 mcg SQ QW
2. ribavirin 600 mg PO BID
3. telaprevir 750 mg PO every 7-9 hours with food

Upon order receipt, the pharmacy technician sends a fax to the prescribing physician’s office indicating that a prescription for Mr. Smith was received by the pharmacy. The pharmacy technician enters the prescription information into the pharmacy’s computer system, attempting to adjudicate a claim using the provided prescription insurance information. The claim is rejected by the patient’s insurance, with the request that a prior authorization be obtained. The pharmacy technician collects the necessary prior authorization forms from the third-party Web site and faxes them, along with a message to the prescribing physician requesting that the forms be completed and sent in to the third party for processing.

Day 2
The pharmacy technician resubmits the claim to see if it can be processed; the claim still can not be processed.

Day 3 The pharmacy technician resubmits the claim to see if it will be processed and the claim is paid. Mr. Smith is responsible for a $200 co-pay for a 1-month supply of medication. The pharmacy technician contacts the prescribing physician, letting her know that the claim was successfully processed and that a co-pay is due.

Next, the pharmacy technician calls Mr. Smith and explains the cost of the medication. Mr. Smith states that he will have a hard time paying $200 every month for his medication. The pharmacy technician informs him about assistance that may be available from the manufacturer and other charitable funding sources. The pharmacy technician is able to enroll Mr. Smith in an assistance program that will reduce his out-of-pocket expense to $50 a month.
The pharmacy technician goes on to explain the pharmacy’s free medication delivery, refill reminder program, injection training services, and drug–drug interaction check service. Mr. Smith signs up for an injection training session and provides the pharmacy technician with a list of his medications so that the clinical pharmacist can review it.

The pharmacy technician fills the patient’s order and places it in a queue so that it can be verified by a pharmacist. The patient’s initial shipment includes his medications, a welcome packet with a description of the pharmacy’s services, and an HCV starter kit from the manufacturer of the pegylated interferon. The staff pharmacist verifies the prescription order, ensuring proper dose, duration, and directions. Mr. Smith’s medication order is then set aside in preparation for Mr. Smith’s injection training.

The pharmacy technician sends a fax to the prescribing physician’s office letting her know when Mr. Smith will receive his medication. The pharmacy technician also provides the clinical pharmacist with the list of medications that Mr. Smith is taking, so that a drug–drug interaction check can be performed. The following list of medications is collected from the patient: amlodipine, lisinopril, St. John’s wort, bupropion, aspirin, and ibuprofen.

The clinical pharmacist notices 2 drug–drug interactions, which she calls the patient to discuss:
• Telaprevir amlodipine = increased concentrations of amlodipine
• Telaprevir St. John’s wort = decreased concentrations of telaprevir

The clinical pharmacist explains the interactions to Mr. Smith and provides additional counseling for the new medications he will receive from the pharmacy. She reviews the importance of adherence, what side effects he may experience, what to do if he experiences side effects, what over-the-counter and herbal products to avoid, and what to do if he misses a dose of his medications. Finally, the clinical pharmacist informs Mr. Smith that he will receive a call in approximately 3 weeks so that his next medication shipment can be ordered.
Noticing that Mr. Smith has signed up for an injection training session at the pharmacy, the clinical pharmacist proceeds to schedule the training and have Mr. Smith come into the pharmacy in 2 days. She explains that this will give her enough time to speak with the prescribing physician about the drug–drug interactions.
After speaking with Mr. Smith, the clinical pharmacist drafts a fax to the prescribing physician to let her know about the drug–drug interactions present within Mr. Smith’s medication regimen.

Day 4
Upon receipt of the drug–drug interaction report, the prescribing physician calls the clinical pharmacist and thanks her for collecting the medication list from Mr. Smith. She admits that she was not aware that he was taking St. John’s wort or ibuprofen. She asks that the pharmacy reduce his dose of amlodipine to 5 mg.
Mr. Smith arrives at the pharmacy to receive his injection training. During the training, the clinical pharmacist walks Mr. Smith step by step through the injection for pegylated interferon (PEgASyS). She also takes time to stress adherence and how important it is to report side effects. As the training session is about to end, the clinical pharmacist asks Mr. Smith if he has any additional questions. He replies “No, but thank you for taking so much time to help me.”

