Four ways health execs can prep for costly CAR-T cell therapies

Recent FDA approvals of Novartis' tisagenlecleucel (Kymriah), the first chimeric antigen receptor (CAR) T-cell therapy for the treatment of certain pediatric and young adult patients with a form of acute lymphoblastic leukemia, and of Gilead's axicabtagene ciloleucel (Yescarta), developed by Kite Pharma, the first for certain types of non-Hodgkin lymphoma, have been hailed as significant treatment breakthroughs.

But the high cost of these drugs ($373,000 for Yescarta for one injection) and $475,000 for the Kymriah for one injection have healthcare executives wondering how to manage the budget implications.

With the high efficacy and dire diagnosis, there will be demand for both Kymriah and Yescarta, according to the experts.

Velie

“In the managed care world, we are constantly looking for ways to avoid treatment that’s not optimal for patients,” Jake Velie, CEO of Rx-Precision, a prescription risk management company, says. “In support of the medical providers, we want to bring the best possible scientific approaches to each individual patient-especially when the patient is diagnosed with a high-risk, high-mortality disease and involved in a treatment protocol that can be very lengthy, painful and hard on the patient and family. We see all advances in gene-specific treatment as a huge progression towards the medicine of the future. Fortunately, it's available today and only gaining momentum.”

Rebecca Sutphen, MD, FACMG, president and chief medical officer at InformedDNA, agrees that the approval the two CAR-T therapies for advanced cancer patients within a short period of time, "along with the pipeline of similar therapies in development for several cancer types, indicates that there will likely be a number of FDA-approved CAR-T therapies over the next few years," she says.

Sutphen

The two approvals mean that managed care executives need to budget for these therapies by understanding the patient volume and likely uptake in the market, says Jeremy Schafer, PharmD, MBA, senior vice president, director, payer access solutions, Precision for Value.

“Managed care executives also need to understand that these approvals are the first of likely many so the payer market must develop ways to pay for high-cost, one- time-use therapies, with an outlook on how costs are impacted later,” Schafer says.

There’s an opportunity for healthcare executives to influence the adaptation of these tools being used as clinical standards of care, according to Velie.

“They can help them become a normal and familiar part of treating serious diseases, even those that are chronically managed,” he says.

Tips for how to prepare:

• Understand that this is just the beginning.

These cellular immune therapies must be taken seriously by healthcare providers, hospital administrations, payers and every aspect of cancer treatment with these emerging beneficial therapies, says Gerry Messerschmidt, MD, FACP, chief medical officer, Precision Oncology.

Messerschmidt

“Because of the high-efficacy rates observed, these types of therapies will be attaining additional expanded indications and likely new cancer indications,” he says. “Payers will need to assess these approved populations and then begin formulating policies on ‘certification’ and payment. These initial policies should account for the spread of such therapies to a wide variety of malignant diseases. These CAR-T cell therapies and other cellular therapies not yet approved are moving rapidly into the clinic and not just helping a few people, but perhaps the majority of patients treated. Benefit may vary by tumor type and toxicity may improve, however it appears inevitable that these therapies will increase in number, prevalence and costs over the next decade and beyond.”

      2.  Adapt current payment models.

Managed care executives should begin assessing how the current payment models and organizational goals can be evolved to accommodate these new therapies, according to Schafer.

Schafer

“Managed care executives should look into how organizational goals can be adapted to reward overall patient health and potential long-term improvement, particularly in areas impacted by gene therapies,” he says. “This will allow payer organizations to be rewarded for supporting innovative therapies that while having high upfront cost, have significant beneficial impact on patient health long term.”

      3.  Engage in a dialogue with payers.

Executives may also want to work with manufacturers of these products to develop new payment models that may allow the payer to bear less risk up front but also ensure adequate profitability for the manufacturer, Schafer says.

      4.  Work with other health plans.

Finally, executives should engage each other across organizations to brainstorm ideas for the industry on funding such therapies. “With the movement of members from one plan to the next, a plan that pays for a CAR-T therapy today, may receive another member tomorrow whose therapy was funded by a competitor,” Schafer says. “Understanding this concept may help all payers be more flexible on genetic therapies.”