Abstract
Biological products for treatment of rheumatoid arthritis usually are cost effective for healthcare systems in Europe, but they are huge financial burden due to the high number of patients and the significant budget impact. The expected saving from introduction on the market of biosimilars are significant and are linked to better access and affordability. The aim of this study was to conduct comparative price analysis of biological products for rheumatoid arthritis therapy among seventeen EU countries. The point of view is that of the Bulgarian pricing and reimbursement system and the chosen countries are those from external reference basket for prices comparison at manufacturing level. All authorized biological products by EMA with therapeutic indication rheumatoid arthritis were selected. The access for treatment is evaluated as the availability of the product on the market and the prices level. We assessed the availability of all trade names in the price lists of the observed countries. The prices data was obtained from the official web pages of the responsible institutions up to date December 2017. The results show that four out of all six INNs have authorized biosimilars in EMA. Despite its earlier authorization biosimilar adalimumab is not present in any of the price lists of countries. From all eighteen countries only in Lithuania and Estonia there were no published prices of any of the selected medicinal products. Countries with higher number of biosimilar prices are Spain and France. Differences in manufacturers’ prices of reference biological products in selected countries in comparison with the lowest manufacturer price are higher with 22 to 69% while the retail prices between 62 and 95%. Differences are mostly notable for rituximab, and less notable for tocilizumab. Manufacturers’ and retail prices of biosimilar products were established only for three INNs (etanercept, rituximab, and infliximab). Manufacturers’ prices differ between 26 and 75%, while retail prices differ between 40 and 92% for biosimilars. Comparison of the differences between manufacturer prices of reference biological product and biosimilars shows 36% difference for etanercept, 39% for rituximab, and 31% for infliximab, while at retail level the differences are 11, 86, and 143%, respectively. The limitation of the study is that the prices are the official ones without discounts due to confidentiality and the real prices may be lower. The second limitation is that the methodology for pricing differs in the countries and this could also influence the prices on both levels (manufacturer and retail). Introduction of biosimilars on the national markets led to significant decrease in reimbursed prices paid by public funds and thus might benefit the patients’ access to biological therapy. The decrease of prices after biosimilars entrance on the market is not as notable as for commodity generics.
Highlights
Rheumatoid arthritis (RA) is the most frequent chronic, systemic autoimmune inflammatory disease that causes systemic pain, swelling, and destruction of the joints
We explored the date of marketing authorization of biological and biosimilars with therapeutic indication RA by EMA and compared manufacturer and retail prices
We found that despite its earlier authorization biosimilar adalimumab is not present in any of the price lists of countries under consideration pointing out that this might be due to data exclusivity
Summary
Rheumatoid arthritis (RA) is the most frequent chronic, systemic autoimmune inflammatory disease that causes systemic pain, swelling, and destruction of the joints. The prevalence is around 0.5–1% of the population worldwide (Kobelt and Kasteng, 2009). The etiology may be different, but RA is often classified as autoimmune disease and has a genetic predisposition. The disease leads to functional disability, worsening in the quality of life and premature mortality (Chen et al, 2006; Aletaha et al, 2010). The life expectancy is significantly decreased with approximately 4 years in men, while in women with 10 years. The mortality is high especially in patients with early loss of mobility, those with acute episodes and patients with co-morbidities (Scott et al, 2010)
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