Limited availability of subcutaneous immunoglobulins

date: 21/12/2021

Due to a decrease in the availability of subcutaneous immunoglobulins around the world, there is also a critical level of limited availability in Belgium. The FAMHP issues several recommendations for hospital and retail pharmacists, medical doctors (specialists), and patients.

Fewer subcutaneous immunoglobulins (SCIgs) have been available since July 2021, and the reasons for this are the reduced collection of plasma around the world, the ever increasing need for immunoglobulins, and the dependence on plasma from other countries. The shortage is persistently noticeable but has been exacerbated by the COVID-19 situation.

In order to find a solution in the very short term, a task force has been organised with medical doctors (specialists), hospital and retail pharmacists, patient associations, and competent authorities.

A short-term solution is to import foreign packages of SCIgs for patients with primary immune deficiencies (PIDs). These packages will be available during the course of January 2022 and will be reimbursed for these patients. Furthermore, since October 2021, an additional quantity of intravenous immunoglobulins (IVIgs) based on plasma from Belgium has been made available for twelve months. The FAMHP hopes that every patient can be helped as much as possible with these additional quantities and the recommendations below.

Recommendations for the attention of hospital and retail pharmacists, medical doctors (specialists)
In order to safeguard the availability of these essential medicinal products for the most vulnerable patients as much as possible, the task force has developed the following prioritisation system and recommendations:

  • subcutaneous immunoglobulins must be reserved for patients who cannot switch to intravenous administration:
    • paediatric PID patients,
    • patients who are currently on SCIgs and cannot switch to IVIgs.

Whenever possible, patients currently on SCIgs are being switched to intravenous administration during the current critical shortage of subcutaneous forms. The aim is to reduce total consumption of SCIgs by about 14 %. The medical doctor treating a patient decides for him or her based on the assessed risk for the individual patient and the expected efficacy and adverse effects of the treatment. This requires closing the current authorisation and requesting a new authorisation through the existing reimbursement request system: CIVARS, Chapter IV Agreement Requesting System.

  • IVIgs must be reserved as a priority for the following indications:
    • PIDs in adults and children;
    • secondary hypogammaglobulinemia in patients with chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or after treatment for lymphoid malignancies, who have recurrent infections, as well as after allogeneic stem cell transplantation or CAR-T cell therapy;
    • immune thrombocytopenia (ITP) in children and adults in case of urgent need for treatment, such as acute bleeding in combination with relative contraindication for or being refractory to corticosteroids;
    • Guillain-Barré syndrome;
    • Kawasaki disease;
    • multifocal motor neuropathy (MMN);
    • patients who are being switched to IVIgs during the current critical shortage of SCIgs;
  • The following indications have been considered as having a lower priority and alternatives should be considered for them:
    • immune thrombocytopenia (ITP) in adults: alternative treatments should be considered. For example, thrombopoietin receptor agonists (TPO receptor agonists) from 1 January 2022*;
    • chronic inflammatory demyelinating polyneuropathy (CIDP): alternative treatments should be considered. For example, plasmapheresis, high-dose corticosteroids and immunosuppression*.

* The medical doctor treating a patient decides for him or her based on the assessed risk for the individual patient and the expected efficacy and adverse effects of the treatment.

  • It is recommended that medical specialists critically evaluate the dose used so that the lowest effective dose is used for each patient.
  • The FAMHP also urges (hospital) pharmacists to avoid keeping a stock of SCIgs in the pharmacy and to only supply medicinal products to patients for a maximum period of four weeks. This is intended to ensure that the current stock levels of SCIgs are available as much as possible at the wholesaler-distributors, so that every patient can receive his/her drug during this period of acute shortage.
  • The task force also reminds practitioners to limit off-label use as much as possible.

As a reminder
SCIgs are reimbursed for the following indications, and within the provisions of §3410000 and §10340000:

  • PID,
  • CLL, MM, other B-cell malignancy or with an iatrogenic immunodeficiency-associated lymphoproliferative disorder of B-cell type due to use of monoclonal antibodies or chemotherapy, with severe secondary hypogammaglobulinemia,
  • CIDP.

IVIgs are reimbursed for the following indications, and within the provisions of §6790100, §6790200, §6790300 and §6790400:

  • PID,
  • CLL, MM, other B-cell malignancy or with an iatrogenic immunodeficiency-associated lymphoproliferative disorder of B-cell type due to use of monoclonal antibodies or chemotherapy, with severe secondary hypogammaglobulinemia,
  • ITP,
  • Guillain-Barré syndrome,
  • Kawasaki disease,
  • invasive infections with Group A Streptococcal toxic shock syndrome when other treatments have failed,
  • CIDP,
  • MMN.

Recommendations for the attention of patients
During this period of critical shortage of SCIgs, you as a patient may see a change in your treatment, for example, switching from SCIgs to IVIgs or using a pre-filled syringe instead of a vial. The medical doctor treating you will consider whether a change is possible. We understand that this may create inconvenience and require additional effort from you during this difficult time. We hope that by doing this, all patients who, according to their medical doctor's assessment, can only receive SCIgs, can also actually receive them. Unfortunately, some patients can indeed only be treated with the subcutaneous forms. Your medical doctor will work with you to minimise the practical impact.

New supplies of SCIgs are being made available every month and they must go to patients who have no other treatment option as a priority. Therefore, we would like to expressly ask you to refrain from stockpiling and to only buy what is necessary for treatment over no more than four weeks. We want to avoid a situation where one place has a supply while other patients have nothing. If you stock up, other patients will be left out in the cold. Every patient would like to continue his/her treatment. At the beginning of the next month, you will be able to collect your medication again for the coming month.

We would therefore like to appeal to your sense of solidarity and ask you to follow these guidelines on SCIgs as closely as possible so we can help as many patients as possible.

Follow-up of situation
In the meantime, the FAMHP is closely monitoring the situation and it is working together with the Belgian National Institute for Health and Disability Insurance (RIZIV/INAMI), the FPS Public Health, Food Chain Safety and Environment, the FPS Economy, and the competent minister's policy unit, to continue to seek additional solutions in the very short term, as well as systemic solutions for the medium and long term.

Last updated on 21/12/2021