Radar on Specialty Pharmacy

The advanced therapies market shows no signs of slowing, as scientific innovation continues to bring revolutionary new treatments out of the laboratory and onto the U.S. market. But some barriers to access, including the lack of patient caregiver support, payer hurdles and high costs, still remain and must be overcome if these agents are able to realize their potential and be even more impactful than they already are, according to a recent report from Cardinal Health.

Multiple advanced therapies — 22 cell and gene therapies (CGTs) and 22 ultra-specialty therapies — are available in the U.S., and that total is expected to more than quadruple by 2030. By that time, estimates find that more than 100,000 will have undergone treatment with them.

As the number of biomarker tests continues to rapidly grow, some health plans may struggle with coverage of them. A recent Zitter Insights survey found that 30% of commercial and Medicare payers do not provide coverage of companion diagnostics — a type of biomarker testing — for their members. But payer coverage of many of these tests can lead to lower health care costs. With that in mind, many states are mandating coverage of biomarker testing for state-regulated plans, with New Jersey recently becoming the latest one to do so.

On April 23, New Jersey Lieutenant Governor and Secretary of State Tahesha Way signed A-4163/S-3098 into law, mandating that state-regulated health insurance plans, Medicaid, the State Health Benefits Program and the School Employees’ Health Benefits Program cover “biomarker precision medical testing…for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a disease or condition, excluding asymptomatic screening, to guide treatment decisions of a subscriber when the test is supported by medical and scientific evidence.”

April 30: The FDA granted interchangeability status to the Fresenius Group’s unit Fresenius Kabi USA, LLC and Formycon AG’s Otulfi (ustekinumab-aauz) for the 45 mg/0.5 mL single-dose vial for all of its indications: the treatment of adults and pediatric patients at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adults and pediatric patients at least 6 years old with active psoriatic arthritis, adults with moderately to severely active Crohn’s disease and adults with moderately to severely active ulcerative colitis. The agency first approved the biosimilar of Johnson & Johnson Innovative Medicine’s Stelara (ustekinumab) on Sept. 27, 2024, and gave it provisional interchangeability due to the unexpired period of exclusivity for Amgen Inc.’s Wezlana (ustekinumab-auub). Dosing for the interleukin-12/IL-23 antagonist varies based on indication. Fresenius Kabi did not respond to a request by AIS Health, a division of MMIT, for Otulfi pricing information.

The FDA has revised prescribing labels for two programmed death receptor-1 (PD-1) inhibitors to narrow their gastrointestinal indications to programmed death ligand-1 (PD-L1)-positive disease. In May 22 letters, the agency confirmed the changes to Merck & Co., Inc.’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Opdivo (nivolumab). The moves follows a Sept. 26, 2024, Oncology Drug Advisory Committee (ODAC) meeting on the use of immune checkpoint inhibitors in people with unresectable or metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Committee members voted 10-2, with one abstention, that the risk benefit assessment for using PD-1 inhibitors in first-line advanced HER2-negative microsatellite stable gastric/GEJ adenocarcinoma in people with PD-L1 expression <1 was not favorable. They also voted 11-1 that the risk benefit assessment for using PD-1 inhibitors in first-line unresectable or metastatic esophageal squamous cell carcinoma with PD-L1 expression <1 was not favorable.

Multiple oncology drugs that first launched as intravenous (IV) infusions are now available as subcutaneous (SC) injections. The new formulations can provide advantages such as shorter infusion times, which can benefit both patients and crowded infusion suites. But an array of considerations should be taken into account, and not every patient may be a suitable candidate for the therapies.

Among the agents are Roche Group member Genentech USA, Inc.’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), Johnson & Johnson Innovative Medicine’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) and Bristol Myers Squibb’s Opdivo Qvantig (nivolumab and hyaluronidase-nvhy). Merck & Co., Inc.’s SC Keytruda (pembrolizumab) is awaiting an FDA decision on its approval, which is expected by Sept. 23.