PBMI: Drug Benefit Design for Specialty Medications

Copay assistance programs and alternative funding solutions have the potential to provide patients with access to specialty drugs while at the same providing savings to PBMs and health plans, according to Kali Panagos, Pharm.D., executive vice president, consulting & clinical at ARMSRx, a pharmacy benefit consultant.

Kali Panagos, Pharm.D.

“But specialty assistance programs need to be fully analyzed and vetted to factor in all the pros and cons and determine what's right for a particular client,” she said. “These programs have to be monitored to ensure compliance and to make sure they are producing the savings projected.”

As drug costs continue to rise, drug manufacturers and third-party party organizations have designed ways that help patients afford expensive medications, but they can be challenging to evaluate, she said at the Pharmacy Benefit Management Institute (PBMI) annual meeting in Orlando.

Specialty medicines now account for 55% of medication spending in the United States, up from 28% in 2011, according to IQVIA. This is being driven by prescriptions growth in the HIV, autoimmune, and oncology drug classes. Spending on treatments for autoimmune disorders is expected to exceed $70 billion at net prices by 2026, slowing after 2022 because of biosimilars. Beginning in 2023, seven biosimilars of Humira (adalimumab), an immunosuppressive drug to treat patients with arthritis, plaque psoriasis, Crohn’s disease, and ulcerative colitis, is expected to be launched. Beyond Humira, biosimilars of Stelara (ustekinumab), also an immunosuppressive drug to treat plaque psoriasis and psoriatic arthritis, are also expected.

Panagos stressed it’s important for PBMs and plans to develop a management strategy and formulary placement now. “Most of the PBMs are still figuring this out and haven’t made a conclusive strategy on where they’re going to place these and other biosimilars,” she said.

Copay assistance programs, manufacturer assistance, and copay cards have increased in the pharmacy benefit space, she said, and nearly all PBMs will have some type of program around copay assistance. With the use of these options, specialty drugs are not carved out from the pharmacy benefit plan and rebates remain intact.

Alternative funding mechanisms, however, remove specialty drug coverage out of the pharmacy benefit plan and the rebates no longer apply. Patients are often required to meet financial eligibility requirements. However, the full cost of the therapy may not be fully covered and there may be fees.

Panagos said, however, some state regulators have expressed concern about these types of programs. “Certainly use them for your members to offset their costs. But keep a very close eye on the laws by state by state that could change the utilization of these programs and impact,” she said.

Panagos also suggested PBMs and plans consider outside-the-box strategies for managing specialty therapies. An example she cited was a plan that assisted a patient in enrolling in a clinical trial in the patient’s care facility for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to treat cystic fibrosis. The treatment specifically targets the defective CFTR protein. The savings to the plan was $290,000 year.

She also suggested that there may be clinically appropriate interventions that can help to manage costs. She cited a patient who was able to have a lower starting dose of Korlym (mifepristone) to treat Cushing’s syndrome. Korlym is cortisol receptor blocker to treat adult patients with Cushing’s. The savings from titrating up was $48,000 for the claim.

“Data is important to the overall evaluation of the program,” Panagos said. “Auditing and having access to your pharmacy data is important for evaluating whether these programs are the right fit for you and for making the best-informed decision.s”