As the FDA tries to navigate the COVID-19 pandemic and keep up with pharma inspections, the agency touts its expanding use of remote tools such as teleconferences and livestreaming video of operations.
The FDA says it is making records requests ahead of inspections to limit the amount of time spent on-site at manufacturing facilities and awaiting input from its new council that was launched in July on how to prioritize the implementation of new technologies for inspections.
Launching on orphan drug in and of itself can be a challenge. But bringing one to market during a pandemic poses a whole additional set of challenges. In 2020, pharma companies accustomed to in-person meetings suddenly found themselves faced with lockdowns not only in the U.S. but around the world.
Some firms chose to delay bringing their drugs to market, while others needed to move quickly to modify their launch strategies. Swedish Orphan Biovitrum AB’s (Sobi), with the help of Real Chemistry (previously known as W2O Group), fell in the latter group. The companies recently discussed how a holistic engagement model can help make experiences better for people with rare diseases who have a new treatment option during COVID.
PULSE Analytics, offered by MMIT partner The Dedham Group, equips market access teams with the tools to better understand the organizational structure, control, and influence of health systems and integrated delivery networks (IDNs).
AIS Health’s data team on Sept. 23 updated the Directory of Health Plans (DHP) subscriber dashboard and in-app spreadsheets with new enrollment numbers. This data primarily reflects second-quarter 2021 status but includes third-quarter 2021 lives for Medicare Advantage (MA) products and some Medicaid figures, based on availability at the state level.
The FDA recently expanded the indication of a drug for certain types of urothelial cancer, the most common form of bladder cancer. Payers and oncologists appear to be divided, however, on the drug’s place in a treatment regimen. But in a therapeutic class with limited therapeutic options, the approvals are a welcome addition, particularly in the second-line setting.
Founded by a group of providers in 1959, Triple-S Management Corp. is now a publicly traded company and the largest insurer in Puerto Rico, serving 35% of the U.S. territory’s insured population. It is also the primary Blue Cross and Blue Shield affiliate for the island. Miami-based Abarca Health serves as Triple-S’s pharmacy benefits manager for commercial and Medicare products, while ProCare Rx subsidiary MC-Rx serves the Medicaid population.
Risk of a COVID-19 infection and problems with hospital capacity led to a substantial decline in new cancer cases diagnosed early in the pandemic. Though medical practices reopened after early lockdowns, the number of newly diagnosed patients remained below prepandemic level through March 2021, according to a JAMA Network Open research letter. The study analyzed patients newly diagnosed with eight cancer types in four periods: prepandemic (January 2019 to February 2020), first pandemic period (March to May 2020), second period (June to October 2020) and third period (November 2020 to March 2021). During the first pandemic period, the average monthly number of new diagnoses fell 29.8% from 32,407 to 22,748 for the eight cancers combined. During the second period, the average number only declined 9.6%, statistically at the same level as it was before the pandemic for all cancers except prostate cancer. However, during the third period, average diagnoses showed a significant decline, dropping by 19.1% compared with prepandemic. “Our findings call for planning to address the consequences of delayed diagnoses, including strengthened clinical telehealth offerings supporting patient-clinician interactions,” the study authors wrote.
The COVID-19 pandemic has fueled and accelerated merger and acquisition activity in the health care sector, according to the 2021 HealthLeaders Mergers, Acquisitions, and Partnerships Survey conducted by the HealthLeaders Intelligence Unit. The analysis of 119 completed surveys of executives at health systems, hospitals, physician organizations, skilled nursing and assisted living facilities and other provider entities shows that while the pandemic delayed or stalled 49% of respondents’ M&A plans, 90% expect their organizations’ M&A activity to increase or remain the same within the next three years. The top driver of M&A activity is increasing scale to improve negotiations with payers (66%), followed by improving patient care (38%). Meanwhile, data compiled by market research firm Mercom Capital Group shows that digital health M&A set a record in the first half of 2021, with 136 digital health transactions compared to 83 during the same period last year.
The FDA is requiring revisions about increased risk of serious heart-related events such as heart attack, stroke, cancer, blood clots and death to the labels of Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and AbbVie Inc.’s Rinvoq (upadacitinib) following the agency’s review of a large, randomized safety clinical trial of Xeljanz. The trial compared Xeljanz with tumor necrosis factor (TNF) inhibitors in people with rheumatoid arthritis and showed an increased risk of blood clots and death with a lower dose of Xeljanz. A prior study whose results Pfizer disclosed on Jan. 27, 2021, showed the same results but only at a higher dose.
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.
