As precision medicine continues to evolve, companion diagnostics (CDxs) are increasingly being used to guide sometimes life-or-death treatment decisions. Their aim is to improve clinical outcomes by using predictive biomarkers to target patients, especially those with cancer, who could respond well to particular therapeutics. But industry experts cite a disconnect at times between FDA approval and payer reimbursement, slowing the potential impact of a burgeoning array of CDxs and prompting pharma companies to take proactive steps to market them.

MMIT’s FormTrak solution allows pharma companies to keep providers updated with real-time, accurate data about coverage for their brands — a critical step in ensuring a therapy gets to patients who need it. Now it’s even easier to communicate new coverage wins to healthcare providers, with FormTrak’s native integration with Veeva CRM.

This summer, Incyte Corp. hit a roadblock in the company’s quest to have its drug retifanlimab become the first FDA-approved treatment of its kind for patients with the most common type of anal cancer.
Retifanlimab is an immune checkpoint inhibitor (also known as immunotherapy) that aims to treat adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) whose disease has progressed after receiving platinum-based chemotherapy or who were intolerant of that type of chemotherapy. Currently, there are no approved treatment options available to patients who meet these criteria, according to Incyte.

Founded in 2012, Oscar Health Inc. calls itself “the first health insurance company built around a full stack technology platform.” Since its founding, Oscar has grown to serve more than 500,000 members in 18 states, largely via the Affordable Care Act (ACA) exchanges and off-exchange individual and family plans. Oscar also offers Medicare Advantage (MA) plans in three states and in 2020 partnered with Cigna Corp. to offer co-branded small group commercial products in California, Connecticut, Georgia, Missouri and Tennessee. CVS Caremark serves as Oscar’s pharmacy benefits manager.

The FDA is requiring revisions about increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots and death to the labels of the Janus kinase (JAK) inhibitors indicated for inflammatory conditions: Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and AbbVie Inc.’s Rinvoq (upadacitinib). The move follows the agency’s review of a large, randomized safety clinical trial of Xeljanz.

In 2020, specialty trend — which consists of utilization and cost trend components — continued to increase, but it did so at a slower pace than that of the past five years. That’s one of the findings of Pharmaceutical Strategies Group (PSG), an EPIC company, in its State of Specialty: Spend and Trend Report, published in August. The report, which is based on PSG’s Artemetrx platform and uses integrated pharmacy and medical claims data, also found that biosimilars finally are beginning to produce real savings.

On Oct. 1, the FDA gave another indication to Gilead Sciences, Inc. division Kite Pharma, Inc.’s Tecartus (brexucabtagene autoleucel) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). According to a Zitter Insights survey, oncologists said they are likely to prescribe the drug over certain therapies with that indication.

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).