BMS Upgrades Opdivo Patient Assistance Program in China: Aid Granted After Just 3 Self-Paid Cycles

GBI News: At the beginning of 2020, the China Cancer Foundation announced adjustments to the patient assistance program for Bristol-Myers Squibb’s Opdivo (O drug). The program was changed from the original “6+7” model to a new structure of “initial 3+3, followed by cycles of 3+4.” Under the adjusted plan, patients’ out-of-pocket costs per cycle decreased by 50%, and the interval for receiving assistance was shortened. Specifically, after self-paying for the first three treatment cycles, patients became eligible for up to three cycles of free medication. In subsequent treatment, for every three self-paid cycles, patients could receive up to four cycles of assisted medication, until disease progression or unacceptable toxicity occurred. The maximum duration of assistance was capped at two years from the initiation of treatment. The new program took effect in February 2020.

In June 2018, Bristol-Myers Squibb’s PD-1 monoclonal antibody Opdivo (nivolumab) was approved for marketing by the National Medical Products Administration, becoming the first approved tumor immunotherapy drug in China. Previously, second-line treatment for malignant tumors such as lung cancer and head and neck squamous cell carcinoma primarily relied on chemotherapy. However, clinical trial results demonstrated that the five-year survival rate for patients with advanced non-small cell lung cancer receiving Opdivo as second-line therapy was 13.4%, five times higher than that achieved with chemotherapy. The Phase III clinical study CheckMate 078, which predominantly enrolled Chinese patients, showed that one-third of patients treated with Opdivo survived for more than two years, further confirming the significant benefits of Opdivo.

Following its market launch, the domestic pricing of Opdivo (O drug) was set at RMB 9,250 (100 mg/10 mL) and RMB 4,587 (40 mg/4 mL). Although this pricing was significantly lower than that in the United States, Japan, and Singapore, it remained unaffordable for some patients with limited financial means. On January 25, 2019, the China Cancer Foundation’s Opdivo Patient Assistance Program announced a charitable assistance policy for Opdivo, known as the “6+7” program. Under this scheme, low-income patients diagnosed at designated medical institutions as meeting specific medical criteria could receive free medication for up to seven subsequent treatments after completing six consecutive doses of Opdivo, provided that designated physicians assessed them as continuing to benefit from Opdivo therapy without disease progression and without intolerable side effects, and upon approval by the program office. The “6+7” assistance program targeted adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who were negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK), and whose disease had progressed or who had experienced intolerance following prior platinum-based chemotherapy.

Professor Zhao Ping, Chairman of the China Cancer Foundation, stated, “Immunotherapy drugs for lung cancer and head and neck squamous cell carcinoma are not currently included in the national medical insurance coverage. Under these circumstances, patient assistance programs have largely alleviated the financial burden for some patients. However, even so, there are still patients who abandon treatment due to economic reasons. To further assist patients who are hesitant to initiate or forced to discontinue treatment midway due to financial pressure, the Opdivo Patient Assistance Program will implement a new assistance scheme. The new scheme will lower the economic threshold for patients to access immunotherapy, advance the time point at which patients begin to benefit, and provide new opportunities for their treatment.” Therefore, starting from February 2020, eligible low-income patients with non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma can benefit from the new assistance scheme of “first 3+3, followed by a cyclic 3+4 regimen.”

Currently, seven PD-1/L1 immune checkpoint inhibitors have been marketed in China. Among them, only Innovent Biologics’ sintilimab successfully entered the 2019 National Reimbursement Drug List through price negotiations on November 28, 2019. Merck’s Keytruda, Junshi Biosciences’ Tuoyi, and Hengrui Medicine’s Airuika have all launched various patient assistance programs, as detailed in the table below: