Ongoing patent litigation and the “patent dance” in general have been thorns in the side of biosimilar drug manufacturers and payers who are anticipating lower-cost alternatives to high-cost reference biologics.
In the past 5 years, there has been a large increase in the number of employers focused on effective ways to manage the rising cost of specialty drugs. At the same time, employers have been working hard to comply with the Affordable Care Act (ACA) and are cognizant of the expected excise tax.
With the 2015 extension of time offered to employers for Affordable Care Act (ACA) compliance, many employers are back to focusing their attention on cost management efforts.
After the passage of the Affordable Care Act (ACA) in 2010, market changes beyond those already in play began to emerge. Traditional roles, responsibilities, and authority of various healthcare stakeholders could now be tested or altered as a result of some sections of the ACA.
The development of innovative medications is largely a private enterprise that relies chiefly on the investment of pharmaceutical companies in research and development (R&D).
True managed care is based on the notion of an integrated delivery system, an industrialized system of care designed to enhance population, as well as individual health status. The Affordable Care Act (ACA) and the philosophy embodied in the Triple Aim (ie, the triangle of care, population health, and costs)1 are leading the evolution toward the integrated delivery system and away from the component-based episode of care strategy or the fee-for-service method, where goods and services are applied and reimbursed individually, usually during an episode of sick care.
The increased approvals and rising costs of specialty pharmacy drugs have created a significant management challenge for health plans. The 3 primary disease areas that account for the majority of the specialty drug spending include autoimmune disorders, multiple sclerosis, and cancer.

President Obama’s victory in November resolves whether the Affordable Care Act (ACA) will be implemented. In general terms, it will. Although the Republican-controlled House of Representatives may pass another resolution to abolish the ACA, that threat is not credible, with Democrats in charge in the Senate. But that does not settle what will actually become of the law.

The opinions expressed in this article are soley those of the author and do not necessarily reflect the opinions of the author's employer or of any other entity mentioned herein.

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