Interchangeability of Diosmin and Micronized Purified Flavonoid Fraction
Among the medicinal products reimbursed for chronic venous disease, those containing micronized diosmin (Diozen 180 tbl.) have been newly included. Which substances are available for this indication, and what determined the interchangeability of micronized diosmin with micronized purified flavonoid fraction (MPFF) and other selected venotonics stabilizing capillaries?
COMMERCIAL ANNOUNCEMENT
Substances from the group of venotonics stabilizing capillaries are primarily bioflavonoids (ATC: C05CA) such as rutoside, monoxerutin, diosmin, troxerutin, or hidrosmin, which are available in single-component and combined preparations.
MPFF
According to international guidelines, micronized purified flavonoid fraction holds the highest recommendation. MPFF is represented on the market by a preparation containing diosmin (90%) and other flavonoids (10%) expressed as hesperidin, i.e., diosmin/hesperidin.
Micronized Diosmin
However, in light of the decision by the Czech Ministry of Health (MZ) from October 2021, which states the therapeutic interchangeability of medicinal products containing MPFF and micronized diosmin due to their similar efficacy, safety, clinical use, and close composition, the State Institute for Drug Control (SÚKL) included preparations containing diosmin alone into the group of therapeutically interchangeable medicinal products for the indication of chronic venous disease. SÚKL also determined reimbursement for the Diozen preparation, whose conditions fully correspond to this therapeutic interchangeability.
SÚKL adds that preparations containing diosmin (ATC: C05CA03), fixed combinations of diosmin/hesperidin (C05CA53), and fixed combinations of substances Rusci extractum siccum (dry extract of butcher's broom – genus Ruscus), hesperidin methyl chalcone, and ascorbic acid (vitamin C) (C05CA51) are interchangeable and comparable in terms of efficacy, safety, clinical use, and indication.
Conclusion
From the aforementioned decisions of MZ ČR and SÚKL, it is clear that medicinal products containing diosmin alone are essentially therapeutically interchangeable with medicinal products containing MPFF. Micronized diosmin is included in the Diozen preparation, which has been reimbursed at 273.33 CZK since March 2022.
(lexi)
Sources:
1. SÚKL. 1st evaluation report on setting the amount and conditions of reimbursement for the medicinal product Diozen. Administrative proceedings ref. no. SUKLS308034/2021. State Institute for Drug Control, 17. 12. 2021.
2. SÚKL. Decision, ref. no. sukl7419/2022. Administrative proceedings ref. no. SUKLS308034/2021. State Institute for Drug Control, 11. 1. 2022.
3. MZČR. Minister of Health's decision in the appeals procedure of health insurance companies from July 19, 2021, against the Minister's decision from June 30, 2021, ref. no. MZDR 23415/2021-16/PRO. Ministry of Health of the Czech Republic, 25. 10. 2021.
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