Step therapy, prior authorization, and consumer cost-sharing are strategies used by organizations to control the cost of specialty pharmaceutical drugs, but these strategies may present barriers to patient access.

In a viewpoint article published in JAMA, researchers advocate for value-based patient access to specialty pharmaceuticals, which dictates that medications “priced at or below the value-based levels should face streamlined and more modest prior authorization, step therapy, and cost-sharing requirements than those prevalent in the US healthcare system today.”

The cost of specialty drugs has rapidly increased in recent years, despite few increases in commensurate efficacy. To manage costs, pharmacy benefit managers, employers, and insurers have created strict administrative requirements for prescribing physicians, with prior authorization and step therapy being 2 primary methods of cost control. These methods, however, create a substantial barrier to timely patient access. Prior authorization, for example, is a time-consuming and lengthy process that requires documentation of the patient’s US Food and Drug Administration (FDA)-approved indication for the drug so the physician can know whether or not the costs will be reimbursed.

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Value-based price benchmarks, which take into consideration both the clinical and cost effectiveness of new medications, have been suggested to improve patient access to much-needed specialty treatments. Despite their potential benefit, many drug manufacturers believe these benchmarks may compromise revenue. It is suggested, however, that lowered access restrictions as a result of value-based prices cause increases in prescription volume, ultimately improving the manufacturers’ bottom line.

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In the value-based model, drugs that are priced at or below the proposed benchmarks should require no prior authorization beyond physician documentation according to the label set forth by the FDA. Only those drugs priced above value-based benchmarks would require prior authorization. In addition, it is suggested that drugs priced at or below the benchmark should require no consumer cost-sharing.

Not only will reducing prescribing barriers possibly increase the overall use of specialty medications and subsequently increase pharmaceutical revenue, many physicians may “benefit from reduced administrative burdens and patients would benefit from access to the medications they need to sustain and improve their health,” according to the investigators.


Robinson JC, Howell S, Pearson SD. Value-based pricing and patient access for specialty drugs. JAMA. 2018;319(21):2169-2170.