The Mukobohaterowie Foundation has turned to the RPO regarding access to medicines for people with cystic fibrosis. At issue is an announcement by the Ministry of Health, according to which some drugs used in the treatment of cystic fibrosis are not financed under emergency access to drug technologies.
RPO writes to health minister on cystic fibrosis drugs
Published Dec. 6, 2023 08:51
According to the MZ Announcement of October 20, 2023 on the list of reimbursed drugs, foodstuffs for special nutritional purposes and medical devices as of November 1, 2023 under the drug program , "B.112. TREATMENT OF CANCER DISEASE (ICD-10: E84)", public funding is available for some patients. The introduction of treatment for new groups of patients requires consideration of a new reimbursement application.
A pharmaceutical company applied for reimbursement coverage and an official price for both drugs in this indication. After lengthy negotiations, the application was withdrawn.
On November 28, 2022, these medicinal products received a conditional recommendation from the President of the Agency for Health Technology Assessment and Tarification on the appropriateness of their public funding, subject to deepening the proposed risk-sharing instrument and proposing an additional risk-sharing mechanism to safeguard the total impact on the payer's budget.
According to the Communiqué, it was alleged that Article 47f (3) para. 3. of the Law on Health Care Services Financed from Public Funds, as amended by the Medical Fund Law of October 7, 2020, provided the basis for including these drugs in the list under consideration. This article stipulates that, as a consequence of the issuance of a recommendation by the President of the AOTMiT that a drug is not justified for reimbursement, it is not financed under emergency access to drug technologies. In contrast, no recommendation has been issued on the unreasonableness of reimbursement coverage for the drugs Kaftrio and Kalydeco.
In addition, the letter raised doubts about the description of the scope of the previously requested reimbursement, i.e. that the decision resulting from the application would apply to "patients aged at least 6 years homozygous for the F508del mutation of the CFTR gene or heterozygous for the F508del mutation with a mutation of minimal function (MF) of the CFTR gene." The discontinued reimbursement proceedings for the drugs Kaftrio and Kalydeco involved patients at least 6 years old with at least one F508del mutation of the CFTR gene (F/x).
In addition, it was noted that as early as 2022. The Supreme Audit Institution requested in its audit speeches to the Minister of Health that lists of medicinal products not subject to RDTL funding be reliably developed.
RPO Marcin Wiącek is therefore asking the Minister for her position on the matter.
Source: RPO
