Fosun Kite Launches China's First Outcomes-Based Payment Plan for CAR-T Therapy Yescarta, Offering Up to RMB 600,000 Refund for Non-Complete Response

Since the first CAR-T product entered the Chinese market in 2021, its commercialization and accessibility have been closely watched. At the start of 2024, this drug welcomed a new payment method in the Chinese market.

Following its inclusion in惠民保 and commercial health insurance, on January 11,Fosun KiteAnd Sinopharm Group'sMedi CoverJointly Released Yikaida® China's First Lymphoma Value-Based Payment Plan: Eligible patients who do not achieve Complete Response (CR) after using Yikaida® will receive a refund of up to 600,000 RMB.

This program will be China's first innovative payment model for lymphoma drugs based on efficacy value, and Yikaida® will become the first biologic innovation drug in China to be paid for based on efficacy value.

However, on a global scale, Fosun Kite is not the first player to adopt a pay-for-performance model. In 2017, AstraZeneca launched the Tagrisso Cost Coverage Assurance Program, and Novartis' CAR-T therapy also utilized a pay-for-performance approach.

However, this innovative payment method has not made much of a splash in the past few years. People can't help but wonder what has supported Fosun Kite’s decision to launch this initiative, and how it will accelerate project implementation to pave a new path for CAR-T's innovative payment solutions?

Confidence Comes from Efficacy and Data

"In fact, payment based on efficacy is often seen among high-value products globally. In the Chinese market, it's frequently discussed and desired, but rarely successfully implemented."

Qi Yuanyuan, the project leader of Fosun Kite, pointed out the underlying reason in an interview with the media on site: "First,So far, China does not have a good database or objective data to support the calculation of payment based on the efficacy of a drug.; Second,Is there a very clear evaluation criterion?, allowing everyone to view this matter more fairly. If these two points can be achieved, there will be great confidence in the implementation of the plan."

For Fosun Kite's Yikaida®, the confidence to pay based on efficacy stems precisely from the two points above.

"From the perspective of clinical trials, we have accumulated six years of data globally, and 2.5 years of data in the Chinese market," said Qi Yuanyuan.

In 2017, Yescarta® was approved for marketing in the United States, and subsequently, Axicabtagene Ciloleucel (Yikaida®) entered the Chinese market in 2021. Over the past six years, it has accumulated real-world research data from 13,000 cases globally. Currently, Axicabtagene Ciloleucel (Yikaida®) is the CAR-T product with the largest number and sample size of real-world research data worldwide, and also the CAR-T product with the longest follow-up time to date.

Based on these data, Fosun Kite Biotechnology Co., Ltd. calculated and established the evaluation criteria for the compensation of this project. "We chose not to use OS but instead adopted a 3-month CR because our research found that the 3-month CR data indicates significant efficacy and has a strong correlation with OS and FPS. Additionally, adopting this standard can better assist doctors and patients in making decisions for subsequent treatment. From the patient's perspective, they also hope to predict future efficacy earlier," Qi Yuanyuan explained.

In terms of evaluation criteria, the approved indications for Yikaida® are concentrated in the lymphoma field, where it also has its advantages.

According to Fosun Kite, the efficacy-based value payment plan for Yikai Da®—China’s first lymphoma treatment—will strictly adhere to the assessment of complete response (CR) results based on the 2014 Lugano Evaluation Criteria. Qi Yuanyuan stated: "Every two years in Lugano, Switzerland, an international conference on malignant lymphoma is held to revise all lymphoma efficacy evaluation standards, with the 2014 version being the latest authoritative international standard for assessing lymphoma treatment outcomes. Additionally, PET-CT scans are used to evaluate lymphoma treatment efficacy, providing clear and intuitive results. This is also a distinguishing feature of lymphoma compared to other diseases."

Innovative Projects Driven by Special Treatment Methods

In fact, this is not the first time that the pharmaceutical industry has adopted a pay-for-performance model. Before Fosun Kite, there were already quite a few companies entering the field.

In 2017, Novartis' CAR-T Kymriah was approved for marketing by the FDA. Faced with a price of up to two million yuan per injection, Novartis also attempted to explore new payment methods to accelerate commercialization. At that time, it publicly stated that it was discussing a "pay-for-performance" pricing plan with the U.S. Centers for Medicare & Medicaid Services (CMS). In the same year, AstraZeneca also launched the Tagrisso Cost Coverage Assurance Program.

In this regard, Wang Zhengjue, Deputy General Manager of the Innovation Center of Sinopharm Holding, said that Medi Cover had also launched similar payment plans for large-molecule drugs and small-molecule drugs in the past two years. However, CAR-T is relatively special compared to other drugs.

He explained: "The efficacy insurance is generally divided into two phases: enrollment and claims processing. In the past, small-molecule or large-molecule drugs set relatively high thresholds for enrollment. However, with Yikaida®, it’s very straightforward—eligibility can be activated right after clinical infusion. This is a major breakthrough, which, of course, is also inseparable from the unique treatment approach of CAR-T products."

From the project plan, currently, patients who meet the project criteria can join as project members for free. They can activate their treatment assurance rights by completing apheresis. Three months after purchasing the medication and receiving the infusion, the patient's therapeutic effect will be evaluated. If complete remission (CR) is not achieved, the patient can receive a refund of up to 600,000 yuan.

Professor Wang Pei from the School of Public Health at Fudan University also stated that this is a significant mechanism innovation. "Previously, the approach was to address the symptoms but not the root cause, but cell therapy has the potential to achieve a cure. In terms of evidence collection and accumulation, we hope other companies can learn from this and gradually pave the way for payment based on efficacy."

In 2022, Yescarta® achieved an annual revenue of $1.16 billion in the U.S. market, surpassing the $1 billion milestone. After being included in U.S. commercial insurance, Yescarta® saw rapid growth in sales.

Although the Chinese market did not disclose specific sales figures, according to Qi Yuanyuan, as of 2023, Yikaida® has successfully treated over 600 patients with relapsed/refractory large B-cell lymphoma in China. "The initial momentum in China now is similar to that in the U.S. when it was first launched," he said.

Currently, Fosun Kite Biotechnology Co., Ltd. has been continuously exploring innovative payment methods. To date, Yikaida® has been included in over 100 city-level inclusive insurance programs in China, as well as more than 75 commercial health insurance programs.

Following the introduction of this payment-by-efficacy model, we will continue to monitor and look forward to whether Fosun Kite's Yikaida® can achieve greater market expansion.