Richard T. Miller, RPh, MBA

As part of its pharmacist-driven ConnectedCare Oral Oncology Program, Walgreens Specialty Pharmacy recently conducted a unique 3-month monitored-dispense pilot program, which reflects continued innovation, additional cost savings, and improved health care system communication.

Oral chemotherapy—an increasingly used method of cancer treatment&mdash;provides cost savings and significant quality of life benefits to patients.

 Despite its benefits, however, the treatment imparts challenges because patients take the medication at home and are not under the watchful eye of clinicians as they would be if they were receiving intravenous therapy. Patients are therefore more likely to take medications incorrectly, or stop them altogether due to side effects.

Pharmacists have stepped in to fill the gap in oversight, providing patient monitoring and counseling, and serving as a bridge between patients and physicians. As part of its pharmacist-driven ConnectedCare Oral Oncology program, Walgreens Specialty Pharmacy recently conducted a unique 3-month monitored-dispense (split-fill) pilot program. Building on an extensive, patient-centric program, the pilot reflects continued innovation, additional cost savings, and improved health care system communication.

Walgreens Specialty Pharmacy manages 27 oral chemotherapy specialty medications, supported by our ConnectedCare Oral Oncology program, which provides high-touch patient care on a continuum based on patient need and clinical current status. All patients who receive their oral chemotherapy through Walgreens Specialty Pharmacy are provided this care, which, at a minimum, also includes patient education and an extensive initial assessment prior to the start of therapy, as well as an additional assessment in the first month, and once-a-month assessments for the course of treatment. Conducted by pharmacy clinicians, assessments include compliance and refill reminders, adherence monitoring, side effect counseling and management, clinical data collection, and review of the medication profile for potential interactions.

A subset of ConnectedCare Oral Oncology patients—those who are prescribed 11 oral chemotherapy medications with a known high drop-off rate&mdash;are included in the Walgreens Specialty Pharmacy Cycle Management Program (CMP) and receive an additional assessment the first month. Those medications include sorafenib, sunitinib, erlotinib, everolimus, pazopanib, dasatinib, nilotinib, bexarotene, vorinostat, bosutinib, and regorafenib.

Additionally, patients who take these high drop-off drugs (other than bosutinib and regorafenib), and whose insurance providers support the option, are eligible for the Walgreens split-fill program. The split-fill program prevents medication waste by providing a half-month’s worth of the medication at a time, rather than a full month. Many oral chemotherapy patients stop taking their medication long before the monthly supply is depleted, typically due to intolerable side effects or lack of therapeutic benefit. In the program, the patient receives a 14- or 16-day supply of the chemotherapy.

 If the patient tolerates and is able to continue with the chemotherapy, the remaining half-month of the prescription is filled.

Walgreens CMP was named best in class by an independent consulting firm, and early results of an ongoing analysis demonstrate the program’s benefit due to the patient assessment and split-fill features.

 The average potential direct savings for the payer from avoiding medication wastage is more than $934 per patient who discontinued use in the first month of therapy

Because Walgreens pharmacists are available to help address adverse effects, patients in the program are less likely to visit the emergency department. Researchers estimate the probability of reduced hospital admission saves an average of $440 per patient.

 The combination of direct and indirect savings adds up to more than $1300 per patient, potentially resulting in multi-millions in savings when projected to a larger patient population.

Initially, the split-fill option was available only in the first month of treatment, but after analyzing the data, Walgreens realized that some patients were able to take their medication for the first month, but stopped taking it in the first half of the second or third month. Walgreens launched a pilot program to determine whether the split-fill option would be valuable if applied to months 2 and 3 as well.

The pilot program included 50 patients who were members of a large regional insurance plan in the Northwest. During the first 3 months, Walgreens filled the prescriptions twice a month (rather than once a month). After the initial pre-therapy assessment, pharmacists continued to assess the patients twice each month—once in the middle of the month and once at the end, around the time of the refills.

From July to December 2012, Walgreens tracked outcomes and 11 of the 50 patients stopped taking their medications at some point in the first half of the dispensed month during the expanded 3-month splitfill program: 5 stopped in the first half of the first month, 3 in the first half of the second month, and 3 in the first half of the third month. After 3 months, the 39 patients remaining on their initial therapy received monthly refills and assessments.