21 Days Later
The pharmacy technician calls Mr. Smith to schedule his medication refill. During the call, the pharmacy technician asks Mr. Smith how everything is going. She makes sure to ask him if he has been seen by the prescribing physician since he started his medication and if he has been adherent with his laboratory visits. Mr. Smith mentions to the pharmacy technician that he has developed a rash since he started taking his medications. He also mentions some anorectal discomfort.
Unable to address his concerns, the pharmacy technician proceeds in scheduling Mr. Smith’s refill and transfers the call to the clinical pharmacist, so that Mr. Smith’s concerns can be addressed. The clinical pharmacist assesses the patient for self care and recommends an over-the-counter steroid cream for the rash and a sitz bath for the anorectal discomfort. Finally, it is recommended that Mr. Smith discuss these side effects with his doctor at the next scheduled appointment.

7 Days Later
It has been about a month since Mr. Smith started taking his medication. The clinical pharmacist calls him to check in with him and see how he is doing. She is particularly concerned about the side effects that he was experiencing since starting the medication. Mr. Smith states that he is doing well and that his side effects have subsided thanks to the advice he received from the clinical pharmacist about a week ago. He states that he has been in to see the prescribing physician since he started the medication and was told that he is responding well to therapy.

Opportunities for Pharmacy-Based Clinical Services

Opportunities to provide clinical services through a specialty pharmacy are numerous due to the “high-touch” nature of this niche. As prescription volumes begin to increase due to a growing specialty pipeline, and the concept of payment for pharmacy-based clinical services matures, demand will shift toward pharmacy services designed to address medication adherence.
Determining where to integrate clinical services into the pharmacy work flow is the most challenging aspect of this endeavor. Specialty pharmacies might seek the talents of community pharmacists who have experience with clinical program development or those who have completed a community practice residency to address this demand. Training programs available through pharmacy associations may also assist in preparing pharmacists to provide specialty pharmacy–based clinical services. SPT
Stephanie S. Holliday, PharmD, is the clinical pharmacy specialist for Prosperity Specialty Pharmacy, an independentlyowned specialty pharmacy focusing on the medication-related needs of patients with complicated disease states. Dr. Holliday creates and manages the pharmacy’s clinical initiatives, including a refill reminder program, injection trainings, immunization clinics, and MTM.

Rosemary Kerwin, PharmD, is the director of clinical programs for Community Specialty Pharmacy Network (CSPN). She is also an independent clinical consultant for the pharmaceutical industry and practicing clinical pharmacist at Elwyn Pharmacy and Specialty Care in Glen Mills, Pennsylvania, where she focuses on disease management projects.

About CSPN
Community Specialty Pharmacy Network (CSPN) is a company founded by a group of independent pharmacy owners who have specific expertise in the specialty pharmacy segment. Their purpose of organizing collective capabilities provides a viable solution for specialty pharmaceuticals. CSPN is the largest community specialty network in the country. CSPN will provide a comprehensive framework of accredited members and web-based software to uniformly collect and report data. We partner with healthcare payors, pharmaceutical manufacturers, wholesalers, GPO’s, physicians, and patients, to deliver cost-effective biopharmaceuticals and programs that provide optimal patient outcomes.

CSPN Mission Statement
Our mission is to deliver a comprehensive care model that will have a positive impact on our patient’s lives. Our services are built on local trusted relationships with our patients, physicians, and healthcare providers. CSPN offers a unique costsavings alternative for managed care organizations and payors. We are currently composed of 185 credentialed specialty pharmacy operations in forty-two states and the District of Columbia and Puerto Rico.

http://www.pharmacytimes.com/publications/specialty-pt/2011/August-2011/Hepatitis-C-Case-Study-at-Prosperity-Specialty-Pharmacy-