The State Institute for Drug Control (the Institute) discontinued reimbursement for specific variants of a medicinal product from the allergen group following an application by the manufacturer. As part of the proceedings, the Institute assessed market availability and the public interest. The analysis confirmed that discontinuing reimbursement would not put patients at risk, as fully adequate therapeutic alternatives for the treatment of allergies are available within the relevant therapeutic group.
In assessing treatment availability and the public interest in connection with the discontinuation of reimbursement, the Institute considered the following:
1. Statutory
assessment criteria
The Institute may
decide to discontinue the amount and conditions of reimbursement if a medicinal
product has not been supplied to the Czech market for more than 12 months and,
at the same time, the discontinuation of reimbursement is not contrary to
the public interest in ensuring access to effective and safe healthcare. Where
the application is submitted by the marketing authorisation holder, the
condition requiring the product to have been absent from the market for 12
months does not have to be met; however, the assessment of the public interest
remains essential.
2. Assessment
of market availability
The Institute
examined actual supplies of the medicinal products to the market over the
preceding 12 months. For two of the three product codes, supplies to the
market had been recorded during this period.
3. Therapeutic
alternatives and ensuring access to care
The key argument
supporting the conclusion that access to reimbursed healthcare would not be
jeopardised was the availability of alternatives within the same reference
group. The Institute confirmed that other reimbursed medicinal products were
available to patients.
In view of this therapeutic
substitutability, the Institute concluded that discontinuing reimbursement
would not affect patients’ access to effective and safe healthcare.
4. Public
interest
Based on the
availability of therapeutic alternatives described above, the Institute
concluded that the discontinuation of reimbursement was not contrary to the
public interest.
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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).
A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.
The English translation was prepared using the latest available ChatGPT model.