Of those who discontinued therapy in the first 3 months: 29% did so due to challenging side effects; 29% had died; 14% transitioned to hospice care; 14% had a change in insurance to a company that did not support the split-fill option; and 14% had their therapy discontinued by their physicians for unknown reasons. By extending the split-fill program to 3 months for those patients, the insurer saved 5% of the total monthly specialty oncology drug spend on those patients. That is significant, as a 1-month prescription for these medications is typically about $10,000. Preventing $5000 a month in unnecessary spending per patient can add up quickly.

Walgreens tracks potential savings in all patients prescribed any of the 9 potential split-fill medications, even if the payer does not support the option. Walgreens reports data on a quarterly basis to those insurers regarding the savings they would have accrued had they supported the splitfill option. In light of those reports, several payers have begun supporting the split-fill program.

Walgreens continues to look for innovative opportunities to better serve patients and help customers save costs. Extending the split-fill option to 3 months is an example of such an enhancement. As more oral chemotherapy medications are approved, Walgreens will continue to assess whether they should be included in the CMP and split-fill programs.

Mike Ellis, BSPharm, is corporate vice president, specialty pharmacy and infusion for Walgreens. Before joining Walgreens in October of 2011, he served as the senior vice president of specialty trade relations and contracting and pharmaceutical services for CVS Caremark. His more than 29 years of experience covers both the specialty pharmacy and infusion services industries, including senior positions with companies including AdvancePCS, Olsten Health Services, Caremark, CVS, and Quantum Health Resources. Ellis is a licensed pharmacist and earned his bachelor of science in pharmacy from the University of Arkansas, College of Pharmacy.

Richard T. Miller, RPh, MBA, is the director, specialty clinical services for Walgreens Specialty Pharmacy, based in the Carnegie, Pennsylvania office. He has more than 20 years of experience in pharmacy practice and health care management, working on a wide variety of projects involving pharmacy operations in retail, specialty, institutional, and industry pharmacy settings. In his current role, Rick is responsible for managing clinical program content, development, and strategy; clinician and patient education programs; oversight of the Walgreens Specialty Pharmacy — Duquesne University PGY1 residency program; and specialty pharmacy pipeline analysis, with all responsibilities focusing on improving clinical outcomes and the quality of life of Walgreens Specialty Pharmacy patients. Rick holds an MBA from the University of Florida Warrington College of Business Administration as well as a BS in pharmacy from the University of Florida College of Pharmacy and a Master Certificate in Six Sigma – Healthcare from Villanova University. Rick is currently a registered pharmacist in Pennsylvania, Florida, Virginia, and Illinois.

Articles

Walgreens Split-Fill Case Study: Preventing Waste Through Extension of a Cost-Saving Program

The challenges of new oral chemotherapy treatments lead to a renewed focus on high-touch patient care and the expanded role of the specialty pharmacist.

The oncology chemotherapy landscape is evolving rapidly. Not long ago, cancer patients could only receive chemotherapy intravenously at a doctor’s office, hospital, or clinic. Although intravenous oncolytics still dominate the market, cancer medications increasingly are available in oral form. It’s probable that this trend will continue since nearly half of all medications in the chemotherapy pipeline are oral. This presents one of the biggest challenges in oncology in recent years as adherence increasingly becomes the responsibility of the patient.

Patients perceive the shift to oral chemotherapy as a positive, citing convenience as a major—and understandable&mdash; benefit. However, they also are likely to believe oral chemotherapy is safer than intravenous treatment when in reality the protocol poses added risks. No longer under the watchful eye of clinicians, patients are more likely to take the medication incorrectly, inadequately, or stop taking it altogether due to adverse events. These and other factors lead to waste and less effective treatment.

But with this challenge comes the opportunity to elevate the role of specialty pharmacy and improve patient care. Effectively addressing these issues can lead to a renewed focus on hightouch patient care, improved integration of health care teams, and decreased costs. That translates into benefits for patients, providers, and payers. Walgreens Specialty Pharmacy bases its oral chemotherapy programs on extensive patient contact and follow-up, close communication with providers, and realworld solutions to problems. Results to date have borne out the approach.

While a few oncology medications have been available in oral form for a number of years, recently the cancer medication development pipeline has become flooded with oral forms of chemotherapy. Currently, more than 2 dozen oral chemotherapy medications have received approval from the Food and Drug Administration. Of the 51 unique new molecular entities in the chemotherapy medication development pipeline being tracked by Walgreens, we estimate that nearly half are oral, while the remainder are infused or injected.

This evolution is causing an increasing shift away from treatment in hospitals and clinics toward in-home care. While convenient, oral chemotherapy places the responsibility on patients to ensure they are taking the medication correctly. Consequently, adherence becomes a major problem due to several factors:

		Patients frequently misunderstand directions for taking medications. A Northwestern University study of 395 patients found that they misunderstood dosing instructions up to 33 percent of the time. This is of particular concern in the case of oral chemotherapy, as regimens can be especially complicated.

