Psoriasis Patient Group Seeks to Curb Step Therapy Use With State Legislation

A patient group for those affected by psoriasis and psoriatic arthritis (PSA) has spent the past several years seeking to get a model law passed at the state level that seeks to curb the use of step therapy used by payers and pharmacy benefit managers for pharmaceutical treatments.

Step therapy, sometimes called “fail first,” requires that patients try the payer’s preferred treatment before the one a physician recommends. The National Psoriasis Foundation (NPF), like other patient groups that deal with chronic, incurable conditions, has become more involved in advocacy in recent years as the use of step therapy has grown at the same time pharmaceutical costs continue to rise. For instance, a study published earlier this year found that between 2013 and 2017, the cost of specialty medications used in psoriasis rose between 9% and 18% (9% for ustekinumab, 16% for apremilast, 17% for etanercept, and 18% for adalimumab) and that the rates of increase in the cost of drugs were the same for treatment in the first year and maintenance treatment.¹

Each year NPF conducts an internal survey of patients to ask about barriers to care, said Amy Prentice, NPF’s associate director of state and government relations, in an interview with The American Journal of Managed Care^® (AJMC^®). In its 2018 study, 43% of those surveyed said they had experienced step therapy; 68% requested exemptions; and 21% said their appeal was denied.

“A lot of them were seeing and encountering the step therapy process,” she said, noting the emergence of newer therapies that have come to market in recent years.

Those treatments include: biologics that blocks interleukin-23 (IL-23), IL-12, and IL-17; tumor necrosis alpha inhibitorss; T-cell blockers; systemic treatments; and topicals.

The nature of psoriasis, which affects more than 8 million Americans, makes treatment complex, as there is no one-size fits-all treatment, and patients can stop responding to a medication. About 25% of the time, psoriais may progress to PSA; the autoimmune disorder is also linked to various comorbidities, including cardiovascular disease, diabetes, and metabolic disorders. A 2015 study calculated the economic burden of psoriatic disease at up to $135 billion a year.

While the organization does not keep track of how many patients are affected by step therapy, Prentice cited a 2014 report that said 67% of employer-sponsored health plans were using step therapy, compared with 27% of plans in 2005.²

Around the time the report came out, NPF began to get more involved in promoting the model bill, Prentice said. To date, there are 27 state laws total; 18 are closely aligned with the model that NPF proposes, she said. The model includes 3 main components:

• That when a step therapy protocol is put in place, it must be based on clinical guidelines
• That any protocol must have a clear and quick process to request exceptions, accessible to both patients and providers
• That any decisions made by insurers or pharmacy managers must be made expeditiously, such as 1 day for an emergency request and 3 days for nonemergency appeal

But the issue is bipartisan, Prentice said, noting she has had support from both sides of the aisle. In addition to the state efforts, a federal bill, HR 2279 or the Safe Step Act, has been introduced in the House of Representatives by Representative Raul Ruiz, D-California, and Representative Brad Wenstrup, R-Ohio, that also models the NPF proposal. There is no companion bill on the Senate side.

In Maine, a step therapy bill that hews pretty closely to the model was signed into law recently by Democratic Governor Janet Mills after being vetoed previously by former Republican Governor Paul LePage.

"We're not creating any new type of process for health insurance plans," said Prentice, speaking about the appeals process. "We're just trying to make it a little more efficient."

She also said they are not trying to end step therapy altogether. “For some patients step therapy is appropriate,” she said. But for a small group of patients, it is not.

References

1. Yang EJ, Beck KM, Sekhon S, Bhutani T. Pharmacy costs of specialty medications for plaque psoriasis in the United States. J Am Acad Dermatol. 2019;80(1):274-275. doi: 10.1016/j.jaad.2018.04.019.

2. Nayak RK, Pearson SD. The ethics of ‘fail first’: guidelines and practical scenarios for step therapy coverage policies. Health Aff (Millwood); 2014; 33(10):1779-85. doi: 10.1377/hlthaff.2014.0516