March 24, 2018 | Lopamudra Das, Brian Duffant, Courtney Coles
Chimeric Antigen Receptor T-cell (CAR-T) therapies represent a breakthrough in cancer care due to the significant clinical response induced in patients who do not respond to currently available treatments. In 2017, two CAR-T therapies were approved by the FDA – KYMRIAH™ (Novartis) was approved for use in children with acute lymphoblastic leukemia in August and YESCARTA™ (Kite Pharma) was approved in for adults with relapsed or refractory lymphomas in October.
The nearly back-to-back approval of these innovative gene therapies set payers scrambling to design appropriate coverage policies and introduced questions as to what initial access for these new therapies might look like. BPS evaluated initial commercial access for these two therapies by comparing the product labels with medical policies of five large commercial plans to understand relative levels of access for the new CAR-T agents.
Four of five payers have medical policies which are more restrictive than the product label for both products. This was achieved by adding stricter definitions of relapse or refractory status or by restricting duration of pre-authorization. In addition, some payers denied coverage to members that have undergone previous gene therapy or transplantation.
Payers were aligned on dosing restriction and pre-authorization requirements but showed some variance in site of care preferences (see Figure 1)
Figure 1 Overview of coverage restrictions for CAR-T therapies for commercial payers
Implications for Life Science Organizations
Not all major commercial payers have finalized access policies for the CAR-T therapies. As such, the findings of this research represent a limited sample of policies which may be subject to change as more payers finalize access policies for the CAR-T agents.
There is some variance as to what payers consider the proper site of care for CAR-T therapies which have primarily been studied in an inpatient setting. Some of the medical policies evaluated provide initial evidence that site of care may be expanded to an outpatient setting.
Payer access for CAR-T therapies is an emerging area and coverage policies should be monitored to fully understand how access for these new therapies will evolve over time. Manufacturers should understand commercial payer rationale for excluding CAR-T coverage to members (such as the exclusion of coverage for patients who have received ANY prior gene therapy) so they can successfully communicate appropriate patient types to prescribing physicians.
It will be important for manufacturers who enter the CAR-T market in the future to understand how the once-per-lifetime treatment limitation may impact future levels of demand.