Health Plan Restrictions Likely to Have an Impact on Biosimilars, Orphan Drugs

Despite their benefits to patients, innovative treatments, including biologics, come at a high cost to the healthcare system, and those in a position to make coverage decisions for these products must grapple with these therapies’ affordability. During the ISPOR 2019 meeting, researchers presented findings on how health plan restrictions could limit orphan drug coverage—and encourage biosimilar use—as a means to manage their budgets.

First, a research group presented findings from their investigation of whether US commercial health plan restrictions are likely to be implemented as a means to control spending on orphan drugs.¹

Using the Tufts Medical Center Specialty Drug and Evidence Coverage database, which includes information on coverage decisions among 17 of the 20 largest US commercial plans, the team estimated a drug’s budget impact by considering its annual cost and the US prevalence of the disease for which it is indicated.

They considered patient subgroup restrictions, step therapy, limitations on which specialists can prescribe a drug, or any other restriction type, and included 2168 coverage decisions in their analysis.

They found that the odds of restricted coverage were 1.5 greater for orphan drugs with the largest budget impacts versus those with the smallest budget impacts, and that noncancer treatment, availability of alternative therapies, number of years since FDA approval, and self-administration of a drug were all associated with increased likelihood of restriction.

Another research team presented results of a survey of health plan executives that sought to investigate how health plans will address biosimilars as an alternative to higher-cost innovator drugs.²

The investigators conducted an online survey of 85 health plan executives on their plan information, including expected biosimilar coverage, restrictions, and copays. Plans represented by the respondents were national, regional, and local, and covered commercial, Medicaid, Medicare, employer- or self-funded, and integrated delivery network members.

In total, 46% of respondents reported their plan’s pharmacy benefit manager (PBM) as their specialty pharmacy provider, and 58% reported that providers were restricted with respect to products. Biosimilar use was expected to be allowed for all reference product indications by 58.8% of respondents, and 31.5% reported that their plans will restrict biosimilar use to approved indications. Another 9.8% said that indications will be used as the basis for copays for biosimilars, and 10% said that biosimilars are expected to be the only product made available.

Fifty-eight percent expected copays to be discounted off the innovator product’s copay, and 32% expected copays to vary based on the timing of a given biosimilar’s approval.

Respondents said they would provide education about biosimilars through different copays for biosimilars versus reference products (64.7%), prescriber and patient mailings (76.5%), prescriber and patient phone calls (51%).

In total, 66% of respondents said that they expect 20% savings from biosimilars within 5 years, the researchers found.

References

1. Margaretos N, Neumann PJ, Kim DD, Chambers J. Are health plans more likely to restrict coverage of orphan drugs with larget budget impacts? Presented at: International Society for Pharmacoeconomics and Outcomes Research 24th Annual International Meeting; May 18-22, 2019; New Orleans, Louisiana. Abstract PRO42.

2. Brook R, Smeeding JE, Carlise JA, Sax MJ. Management of specialty drugs, specialty pharmacies, and biosimilars in the United States. Presented at: International Society for Pharmacoeconomics and Outcomes Research 24th Annual International Meeting; May 18-22, 2019; New Orleans, Louisiana. Abstract PNS112.