10
Specialty Pharmacy Continuum • November/December 2021
CLINICAL
Specialty spending ekes out a win over traditional meds
2021 New Drug Approvals: A Year of Firsts Aurora, Colo.—Two of the most notable new drug approvals in 2021 were not technically new; they were new indications, but they should have a significant effect on the specialty market. Two biosimilars became the first interchangeable biologics approved by the FDA. Just more than one year after it was approved, insulin glargine-yfgn (Semglee, Viatris/Biocon Biologics) was granted interchangeable status with its reference product Lantus (Sanofi) in July 2021. It can be automatically substituted with the reference product by a pharmacist, similar to the substitutions made for traditional generics. On Oct. 20, Express Scripts listed insulin glargine-yfgn as a preferred insulin on its National Preferred Formulary, due to take effect in January 2022. “Semglee currently costs about half as much as Lantus,” explained Aimee Tharaldson, PharmD, at the 2021 AMCP Nexus meeting. “This could save clients $20 million next year due to this decision,” added Dr. Tharaldson, a senior clinical pharmacist of Emerging Therapeutics at Express Scripts. The second biosimilar to be designated as interchangeable is adalimumabadbm (Cyltezo, Boehringer Ingelheim), a biosimilar to Humira (AbbVie). Adalimumab-adbm, which was originally approved in August 2017, was made interchangeable on Oct. 18. Unlike insulin glargine-yfgn, however, adalimumabadbm will not launch immediately due to patent settlement agreements with AbbVie. It will launch in 2023, along with five other biosimilars to adalimumab, but only adalimumab-adbm has interchangeability at this point. Another biosimilar approved this year, ranibizumab-nuna (Byooviz, Samsung Bioepis/Biogen), a biosimilar to Lucentis (Genentech), is the first ophthalmic biosimilar. The anti–vascular endothelial growth factor therapy was approved to treat several eye conditions, including neovascular age-related macular degeneration, the leading cause of blindness in those 65 years of age and older. Bevacizumab (Biothera), a biosimilar to Avastin (Genentech) for several cancer types, and another adalimumab biosimilar by Coherus were expecting approvals before the end of the year. “So far, FDA has approved 31 biosimilars to 11 biologics. And 21 biosimilars to 8 biologics are currently available on the market,” Dr. Tharaldson explained. “These biosimilars have combined sales of about $4 billion.” Specialty spending, which has been creeping up each year, has overtaken the traditional drug spend, Dr. Tharaldson
noted. “Fifty-one percent of per member per year drug spend under the pharmacy benefit is for specialty drugs,” she said, but only about 2% of the patients covered take specialty medications.
More Firsts Long-Acting HIV Medication
ViiV Healthcare kicked off the year with the approval of the first long-acting HIV medication. Cabotegravir-rilpivirine injectable (CAB/RPV; Cabenuva) is an alternative to oral treatment for adults with low viral loads who are on a current stable regimen and no history of treatment failure, she explained. Dosed monthly, CAB/RPV comes as a copack with two injectable medications, ViiV’s cabotegravir and Janssen’s rilpivirine.
options, and these have been only modestly effective but highly toxic,” Brad H. Rovin, MD, the director of the Division of Nephrology at The Ohio State University Wexner Medical Center, in Columbus, and an AURORA clinical trial investigator, said in a press release announcing the approval (bit.ly/30ekHkz). “About 10% of these patients with lupus nephritis develop end-stage renal disease,” Dr. Tharaldson said. Genetic Disorders
Casimersen (Amondys 45, Sarepta Therapeutics) is the first drug approved to treat Duchenne muscular dystrophy (DMD) with a mutation amenable to exon 45 skipping. About 10,000 boys and young men have DMD, but only about
Non-small cell lung cancer (NSCLC) patients benefited from several approvals in 2021, with drugs hitting a variety of targets, including KRAS G12C, epidermal growth factor receptor exon 20 insertion mutations and METexon14 alterations. Although lung cancer rates are decreasing in the United States, 235,760 adults still are diagnosed each year, 85% of whom have NSCLC, according to the American Society of Clinical Oncology.
