Radar on Specialty Pharmacy

Oct. 21: The FDA granted another indication to AbbVie Inc.’s Rinvoq (upadacitinib) for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) inhibitors. The agency first approved the Janus kinase (JAK) inhibitor on Aug. 16, 2019. Dosing of the extended-release tablets for the newest indication is 15 mg once daily. The wholesale acquisition cost (WAC) of a 30-day supply is $5,671.26.

Oct. 21: The FDA approved AstraZeneca’s Imjudo (tremelimumab-actl) in combination with the company’s Imfinzi (durvalumab) for the treatment of adults with unresectable hepatocellular carcinoma. Dosing for people weighing at least 30 kg is 300 mg of Imjudo, a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor, via intravenous infusion one plus 1,500 mg of Imfinzi, a programmed death-ligand 1 (PD-L1) inhibitor, also via intravenous infusion at cycle one/day and then Imfinzi as a single agent every four weeks. For those weighing less than 30 kg, dosing is 4 mg/kg of Imjudo plus 20 mg/kg of Imfinzi at cycle one/day one and then Imfinzi every four weeks.

Biosimilars have produced about $21 billion in savings for the U.S. health care system over the past six years, according to the 2022 Amgen Biosimilar Trends Report. That competition is resulting in decreasing average sales prices (ASPs) for both biosimilars and their reference products, found the ninth edition of the report, and uptake of biosimilars continues to increase. In the second quarter of 2022, drug spend savings were estimated to be $3.2 billion. Biosimilars for more classes, pharmacy benefit drugs and interchangeable biosimilars are among the trends expected over the next few years.

Rheumatologists are reporting a growing familiarity with biosimilars, with three-quarters of respondents to a Cardinal Health survey saying they are “very familiar” with the agents compared with 53% who said that in 2020. The Rheumatology Insights: October 2022 report found that, among other things, almost two-thirds of respondents said they are “very comfortable” with prescribing the drugs. New patients and existing patients whose payers have mandated the use of a biosimilar are the top categories of patients for whom respondents are likely to prescribe biosimilars, both cited by about 40% of respondents.

With companies trying to keep their prescription drug spending down, some have turned to alternate funding companies. While their approaches may seem appealing initially, some — such as ones that carve out certain specialty drugs and seek coverage from patient assistance funds — may not be worth the investment, say industry sources, who encourage companies to take a closer look at what their savings actually are.

During a July 29 webinar titled Specialty Drugs Update: Trends, Controversies, and Outlook, longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, noted that while the use of copay accumulators and maximizers has risen, “there is another newer trend that’s even scarier, and that’s the business of what some people call specialty carve-outs,” he said, calling this “the shady business of specialty carve-outs.” Vendors such as ImpaxRX, Paydhealth, SHARx, PayerMatrix and Script Sourcing get payers to exclude specialty drugs and then get those drugs covered via patient assistance programs at manufacturers or charitable foundations. If patients are denied patient assistance, coverage reverts to the company’s payer/PBM/specialty pharmacy.

As spending on specialty drugs continues to rise, payers are implementing various utilization management strategies in an effort to rein in their costs. While prior authorization and step therapy are perhaps the most common tactics, other approaches, such as quantity limits, site-of-care optimization and dose optimization also can be successful tools, as evidenced by one specialty pharmacy’s recent announcement.

In September, AllianceRx Walgreens Pharmacy revealed that its use of dose optimization resulted in $6.2 million in savings in 2021. The strategy reduces the number of dispensed units of an oral, injectable or infusible agent while delivering the same appropriate dose. Some manufacturers charge the same or similar price for different doses of a drug, so if a patient is given a prescription for two 10 mg tablets per day, and a 20 mg tablet is available, it can be more efficient and economical for the patient to take the single 20 mg tablet.

A new formulation of a narcolepsy drug may get uptake among providers, according to Zitter Insights research. But payers indicate that they are likely to require patients to fail at least one generic drug before getting access to the new agent and other branded medications. Still, the agent’s less onerous dosing may allow it to pull market share from similar medications within the class.

On July 19, Avadel Pharmaceuticals plc said that the FDA had granted tentative approval to its Lumryz (sodium oxybate) for the treatment of excessive daytime sleepiness or cataplexy — an abrupt loss of muscle tone that can be triggered by strong emotion — in adults with narcolepsy. The drug — which is also known as FT218 — is a once-at-bedtime extended-release version of Jazz Pharmaceuticals plc’s Xyrem, a drug that requires one dose at bedtime and then another dose between two-and-a-half to four hours later.