The medicinal product Pegasys® 180µg, solution for injection, will have limited availability in Belgium until June 2025. Experts of the task force Unavailability recommend the following.
Pharmaand, the company that holds the marketing authorisation for the medicinal product Pegasys® 180µg (solution for injection), has notified the Federal Agency for Medicines and Health Products (FAMHP) of a limited availability until June 2025 due to increased demand.
Until the medicinal product becomes available again in sufficient quantities, the FAMHP, upon consultation with experts from the task force Unavailability, issues recommendations targeting physicians (-specialists) and (hospital) pharmacists.
Recommendations for physicians (-specialists) and (hospital) pharmacists
The use of Pegasys should be reserved as a priority for the following indications (the treating physician decides for each patient based on the estimated risk to the individual patient and the expected efficacy and side effects of the treatment):
- pregnant patients with essential thrombocythemia (ET), chronic myeloid leukaemia (CML) or polycythemia vera (PV or Vaquez disease);
- patients with essential thrombocythemia (ET) with intolerance to hydroxycarbamide or anagrelide;
- patients with cutaneous T-cell lymphoma already being treated with Pegasys;
- Erdheim-Chester disease;
- hepatitis B/delta co-infections.
The following indications are considered to be of lower priority (the treating physician decides for each patient based on the estimated risk to the individual patient and the expected efficacy and side effects of the treatment):
- hepatitis B mono-infected patients can be treated with entecavir or tenofovir;
- hepatitis C mono-infected patients can be treated with velpatasvir + sofosbuvir, glecaprevir + pibrentasvir, sofosbuvir + velpatasvir + voxilaprevir in the 2nd line;
- new patients with T-cell lymphoma can be treated with Targretin (bexarotene);
- patients with polycythemia vera (PV) can be treated with the medicinal product Besremi® (ropeginterferon alfa-2b);
- some patients with Erdheim-Chester disease may be treated with BRAF inhibitors (B-Raf serine-threonine kinase inhibitors).
A possible solution is import of peginterferon alfa-2a by the pharmacist based on a medical prescription and a doctor's declaration (in accordance with Article 105 of the Royal Decree of December 14, 2006). Import by the pharmacist is not reimbursed to the patient.
The government is currently exploring the possibility of purchasing strategic stock of peginterferon alfa-2a. As soon as it is available for delivery to patients, this will be communicated.
Recommendations for patients
During this period of critical shortage of Pegasys, it is possible that there will be a change in your treatment. Your treating physician will determine if a change is possible. We understand that this may cause discomfort and requires additional efforts on your part. If you have any questions, we encourage you to contact your physician or pharmacist.
Follow-up by the FAMHP
The FAMHP is closely monitoring the situation in collaboration with the NIHDI, the FPS Public Health, Food Chain Safety and Environment and the policy cell of the competent minister, both at national and European level.