Mike Ellis, BSPharm

The cost of complex therapies is soaring, and the challenge is to deliver access to these medications in the most cost-effective and clinically appropriate site of service.

From cancer and immune disorders to viral infections and infertility, specialty pharmacy is booming as the number of complex therapies for a range of diseases and conditions continues to grow. These medications often serve an unmet need—saving lives and providing significant improvement in quality of life.

While the clinical developments truly are remarkable, specialty medications are extremely expensive, costing an average of more than $3000 for a 30-day prescription—with some costing more than $300,000 per year.

 By next year, 7 of the top 10 medications by sales dollars will be specialty.

As a result, costs to payers for these complex therapies are soaring, despite the low prevalence of many of these diseases. For example, out of a sample size of 10,000 commercial health plan members, only an average of 8 or 9 typically receive infusions of Remicade (infliximab), a drug treating certain chronic inflammatory conditions in certain circumstances.

 But because Remicade, like virtually all specialty drugs, is expensive, covering even a few patients who receive it can have a significant financial effect on a health plan or self-insured employer.

The challenge is to deliver access to medications at the most cost-effective and most clinically appropriate site of service. Certain specialty pharmacies offer a number of programs that not only mitigate costs, but help to optimize care with a goal of driving out potential waste related to specialty drug use. Because of the high-cost nature of specialty drugs, even 1 missed opportunity to reduce waste can have a material financial impact on the patient and payer. Opportunities to minimize specialty pharmacy waste include clinical programs that help improve medication adherence (paying for a drug a patient doesn’t take correctly is a significant form of waste); utilization management programs that help minimize cost and ensure patients are taking the right medication at the right dosage; and site-of-care optimization programs that allow patients to receive specialty infusion therapy at home (or another location) at a cost that may be far less than the cost in a hospital outpatient setting, while benefitting from better quality of life.

These programs call attention to the benefits of focusing on individual patient management. Even though many of the diseases treated by these specialty medications are low prevalence, using 1 of these cost interventions for a single patient can result in significant cost savings—translating to more dollars available to pay for the treatment of other patients. Conversely, not employing these programs increases the financial burden of already costly therapies because those costs will otherwise continue to grow at an excessive rate. By mitigating the costs, these programs ultimately can help prevent the specialty trend from becoming unsustainable.

Medication adherence programs have long been recognized for their role in helping to ensure that patients take their medications correctly and as prescribed. This not only enables them to achieve the maximum clinical benefit from the therapy, it also results in decreasing the costs associated with disease progression. Many specialty pharmacies feature medication adherence programs that help maximize clinical outcomes and control costs, led by specially trained pharmacists, nurses, and technicians who provide ongoing patient support, helping them manage side effects and understand the importance of adhering to their therapy.

Less well recognized are utilization management and site-of-care optimization programs, which also decrease costs while improving care.

Utilization management programs—including dose-level monitoring, dose-frequency monitoring, formulary compliance, and waste minimization programs&mdash;can help reduce the cost to treat patients by increasing the likelihood that they are taking the correct medication at the most appropriate dose for the right length of time. Specialty pharmacy utilization management programs involve taking a close look at each patient.

For example, Stelara (ustekinumab), a treatment for adult psoriasis, comes in 45-mg and 90-mg doses.

 The average wholesale price of the lower dose is $31,000 annually and the higher dose is $62,000 annually.

 While Stelara’s prescribing information indicates that patients who weigh less than 220 pounds be prescribed the lower dose, Walgreens pharmacists have found that physicians occasionally prescribe the higher dose for patients below that weight threshold.

 Through the utilization management program, Walgreens’ clinicians communicate with the physician to allow the physician to reconsider whether the lower dose should be prescribed for those patients, potentially cutting the cost of treating that patient in half while maintaining a regimen consistent with the drug’s prescribing information.

Another example is Incivek (telaprevir), a treatment for adults with genotype 1 chronic hepatitis C in combination with certain other drugs.

 The prescribing information indicates that the Incivek treatment should continue for up to 12 weeks as part of a therapy regimen with peginterferon and ribavirin.

 However, sometimes physicians write a prescription for Incivek with “3 refills.”

 Filling all 4 prescriptions would result in 16 weeks of therapy at a drug cost for Incivek based on average wholesale price of $96,753 versus $72,565 for 12 weeks of therapy.

 Through Walgreens’ utilization management program, clinical staff communicate with the prescriber regarding when the patient should appropriately stop Incivek therapy. This may prevent the patient from refilling Incivek for the third time and taking therapy longer than required as well as save $24,188 of Incivek cost per unnecessary month of therapy.

Other medications are offered in a variety of strengths. Walgreens works closely with physicians as members of a patient’s health care team to discuss the prescription of a higher strength, when appropriate, rather than prescribing the lower strength and directing the patient to take 2 or 3 of those pills to equal the appropriate dose—a move that can be less cost-effective for many specialty medications. Walgreens also works closely with payers to uncover any opportunity for them to modify their prior authorization or other coverage criteria to better recognize these cost-savings opportunities as part of their coverage determination process.

Walgreens’ "split-fill" program is another utilization management program that can help reduce medication waste and cost. (See 

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

 online.) The program includes patients who are prescribed certain oral medications that have a high drop-off rate, typically due to the significant side effects of these medications or due to discontinuation associated with circumstances related to the disease itself. The split-fill program helps prevent medication waste by providing a half-month’s worth of the medication at a time, rather than a full month.