The approval was based on the phase 3 ATLAS and FLAIR studies that included more than 1,100 patients from 16 countries. Prior to initiating treatment, oral dosing of CAB and RPV are given to assess tolerability with therapies. The first therapy for adults with active lupus nephritis was also approved in January. Lupus nephritis, a common complication of systemic lupus erythematosus, causes irreversible kidney damage and significantly increases the risk for kidney failure, cardiac events and death. Voclosporin (Lupkynis, Aurinia), an oral therapy used with a background immunosuppressive regimen, is a calcineurin inhibitor. In the pivotal AURORA trials, patients treated with voclosporin with immunosuppressives were more than twice as likely to achieve renal response and experience a decline in the urine protein to creatinine ratio. “For years, treating patients with lupus nephritis has been challenging. We have had a very limited number of therapeutic
8% have this genetic mutation, according to Dr. Tharaldson. Casimersen is an antisense oligonucleotide that skips over exon 45 to enable a partially functioning dystrophin protein. The medication is given as a weekly infusion. The new indication is based on a statistically significant increase in dystrophin production in skeletal muscle observed in patients treated with casimersen, which is reasonably likely to predict clinical benefit. Fosdenopterin (Nulibry, BridgeBio/ Origin Biosciences) is the first drug for patients with molybdenum cofactor deficiency (MoCD) type A, which affects fewer than 150 infants and young children worldwide. MoCD type A is an autosomal recessive, inborn error of metabolism caused by mutations in the molybdenum cofactor synthesis 1 gene and characterized by a deficiency in molybdenum cofactor production and enzyme activity. The lack of activity leads to a buildup of sulfite and secondary metabolites in the brain, which causes irreversible, progressive neurologic damage.
“Nulibry the off a lib allows ll h production d i missing enzyme that reduces the buildup of the harmful substances in the brain. It’s administered as a daily IV infusion,” Dr. Tharaldson said. Small studies showed improved overall survival (OS) compared with an untreated cohort. Belzutifan (Welireg, Merck), an oral hypoxia-inducible factor-2 alpha (HIF2alpha) inhibitor, is the first treatment for von Hippel-Lindau (VHL) syndrome, a rare genetic disorder that leads to the development of cancerous and noncancerous tumors. Seventy percent of people with this condition develop renal cell carcinoma, Dr. Tharaldson explained. Belzutifan reduces transcription and expression of HIF-2alpha target genes associated with cellular proliferation, angiogenesis and tumor growth. “In Study 004, nearly half of all patients with VHL-associated renal cell carcinoma, as well as the majority of patients with VHL-associated central nervous system hemangioblastomas or pancreatic neuroendocrine tumors, who were treated with Welireg experienced a reduction of their respective tumor size,” explained Ramaprasad Srinivasan, MD, PhD, the head of the Molecular Cancer Therapeutics Section, National Cancer Institute.
Cancer Drugs Approved Non-small cell lung cancer
Non-small cell lung cancer (NSCLC) patients also benefited from several approvals. Although lung cancer rates are decreasing in the United States, 235,760 adults still are diagnosed each year, and 85% with NSCLC, according to the American Society of Clinical Oncology. • Sotorasib (Lumakras, Amgen) is the first targeted treatment for KRAS G12C mutated locally advanced or metastatic NSCLC. About 13% of NSCLC patients have this “previously elusive mutation,” according to David M. Reese, MD, the executive vice president of Research and Development at Amgen. A phase 2 study found a 37% objective response rate. • Mobocertinib (Exkivity, Takeda) is the first medication to target epidermal growth factor receptor (EGFR) exon 20 insertion mutations, and is indicated for locally advanced or metastatic see 2021 APPROVALS, page 12
