INTRODUCTION

Psoriatic arthritis [(PsA), ICD-10: L40.5, M07.1, M07.2, M07.3] is a chronic immune-mediated inflammatory joint disease in patients with psoriasis. It is one of the seronegative spondyloarthropathies [1]. Psoriatic arthritis manifests as inflammation of the peripheral joints, spinal joints, sacroiliac joints and/or tendinous attachments, but also overlaps with the aforementioned, forms of the disease [2].

The Moll and Wright criteria distinguish between five forms of PsA:

— asymmetric oligoarthritis — the arthritis is usually asymmetric (about 70% of patients);

— symmetric polyarthritis resembling rheumatoid arthritis (RA) — 15–20% of patients;

— distal interphalangeal arthritis, with predominant inflammation of the distal interphalangeal joints, with frequent nail involvement (about 5% of patients);

— mutilating arthritis, with a very severe course (about 5% of patients);

— axial, resembling ankylosing spondylitis (AS), although asymmetric sacroiliac arthritis is typical (about 5% of patients).

All the above-mentioned types can overlap and, therefore, a division of psoriatic arthritis into three forms was developed in 1994:

— with asymmetric involvement of individual joints;

— with symmetrical involvement of multiple joints, including distal interphalangeal and spinal joints, often leading to deformational changes;

— with predominant spinal lesions with possible involvement of individual minor joints [3].

The ICD-10 (International Statistical Classification of Diseases and Related Health Problems) classifies PsA as follows:

— L40.5 — arthropathic psoriasis;

— M07.1 — arthritis mutilans (L40.5+);

— M07.2 — psoriatic spondylitis (L40.5+);

— M07.3 — other psoriatic arthropathies (L40.5+) [4].

There are no precise data on the prevalence or incidence of PsA in Poland. The prevalence of PsA worldwide is estimated to be 0.02–0.2% [5]. There are currently 108 ongoing drug programmes. Drugs guaranteed under these benefits and indications cannot be funded under other reimbursement modes [6]. Treatment is provided in both dermatology and rheumatology centres implementing the above programme.

Figure 1. Number of patients in the B.35 drug programme between 2016 and 2021

As in the case of the B.47 drug programme, patients qualified for the B.35 programme are also treated free of charge, while the decision on eligibility is made by a physician of a contracted facility after approval by the Coordination Team for Biological Treatment in Rheumatic Diseases [7].

The B.35 drug programme “Treatment of active form of psoriatic arthritis (ICD-10 L 40.5, M 07.1, M 07.2, M 07.3)” became effective from 1 July 2012 thanks to the great commitment of dermatologists and rheumatologists.

Aim of the paper

The aim of this paper is the analysis of the performance of the B.35 drug programme “Treatment of active form of psoriatic arthritis (PsA) (ICD-10 L 40.5, M 07.1, M 07.2, M 07.3)” from 2016 to 2021.

MATERIAL AND METHODS

The work examined publicly available data published by the Ministry of Health and the National Health Fund. The 2016–2021 reports for the B.35 drug programme were compared in terms of:

— access to drugs;

— number of patients;

— value of implementation contracts;

— the number of providers implementing the programme.

RESULTS

Access to drugs under the B.35 drug programme

In 2021, 8 active substances were funded under the B.35 drug programme:

— adalimumab;

— certolizumab;

— etanercept;

— golimumab;

— infliximab;

— ixekizumab;

— secukinumab;

— tofacitinib.

Adalimumab, etanercept and infliximab were the first publicly funded drugs under the B.35 programme in 2012. In 2014, golimumab was included in the reimbursed drugs list, while certolizumab was added in 2017. Secukinumab was the next reimbursed drug (2018). The last drug added to this programme was tofacitinib (2020). The dates of reimbursement coverage for individual drugs under the B.35 programme are presented in Table 1.

Number of patients covered by the B.35 drug programme

Over six years, the number of patients has increased by 2087. The number of patients increased proportionally year on year (Fig. 1):

— by 201 in 2017;

— by 235 in 2018;

— by 577 in 2019;

— by 373 in 2020;

— by 701 in 2021;

The Małopolskie Voivodeship accounts for the largest number of patients treated. In the space of six years, their number has increased by 513 patients. Opolskie Voivodeship is the voivodeship with the smallest number of patients, only 18. The number of patients treated under the B.35 drug programme between 2016 and 2021 by voivodeship against the population of the voivodeship is shown in Table 2. Figure 2 shows the difference between the number of patients treated under the B.35 drug programme in 2016 and 2021 by voivodeship.