 If a patient stops taking the medication before the monthly supply is depleted, the medication for the second half of the month is not wasted, as it would be were a full month of medication prescribed. If the patient tolerates and is able to continue with the therapy, the remaining half-month of the prescription is filled.

Infused therapies make up approximately one-third of specialty medications and are increasingly being provided in a hospital outpatient department (HOPD).

 Yet many of the same infusion therapies can be provided at an alternative treatment site (ATS), such as in the home or at an infusion pharmacy, where it may be significantly less costly and can offer the patient a more convenient location for service.

 A Walgreens analysis of more than 5 million commercially managed lives over a 3-year period found that by choosing an ATS, health plans can benefit from savings of 20% to 60% in average cost per infusion.

Consider a patient receiving 32 grams of immune globulin every 3 to 4 weeks. The estimated cost based on average wholesale price for 15 infusions a year at the average HOPD would be $84,315 versus $49,150 for home infusion, a savings of more than $35,000.

 Based on Walgreens’ data, 7 500-mg Remicade infusions cost $38,850 a year at the average HOPD versus $24,500 a year at an ATS, a cost savings of $14,350 a year.

 Additional benefits may include improved quality of life, particularly if the patient is treated at home in the comfort of familiar surroundings.

One other consideration is to focus not just on the average HOPD cost, but recognize that costs vary widely by hospital, with some hospitals priced 2 to 3 times higher for the same medication versus an ATS.

 These particular situations can provide substantial savings opportunities through just a few successful interventions.

Ideally, all stakeholders in the industry—physicians, pharmacies, payers, and patients alike&mdash;should share the same objectives related to specialty pharmacy: eliminate financial waste and maximize the clinical outcomes of patients in an operationally efficient manner. Adherence, utilization management, and site-of-care optimization programs illustrate avenues for reducing the costs of therapy while maintaining or improving care patient by patient.

		Walgreens Specialty Pharmacy state of the industry report. Walgreens Health. www.walgreenshealth.com/pdf/newsletterreport/SOIReport2009.pdf. Published 2009. Retrieved May 23, 2013

		Host K. What lies ahead for specialty pharmacy? Benefitspro; March 19, 2012. www.benefitspro.com/2012/03/19/what-lies-ahead-for-specialty-pharmacy. Retrieved May 23, 2013.

		Remicade [prescribing information]. Horsham, PA: Janssen Biotech, Inc. www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5345lbl.pdf.

		Einodshofer M, Kansler S. Cost management through care management: a perspective on choosing the right specialty pharmacy partner: part 1. 

		Khandelwal N, Duncan I, Ahmed T, Rubinstein E, Pegus C. Impact of clinical oral chemotherapy program on wastage and hospitalizations. 

		Miller R, Ellis M. Walgreens split-fill case study: preventing waste through extension of a cost-saving program. 

		Stelara [prescribing information]. Horsham, PA: Janssen Biotech, Inc. www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s086lbl.pdf.

		Medi-Span Price Rx. Wolters Kluwer Health. www.medispan.com/drug-pricing-analysis-pricerx.aspx. Retrieved May 23, 2013.

		Incivek [prescribing information]. Cambridge, MA: Vertex Pharmaceuticals Incorportated. www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s008lbl.pdf.

		Milliman Specialty Medical Drug 2010 Commercial Benchmark Study, November 26, 2012. http://publications.milliman.com/research/health-rr/pdfs/specialty-medical-drug-benchmark-study.pdf. Retrieved June 3, 2013.

		Einodshofer M. Cost management through care management: part 2: the importance of managing specialty drug utilization in the medical benefit. 

		Einodshofer M. A plan for medical specialty medications — increase member access, affordability and outcomes while decreasing plan costs. Presented at 2012 Pharmacy Benefit Management Institute Annual Drug Benefit Conference, February 22-24, 2012; Scottsdale, AZ.

		Einodshofer M. Immune globulin model for success in the specialty pharmacy. Presented at the Armada Specialty Pharmacy Summit, May 7-10, 2013; Las Vegas, NV.

		Pharmacy Benefit Management 2013 Annual Report. www.pbmi.com. Accessed June 12, 2013.

Michael Einodshofer, RPh, MBA, is the director of utilization management at Walgreens Specialty Pharmacy in Pennsylvania. He is an adjunct instructor in pharmaceutical sciences at the University of Pittsburgh School of Pharmacy and a member of the peer review panel of American Health & Drug Benefits. Prior to joining Walgreens, he served as director of pharmacy operations at University of Pittsburgh Medical Center Health Plan Insurance Services Division. He has received the University of Pittsburgh Medical Center Health System ACES Award for Commitment and Excellence in Service and Six Sigma Green Belt Certification. Einodshofer earned his bachelor of science in pharmacy and his master of business administration from the University of Pittsburgh.

Mike Ellis, BSPharm, is corporate vice president, specialty pharmacy and infusion for Walgreens Specialty Pharmacy. Before joining Walgreens in October 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 in 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.

Articles

The Challenge of Specialty Pharmacy: Mitigating Costs While Providing Quality Care

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.