As specialty pharmaceuticals continue to drive a substantial share of total drug spend, rigorous controls affect pharmacy’s ability to access these products and maintain continuity of care for patients. To address this ongoing challenge, many organizations have established specialty pharmacies or are considering this option. Implementing and expanding specialty pharmacy services requires robust management in order to achieve meaningful benefits, including increased access to medications and drug cost control.

Michigan Medicine, a 1000-bed academic medical center, is ranked sixth in the nation and number one in Michigan by US News & World Report for high quality patient care, commitment to patient safety, and clinical resources.1 Michigan Medicine’s Specialty Pharmacy Services was launched in 2008 to ensure patient access to important medications and resource multiple funding sources to prevent cost barriers to treatment. Historically, health system and social work resources had been utilized to facilitate medication access. The specialty pharmacy program was initiated to address a specific challenge long affecting our solid organ transplant patients: obtaining a reliable supply of immunosuppressive medications. Thereafter, the program grew to include multiple specialty disease states and medications.

In the nearly 10 years Michigan Medicine Specialty Pharmacy Services has been in operation, patients have been able to fill oral and self-injectable specialty medications in multiple categories, in addition to receiving the clinical and financial support they may require. The program has actively partnered with several specialty clinics to support patients in the following therapeutic areas: transplant, hepatitis, oncology and oral chemotherapy, multiple sclerosis (MS), gastrointestinal disease (eg, Crohn’s disease), rheumatology, dermatology (eg, psoriasis), and cardiology (ie, PCSK9 inhibitors). The specialty pharmacy program also serves the specialty medication needs of the University of Michigan employees, retirees, and dependents.

Gaining Administration’s Buy-In

Support from hospital administration is a prerequisite to developing a strong specialty pharmacy program. A business plan was devised within the transplant department that described the advantages of creating an in-house specialty pharmacy program, including the following:

• Increase patient access to medications through the health-system pharmacy
• Remove coverage and cost barriers to initiate and maintain long-term treatment
• Decrease the administrative burden on clinic staff
• Increase clinical pharmacy support in direct patient care
• Retain revenue within the institution

As these goals are in line with the health system’s mission of patient care, education, and research, implementation of a formal specialty pharmacy program was deemed to be a worthwhile pursuit.

Essential Program Elements

The Michigan Medicine Specialty Pharmacy Services strategy is based on comprehensive coordination of care and timely communication. The core components of the specialty pharmacy program encompass operational, clinical, and financial services.

Clearly communicating the services offered by the specialty pharmacy program is crucial to ensure patients and employees are aware of the benefits of participation. Michigan Medicine maintains a website where patients can learn about the program and access available resources, including information by disease state and/or medication: www.uofmhealth.org/conditions-treatments/specialty-pharmacy-services.

The Specialty Pharmacy Team and Operations

The specialty program’s lead team consists of a program manager, an operations manager, a supervisor of financial coordination activities, and a project coordinator. The majority of the team consists of pharmacists, pharmacy technicians, and financial coordinators. The specialty program also supports the educational mission of Michigan Medicine by incorporating learners into its standard operations and clinical practice, including pharmacy interns, introductory and advanced-practice pharmacy students, and PGY1 and PGY2 pharmacy residents.

Patients who are eligible to fill with Michigan Medicine Specialty Pharmacy Services are offered the opportunity to enroll in our program. If the patient decides not to utilize our services, the prescription is transferred to an outside pharmacy based on the patient’s insurance, manufacturer restrictions, or patient preference. Of note, Michigan Medicine has access to numerous manufacturer limited-distribution specialty medications.

Patients who may benefit from our services are identified in collaboration with the clinics. The specialty prescription is sent to Specialty Pharmacy Services, where a specialty pharmacy technician notifies one of our pharmacy financial coordinators (PFCs). The PFC then triages the prescription for pharmacy eligibility, insurance coverage, any prior authorization requirements, copay determinations, and available programs that may provide financial assistance.

In the main specialty pharmacy hub, pharmacists and licensed-certified pharmacy technicians (CPhTs) support medication fulfillment, packaging, and distribution. Patients have the option to pick up their prescriptions from any of the Michigan Medicine community pharmacy locations or may opt to have their medication(s) mailed to their homes. Monthly medications are shipped in temperature-appropriate shipping containers from the specialty pharmacy to patients’ homes within Michigan at no additional cost.

The Role of the Call Center

The specialty call center staffs nine CPhTs, divided into transplant and non-transplant specialty pharmacy teams, to process prescriptions, set up shipments, receive inbound patient calls, make outbound specialty medication refill reminder calls, and monitor medication adherence. CPhTs reach out to patients about 1 week prior to their next refill to ensure timely medication delivery. The call center processes all orders through patients’ insurance and refers any coverage or copay issues to a patient’s respective PFC. Additionally, the staff helps identify potential adherence issues and notify the PFC, who then notifies the pharmacists and/or clinic staff for follow-up.

