Biosimilars Come to Community Pharmacy

The long-awaited wave of biosimilar biologic agents is finally moving into community pharmacy. PBMs and payers are encouraging patients to move from the familiar long-acting insulin Lantus (insulin glargine, Sanofi) to Basaglar (insulin glargine, Lilly), approved by the FDA in late 2016.

The cost difference between the two is relatively small, about 15%, but the impact at the pharmacy counter could be huge.

“The PBM and payer push made Basaglar a kind of explosion at retail in January because no one knew anything

Ken Sternfeld, PharmDabout it,” said Ken Sternfeld, PharmD, founder of RxVIP Concierge. “When you think about a generic, you think about an identical product. When you think about a biosimilar, you think about something that is similar to-sort-of like-the Lantus that keeps me alive.”

It’s a different story in managed care. Major integrated-care organizations adopted Basaglar for patients starting on long-acting insulin and actively promote switching for patients who were already taking Lantus.

Managed care organizations prepared prescribers, patients, and pharmacists in 2016 for the coming switch. It wasn’t the first time payers had switched preferred insulins.

“Over the years, a number of insurers have switched from a Lilly product to a Novo Nordisk product at various times,” said Susan A. Cantrell, RPh, CAE, CEO of the Academy of Managed Care Pharmacy (AMCP). “This kind of switching has

Susan A. Cantrell, RPhoccurred numerous times and the results have been very good. It’s something pharmacists have a lot of experience with.”

When a Biosimilar Is Not a Biosimilar

Biosimilars are not generics and cannot be switched without the prescriber’s authorization. Nor can pharmacists switch patients from Lantus to Basaglar, even though, strictly speaking, Basaglar is not a biosimilar. Basaglar is a follow-on biologic. The difference is regulatory, not clinical.

Nearly all biologics are licensed under the Public Health Service Act (PHSA). But a handful of biologics, including insulin glargine, are approved under Section 505 of the Food, Drug, and Cosmetic Act. That regulatory distinction makes Basaglar a follow-on biologic, not a biosimilar. The distinction is not meaningful in most settings.

“For all intents and purposes, Basaglar is a biosimilar, just under a different regulatory pathway, said Mary Jo Carden, RPh, JD, AMCP Vice President for Government and Pharmacy Affairs. “We are treating follow-on insulins as biosimilars.” 

Follow the Money

Biosimilars, biologics, and generics do share one important attribute. All three promise cost savings.

Biosimilars approved by the European Medicines Agency are priced about 30% less than the reference biologic according the Express Scripts. The PBM is projecting U.S. savings of about $250 billion by 2024 from biosimilars that are already approved by the FDA or under submission.

Mary Jo Carden, RPh, JDBut the actual savings may be less. Zarxio (filgrastim-sndz, Novartis), the first biosimilar to reach to U.S. market, is priced about 15% below Neupogen (filgrastim, Amgen). Basaglar offers similar savings compared to Lantus.

Express Scripts has both Basaglar and Lantus as preferred agents. Pharmacists report the PBM is actively promoting Basaglar for both new starts and existing Lantus patients.

The company declined to provide comparative utilization data, but spokesperson Jennifer Leone Luddy said the addition of Basaglar added much needed competition to the class that is helping to drive down the cost of these drugs for payers and patients.

Up next: Making the switch

CVS Health is taking a more assertive stance. It replaced both Lantus and Toujeo, Sanofi’s own successor insulin glargine, with Basaglar in its 2017 formulary. Spokesperson Christina Beckerman said the company is seeing significant savings without compromising patient outcomes or care.

Diana Isaacs, PharmD“We were disappointed Basaglar isn’t quite as cheap as we were hoping, but it is cheaper than Lantus,” said Diana Isaacs, PharmD, BCPS, BC-ADM, CDE, Clinical Pharmacy Specialist at the Cleveland Clinic Diabetes Center. “It’s a one-to-one conversion, so it is pretty easy to switch. It’s the patient education piece, and calling prescribers, that complicates things.”

Lantus is losing massively on new starts, Isaacs added, thanks largely to payer preferences. Sanofi has adjusted its copay to fight loss of existing scripts. Patients can now obtain Lantus for $10 per month even if their plan designates Basaglar as the preferred product.

Making the Switch

“Biosimilars put pharmacists in a bit of a quandary,” said Salvatore Giorgianni, PharmD, President of Griffon Consulting Group. “In the institutional setting, you can simply declare a therapeutic interchange and it’s done. You can’t do that in the community setting because biosimilars cannot be switched by the pharmacist. It is up to the pharmacist and the prescriber to help the patient understand the switch.”

Mostly, it’s up to the pharmacist. “The pharmacist has to take the time to tell the story of biosimilars and how they are the right stuff. And in too many retail settings, the time isn’t there,” said Sternfeld.

Some patients don’t care what insulin they take as long as it works, he said. Others want the full story behind the switch. And switching from a reference product to a biosimilar, or among biosimilars as more products are approved, requires prescriber authorization. Calling prescriber offices adds still more time to each switch, even if the prescriber is amenable, he noted.

But just because a biosimilar is available or preferred by formulary does not mean every patient should switch, Isaacs said.

Lilly may have tried to make Basaglar as similar to Lantus as possible, but that similarity didn’t extend to product delivery. Basaglar is available only as a pen, while Lantus comes in 100-ml vials. For patients who need more than the 80-unit Basaglar pen, Lantus may be the simpler alternative, Isaacs noted.

“Pharmacists are very good at recognizing the differences between different products and different formulations,” Giorgianni said. “In that sense, biosimilars are very much business as usual for us. It is still the pharmacist in the community setting who is on the front line trying to address all the issues that play into product selection. Biosimilars are part of our job.”