Currently Viewing:
Newsroom
Currently Reading
Study Shows That Volanesorsen Reduces Disease Burden in Patients With FCS
June 17, 2018 – Kelly Davio
Gene Editing Could Reduce Toxicity of CAR T Treatment in AML
June 15, 2018 – Laura Joszt
With Payer Coverage, Food Is Medicine Movement Takes Flight
June 15, 2018 – Mary Caffrey
The Common Factor in Models Trying to Predict COPD: Smoking
June 15, 2018 – Allison Inserro
5 Updates on Maternal Health in the United States
June 15, 2018 – Surabhi Dangi-Garimella, PhD
FDA Approves First Generic Version of Suboxone for Opioid Dependence
June 15, 2018 – Jaime Rosenberg
Experts Suggest Interventions for High-Need Patients
June 15, 2018 – Alison Rodriguez
What We're Reading: Government Doesn't Owe Insurers ACA Money; Hep A Outbreak; Risky Teen Behaviors
June 15, 2018 – AJMC Staff
This Week in Managed Care: June 15, 2018
June 15, 2018

ICER Report: Costs of Approved CAR T-Cell Therapies Aligned With Clinical Benefit

Jaime Rosenberg
CAR T-cell therapies tisagenlecleucel (Kymriah, Novartis) and axicabtagene ciloleucel (Yescarta, Kite Pharma/Gilead) may come with hefty price tags, but the cost-effectiveness of both therapies fell below or within commonly cited thresholds of $50,000 to $150,000 per quality-adjusted life years, according to a report by the Institute for Clinical and Economic Review.
Both FDA-approved chimeric antigen receptor (CAR) T-cell therapies, tisagenlecleucel (Kymriah, Novartis) and axicabtagene ciloleucel (Yescarta, Kite Pharma/Gilead), may come with hefty price tags, but the therapies are priced in alignment with their clinical value, according to an Institute for Clinical and Economic Review (ICER) report.

In August, tisagenlecleucel gained approval for the treatment of B-cell acute lymphoblastic leukemia (B-ALL) in certain pediatric and young adult patients. In October, axicabtagene ciloleucel was green lit by the FDA for the treatment of adult patients with diffuse large B-cell lymphoma who have not responded to or have relapsed after 2 other kinds of treatment; tisagenlecleucel is currently under FDA evaluation for this indication.

Using a cohort of patients aged 0 to 25 with relapsed/refractory B-ALL and a cohort of patients aged 18 and older with relapsed/refractory B-cell lymphoma who were ineligible for auto-stem cell transplant, the report compared the CAR T therapies with chemotherapy. The average sales price for chemotherapy treatments were used, while the wholesale acquisition cost was used for CAR T therapies, as it was the only available estimate. For this indication, the cost of tisagenlecleucel is $475,000, and the cost of axicabtagene ciloleucel is $373,000, not including other costs related to the administration of CAR T therapy. A hospital mark-up was added for each hospital-administered treatment. It was assumed that the survival benefits demonstrated over the short duration of clinical trials would persist over a patient's lifetime.

In the B-ALL cohort, the tisagenlecleucel arm had a total discounted cost of approximately $667,000 with 10.34 discounted life years (LYs) gained and 9.28 discounted quality-adjusted life years (QALYs) gained. The clofarabine comparator arm had a total discounted cost of approximately $337,000 with discounted LYs and QALYs gained of 2.43 and 2.48, respectively.

With a $330,000 cost difference, incremental results showed that the total cost for tisagenlecleucel was nearly twice that of clofarabine; however, gains in LYs and QALYs were more than 4 times greater, which resulted in an incremental cost-effectiveness ratio of approximately $46,000 per QALY gained an approximately $42,000 per LY gained.

In the B-cell lymphoma cohort, the axicabtagene ciloleucel arm had a total discounted cost of approximately $617,000 with 7.35 discounted LYs gained and 5.87 discounted QALYs gained. In the chemotherapy comparator arm, there was a total discounted cost of approximately $155,000 with discounted LYs and QALYs gained of 3.23 and 2.48, respectively.

The results represent a $462,000 price difference with total costs for axicabtagene ciloleucel approximately 4 times greater than the total costs for chemotherapy. Meanwhile, gains in LYs and QALYs were more than double. This resulted in an incremental cost-effectiveness ratio of approximately $136,000 per QALY gained and approximately $112,000 per LY gained.

According to the report, the cost-effectiveness of both CAR T therapies fell below or within commonly cited thresholds of $50,000-$150,000 per QALY.

“CAR T therapies represent a critical advancement in treating B-cell malignancies. Based on the evidence currently available, these therapies provide important clinical benefits and appear to be priced in alignment with these benefits,” said Dan Ollendorf, PhD, chief scientific officer, ICER, in a statement. “However, the evidence is limited and very short-term, and we may still face short-term affordability questions that will require innovative solutions.”

CAR T-cell therapy has emerged as a novel way to treat cancer, genetically reprogramming a patient's own white blood cells to attack tumor cells, and was recently named the American Society of Clinical Oncology's Advance of the Year. Earlier this month, long-term follow-up analyzing the toxic effects and results from a phase 1 clinical trial of adult patients with relapsed B-ALL who were treated with CAR T cells found patients with low disease burden had a longer median overall survival and a lower incidence of toxicity. Final updated results of the pivotal phase 2 study that led to the approval of tisagenlecleucel were published last month, showing an overall remission rate of 81%; 60% of patients had complete remission, and 21% had complete remission with incomplete hematologic recovery.

 
Copyright AJMC 2006-2018 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up
×

Sign In

Not a member? Sign up now!