Change in Release of Medication Pradaxa
Dear Doctor,
We would like to inform you that from April 1, 2021, based on the decision of the State Institute for Drug Control (SÚKL), the release of the medication (LP) Pradaxa (dabigatran-etexilate) 150 and 110 mg in the indication “Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation” will be changed to first-line treatment.
From the beginning of 2021, it is possible to prescribe LP Pradaxa to newly diagnosed patients with non-valvular atrial fibrillation or to switch them, for example, from warfarin treatment without the need to prove warfarin contraindication.
New reimbursement conditions for the above-mentioned indication for LP Pradaxa 150 and 110 mg from April 1, 2021:
P: The medication is reimbursed based on the prescription by an internist, neurologist, cardiologist, angiologist, hematologist, orthopedist, surgeon, and geriatrician in the following indications:
1. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation indicated for anticoagulation treatment, specifically:
a) in secondary prevention (i.e., after a stroke, transient ischemic attack, or systemic embolization);
b) in primary prevention provided one or more of the following risk factors are present: symptomatic heart failure of class II or higher according to NYHA classification, age ≥ 75 years, diabetes mellitus, hypertension.
The wording of the reimbursement conditions for the treatment and secondary prevention of deep vein thrombosis or pulmonary embolism remains unchanged.
In connection with the release of LP Pradaxa as a first-line treatment, the reimbursement will be reduced by more than 20%, with the maximum co-payment for the patient for monthly treatment not exceeding 75 CZK.
For LP Pradaxa 110 mg 60 cps., it remains necessary to state “increased reimbursement” on the prescription.
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