The adherence impact of a program offering specialty pharmacy services to patients using retail pharmacies.

BACKGROUND: A new service model integrates the specialty pharmacy's comprehensive service with the retail pharmacy's patient contact, giving patients options for medication delivery to home, pharmacy, or doctor's office. OBJECTIVE: Evaluate the impact of the new service model on medication adherence. DESIGN: Retrospective cohort study SETTINGS: One hundred fifteen CVS retail stores in Philadelphia participated in a pilot from May 2012 to October 2013, and 115 matched CVS retail stores from around the nation served as controls. PATIENTS: All eligible patients from the intervention and control stores received specialty medications through CVS retail pharmacies prior to implementation of the new service model. INTERVENTION: The intervention patients were transitioned from retail pharmacy service to the specialty pharmacy with delivery options. The control patients received standard retail pharmacy services. MAIN OUTCOME MEASURES: Proportion of days covered and first fill persistence were tracked for 12 months before and after program implementation. RESULTS: Under the new service model, 228 patients new to therapy in the post period had a 17.5% increase in the rate of obtaining a second fill as compared to matched controls. Patients on therapy in both the pre- and the post-periods had a pre-post increase of 6.6% in average adherence rates and a pre-post increase of 10.8% in optimal adherence rates as compared to 326 matched controls. CONCLUSION: The study demonstrated significant improvement in both adherence to therapy and first-fill persistence among patients in the new service model integrating specialty pharmacy's comprehensive services with the retail pharmacy's patient contact and medication delivery choices.

The economic implications of biosimilars.

Between 2013 and 2014, spending on specialty drugs, including biologics, increased 32.4%, while spending on small-molecule drugs increased just 6.8%. By 2016, 8 of the 10 top-selling drugs are expected to be biologics. While many biologics will be going off patent, there will likely be multiple prospective manufacturers of biosimilars, and a growing emphasis on regulatory guidelines to ensure their efficacy and safety, in the very near future. A strong factor and assumption surrounding biosimilar development and use is the potential for healthcare cost savings; the introduction of biosimilars is expected to reduce drug costs, although to a lesser degree than seen with small-molecule generic drugs. Managed care clinicians and providers must carefully consider the economic implications and potential cost-effectiveness of uptake of biosimilars for therapy in clinical practice.

Biosimilar competition in the United States: statutory incentives, payers, and pharmacy benefit managers.

Widespread adoption of generic medications, made possible by the Hatch-Waxman Act of 1984, has contained the cost of small-molecule drugs in the United States. Biologics, however, have yet to face competition from follow-on products and represent the fastest-growing sector of the US pharmaceutical market. We compare the legislative framework governing small-molecule generics to that which regulates follow-on biologics, and we examine management tools that are likely to be most successful in promoting biosimilars' adoption. The Biologics Price Competition and Innovation Act established an abbreviated pathway for follow-on biologics, but weak statutory incentives create barriers to entry. Many authors have raised concerns that competition under the biologics act may be weaker than that posed by small-molecule generics under Hatch-Waxman, in part because of legislative choices such as the absence of market exclusivity for the first biosimilar approved and a requirement that follow-on manufacturers disclose their manufacturing processes to the manufacturer of the reference product. Provider skepticism and limited competition from biosimilars will challenge payers and pharmacy benefit managers to reduce prices and maximize uptake of follow-on biologics. Successful payers and pharmacy benefit managers will employ various strategies, including tiered formularies and innovative fee schedules, that can control spending by promoting uptake of biosimilars across both the pharmacy and medical benefits.

Specialty medications: traditional and novel tools can address rising spending on these costly drugs.

Spending on specialty medications, which represented a small proportion of US pharmacy spending at the beginning of this decade, is growing by more than 15 percent annually. It is expected to account for approximately half ($235 billion) of total annual pharmacy spending by 2018. Among the numerous reasons for the high cost of this heterogeneous group of medications are the increasing size of target patient populations, the high cost of drug development, and a complex and uncoordinated delivery system. In this article we describe the evolution of the specialty market, characterize the current state of specialty medication use, and articulate key challenges and potential solutions. Fully realizing the potential value of the expanding universe of specialty medications will require collaborative efforts to reduce waste and promote value. Those who prescribe, dispense, deliver, and pay for specialty medications will need to employ a combination of traditional and novel management approaches, such as prior authorization, step therapy, tiered formularies, administration at lower-cost sites, and the unique tools being developed for cancer medications.