When should biologicals not be taken? | Biologics

When should biologicals not be taken?

If there is a previous history of tuberculosis, TNF-α inhibitors must not be used. This is independent of how long ago the tuberculosis occurred. The reason for this is that inactivated tuberculosis bacteria are still present in the body once someone has contracted tuberculosis.

These tuberculosis bacteria are inactive because so-called macrophages watch over them. They make sure that the bacteria do not become active again. In order for the macrophages to fulfil this task, they need TNF-α.

If this is no longer available to the macrophages due to the effect of the medication, they can no longer perform their task. Consequently, the tuberculosis bacteria can become active again and reactivate tuberculosis. In addition, hepatitis B is a contraindication for treatment with a biological agent.

It has been found that in this case treatment with a TNF-α inhibitor can lead to reactivation of herpes zoster. This was manifested in an increased incidence of shingles and chickenpox in adults. However, differences were found between the various active ingredients of the TNF-α inhibitors.

For example, the disease occurred more frequently in patients treated with Infliximab, whereas this side effect was hardly ever observed with therapies using Etanercept. The risk of reactivation correlated with age in both diseases, with so-called comorbidity (additional diseases) and with additional treatment with glucocorticoids, for example cortisone. For the protection of the patient, it is nevertheless valid at the present time that in general, both with a preceding tuberculosis and with hepatitis B, no treatment with a TNF-α-inhibitor may take place.

Biologicals and alcohol – is that compatible?

When treating with biologicals, it is not necessary to completely avoid alcohol. However, there are experience reports in which intolerances have been described. As biologicals influence the functions of the kidneys and liver, it is quite possible that alcohol consumption can lead to acute intolerances. In addition, long-term alcohol consumption in combination with Biologikas may increase the risk of liver and kidney disease.

Medical expenses

The costs are very high due to the manufacturing process and parenteral administration. TNF-α inhibitors cost approximately 40,000 to 50,000 euros per year. A single application is at least in the upper two-digit range.

In addition, there are personnel costs, costs for preliminary examinations, etc. If a specialist in a practice or clinic should decide that treatment with a biological is the best form of therapy, he or she must give good reasons for this. He or she can apply to the health insurance company for reimbursement of costs.

It usually takes a few weeks to process the application. Once the application has been examined, processed and approved, the health insurance company will cover the costs. However, it can limit the length of time for which the costs are covered.

Treatment Guarantee is often initially given for 3 months. After that, a new request must be made. In 2016, the first so-called biosimilars were officially approved for the treatment of rheumatic diseases.

As the name suggests, they are similar to the biologics, but not the original. Some authors suspect that they are a cheaper alternative to the biologics. It is controversially discussed whether their effect actually corresponds to that of the original.

The health insurance companies hope to save billions of euros. Other experts are sceptical about the estimates. So far, biosimilars have only been used in about 1-2% of rheumatism patients.

The biosimilars are recommended by the German Society for Rheumatology. However, it advises against changing from the original to a substitute product. Since there are no long-term studies on this, the Society cannot yet welcome a change of active substance in such a way.

It also advises against making such decisions only for cost reasons. Furthermore, the Society is too optimistic about the cost savings. In summary, it can be said that it is not yet possible to assess how the use of biologics will look like in the future, despite the costs.