Description
The B101 reimbursement drug program for the treatment of patients with lipid disorders (ICD-10: E78.01, I21, I22, I25) with PCSK9 inhibitors was launched in November 2018 for patients with heterozygous FH (heFH), and since November 2020, a post-ACS arm has also been included. Inclisiran was added in September 2022, lomitapide was introduced for homozygous FH patients in September 2023, and evolocumab has been available for children with heFH aged >10 years since April 2024. The inclusion criteria have evolved over the past >6 years, with recent criteria allowing the inclusion of heFH patients optimally treated with statins and ezetimibe (for ≥3 months) with LDL-C ≥100 mg/dL (2.5 mmol/L), and post-MI patients (within the past 24 months) with additional CVD risk factors, treated optimally with statins and ezetimibe for ≥3 months and LDL-C ≥70 mg/dL (1.8 mmol/L). The drug program is currently being implemented in 146 centers in Poland (data for October 2025).Program launch date
November 2018Responsible entity
Ministry of Health / National Health FundAvailable results and quality metrics
The analysis was based on data from 2844 patients (1650 heFH and 1194 ACS patients; mean age 61.3 years) who were included in the drug programme by the end of June 2025. 38.4% commenced the programme with alirocumab, 27.3% with evolocumab, and 34.5% with inclisiran. The mean LDL-C reduction for FH patients within at least 2.5 years of follow-up was 65.6% for alirocumab, 60.4% for evolocumab, and 57.9% for inclisiran. At the end of follow-up, 41.8% of heFH patients achieved an LDL-C goal <55 mg/dL (<1.4 mmol/L), and 53.5% achieved an LDL-C goal <70 mg/dL (<1.8 mmol/L). In ACS patients, the LDL-C reduction was 65.3% for alirocumab, 66.1% for evolocumab, and 48% for inclisiran, and at the end of follow-up, 48% of ACS patients achieved an LDL-C goal <55 mg/dL (<1.4 mmol/L), and 65% achieved an LDL-C goal <70 mg/dL (<1.8 mmol/L). This resulted in an estimated cumulative death rate for heFH patients within the follow-up of 6.3 years of 6.3% and for the ACS patients (at 4.6 years) – 4.8% [24]. Comparing these results of very high and extremely high-risk patients with, for example, those from the Polish ACS and TERCET Registries, where even 20-25% mortality is observed after 3 years, it suggests that intensive combination lipid-lowering therapy with optimal statin and ezetimibe therapy, supplemented with innovative drugs like PCSK9 inhibitors or inclisiran, may significantly reduce the risk of death and prolong life in these individuals. Therefore, experts and scientific societies have been working with the Ministry of Health in Poland to extend this program to more at-risk patients to significantly reduce the CVD risk burden for the population. Based on this, a new version of the B101 program, covering all the changes mentioned above – including treatment of heFH patients with PCSK9 modulators (LDL C >70 mg/dL [>1,8 mmol/L], or >55 mg/dL [>1.4 mmol/L] with additional risk factors or ASCVD) and post MI patients (LDL C >70 mg/dL [>1.8 mmol/L] within the last 24 months with no other risk factors, or LDL C >55 mg/dL within 60 months with additional risk factors) – has been in effect since October 1st.Limitations / comments
The program remains limited to patients with familial hypercholesterolemia (evinacumab is expected to be added in the coming months for hoFH) and to post–myocardial infarction patients. PCSK9 modulators are still unavailable for pre-event patients and for those at high risk in primary prevention. Participation also requires signing a contract with the NHF, which effectively restricts access and reduces the program’s effectiveness. Ongoing payment issues with the Fund further limit enrollment of new patients. Hopefully, the reimbursement legislation changes planned for May 2026 will allow a semi-open program (similar to that for chemotherapeutics), greatly expanding access and potentially including pre-event patients, supported by recent results from the VESALISUS CV trial with evolocumab.