Figure 2. Difference between the number of patients treated under the B.35 drug programme in 2016 and 2021 by voivodeship

Number of patients covered by the B.35 drug programme by drug

Over the 2016–2021 period, the largest number of patients were treated with adalimumab, while the smallest number of patients were treated with tofacitinib, which became reimbursed in September 2020. The number of patients covered by the B.35 drug programme between 2016 and 2021 by the drug is shown in Figure 3.

Figure 3. Number of patients under the B.35 drug programme between 2016 and 2021 by drug

The drug secukinumab (Cosentyx) has the highest number of new patients in 2021, at 35%. No year-on-year reduction in the number of patients was observed in any of the provinces. In 2016, four active substances were available as part of the drug programme. Their share of the sales market varied by voivodeship. Adalimumab was the most used drug. The highest number of patients treated with adalimumab in 2016 was in the Śląskie Voivodeship, amounting to 128. The fewest patients (two) were treated with adalimumab in the Lubuskie Voivodeship (Fig. 4).

Figure 4. Number of patients treated with adalimumab under the B.35 drug programme in 2016; Microsoft product screenshot reprinted with permission from Microsoft Corporation

Another drug used in the programme was etanercept (Enbrel, Benepali). The largest number of patients was also treated in the Śląskie Voivodeship, amounting to 35 people. The fewest (two) patients treated with etanercept in Poland in 2016 were in the Podlaskie Voivodeship (Fig. 5).

Figure 5. Number of patients treated with etanercept under the B.35 drug programme in 2016; Microsoft product screenshot reprinted with permission from Microsoft Corporation

The third drug available within the B.35 programme in 2016 was golimumab. The highest number of patients was observed in the Małopolskie Voivodeship, at 49. The smal­lest number of patients treated with this drug (one patient each) occurred in the Warmińsko-Mazurskie and Opolskie voivodeships (Fig. 6).

Figure 6. Number of patients treated with golimumab under the B.35 drug programme in 2016; Microsoft product screenshot reprinted with permission from Microsoft Corporation

The fourth drug available within the B.35 programme in 2016 was infliximab. This drug was used most frequently in the Wielkopolskie Voivodeship — in 10 patients. In contrast, it was not used in the Podlaskie and Opole voivodeships (Fig. 7).

Figure 7. Number of patients treated with infliximab under the B.35 drug programme in 2016; Microsoft product screenshot reprinted with permission from Microsoft Corporation

Five years later, in 2021, eight active substances were already funded under the B.35 drug programme. Adalimumab (Humira and biosimilars) continued to be the market leader in sales. The proportion of individual drugs varied by voivodeship.

Adalimumab was used most frequently in the Śląskie Voivodeship — in 195 patients, 67 more than five years earlier. This time, the fewest patients (eight) were treated in the Opolskie Voivodeship (Fig. 8).

Figure 8. Number of patients treated with adalimumab under the B.35 drug programme in 2021; Microsoft product screenshot reprinted with permission from Microsoft Corporation

Etanercept was also most used in the Małopolskie Voivodeship, with 81 patients, 47 more than in 2016. The smallest number of patients treated with this drug was once again in the Podlaskie and Lubuskie voivodeships (Fig. 9).

Figure 9. Number of patients treated with etanercept under the B.35 drug programme in 2021; Microsoft product screenshot reprinted with permission from Microsoft Corporation

Golimumab was used most frequently in the Małopolskie Voivodeship, with 124 patients, an increase of 75 patients over 6 years. The fewest patients (five) were treated in the Lubuskie Voivodeship (Fig. 10).

Figure 10. Number of patients treated with golimumab under the B.35 drug programme in 2021; Microsoft product screenshot reprinted with permission from Microsoft Corporation

Infliximab was used most frequently in 2021 in the Lubelskie Voivodeship — in 13 patients. Two voivodeships (Podlaskie and Lubelskie) have not recorded treatment with this drug (Fig. 11).

