Description of the medical insurance process and reimbursement time points for pitobrutinib/pirtobrutinib

Pirtobrutinib (pirtobrutinib) is currently on the market in China and has been successfully included in the medical insurance. It will be officially implemented on January 1, 2026. This means that eligible patients will be able to reimburse part of their drug costs through medical insurance, greatly reducing their financial burden. Although it has been covered by medical insurance, it needs to be clear that the price base of its original drug is relatively high in the early stage of marketing. The domestic original drug specifications are 100 mg 14 tablets and 4 tablets. Each box is priced at more than 40,000 yuan. Even after medical insurance reimbursement, the patient's personal responsibility may still require careful planning for lymphoma patients who require long-term medication.

The medical insurance access of pitubrutinib is the latest result of the normalized adjustment of the national medical insurance directory. The National Medical Insurance Directory is usually updated once a year, and the entire cycle from application, review, economic analysis to formal negotiation is relatively fixed, generally concentrated between 6 and 11 months. Pitobrutinib was successfully included this time because it passed this strict value assessment and cost-benefit analysis system. The key clinical value of its approval is that it is the world's first non-covalent (reversible) BTK inhibitor, specifically used to treat adult patients with relapsed or refractory mantle cell lymphoma who have previously failed treatment with covalent BTK inhibitors (such as ibrutinib and zanubrutinib), effectively filling the gap in clinical treatment thereafter. Experts pointed out that after the failure of the old treatment regimen, the median survival period of these patients may be only 4 to 10 months. Therefore, the medical insurance coverage of pitubrutinib is of great significance in improving patient prognosis and increasing drug accessibility.

In overseas markets, the original drug Pitobrutinib has been launched in many countries, but the price is even higher. Common European and American specifications include 50 mg 30 tablets and 100 mg 60 tablets. The price per box is close to 100,000 yuan. The main reasons are large investment in research and development, strict pricing system, and long patent protection period. This also makes many overseas patients also face a heavy financial burden. For domestic medical insurance evaluation, overseas selling prices can often be used as an important comparative indicator of pharmacoeconomics, and may also affect future negotiation strategies and price positioning.

It is worth noting that generic versions of Pitobrutinib are already on the market in some regions, such as those produced in Laos50mg 30The tablet version is priced at more than 2,000 yuan per box, which is significantly lower than the original drug. However, the quality standards, production systems and regulatory specifications of generic drugs may be different, so their reliability needs to be carefully evaluated when choosing. Overall, the medical insurance goals that domestic patients are most concerned about have been achieved. Based on past experience, after drugs are negotiated by the national medical insurance, the price will usually drop significantly. When combined with proportional reimbursement by medical insurance, patients' actual out-of-pocket expenses are expected to be significantly reduced. Therefore, the successful entry of pitubrutinib into medical insurance is expected to lower the cost of medication for patients from the high level of "more than 40,000 per box", greatly reducing the burden on patients and improving the long-term treatment accessibility of this breakthrough innovative drug.

Reference materials:https://pmc.ncbi.nlm.nih.gov/articles/PMC10841293/