Presentation (CTI)

OBJECTIVES: To evaluate and compare access to advanced therapy medicinal products (ATMPs) in the Visegrád Four nations - Czech Republic, Hungary, Poland and Slovakia.
METHODS: Information was derived from official sources on the ATMPs approved for standard reimbursement, or reimbursed through any other channel (e.g. exceptional reimbursement). Data on the expenditures on individual therapies was also gathered, as well as patient numbers, where available. Information on the relevant pricing and reimbursement regulations relating to ATMPs in the respective markets was evaluated and compared.
RESULTS: The Czech Republic is well ahead in terms of access to ATMPs through standard reimbursement mechanisms, with 40% of the approved ATMPs in the EU available in such a way. Poland is in the second position, with 27%, followed by Slovakia with 18% and Hungary with 4%. The more rigid pricing and reimbursement regulations in place in Slovakia and Hungary contribute to making access to these therapies significantly more challenging; in the case of Slovakia, this can be seen with the case brought by health insurance companies against the Ministry of Health’s decision to approve the reimbursement of Novartis’s spinal muscular atrophy gene therapy Zolgensma, and its subsequent removal from the reimbursement list.
CONCLUSIONS: The public health insurance systems in the Czech Republic and Poland have so far been better able to cope with the economic and logistical challenges posed by ATMPs up to this point. The greater flexibility of the pricing and reimbursement systems in these countries has translated into better access for patients. The challenge of providing access to ATMPs will only become greater as the number of products approved increases and overall healthcare budgetary pressure increases concurrently.