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Pricing adjustments for CAR-T therapies likely to take place in 2018, forecasts GlobalData

April 5, 2018 Statistics & Trends No Comments Email Email

Despite the promising findings that the currently approved chimeric antigen receptor T-cell (CAR-T) immuno-oncology (IO) therapies – Kymriah and Yescarta – are beneficial, practical challenges associated with their pricing and reimbursement remain, says leading data and analytics company GlobalData.

Currently, Novartis’s Kymriah and Gilead/Kite Pharma’s Yescarta are the only CAR-T cell therapies available in the US market. The labels for both drugs contain boxed warnings for severe adverse events—cytokine release syndrome as well as neurologic toxicities.

Upon launch, Kymriah (August 2017) and Yescarta (October 2017) were priced at $475,000 and $373,000 per treatment, respectively, placing these among the highest-priced drugs on the oncology market.

Fern Barkalow, PhD, Oncology Director at GlobalData says: “With both Kymriah and Yescarta currently being considered for approval by regulatory authorities in the cost-conscious European market, pricing is even more of a concern to stakeholders. In addition, approval by the FDA for additional indications, will increase the available population for treatment and could have some effect on the cost of these drugs.”

The majority of studies examining CAR-T -pricing have indicated that the costs are not justified. A fairly comprehensive study reported in February 2018 on the Health Affairs Blog claims that Novartis could lower the price of Kymriah by two-thirds and still achieve a profit.

On the other hand, the Institute for Clinical and Economic Review’s (ICER) weighed in just a week or so after release of the Health Affairs site study, with release of a report stating that the drugs were appropriately priced.

Barkalow concludes: “In the short term, affordability for those who stand to benefit from CAR-T treatment is of major concern. In addition to the cost of the drug itself, further costs will most likely be incurred, including potential hospitalizations in the case of severe adverse events.

“Given the constraints of toxicity issues, insufficient real-world data on cost-effectiveness and efficacy, the eventual development of both off-the-shelf and next-generation therapies, and pressure from payers to reduce prices, GlobalData believes that price adjustments in the initial wave of approved CAR-T drugs will be seen starting in the second half of 2018.” 

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