Approved by the U.S. Department of health! Novartis can bear the travel expenses of car-t treatment for low-income patients

Generally speaking, pharmaceutical enterprises' acceptance and use of their own products by providing financial support to patients will be considered as a violation of business rules, which is similar to the nature of providing kickbacks and will be punished by regulators But the U.S Department of Health (HHS) recently made a special exemption rule for kymriah, an innovative drug therapy of Novartis Under the specific rules of HHS, for the low-income patients covered by Medicare and Medicaid medical insurance, Novartis is allowed to pay for all the transportation, accommodation, catering and other expenses that need to be paid by the patients themselves during the period of admission to kymriah treatment and later clinical monitoring if the specific conditions are met Kymriah is a kind of car-t therapy It needs to isolate T cells from patients first, then reconstruct T cells in vitro to express car that can recognize cancer cells, then expand car-t cells, and finally transport them back to patients to eliminate cancer cells As a special therapeutic drug, car-t therapy needs to be prepared by the laboratory personnel with specific operation ability, with higher requirements for storage and quality testing, and needs to closely monitor and deal with serious and fatal adverse reactions (mainly cytokine storms) that may occur at any time after reinfusion Currently, two approved car-t products are required to be used in treatment centers that meet FDA safety requirements This rule of HHS is actually aimed at the kymriah travel assistance program launched by Novartis The program aims to reduce the cost of treatment for patients But before the HHS allows the aid program, market regulators will think that this kind of behavior will make patients more inclined to accept kymriah treatment, directly increase the burden of the government health system, and then punish Novartis According to Novartis' letter of persuasion to HHS, low-income rural patients usually live far away from the treatment center If they fail to pay for travel, they may face higher risk of health and death due to their inability to deal with adverse reactions such as CRs in time after receiving treatment According to the label, patients need to be monitored for at least 1 month after kymriah treatment However, HHS's exemption from the Novartis assistance program also has many strict restrictions, such as the patient's residence must be more than 2 hours' drive or more than 100 miles from the nearest treatment center In addition, Novartis has promised not to publicize the details of the assistance program to the public, and patients will not be informed of the relevant provisions until they are diagnosed with the indications conforming to the kymriah label HHS made it clear that this aid program is only applicable to kymriah project Gilead did not respond to the news.