The extra surveillance by a specialty pharmacy teams allows for faster initiation of therapy, earlier recognition of adverse effects, and promotes patient safety.
Health-system specialty pharmacies and the specialty pharmacy drug market are growing at a rapid rate. In 2022, the specialty drug market was estimated at $706.89 million and is expected to reach $804.64 million in 2023 with projection to more than $2 billion by 2030.1 Specialty pharmacies within health systems continue to become more prevalent, increasing from 20% to 26% from 2018 to 2019.
Within the health-system specialty pharmacy care model, medication assistance specialists and specialty pharmacists work together to aid with prior authorizations, patient assistance applications, clinical review, verification, dispensing, and monitoring of drug therapy. The specialty pharmacy care model is taken to another level in states such as North Carolina, where specialty clinical pharmacist practitioners (CPPs) have the ability to prescribe, monitor, and alter medication regimens through a collaborative practice agreement under a supervising physician.
This care model is much more comprehensive compared to an external pharmacy care model. External pharmacies place more responsibility on a single provider to complete the prior authorizations and ensure appropriate monitoring is completed. The extra surveillance by the specialty pharmacy team allows for faster initiation of therapy, earlier recognition of adverse effects, and promotes patient safety.
There are limited studies regarding the improvement of patient outcomes with the specialty pharmacy care model. However, this positive impact is evident in both primary care and specialty disease states in several scenarios at Novant Health New Hanover Regional Medical Center (Novant Health NHRMC) in Wilmington, North Carolina.
A patient with granuloma annulare (GA) was referred by the primary care physician to the specialty CPP for medication management. The patient had been struggling with round, red lesions on their legs and feet for more than 10 years, hiding the lesions with certain clothing and tanning cream.
The patient had failed several first-, second-, and third-line therapies including systemic dexamethasone, multiple topical steroids, tacrolimus, apremilast, dapsone, isotretinoin, and methotrexate. With an incidence of 0.04% in the United States, the use of specialty medications outside of those aforementioned is scarce.2
Through referral and collaboration with the primary care physician, the CPP initiated adalimumab (Humira), an injectable specialty medication for home use, for the treatment of GA. Following the standard process for medications prescribed within the Novant Health NHRMC health system, the prescription populated into a multistep order transmittal (MSOT) queue, prompting a benefits investigation from the specialty pharmacy team.
Prior authorization approval was obtained within 48 hours and the patient was contacted for home delivery within the week. As standard for patients who fill specialty medications within the health-systems specialty pharmacy, the pharmacist team provided routine clinical follow up calls to monitor for the safety and efficacy of the new regimen.
Lesions started to improve approximately 2 months after initiation of therapy and the patient reported the lesions on their knees and feet had completely resolved at 8 months post-initiation. The improvement of quality of life for this patient is only one example of a success story resulting from the specialty pharmacy services that a health system team can offer.
This clinical impact may translate to primary care disease states such as hyperlipidemia being managed with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. Within this same health system, a retrospective analysis was conducted for adult patients who were prescribed a PCSK9 inhibitor in the outpatient or discharge setting between May 1, 2021, and November 1, 2022.
The primary objective was to compare the number of patients who met their LDL goal for those utilizing the internal specialty pharmacy care model versus an external pharmacy, or “usual care.” One hundred and ninety-seven patients were included in the final analysis, with 78 patients receiving usual care and 119 patients receiving specialty pharmacy care.
The LDL goal was met by 60.3% (n = 47) of patients receiving usual care compared to 63.9% (n = 76) of specialty pharmacy patients. Usual care also resulted in a higher rate of patients lost to follow up compared to specialty pharmacy care (37.2% versus 31.1%, respectively). Approximately 66.7% of patients who consulted with a CPP met their LDL goal compared to 59.6% of patients receiving care from solely a physician.
Further education to providers is needed to demonstrate the value of utilizing the specialty pharmacy care model. As specialty pharmacy continues to grow, it is expected that more health systems will adopt the specialty pharmacy care model to make a larger impact on their patients. As pharmacists, we can recognize the value of driving this effort forward to improve patient outcomes.