The State Institute for Drug Control (the Institute) determined the first temporary reimbursement for a highly innovative medicinal product (HIMP) at the lower reimbursement rate under JUHR2.
When determining reimbursement for the medicinal product, the Institute proceeded in accordance with Section 39d(9) of the Public Health Insurance Act by comparing the reimbursement amount calculated using the standard method (based on price references) with reimbursement amounts previously established for the same medicinal product in other administrative proceedings and applying the lower amount.
Section 39d(9) of the Public Health Insurance Act states:
“Where proceedings are conducted to determine temporary reimbursement for a medicinal product that is already reimbursed under another therapeutic indication through public health insurance on the basis of a decision issued by the Institute pursuant to Section 39h, the Institute shall determine the temporary reimbursement amount at no more than the reimbursement amount established by the Institute's decision pursuant to Section 39h.This shall not apply where such a medicinal product has been included, by a decision of the Institute pursuant to Section 39h, in a reference group or another group of essentially therapeutically interchangeable medicinal products that already includes other medicinal products. Where another highly innovative medicinal product has also been granted temporary reimbursement and the available evidence demonstrates that it has similar clinical use and comparable or closely similar efficacy and safety, the Institute shall determine the temporary reimbursement amount for the medicinal product under assessment at no more than the temporary reimbursement amount established for the highly innovative medicinal product with similar clinical use and comparable or closely similar efficacy and safety, taking into account differences in dosage and pack size.”
In applying the above provision, the Institute verified whether the medicinal products were already reimbursed within the public health insurance system and identified their applicable reimbursement amounts. It found that, in addition to the higher JUHR1 reimbursement amount, a lower JUHR2 reimbursement amount was also in effect. As the applicable JUHR2 reimbursement amounts for the individual product codes were lower than those newly calculated on the basis of price references, the Institute determined reimbursement at the amounts previously established in proceedings concerning temporary reimbursement of the HIMP for another indication.
The application of Section 39d(9) of the Public Health Insurance Act ensured that the newly determined temporary reimbursement amount for the indication under assessment did not exceed the previously established, valid and enforceable temporary reimbursement amount for the same medicinal product in another indication.
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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.