Cheaper biosimilar drugs are ordeal for some patients

The provision of a free arthritis medication by the governmnet’s Pharmacy of Your Choice (POYC) scheme has concerned sufferers who say a cheaper substitute called Erelzi, is not as effective as its biologic ‘original’.

A patient diagnosed with Psoriatic Arthritis administered Enbrel for two years to ease her pain, had to switch to the biosimilar Erelzi in August.

The primary difference is that Enbrel is a biologic medicine derived from living organisms, while Erelzi is a biosimilar – a cheaper and similar counterpart, which concerns about the interchangeability between the two medications.

Cheap as well as effective, biosimilars are increasingly replacing biologics in hospitals around the world. In the UK, patients switching to biosimilars receive a letter or a phone call explaining the switch, as well as a choice to speak to their doctor or specialist before the medication is changed. Generally the switch should not have any noticable difference on the body, but side effects can occur.

“I have now been on Erelzi for the past few weeks. It is a painful, nauseous, adaptation that comes with daily headaches and fatigue. It can take months for the body to adapt and for life to return to normal. It could also result in an adverse reaction that can cause flare ups and further bone deterioration which Enbrel had effectively stopped,” the patient told MaltaToday.

The Ministry for Health only sent out a circular announcing the switch on October 7, around two months after this patient’s experience, informing consultants and pharmacists that Erelzi will be replacing Enbrel once the current stock is exhausted.

“I need to apply once every two months to receive a supply of two boxes, with four injections per box, from the POYC. The treatment is in the form of an injection every Monday. Imagine my surprise one Saturday when upon picking up my usual supply of injections, I found out that my medication had been changed to a different one that I did not know anything about,” the patient told MaltaToday.

“I even needed a prescription from my consultant in order to be able to switch. It being a Saturday, this was impossible and I needed to get an injection by Monday. Halting the medication can cause serious repercussions. In a panic I managed to get hold of the Arthritis Association and luckily for me they had a couple of spare injections which they could give me. This probably saved my life. It gave me enough time to manage to get an appointment with my consultant.”

Erelzi is said to have no significant difference from the originator biologic. But the European League Against Rheumatism (EULAR) makes it clear in their 2019 recommendations that if a drug has proven to be effective and is tolerated by the affected patient, the drug should not be stopped.

Mary Vella, president of the Arthritis and Rheumatism Association of Malta, reiterated this during ARAM’s annual general meeting held over the summer. She asserted that in switching medications between biologics and biosimilars at the pharmacy level, health authorities are going against all recommendations from international bodies about the switching of medication, most especially during a pandemic when many out-patient services have been suspended.

The patient acknowledged that offering the switch could be beneficial for new patients or to those whose consultant recommends the medication – but said that readaptation was a  stressful process, especially when it can take up to six months to adjust to the treatment.

“After a long time of suffering from severe pain which nearly made me work redundant and clouded my enjoyment of life, I was finally diagnosed with Psoriatic Arthritis. The medication took away much of the pain and life was colourful again. My doctors were very pleased with the results and so was I. And then one day your pharmacist hands you a completely different box which at the end of the day might work just as well or not. Would you take it?”