Radar on Specialty Pharmacy

Employers have long been concerned about costs for specialty therapies, but some may have been hesitant about putting too many restrictions on them. However, as these drugs continue to come onto the market with higher and higher price tags, employers should become more familiar with these therapies in order to properly manage them, industry experts suggest.

Over the past three years, specialty drugs have made up almost two-thirds of all new drug approvals, points out Katie Asch, Pharm.D., senior director and U.S. consulting pharmacy practice lead at Willis Towers Watson. And as these drugs make up the bulk of the pharma pipeline, employers should expect their utilization to continue to rise, she says. “Furthermore, specialty drugs are becoming more widely used in disease states like asthma or eczema that have historically been treated with less expensive inhalers or topical creams,” which also will result in increased utilization.

While specialty pharmacy merger and acquisition activity has certainly slowed, one independent specialty pharmacy continues to snap up other complementary organizations — and, as a result, may find the M&A focus on itself.

BioMatrix Specialty Pharmacy revealed in early July that it had acquired InfuCare LTD, an infusion-focused specialty pharmacy. Located in Tyler, Texas, InfuCare provides BioMatrix with a physical location in what the latter calls a “key geographic area,” providing “access to additional covered lives in one of the nation’s largest states,” according to a company press release. It also brings expertise in chronic, complex conditions that require home infusion with therapies such as intravenous immune globulin (IVIG) and parenteral nutrition.

While total Medicare spending on all Part B drugs continued to rise from 2018 to 2019, a Medicare Payment Advisory Commission (MedPAC) report found that average sales prices (ASPs) for some traditionally costly drugs actually decreased, a trend that may be due to biosimilar competition, posits the recent report.

The report, titled Health Care Spending and the Medicare Program, was published in July 2021. In 2018, total Part B drug spending was just shy of $35 billion, an amount that rose to more than $39 billion the following year. Among the top 10 drugs, 2018 total spend was almost $15 billion, increasing to more than $16 billion in 2019 — or about 41% of all Part B spending for the year.

More than 10 years after the passage of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as part of the Affordable Care Act, the FDA finally has approved the first interchangeable biosimilar. But while many in the industry are hailing the move, at least one expert wonders whether interchangeables will hamstring use of biosimilars that do not have that designation.

On July 28, the FDA approved Viatris Inc. and Biocon Ltd. subsidiary Biocon Biologics Ltd.’s Semglee (insulin glargine-yfgn) to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. It is a biosimilar to and interchangeable with its reference product, Sanofi Aventis’ Lantus (insulin glargine), a long-acting insulin analog. The product will be available in 10 mL vials and 3 mL prefilled pens and is administered subcutaneously once daily. It also has 12 months of exclusivity under section 351(k)(6) of the Public Health Service (PHS) Act during which the FDA cannot approve another biosimilar that is interchangeable with Lantus.

The FDA recently approved a third agent to treat paroxysmal nocturnal hemoglobinuria (PNH). With some conditions, that number of treatments may prompt payer preferencing, but that is unlikely to happen with this ultra-rare, potentially fatal disease, observe industry experts.

On May 14, the FDA approved Apellis Pharmaceuticals, Inc.’s Empaveli (pegcetacoplan) as the first and only targeted C3 therapy for the treatment of adults with PNH. It is approved for both treatment-naïve people, as well as ones switching from any C5 inhibitor. The FDA has approved two of those drugs: Soliris (eculizumab) and Ultomiris (ravulizumab-cwvz), both from Alexion Pharmaceuticals, Inc., which was just acquired by AstraZeneca in July.