The stock of Cinqaero 10 mg/ml, used in asthma, is currently limited worldwide. A task force therefore issues recommendations.
The company Teva Pharma Belgium, holder of the marketing authorisation for the medicinal product Cinqaero 10 mg/ml, has informed the FAMHP that supply problems may occur until July 2024 due to a quality problem. The stock that will be available until July 2024 is very limited.
A short-term solution is to switch the medication for patients as much as possible until the Cinqaero 10 mg/ml becomes available again in sufficient quantities.
The experts of the Unavailability Task Force issue the following recommendations to (hospital) pharmacists and physician specialists.
1. Prioritising patients currently treated with Cinqaero
- The following patients have priority: patients with severe eosinophilic asthma who cannot be treated with one of the following alternatives because of previous intolerance or insufficient therapeutic response:
- Mepolizumab (Nucala);
- Benralizumab (Fasenra);
- Dupilumab (Dupixent).
- Patients for whom a switch is recommended: patients currently treated with Cinqaero, who have not received other monoclonal treatment for which intolerance of insufficient therapeutic response was documented, are recommended to switch to the following alternatives, in accordance with the reimbursement criteria of each pharmaceutical specialty:
- Mepolizumab (Nucala);
- Benralizumab (Fasenra);
- Dupilumab (Dupixent).
2. New patients
During this period of critical unavailability, it is not possible to start new patients with Cinqaero, instead the use of one of the following monoclonal treatments is mandatory, in accordance with the reimbursement criteria of each pharmaceutical specialty:
- Mepolizumab (Nucala);
- Benralizumab (Fasenra);
- Dupilumab (Dupixent).
Conditions of reimbursement
The conditions for reimbursement for the different medicinal products remain applicable, namely:
- Mepolizumab (Nucala) - § 8300000 (severe asthma) and § 11460000 (severe nasal polyposis)
- Blood eosinophil level (EOS) ≥ 300 mm³
- Oral corticosteroids (OCS) and non-OCS treated patients
- All the conditions of point a) of § 8300000
- Benralizumab (Fasenra) - § 9410000 (severe asthma)
- EOS ≥ 300 mm³
- OCS and non-OCS treated patients
- All the conditions of point a) of § 94100000
- Dupilumab 300 mg (Dupixent) - § 11880000
- EOS ≥ 150mm³
- Fractional exhaled Nitric Oxide (FeNO) ≥25 ppb
- OCS treated patients
- All the conditions of point a) of §11880000
- Dupilumab 200mg (Dupixent) - § xxxx0000 (will be communicated on the RIZIV-INAMI website) – starting from 1 August 2023
- EOS ≥ 150 mm³
- FeNO ≥25 ppb
- Non-OCS treated patients
- All the conditions of point a) of § xxxx0000
Monitoring the situation
In the meantime, the FAMHP will closely monitor the situation, both at national and European level and is working together with the Belgian National Institute for Health and Disability Insurance (NIHDI), to continue to seek additional solutions.