		Adverse effects from the medications may result in patients taking their medication less frequently or otherwise inadequately.

		The belief that “more is better” can lead to over adherence.

Lack of adherence also can lead to ineffective therapy. Patients may not report adverse events—or report them belatedly. Providers, therefore, may remain unaware of side effects their patients experience and the resultant lack of adherence. Conversely, they may learn of the problems after significant time has lapsed, making interventions more complicated or less likely to be beneficial.

Drug interactions also can be a concern, whether with food or other medications. Adverse effects can prompt patients to stop taking their chemotherapy sooner than prescribed. Although oral chemotherapy prescriptions typically include a month’s supply, patients bothered by side effects often stop taking the drugs long before they are gone. This results in costly drug waste, exacerbated by the extreme expense of some of these medications.

Many of these issues can be attributed to the lack of provider control and monitoring of treatment due to decreased visibility—particularly compared with intravenously administered chemotherapy&mdash;and suggests that patients require more guidance. Although challenging, the scenario creates opportunities for specialty pharmacy to fill the gap by providing patient monitoring and counseling, and facilitating the integration of care through closer communications with physicians and other providers.

The Walgreens Specialty Pharmacy clinical program provided to all of our oral oncology patients is built on a foundation of solid, high-touch patient care that includes extensive and frequent outreach to patients, as well as communication with their physicians. Walgreens Specialty Pharmacy’s clinical oral oncology program was developed based on National Comprehensive Cancer Network and National Cancer Institute guidelines, and is externally validated by an oncology advisory board.

The program features 2 clinical assessments conducted by Walgreens Specialty Pharmacy clinicians: initial assessments for patients new to therapy and follow-up assessments to determine adherence, as well as remind patients when it is time to refill their prescriptions. When patients decline a refill, clinicians explore the reasons, which often are complex, and report the information to the physician.

The initial assessment involves an extensive in-depth review of the patient’s general health, cancer diagnosis, and the range of health-related issues with which the patient is coping. Walgreens Specialty Pharmacy also provides patients with educational materials to aid them in understanding their disease and treatment, as well as financial assistance support when appropriate.

Specially trained clinicians monitor adherence, counsel patients on side effects, and help them manage drugrelated issues. Clinicians track start and stop dates, dose changes, doses withheld, doses missed (and the reasons for the lack of adherence), and side effects. Pharmacists review patients’ entire medication profiles for potential interactions, providing an opportunity for intervention that previously didn’t exist. This in-depth assessment is crucial. For instance, many oncology patients take over-the-counter herbal supplements without their provider’s knowledge. This could impact the effects of a particular drug and is the type of information this assessment is designed to uncover.

An added benefit is the ability of Walgreens Specialty Pharmacy to synergize with Walgreens community pharmacies, which benefits patients by alerting specialty pharmacists to any potential interactions with other medications the patient is taking, provided they are filled through one of Walgreens 8000 community pharmacies.

Throughout the process, we collect clinical data to aid in the development of best practices.

The depth and breadth of the program has proved beneficial, with medication possession ratio rates typically reaching 90 percent or higher based on internal analysis of clinical data.

Serious adverse effects of chemotherapy and the challenges of maintaining a strict medication regimen are key factors in chemotherapy non-adherence. To address these concerns, Walgreens Specialty Pharmacy has instituted the Cycle Management Program (CMP). Named best in class by an independent consulting firm, the CMP provides addi tional support to patients who receive certain oral chemotherapies by focusing on early identification and management of side effects. Side effects are managed by intervening on the patient’s behalf with the provider. These interventions may include a change in dose, change in frequency, discontinuation, or switching to a new medication. The CMP utilizes a unique dose-monitoring plan (split-fill), which reduces medication waste, resulting in cost savings for payers and patients.

Many cancer patients experience severe or intolerable side effects due to specific chemotherapy medications, necessitating the discontinuation of the oncolytic and, in many cases, a switch to a new medication. When medications are administered intravenously in clinical settings, side effects can be quickly identified and managed. Due to the relative lack of clinical supervision, oral chemotherapy adverse effect management is more complicated. When effects are particularly severe, patients often go to the emergency department for treatment. Additionally, while most oral oncolytic prescriptions are filled for a month at a time, many chemotherapy patients experience side effects relatively quickly, resulting in discontinuation of the drug long before the monthly supply is depleted. This results in wastage of valuable and expensive chemotherapy medication.

