The high cost of therapy for patients with chronic hepatitis C (HCV) infection has been an important topic of discussion for key stakeholders in pharmacy benefit design and management. Multiple effective treatments have been introduced, with cure rates approaching 100%.
Although costly, curing HCV early on can prevent serious liver complications, such as hepatic cirrhosis, organ failure, and cancer, for the approximately 2.7 million affected people in the United States.
In 2016, there was a downward cost and utilization trend for the HCV Specialty category. Express Scripts reported in its 2016 Drug Trend Report that utilization of HCV therapies had decreased by 27.3% and the unit cost had decreased by 6.7%. The cost per member per year (PMPY) for HCV drugs decreased to $25.26 PMPY from $38.44 PMPY the previous year.
Why have cost and utilization suddenly decreased after two years of steady growth?
• Fewer HCV patients: The total number of affected HCV patients has decreased due to the high curative rate of new HCV therapies. Additionally, many patients who were in the advanced stages of the disease, and were most likely to seek treatment, have already sought and completed treatment.
• More options: Since the 2013 launch of SovaldiTM (sofosbuvir), seven novel HCV treatments have come to market. These treatments have driven down the cost of treatment per patient through competition in the marketplace and reduction in treatment duration. Viekira PAK™ (ombitasvir/paritaprevir/ritonavir tablets with dasabuvir tablets) created true unit-cost competition as the first all-oral interferon-free HCV treatment released from a competing manufacturer. In 2016, two other manufacturers introduced new HCV treatments targeting additional genotypes and different populations with cofactors. The comparatively low unit price and decreased treatment duration of Mavyret™ (glecaprevir/pibrentasvir), released in August 2017, should further decrease the cost of treatment per patient over the next year.
• More therapeutically effective treatments: All six HCV genotypes can now be treated with novel therapies. Mavyret (glecaprevir/pibrentasvir), like Epclusa® (elbasvir/grazoprevir), is pan-genotypic, or able to treat all genotypes. Mavyret may also provide a shorter duration of treatment for the majority of patients remaining with HCV.
While costs continue to decrease, there may be new HCV drug utilization driven by new testing, treatment, and education initiatives. In 2013, the Centers for Disease Control and Prevention (CDC) expanded testing criteria to include Baby Boomers (those born between 1945 and 1965) and intravenous drug users. Furthermore, pharmaceutical companies have increased efforts to educate consumers about HCV and treatment options through articles in magazines, television commercials, and websites. Finally, payers are starting to loosen restrictions on HCV treatments. For example, the California Medicaid program revised its treatment policy for chronic HCV to include patients who are at high risk of spreading HCV or who have less severe forms of the disease.
While the HCV Specialty drug space changes, specialty drug expenditures will continue to rise. The 2017 Milliman Medical Index found that specialty drug spend now accounts for one of every three dollars spent on prescription drugs. In addition, experts predict that the pipeline for specialty drugs will continue to grow as new treatments are developed for targeted genetic profiles, orphan disease states, and other strategic therapeutic classes (inflammatory conditions, diabetes, oncology, and HIV).
Pharmacy benefit managers (PBMs) will respond to movement in the specialty drug environment with new formulary, network, and pricing strategies. It is important to evaluate any proposed adjustment to ensure that it is appropriate.
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