Position of the Polish Society of Rheumatology on access to innovative and classical treatment in rheumatology in Poland - as of May 1, 2026.

The Polish Society of Rheumatology reports that access to innovative treatment for patients with rheumatic diseases in Poland is steadily improving. Due to the complex pathomechanism, heterogeneous clinical picture, co-occurrence of other diseases and individual variation in response to treatment, there is a need for continuous individualization of therapy.

We publish the position:

The inclusion of more drugs with different mechanisms of action in reimbursement is a key aspect in predicting the long-term efficacy of treatment at the population level. This allows for effective treatment of more and more patients giving them a chance to live without active disease and its distant effects.

Reimbursement of innovative therapies in Poland takes place mainly within the framework of drug programs. In rheumatology, patients have access to treatment under nine drug programs covering a total of 24 active substances in a dozen clinical indications in inflammatory joint diseases, systemic connective tissue diseases and metabolic bone diseases:

TREATMENT OF PATIENTS WITH ACTIVE FORMS OF RHEUMATOID ARTHRITIS AND JUVENILE IDIOPATHIC ARTHRITIS - B.33

TREATMENT OF PATIENTS WITH PSORIATIC ARTHRITIS (PSORIASIS) - B.35

TREATMENT OF PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) - N.36

TREATMENT OF PATIENTS WITH ACTIVE SPONDYLOARTROPATHY (SpA) WITHOUT RADIOGRAPHIC CHANGES CHARACTERISTIC TO DISEASE - B.82

TREATMENT OF PATIENTS WITH SYSTEMIC VASCULITIS - B.75

TREATMENT OF PATIENTS WITH INTERSTITIAL LUNG DISEASE - B.135

TREATMENT OF PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE, SLE) - B.150

TREATMENT OF PATIENTS WITH SEVERE POSTMENOPAUSAL OSTEOPOROSIS - B.160

TREATMENT OF PATIENTS WITH HYPEREOSINOPHILIC SYNDROME (HES) - B.169

According to the Ministry of Health's announcement , as of April 1, 2026, the following medicinal products (in alphabetical order of active substance and medicinal product names) are covered by reimbursement under the programs:

• adalimumab (Amgevita, Hyrimoz, Idacio, Yuflyma),
• anakinra (Kineret),
• anifrolumab (Saphnelo),
• avacopan (Tavneos),
• baricitinib (Olumiant),
• bimekizumab (Bimzelx),
• benralizumab (Fasenra),
• canakinumab (Ilaris),
• certolizumab pegol (Cimzia),
• etanercept (Benepali, Erelzi, Nepexto),
• filgotinib (Jyseleca),
• golimumab (Simponi),
• guselkumb (Tremfya),
• infliximab (Flixabi, Remsima, Zessly),
• ixekizumab (Taltz),
• mepolizumab (Nucala)
• nintedanib (Ofev),
• risankizumab (Skyrizi),
• rituximab (Mabthera, Riximyo, Ruxience),
• romosozumab (Evenity),
• secukinumab (Cosentyx),
• tocilizumab (RoActemra, Tyenne),
• tofacitinib (Xeljanz),
• upadacitinib (Rinvoq).

The reimbursed drugs are characterized by different points of entry into the pathomechanism of inflammatory, systemic and metabolic rheumatic diseases. They cover a total of 13 different mechanisms of action:

• Inhibition of TNF alpha activity,
• IL-1 activity inhibition,
• IL-5 activity inhibition,
• IL-6 activity inhibition,
• Inhibition of IL-17A activity,
• Inhibition of IL-17A/17F activity,
• Inhibition of IL-23 activity,
• Inhibition of B lymphocyte activity(anti-CD20),
• Inhibition of janus kinase activity(JAK inhibitors),
• Inhibition of type I interferon activity,
• inhibition of complement 5a activity (C5aR1 antagonist)
• Inhibition of tyrosine kinase activity (antifibrotic therapy),
• Inhibition of sclerostin activity (bone-forming therapy).

The above treatment is available to patients for the following clinical indications:

• RA (B.33),
• MIZS (B.33),
• LZS / ax£ZS (B.35),
• ZZSK / nr-axSpA (B.36 / B.82),
• SpA peripheral (B.82),
• Still's disease in children and adults (B.33),
• GPA (B.75),
• MPA (B.75),
• GCA (B.75),
• EGPA (B.75),
• HES (B.169),
• SSc-ILD (B.135),
• PF-ILD (RA, PM, SS, others) (B.135),
• TRU (SLE) (B.150),
• POSTMENOPAUSAL OSTEOPOROSIS (B.160).

Among biologic drugs, according to the draft changes to drug programs by the Polish Society of Rheumatology sent to the MZ in 2025, reimbursement of Off-label in accordance with current recommendations in systemic connective tissue diseases included rituximab and tocilizumab:

• Rituximab for the indications of PF-ILD and SSc-ILD under drug program B.135,
• tocilizumab for the indication of SSc-ILD under the B.135 drug program,
• The introduction of a combination treatment option of rituximab + nintedanib and tocilizumab + nintedanib within the B.135 drug program for the indications PF-ILD and SSc-ILD,
• Rituximab for the indication of TRU (SLE) under drug program B.150.

All of the above changes, which are beneficial to patients, are the result of good cooperation between the experts of the Polish Society of Rheumatology and individual national consultants with the Ministry of Health, AOTMiT and the National Health Fund, and represent a joint success of all parties.

