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PTR calls for expanded access to off-label drugs

MedExpress Team

Medexpress

Published April 22, 2025 09:17

PTR calls for expanded access to off-label drugs - Header image
The Polish Society of Rheumatology publishes "Position on the necessity of expanding access to treatment outside registered indications (off-label) in rheumatic diseases in Poland."

According to the positions of the Polish Society of Rheumatology 2025, patient access to innovative treatment is steadily improving. Reimbursement of biologics and synthetic targeted drugs under drug programs is mainly based on registered indications, but for some drugs and indications also includes indications not specified in the SmPC, i.e. off-label. These are in line with current medical knowledge and recommendations.

In addition to access to innovative treatment, the availability of classic drugs should also improve. Currently, the following drugs are available in Poland:

  • methotrexate (p.o., s.c.),
  • azathioprine,
  • chloroquine,
  • cyclophosphamide,
  • cyclosporine,
  • mycofenolate mofetil,
  • leflunomide,
  • sulfasalazine.

According to the Reimbursement Law, all drugs are reimbursed for the indications listed in th...

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