Spotlight on Market Access

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.

Kaiser Permanente, founded in 1945 as a consolidation effort between local hospitals in California and an insurance group for construction employees, has since become the largest integrated delivery network in the U.S. The company operates 39 hospitals, employs more than 20,000 physicians in its medical groups and offers health insurance products in both the private and public sector markets. Kaiser’s seven regional managed care plans enroll more than 11 million lives in eight states plus the District of Columbia. The seven combined entities form the largest provider-sponsored insurer in the U.S., enrolling 29.5% of all provider-sponsored lives.

CVS Health, seeking to leverage its success in COVID-19 vaccine and therapeutics clinical trial recruitment, has opened the doors on a new clinical trial services division that it hopes will offer life sciences companies the opportunity to recruit more diverse study populations.

Forecasting in the pharmaceutical industry is an essential task for companies. While firms have long used Excel-based models to conduct forecasts, those models are outdated and unsuited for the sheer amount of data currently available, maintain industry experts who point out that multiple Web-based options exist. In order to give an accurate picture that’s useful for everyone from executives to sales teams, forecasters should create a model that offers detailed segmentation of the market. Doing this is easier said than done, but strategies exist to help evaluate the different options.

Humana Inc. and Anthem, Inc. are teaming up with hedge fund administrator SS&C Technologies Holdings, Inc. to create DomaniRx, a new joint venture that aims to offer a “best-in-class” PBM cloud-based claims adjudication platform. Humana will be the first customer for DomaniRx, the companies say, and industry observers predict a potential market among Blues plans and Medicare Advantage plans.