Specialty Pharmacy Models and the Oncology Pharmacist’s Role

Ronni Miller, PharmD BCOP
Thoracic Oncology Clinical Pharmacist
University of Colorado Hospital, Anschutz Cancer Pavilion
Aurora, CO

Specialty pharmacy focuses on high-cost, high-touch medication therapy for patients with complex disease states—cancer, multiple sclerosis, and many others.¹ In 2017, the U.S. Food and Drug Administration (FDA) approved 48 oncology drugs, of which 24 were oral medications.² Every year, the number of oral oncolytics approved steadily increases. The cost of these medications has led not only to insurance restrictions but also to specialty pharmacy restrictions. Patients’ access to these medications is further complicated by the need for financial assistance. If a patient is privately insured, then enrollment using a copay card can easily be completed online. However, if a patient is federally insured (e.g., through Medicare), the process becomes more complex: an application with the signatures of both patient and provider, as well as financial documents, must be included. With all these hoops to jump through, members of the clinic staff are often left frustrated and exhausted, while patients may experience delays in treatment initiation or potentially have to go without therapy.

Many drug companies offer hub forms for the provider and patient to fill out. The hub then coordinates benefits, routes the script to the appropriate pharmacy, and helps prepare financial assistance documents. The specialty pharmacy then contacts the provider to complete the prior authorization. This outsourcing model has many benefits, including offering services to many oncology offices that do not have the necessary resources to provide them on their own and giving the clinic staff more control over patient follow-up.³ However, one of the challenges in the age of the electronic medical record is the potential duplication of prescriptions. The application contains an embedded prescription, and the provider must enter a prescription into the patient’s chart. Also, the application process is labor intensive, particularly if the patient cannot provide a signature in person and does not live near the office. Clinic staff must coordinate the application process and follow up with patients in addition to their other responsibilities. Finally, the process can delay the beginning of the patient’s therapy for 14 days or more. All these issues led University of Colorado Health (UCH) to develop the Medication Access and Renewal Center (MARC) program.

The MARC prior authorization program was developed in 2014. This team is composed of pharmacists and pharmacy technicians who complete prior authorizations, write appeal letters, determine and reroute prescriptions to the correct specialty pharmacy (depending on access and insurance restrictions), and helps with financial assistance documents. An automated drug list (ADL) was created to help with completion of these tasks. The list consists of high-cost medications that typically require a prior authorization in more than 90% of cases. When a provider prescribes a medication on this list, the prescription is automatically routed to a queue in the ambulatory pharmacy setting. The specialty pharmacy team then works exclusively on this queue, adjudicating claims and handling insurance issues. When possible, the specialty team offers pharmacy services, like adherence follow-up and toxicity assessments. All documentation is contained in the patient’s chart, allowing for clear communication between the clinic and specialty staff. MARC’s initial attempt to onboard services in the cancer center used an integrated model similar to that used by the University of Illinois and by Vanderbilt.^3,4 The existing clinic-based pharmacist reviewed patient profiles and provided education. In the event that a prior authorization was denied, the specialty pharmacy team notified the clinical pharmacist so that assistance in writing appeal letters could be given. Otherwise, the clinical pharmacist and specialty pharmacy teams operated separately. The benefits of this model included a decreased number of handoffs and improved communication between providers because documentation and staff were within the system. However, the major challenge of the model was that it required a pharmacist to be based in nearly every clinic. The University of Colorado Cancer Center is a National Cancer Institute–designated institution, a National Comprehensive Cancer Network member, and a Quality Oncology Practice Initiative–certified facility that encompasses 14 clinics in Aurora, CO.⁵ However, only 4 of these clinics had clinical oncology pharmacists on staff at the time. Lack of funding for additional pharmacists limited expansion of the program. As a result, the program shifted to a hybrid model.

The hybrid model incorporating specialty pharmacy services into clinical practice was implemented at the University of Colorado Cancer Center in 2015. On the specialty side, a pharmacist completes the previously listed tasks, makes medication-adherence calls for all oncology patients who are filling oral oncolytics at our specialty pharmacy, and writes appeal letters for any clinic that does not have a clinical pharmacist. Adherence calls occur at therapy initiation, at 21 days, and then every 84 days while the patient is on therapy. This same pharmacist also has hours in the thoracic oncology clinic twice a week, giving him or her opportunities to see patients, provide counseling, and recommend supportive care measures. A major benefit of the hybrid position is being able to coordinate more easily between clinic staff and specialty pharmacy staff, providing this pharmacist the ability to identify and triage issues in real time and make adjustments on the specialty pharmacy side. An additional benefit is the ability to build mutual trust with patients up front, which may alleviate stress when insurance issues or copay issues are encountered. This model also allows the pharmacist to stay up-to-date on the latest treatment options and clinical reasoning, which can contribute to improved appeal writing and staff education on criteria for authorizations. The major challenge for pharmacists in this position is the need to balance both roles; however, revenue generated from an increase in internal prescription capture as a result of direct involvement with the clinic and specialty pharmacy may be justification for additional clinical oncology pharmacist support.

With the development of expensive oral oncolytics, the role of specialty pharmacy will continue to grow. Each model described has challenges and benefits ( Table 1 - see PDF), so it is important to carefully consider the needs and resources of the oncology practice to determine which model is the best fit for an institution.

References

1. American Pharmacists Association. Specialty Pharmacy. November 28, 2017. https://www.pharmacist.com/specialty-pharmacy. Accessed February 14, 2018.
2. U.S. Food and Drug Administration. Hematology/Oncology (Cancer) Approvals and Safety Notifications. February 8, 2018. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm. Accessed February 10, 2018.
3. Hanson RL, Habibi M, Khamo N, et al. Integrated clinical and specialty pharmacy practice model for management of patients with multiple sclerosis. Am J Health-Syst Pharm. 2014;71:463-469.
4. Bagwell A, Kelley T, Carver A, et al. Advancing patient care through specialty pharmacy services in an academic health system. J Manag Care Spec Pharm. 2017;23:815-820.
5. UCHealth University of Colorado Cancer Center–Anschutz Medical Campus. (2017). https://www.uchealth.org/locations/uchealth-university-of-colorado-cancer-center-anschutz/. Accessed February 12, 2018.