Introduction of biosimilar drugs to reimbursement in Poland takes almost the longest time in Europe. Nevertheless, obtaining reimbursement is a key factor in the development of business activities of companies, among which PMR conducted a survey specifically for the report “Biological and biosimilar medicines market in Poland in 2019. Market analysis and development forecasts for 2019-2024”.
Problem with access to biological therapies
Many biological drugs in Poland are available only through drug programs. Most of them, however, are characterised by restrictive entry criteria, which makes access to them much more difficult. Treatment is therefore available only to some patients who actually need it. For example, for rheumatoid arthritis (RA) it must be a high disease activity, although in other European countries biological treatment is already included at the average activity of the disease. In the case of Crohn’s disease, access to the drug program, except in exceptional cases, ensures only the severe, active form of the disease.
Additionally, in some drug programs, the therapy is interrupted after the time specified in the regulations, even if it is effective. In the case of RA, it is necessary to interrupt the therapy after 180 days.
Obtaining a reimbursement as a factor in the development of activity
In the opinion of the companies surveyed by PMR especially for the report, the factor that would have the greatest impact on the development of their business at the moment is obtaining reimbursement for their medicine. This is understandable due to the prohibitive price of most biological drugs.
One fifth of the companies would like to see more state support and support for the development of this sector, e.g. introduction of public-private partnership projects, activities aimed at retaining intellectual property in the country (a company with Polish capital), support for early stage clinical trials (a company with Polish capital).
Other development factors mentioned by the companies include patient and physician education on biological and biosimilar drugs, the development of civilisation diseases, the introduction of a national programme for rare diseases and a more predictable reimbursement policy.