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Under a proposal...Medicare would cover CAR-T cell therapies through a Centers for Medicare and Medicaid Services pathway known as Coverage with Evidence Development...The proposal holds a mix of provisions, including that patients must be monitored for at least two years post-treatment. Hospitals administering CAR-T therapy, whether through inpatient or outpatient care, must participate in a CMS-approved registry that collects data on patient outcomes and characteristics and then compares that data to what's been seen in pivotal clinical trials of the therapy or standard of care treatment...Hospitals and clinicians would track certain clinical data elements at baseline, at treatment, and then at three-month, six-month, one-year and two-year follow ups following administration...

...the European Medicines Agency recommended Novartis’ Kymriah (tisagenlecleucel) and Kite Pharma’s Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cells therapies for blood cancer, for approval in the European Union...Kymriah and Yescarta are the first CAR T-cell treatments to be recommended by the agency. In August 2017, Kymriah became the first CAR-T therapy approved by FDA in the United States, with Yescarta becoming the second in October 2017...Both drugs are also the first treatments supported through EMA’s Priority Medicines scheme to receive positive opinions from the Committee for Medicinal Products for Human Use...

Investors should keep an eye on this promising way to treat cancer...For all the talk about biotechs being nimble, it's a big pharma that looks like it'll be the first company to launch a chimeric antigen receptor T-cell (CAR-T) product...Novartis announced last week that the Food and Drug Administration accepted its application to market tisagenlecleucel-T...in patients with B-cell acute lymphoblastic leukemia who are relapsed and refractory to other therapies...A few days later, Kite Pharma completed its application for axicabtagene ciloleucel...Kite's application could be accepted early, putting it less than two months behind Novartis…Since CAR-T therapies are personalized treatments that have to be made individually for each patient, they're likely to be expensive to produce and therefore require a premium price. The first company to get a CAR-T therapy approved will set the price, which later companies may have to match unless they can justify a higher price with higher efficacy...With prices that will probably exceed those of current cancer treatments, investors should expect some pushback from insurers. One way Novarits and Kite can get around the cost issue is by offering money-back guarantees...Kite's and Novartis' CAR-T therapies are just the tip of the iceberg for this new way to treat cancer...