Figure 11. Number of patients treated with infliximab under the B.35 drug programme in 2021; Microsoft product screenshot reprinted with permission from Microsoft Corporation

A new drug, absent from the 2016 funding, was ixekizumab. The drug is reimbursed from 2021 and 142 patients were treated with it that year, the largest number in the Łódzkie Voivodeship — 23. Only in the Podlaskie, Opolskie and Świętokrzyskie voivodeships were there no patients registered with ixekizumab treatment in 2021 (Fig. 12).

Figure 12. Number of patients treated with ixekizumab under the B.35 drug programme in 2021; Microsoft product screenshot reprinted with permission from Microsoft Corporation

Another new drug reimbursed from 2018 is secukinumab. In 2021, 896 patients were treated with this drug, the highest number, 224, in the Małopolskie Voivodeship. The fewest number of patients treated with secukinumab was in the Podlaskie Voivodeship — five (Fig. 13).

Figure 13. Number of patients treated with secukinumab under the B.35 drug programme in 2021; Microsoft product screenshot reprinted with permission from Microsoft Corporation

In September 2020, therapy with the drug tofacitinib was permitted. The drug was used most frequently in the Małopolskie Voivodeship — in 18 patients. In the Warmińsko-Mazurskie, Lubuskie, Dolnośląskie and Opolskie voivodeships, no therapy with this drug was registered in 2021 (Fig. 14).

Figure 14. Number of patients treated with tofacitinib under the B.35 drug programme in 2021; Microsoft product screenshot reprinted with permission from Microsoft Corporation

As of 2017, certolizumab is also reimbursed. In 2021, the drug was the most used in the Małopolskie Voivodeship. Seventeen patients received treatment using this drug. At the same time, in Podlaskie and Opolskie voivodeships, this drug was not used under the B.35 drug programme (Fig. 15).

Contract values for the drug programme

Figure 15. Number of patients treated with certolizumab under the B.35 drug programme in 2021; Microsoft product screenshot reprinted with permission from Microsoft Corporation

In 2016, the value of benefits for drugs in the drug programme amounted to PLN 35.3 million. After six years, the value has increased by PLN 15.7 million. At the same time, the value of contracts to operate the drug programme also increased by PLN 3.7 million [8] (Fig. 16).

Figure 16. Value of contracts for drugs and operation of the B.35 drug programme between 2016 and 2021 (in PLN currency)

The largest increase in funding for both drugs and programme operation was in the Małopolskie Voivodeship, amounting to almost PLN 7.4 million for drugs and PLN 676 thousand for operation. On the other hand, in the Podkarpackie, Podlaskie and Zachodniopomorskie voivodeships, there was a reduction in funding for drugs by a total of almost PLN 590,000 (Tab. 3).

Number of providers implementing the drug programme

Over the five years, the number of providers implementing the B.35 drug programme has increased by one (Fig. 17).

In three voivodeships, the number of providers implementing the B.35 drug programme has decreased (by 1 in each case) in 2021:

— in the Opolskie Voivodeship;

— in the Świętokrzyskie Voivodeship;

— in the Podkarpackie Voivodeship.

Figure 17. Number of centres implementing the B.35 drug programme between 2016 and 2021

At the same time, the number of B.35 programme implementers increased in three voivodeships:

— in the Dolnośląskie Voivodeship — by two;

— in the Małopolskie Voivodeship — by one;

— in the Mazowieckie Voivodeship — by one;

The change in the number of centres implementing the B.35 drug programme between 2016 and 2021 is shown in Figure 18.

Figure 18. Change in the number of centres implementing the B.35 drug programme between 2016 and 2021

DISCUSSION

The B.35 programme is a small drug programme both in terms of funding and the number of patients receiving therapy. The value of contracts for drugs and services within this programme represents only around 1% of the total funding for drugs within drug programmes. At the same time, the number of patients treated within B.35 is also small compared to the total number of patients treated within drug programmes and is also around 1% [9].

Psoriatic arthritis is characterised by periods of exacerbation and remission. The symptoms develop progressively. Usually, the onset of the disease is difficult to pick up, plus the time from first symptoms to diagnosis is often prolonged [10]. In most patients (75%), skin symptoms precede joint symptoms. It is estimated that 10–15% of patients experience symptom manifestation simultaneously on the skin and in the joints. In the remaining patients, joint symptoms usually come first [11]. The progression of the disease can lead to motor disability resulting from, among other things, joint deformity. After only a few years, in the most severe cases, usually, when the peripheral and axial forms of the disease coexist, joint deformity and disability occur. When the disease has a milder course, then it is characterised by periods of exacerbation and partial remission, with gradually increasing joint mobility limitation [12].