Despite a steady increase in the number of available drugs, not all patients' needs are fully met. This applies, both to indications and mechanisms of action already reimbursed, as well as to new clinical indications and drugs with new mechanisms of action not yet available to patients in Poland.

Taking into account current recommendations or registration indications, access to treatment should expand to include the following drugs for the following indications:

1. new active substances in new indications

• obinutuzumab (anti-CD20) - Lupus nephritis (B.150)(on-label),

1. New clinical indications for drugs previously reimbursed

• anakinra (IL-1 inhibitor) - macrophage activation syndrome (MAS)(B.33)(off-label),
• baricitinib (JAK2 inhibitor) - MIZS (B.33)(on-label),
• Tocilizumab (IL-6 inhibitor) - subcutaneous form - MIZS (B.33)(on-label),
• Tocilizumab (IL-6 inhibitor) - intravenous form - GCA (B.75)(on-label),
• upadacitinib (JAK1 inhibitor) - GCA (B.75)(on-label).

2025. The Polish Rheumatology Society has also submitted to the Health Ministry a proposal for changes to the B.33 drug program for the treatment of patients with Still's disease, which is currently under review:

• Equalization of eligibility criteria for anakinra and canakinumab therapy in subsequent lines of treatment,
• reimbursement of anakinra treatment for the indication of Still's disease in children and adults including the possibility of temporary use of the drug in accordance with recommendations at an appropriately higher dose in the course of life-threatening macrophage activation syndrome (MAS).

It should be emphasized that the proposed changes apply to patients with immediate life-threatening conditions, and may generate system savings.

In addition, with regard to reimbursement criteria, the Polish Society of Rheumatology calls for the following changes:

• Lowering the eligibility threshold for the drug program for patients with RA to moderate disease activity (DAS 28 >3.2) (B.33),
• Reducing the time of ineffective treatment with two nonsteroidal anti-inflammatory drugs in patients with ax£S/SpA to4 weeks combined (B.35, B.36, B.82),
• Alignment of the criteria of the drug program in the part covering the treatment of MIZS with current recommendations (B.33),
• In special cases, with the approval of the Coordination Team, to allow the eligibility of patients who do not meet part of the criteria of the drug program - treatment of patients with systemic vasculitis (B.75), interstitial lung disease (B.135) and systemic lupus erythematosus (B.150),
• Change of reimbursement criteria for osteoporosis treatment for denosumab (pharmacy reimbursement) and for romosozumab(PL B.160) - (1) removal of the age criterion in the description of reimbursement indications for denosumab, (2) for the most severe forms of osteoporosis carrying a very high risk of fractures, eligibility criteria for treatment with romosozumab should be based on T-score or past fractures according to current recommendations without age restrictions.

The change in reimbursement criteria for denosumab should be considered very soon due to the significant reduction in therapy costs due to the reimbursement of many biosimilar drugs as of January 1(https://ptr.info.pl/stanowiska/stanowisko-polskiego-towarzystwa-reumatologicznego-dot-poszerzenia-dostepu-do-leczenia-biologicznego-od-1-stycznia-2026/)

Improving access to classic drugs under pharmacy reimbursement should primarily include the following active substances to the following extent (proposal to expand on drugs or reimbursement criteria in relation to current availability):

• Hydroxychloroquine - in all registered indications and autoimmune diseases other than those specified in the SmPC and arthritis of other etiologies (M13.0, M13.8, M13.9),
• Methotrexate- oral form - autoimmune diseases other than those specified in the SmPC,
• leflunomide - for all registered indications (including in SD) and autoimmune diseases other than those specified in the SmPC,
• Sulfasalazine - arthritis of other etiologies (M13.0, M13.8, M.13.9),
• mycofenolate mofetil - interstitial lung disease in the course of RA and other systemic connective tissue diseases (J.99.0, J99.1),
• apremilast - psoriatic arthritis, Behçet's disease (according to the SmPC),
• Zoledronic acid - treatment of osteoporosis in women and men (M80-M81),
• Teriparatide - treatment of osteoporosis in women and men (M80-M81).

Hydroxychloroquine, zoledronic acid and teriparatide have been included in the list for drugs requiring use longer than 30 days for a specific clinical condition and recommended in clinical management guidelines, for which the applicant has not yet applied for reimbursement in the indications and market exclusivity has expired (list dated October 6, 2025, positive opinion of the Transparency Council dated October 13, 2025). The list should also include apremilast, for which generics are already available in Poland (including the domestic manufacturer).

Reimbursement of hydroxychloroquine is now particularly important for patients requiring therapy also due to the withdrawal of chloroquine, which was reimbursed (Arechin, the only domestic manufacturer), and maintaining access only to hydroxychloroquine (including domestic manufacturers).

Expanding access to biologic drugs and JAK inhibitors should also be done by gradually transferring the indicated therapies to outpatient treatment in an optimal model for patients. The overriding goal of systemic changes should be a real benefit for patients meaning easier access to effective treatment with safe therapy.

The Polish Society of Rheumatology, in cooperation with the national consultant in rheumatology, will continue to take active measures resulting in improved access to treatment in rheumatic diseases in Poland.

Marcin Stajszczyk, M.D., Ph.

Chairman of the Committee on Drug Policy
of the Polish Society of Rheumatology

Zbigniew Żuber, MD, UAFM prof.

President of the Polish Society of Rheumatology

Source: PTR