Core Viewpoint - The National Health Commission (NHC) has stated that off-label drug use is currently not covered by basic medical insurance, and patients must bear the associated treatment costs [1][4]. Group 1: Regulatory Framework - The NHC and the National Medical Insurance Administration (NMIA) have emphasized the need for medical institutions to strengthen the regulation of doctors' prescribing behaviors [2][4]. - Off-label drug use, defined as the use of drugs outside the approved indications, dosages, or populations, is legally supported under the Physician Law and the Drug Administration Law when no effective treatment alternatives exist and with patient consent [2][3]. Group 2: Clinical Practice and Monitoring - Experts indicate that off-label drug use is not synonymous with inappropriate use, as clinical observations often reveal new indications for existing drugs [3]. - The NHC has previously issued guidelines for comprehensive drug evaluation, focusing on safety, efficacy, economic viability, innovation, suitability, and accessibility [3]. Group 3: Insurance Coverage and Challenges - Off-label drug use is not included in the basic medical insurance payment scope, leading to potential financial burdens for patients, especially those with chronic diseases or requiring expensive treatments [4][7]. - Commercial health insurance varies in its willingness to cover off-label drug use, with many policies stipulating that reimbursement is contingent upon adherence to approved indications [7][8]. Group 4: Future Directions in Insurance - Some insurance companies are exploring innovative products that would cover off-label drug use based on clinical guidelines, indicating a potential shift in the insurance landscape [8].