Patients with PsA experience a significant impairment in quality of life (this impairment may be greater than in RA due to the co-occurrence of skin and joint lesions). Visible skin lesions are often accompanied by pain in the hands, feet and pruritus [13].

Psoriatic arthritis causes impairment of normal function and the ability to perform daily domestic and occupational activities [14]. The strong sense of shame and stigma associated with the awareness of the presence of visible, extensive skin lesions may lead to depressive disorders. Going to work and school, building social relationships and playing sports and leisure activities become major challenges.

Only about 1.8% of the population of patients with PsA receive treatment under drug programmes. This is, of course, very little, especially compared to other European countries [15]. The B.35 drug programme has now been available for 10 years. It has undergone numerous metamorphoses aimed at increasing patient access to innovative therapies. Currently, the dermatology and rheumatology communities believe that increasing access to therapy will only be possible by shifting treatment to outpatient clinics and changing the reimbursement availability of some of the drugs. It seems that, as in other European countries, physicians regardless of their place of work should be able to treat patients with biological drugs. Currently, almost all biological drugs registered for the treatment of patients with moderate to severe forms of PsA are publicly funded.

According to the announcement of the Minister of Health on 21 December 2020 on the list of reimbursed drugs, foodstuffs for special nutritional use and medical devices for 1 January 2021, the criteria of the drug programme for patients with psoriatic arthritis have been adapted to current medical knowledge and international recommendations [16]. The changes to the description were preceded by a positive assessment by the Transparency Board of the Agency for Health Technology Assessment and Tarification (AOTMiT) and included:

— the removal of the administrative limits of treatment time for patients with PsA;

— permitting patients with PsA to qualify for the programme starting with a moderate degree of disease activity (at least 3 involved joints or tendon attachments or DAS28 > 3.2 or DAS > 2.4);

— permitting patients with PsA with active psoriasis defined as PASI > 10 and DLQI > 10 and BSA > 10 to qualify for the programme with involvement of fewer joints or tendon attachments, i.e. with inflammation and tenderness of at least one joint or tendon attachment;

— in the case of the peripheral form of PsA, removal of the requirement to confirm tendonitis by ultrasound or MRI and giving the treating physician discretion to administer corticosteroids to the area of the inflamed tendon attachment as a local treatment option;

— making it possible to optimise drug dosing (reducing doses or extending the interval between successive doses) in all patients in whom the target of therapy was achieved;

— unification of the description regarding the timing of treatment efficacy assessments and monitoring studies and increasing the margin for all visits to 1 month.

The aim of these changes was, of course, to provide treatment options in line with current medical knowledge and recommendations to achieve and maintain disease remission and increase the likelihood of maintaining full function in an increasing number of patients.

CONCLUSIONS

The inclusion of funding for drugs for psoriatic arthritis patients under the B.35 drug programme was a response to the expectations of both dermatologists and rheumatologists, as well as the patient community. The constantly changing description of the drug programme undoubtedly increases patient access to therapy. In addition, the annual inclusion of new, innovative drugs in reimbursement brings Polish patients closer to the international standards for therapeutic management. The option to prescribe drugs to patients, who can take them at home, significantly improves their quality of life and helps them reduce the number of sick leaves and therefore decrease absenteeism from school and work.

Furthermore, some drugs have already been on the international market for several years and have a proven efficacy and safety profile. In most European countries, these drugs are available to patients on prescription in retail pharmacies. It, therefore, seems reasonable that some of them could be made more widely available to Polish patients under open-list reimbursement. Undoubtedly, shifting some of the drugs to outpatient health care would reduce the workload of physicians in clinical centres and involve more specialist physicians in the innovative, effective treatment of patients with PsA.

Conflict of interest

Lectures and consultancy for Abbvie, Novartis, UCB, Lilly and Janssen companies.

Funding

This work was financed from the statutory funding of the University of Łódź No. 503/5-064-04/503-01.