This article is more than 5 years old. Information may no longer be current.

Specialty pharmacy services aid approvals, costs for HCV therapy

Collaboration between local specialty pharmacies, providers and patients minimized time to therapy, lowered rates of direct-acting antiviral denial, facilitated patient financial assistance and helped optimize clinical outcomes, according to a recently published study.

“Access to DAA therapy is a key component in achieving SVR and is negatively affected by many factors, including high costs, lack of adequate insurance coverage, patient ineligibility for treatment based on insurance restrictions, and high burden of paperwork,” Julia Zhu, MPH, senior analyst of health analytics, research and reporting at Walgreen Co., and colleagues wrote. “It is critical for specialty pharmacies to be able to collaborate with DAA prescribers and have systems in place to promote access and affordability to DAA therapy for patients.”

To evaluate time to therapy and sustained virologic response rates among patients with HCV who used local specialty pharmacy services, the researchers conducted a retrospective study of adult patients prescribed at least one DAA at a single-center liver specialty clinic in Atlanta, Georgia, from December 2013 to December 2015.

Pharmacists in the local specialty pharmacy’s network received training in the clinical aspects of HCV care. Researchers followed patients who used the pharmacy services with a pharmacy-based therapy management program or chart review to verify patient adherence and therapy completion.

Of 388 patients prescribed DAAs, 364 initiated therapy and were followed to end of treatment. Twenty-four patients never initiated therapy. Overall, 337 patients who initiated therapy completed a full course.

Regarding intention-to-treat for the 364 patients who initiated therapy, 316 achieved SVR for a rate of 86.8%. Of the 337 patients who completed a full course of therapy, 316 achieved SVR for a higher rate of 93.8%. SVR rates were also high among patients who completed a full course and were treatment naive (96.3%) and without cirrhosis (97.3%).

“The [intention-to-treat] SVR rate (86.8%) highlights the need to address patient access and adherence at each step of the HCV treatment cascade,” Zhu and colleagues wrote. “Twenty-seven patients in our study were lost to follow-up or died during treatment. The high mortality rate was likely because HCV patients seeking treatment at this hepatology clinic had more advanced liver disease compared with populations in other studies.”

Data on time to therapy and SVR rates were available for 171 patients. Average time to therapy was 12 days with a maximum of 86 days and varied by patient characteristics. Time to therapy for patients with initial approval was an average of 7 days compared with 50 days for patients who required DAA appeals. Additionally, time to therapy was longer for patients with Medicaid (26 days) compared with those who had commercial insurance (14 days) or Medicare (11 days).

SVR rates compared with time to therapy among patients who completed a full DAA course were 96.7% for zero to 10 days, 96.4% for 11 to 29 days and 81% for 30 days or more. Higher SVR rates correlated significantly with shorter time to therapy (P = .0283).

The local specialty pharmacy appealed 60 of 70 initial denials. Of those patients, 53 achieved SVR. Nine of the 10 patients who were initially denied and not appealed switched to different regimens and five achieved SVR for a rate of 61.5%.

Copay information was available for 154 patients. Sixty-six of those patients had monthly copays of more than $20, but assistance from the local specialty pharmacy reduced monthly copays from $20 to $5 or less for 63 patients. The local specialty pharmacy provided full financial assistance for 20 patients without insurance or DAA coverage.

The researchers noted that while the SVR rates were similar to previous studies, their cohort included a “real-world” population of mixed HCV genotypes, prescription treatments and patient characteristics with a high proportion of patients with advanced liver disease, previous treatment failure and previous liver transplants.

“The effective management of costly DAA therapies seemed to be closely linked to the collaboration among the [local specialty pharmacy], specialty clinics, and patients to address insurance barriers,” the researchers concluded. “The [local specialty pharmacy] played an integral role in working with providers and patients to navigate the complex insurance approval process.” – by Talitha Bennett

Disclosure: Zhu reports she was employed by the study sponsor, Walgreen Co., during the conduct of the study. Please see the full study for the other authors’ relevant financial disclosures.