PTR on the access of patients with inflammatory joint diseases to effective therapies

The Polish Society of Rheumatology informs that from May 1, 2022, the drug Benepali containing the biosimilar etanercept is no longer reimbursed in drug programs in rheumatology. This is a continuation of the previously observed trend of withdrawing biological drugs from Poland, including bioequivalent ones, by some marketing authorization holders.

Currently, reimbursement under the above-mentioned The programs cover the following medicinal products (in alphabetical order of active substance name and medicinal product names):

• adalimumab (Amgevita, Humira, Hyrimoz, Idacio),
• baricitinib (Olumiant),
• certolizumabpegol (Cimzia),
• etanercept (Enbrel, Erelzi),
• golimumab (Simponi),
• infliximab (Flixabi, Remicade, Remsima, Zessly),
• ixekizumab (Taltz),
• rituximab (Mabthera, Riximyo),
• secukinumab (Cosentyx),
• tocilizumab (RoActemra, intravenous and subcutaneous forms),
• tofacitinib (Xeljanz).

In the description of drug programs, there are still no changes proposed by the Polish Rheumatology Society, which have been positively assessed by the Transparency Council or the president of AOTMiT:

• enabling RA patients to qualify for the program with moderate disease activity (DAS28> 3.2 or DAS> 2.4),
• shortening the time of ineffective treatment with two NSAIDs in patients with spectrum disorders (AS, PsA, SpA) up to 4 weeks in total.

At the same time, no new drugs and active substances were covered by the reimbursement and the indications for the drugs already reimbursed have not been extended.

Due to the time and advancement of the ongoing reimbursement process and the clinical needs of patients, the drugs that should most urgently be made available to patients are:

Biological drugs:

• ixekizumab (IL-17 inhibitor) - AS and axial and peripheral forms of SpA
• secukinumab (IL-17 inhibitor) - axial and peripheral form of SpA

Janus kinase inhibitors:

• Upadacitinib (JAK1 inhibitor) - RA, AS and PsA

For patients with non-radiographic SpA, all medications reimbursed in the program should be available, both axial and peripheral.

The Polish Society of Rheumatology hopes that further treatments expected by patients and doctors in the following clinical indications will be reimbursed further:

• tofacitinib (JAK1/JAK3 inhibitor) - AS and JIA
• filgotinib (JAK1 inhibitor) - RA
• guselkumab (IL-23 inhibitor) - PsA
• risankizumab (IL-23 inhibitor) - PsA
• anakinra (IL-1 receptor inhibitor) - systemic form of JIA and ch. Still in adults
• canakinumab (IL-1 beta inhibitor) - systemic form of JIA and ch. Still in adults
• anifrolumab (type I interferon receptor inhibitor) - systemic lupus erythematosus
• nintedanib (tyrosine kinase inhibitor) - ch. interstitial lung associated with systemic sclerosis (SSc-ILD) and ch. interstitial lung with a progressive fibrosis phenotype (ILD-PF) in the course of systemic connective tissue diseases, including RA

Due to the complex pathomechanism, heterogeneous clinical picture, coexistence of other diseases and the differentiated individual response to treatment, there is a need for a therapy tailored to the patient's needs. The availability of innovative drugs with different mechanisms of action allows to achieve clinical remission in an increasing number of patients and maintain this state for a longer time throughout their lives.