Radar on Specialty Pharmacy

The FDA recently approved an expanded patient population for Novo Nordisk’s Sogroya (somapacitan-beco), a long-acting growth hormone requiring weekly administration, as opposed to daily administration of short-acting agents. Payers and endocrinologists have expressed a willingness to manage and prescribe the new agents, according to Zitter Insights. Nevertheless, this is a class where agents have not shown clinical differentiation, so payer coverage of the agents likely will come down to cost, industry experts say.

On April 28, the FDA expanded the patient population for Sogroya to include the treatment of people at least 2 1/2 years old who have growth failure due to inadequate secretion of endogenous growth hormone. The agency initially approved the drug on Aug. 28, 2020, for the replacement of growth hormone in adults with growth hormone deficiency. With the newest approval, the injectable becomes the first and only once-weekly growth hormone treatment for both children and adults.

Various randomized controlled trials have found that hypofractionated whole breast irradiation (HF-WBI) for certain patients with early-stage breast cancer is not only equivalent to standard radiation therapy for local control of the disease but also is less toxic, has better patient adherence and provides improved patient well-being. Those results led the National Comprehensive Cancer Network (NCCN) to add the approach to its guidelines. But while hypofractionation can benefit patients, providers and health plans, there has been slow uptake of it. A recent study found that putting clinical pathways in place that include mandating HF-WBI’s use improved compliance with the guidelines.

One retrospective study found that health plans spent $6,375 less for HF-WBI than they spent on conventional whole breast irradiation, and patients saved about $140 aside from travel-related costs.

The traditional pharmacy benefit market is seeing a challenge to its model from patient-paid prescriptions, contended longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a recent webinar. While some generics of specialty drugs are being sold via these routes, the potential exists for disruption in crowded biologic-treated classes facing a lot of competition, particularly via biosimilars.

And with some industry developments such as the Inflation Reduction Act likely to impact the uptake of high-price/high-rebate drugs, patient-paid prescriptions could become an even bigger disruption within the market than they already are.

With an eye on improving medication adherence for people with rare diseases or chronic conditions, AllianceRx Walgreens Pharmacy recently launched RightGuide. The program helps digitally connect pharma manufacturers to patients and their caregivers in order to provide education on a variety of topics, from training people how to self-administer injectable agents to helping with financial issues and addressing the side effects of medications.

The specialty pharmacy is working with manufacturers to create customized, brand-specific resources “to help facilitate patient conversion, adherence and retention — while minimizing treatment barriers for patients and caregivers,” explains Tracey James, R.Ph., chief operating officer at AllianceRx Walgreens Pharmacy.

May 9: The FDA approved Chiesi Group unit Chiesi Global Rare Diseases and Protalix BioTherapeutics, Inc.’s Elfabrio (pegunigalsidase alfa-iwxj) for the treatment of adults with Fabry disease. A PEGylated enzyme replacement therapy, the agent is a recombinant human α–Galactosidase–A enzyme expressed in plant-cell culture that is designed to provide a long half-life. Recommended dosing is 1 mg/kg via intravenous infusion every two weeks.

May 17: The FDA approved a 40 mg/0.8 mL single-dose autoinjector for Boehringer Ingelheim’s Cyltezo (adalimumab-adbm). The agency initially approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) on Aug. 25, 2017, as a single-use prefilled syringe. The drug is approved for multiple chronic inflammatory diseases. The new pen will be available in two-, four- and six-pack options when the tumor necrosis factor (TNF) inhibitor launches on July 1.