The call center operates from Monday through Friday from 9am to 5:30pm and on Saturday from 8:30am to 12:30pm Eastern Time. Technicians rotate between working at the call center and the fulfillment hub.

Comprehensive Clinical Services

An on-call pharmacist is available 24 hours a day, 7 days a week. Pharmacists provide consultation, clinical intervention, and medication reconciliation services. Targeted medication management is provided to patients taking the most commonly utilized specialty medications.

Clinical pharmacist services span baseline counseling for new medications, comprehensive medication review, side effect management, drug interaction monitoring, and coordination with the medical team. For example, a pharmacist calls each transplant patient prior to their first refill to welcome them to our service and to conduct medication reconciliation, medication management, and patient counseling. A pharmacist also completes 6- and 12-month comprehensive medication reviews with the patient and partners with the clinic to manage any treatment issues or concerns. The specialty clinical pharmacist also counsels patients on an as-needed basis, collaborating with clinical pharmacists embedded across the Michigan Medicine specialty clinics.

Financial Assistance

The specialty pharmacy utilizes a team of dedicated PFCs, whose role is to remove barriers to patient access and affordability for specialty drugs. The PFCs are divided into three teams: transplant (including pediatric and discharge patients), oral chemotherapy, and all other specialties. PFCs are responsible for:

• Coordination of benefits issues, including denials and rejections
• Facilitating prior authorizations
• Resourcing funding options, such as manufacturer copay cards, grants, and patient-assistance programs (PAPs) on an ongoing and recurrent basis to minimize patient out-of-pocket costs
• Ensuring accurate billing
• Benefits and insurance coverage monitoring

For example, transplant patients receive in-person financial counseling prior to discharge to ensure the patient understands their benefits. This is particularly important for this disease state due to the complexity of coordination with medical and prescription insurance benefits and billing, as well as to reinforce the importance of medication adherence necessary for transplant patients. PFCs provide ongoing financial coordination if any changes to insurance coverage occur.

Gauging Program Success

In 2016, Michigan Medicine Specialty Pharmacy Services conducted a full-scale patient satisfaction survey. Extremely high satisfaction rates were noted, including an uptick compared to previous years’ survey results. These data were disseminated to hospital administration, pharmacy leadership, and to our collaborative partners.

Moreover, we continually develop and monitor meaningful metrics across each area of program operations, including measures of clinical interventions; prescription capture rates for various disease states and/or services; turnaround times; call center metrics; and financial assistance provided to our patients from various resources, including grants, copay cards, etc. Our clinical pharmacist reports the number of patients reached for counseling and the number of comprehensive medication reviews that occur. The call center uses dashboards that measure the length of these calls, the average hold time for patients, and the number of calls received in the call center.

Balancing clinical and operational service expansion with physical capacity and resources is a continual challenge. Our plan is to expand patient services across additional disease states and specialty drug therapies; however, we must balance that with the availability of space, staff, and equipment. Recently, we were granted some modest additional space for primarily refrigerated medications and hired some new staff. We continually look at areas where expansion is supported by clinic leadership, patient need, prescription volume, and/or revenue.

Benefits Realized and Future Goals

The implementation and expansion of Michigan Medicine’s Specialty Pharmacy program has been extremely successful. One of the central benefits of the service is the personal, comprehensive care patients receive throughout their treatment. Because coordinated, streamlined care is provided to patients within one health system, staff can closely communicate with providers on behalf of patients on a regular basis to remove barriers to care and ensure timely medication delivery and appropriate therapy management. Finally, the specialty pharmacy benefits the health system by retaining prescription revenue in-house.

Future goals include increasing operational capacity and prescription capture, further developing clinical programs, achieving accreditation, increasing access to limited distribution drugs, and transitioning our pharmacy service and clinical documentation into the health system’s electronic health record.

Reference

1. US News & World Report. 2017-18 Best Hospitals Honor Roll and Overview. https://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview. Accessed November 28, 2017.

Sangeeta Goel, PharmD, is Manager, Michigan Medicine Specialty Pharmacy Services, in Ann Arbor. She earned her undergraduate degree and Doctor of Pharmacy from the University of Michigan. Sandy’s professional responsibilities include strategic and operational planning for the specialty pharmacy program with the aim of continually identifying methods and opportunities to better serve both the team and patients.

Kaleigh Fisher, PharmD, is Clinical Pharmacist Specialist, Michigan Medicine Specialty Pharmacy Services, in Ann Arbor. She received her Doctor of Pharmacy from Albany College of Pharmacy and Health Sciences. Her professional responsibilities encompass clinical and quality management of the specialty pharmacy program, including patient counseling, disease state management, and outcomes monitoring.