Patients enrolled in the CMP program are assessed by clinicians prior to beginning therapy, provided patient education, and typically receive a 16-day supply of medication if their payers utilize the split-fill option. The 3 oncolytics initially chosen for inclusion in the CMP program were those that had the highest drop-off rate and were available to be split into half-month supplies: sorafenib (for renal cell cancer and liver cancer), sunitinib (for gastrointestinal stromal tumor and renal cell cancer), and erlotinib (for non-small cell lung cancer and pancreatic cancer). Earlier this month, the program was expanded to include 6 new medications: everolimus and pazopanib (kidney cancer), dasatinib and nilotinib (leukemia), bexarotene and vorinostat (lymphoma).

The clinical team follows up with the patient in the early stages of therapy to assess side effects and provide counseling and intervention for those side effects as needed. The clinician works with the patient’s physician to determine whether the medication for the remainder of the month will be dispensed, or if the patient may benefit from switching to a different chemotherapy medication.

If therapy is progressing as planned and with minimal or manageable side effects, the remaining supply of the medication is dispensed. The pharmacist follows up with the patient again for input regarding side effects and interventions. At the end of the month, an adherence report is sent to the patient’s physician and the patient is transferred to the general oncology program and followed monthly moving forward.

Patients benefit from the program through increased understanding of the treatment protocol and the importance of taking medications as prescribed. Also, adverse events can be managed earlier, pre-empting serious problems. Physicians benefit from the support of increased monitoring of their patients and receive actionable information about their patients in a timely manner.

We have found the CMP to be highly valuable, reducing the amount of medication wasted by early discontinuation, as well as initiating proactive measures to reduce the number of patients who struggle with adverse side effects related to their treatment. Walgreens Specialty Pharmacy conducted a clinical analysis of 823 CMP patients who received 1 of the 3 initial drugs included in the program. Results were compared with 351 control patients who received 1 of those medications before the implementation of the CMP program and completed a patient assessment survey. After 1 month, therapy was discontinued (and the second half of the month’s medications unfilled) for 261 CMP patients (32 percent). Additionally, therapy would have been discontinued mid-month for 20 additional patients (7.7 percent), had their payers utilized the split-fill program. The average potential direct savings from avoiding medication wastage was more than $934 per patient who discontinued use.

The analysis also considered the decreased likelihood of patients visiting the emergency department as a result of unmanaged adverse effects. Using a linear mixed regression model, researchers estimated the probability of reduced hospital admission to be 2.9 percent, potentially resulting in an average savings of nearly $440 per patient.

The combination of potential direct savings from reduced wastage of medication and reduced hospital admissions adds up to approximately $1374 in potential per-patient cost avoidance— not insignificant in light of the growth in oral chemotherapy. Projected to a larger patient population, potential savings are in the multi-millions.

Oral chemotherapy is rapidly changing the setting of cancer treatment. Although patients benefit from the increased convenience, they are also at higher risk for receiving ineffective treatment due to decreased oversight of therapy. The CMP program continues to expand, including additional drugs, extended observation lengths, and additional planned enhancements.

The program utilizes methods to fill in the gaps created by this new treatment paradigm, resulting in cost savings and improved health care system communication. It will be the challenge of every specialty pharmacy service provider to address this changing marketplace. The care model needed to ensure patient care remains a top priority. 

Richard T. Miller, RPh, MBA, is the director of clinical services for Walgreens Specialty Pharmacy in Pittsburgh, Pennsylvania. He is responsible for managing clinical program content, development, and strategy; clinical and patient education programs; oversight of the Walgreens Specialty Pharmacy—Duquesne University PGY1 residency program; and specialty pharmacy pipeline analysis with all responsibilities focusing on improving clinical outcomes and patient quality of life. Rick obtained his bachelor of science in pharmacy and his MBA from the University of Florida. In addition he earned a masters certificate in Six Sigma – Healthcare from Villanova University. He has 20 years of experience related to health care and management, working on a wide variety of projects involving pharmacy operations in retail, specialty, institutional, and industry pharmacy settings. Rick started his career with Walgreens as a pharmacy intern, and held pharmacist, pharmacy manager and district pharmacy supervisor positions within Walgreens Co. Additionally, he has held the positions of director of operations at McKesson Specialty Pharmacy, product manager at McKesson Automation, manger of inpatient operations at Shands Hospital at the University of Florida as well as adjunct professor of pharmacy practice at the University of Florida College of Pharmacy.