Micronized Diosmin Obtained Reimbursement, Based on Its Therapeutic Interchangeability with MPFF

Interchangeability of Diosmin and MPFF

In clinical practice, venoactive drugs have long been used to relieve the symptoms of chronic venous disease, with micronized purified flavonoid fraction (MPFF; diosmin/hesperidin) having the highest level of recommendation in international guidelines. It affects pain, heaviness, swelling, functional discomfort, skin changes, and improves overall quality of life.

In its current decision, SÚKL referred to the decision of the Ministry of Health of the Czech Republic (MZ) from October 2021, which stated the therapeutic interchangeability of drugs containing MPFF and micronized diosmin. This interchangeability means comparable efficacy, safety, clinical use, and indications. SÚKL concluded that if one of the drugs has been granted reimbursement from public health insurance, other drugs should be evaluated in the same way, and consequently set the reimbursement for the drug Diozen.

The decision of the Ministry of Health is based on the registration of another drug containing micronized diosmin (Osmigen), which directly refers to the data of a drug containing MPFF (Detralex) as a reference drug. This procedure, although not common, was satisfactorily explained and justified in the registration procedure from SÚKL's perspective. Based on this, MZ stated that both drugs are so similar in composition that they are essentially therapeutically interchangeable, meaning that if the evidence for MPFF was accepted in the registration procedure as relevant to prove the efficacy and safety of the drug containing micronized diosmin, one cannot conclude otherwise than that the drugs are so similar in composition and dosage form that they can be considered essentially therapeutically interchangeable. Therefore, if a drug containing MPFF has been granted reimbursement, other therapeutically interchangeable substances are entitled to it as well.

Health Insurance Reimbursement

The drug containing micronized diosmin Diozen is included in the group of therapeutically interchangeable drugs containing active substances used in chronic venous disease – bioflavonoids. For the drug with a strength of 500 mg and a package size of 180 tablets, reimbursement from health insurance was set at 273.33 CZK.

Indication Restrictions

Reimbursement for the drug is conditional on its indication. It is covered for the symptomatic treatment of chronic venous disease with objective signs of disease, such as visible varices, edema, skin changes, or ultrasound evidence of venous reflux, and for the healing of venous leg ulcers. Treatment is not reimbursed if there is no clinically significant improvement after 2–3 months of therapy in the case of chronic venous disease or after 6 months of therapy in the case of venous ulcers. The drug is not reimbursed for the treatment of hemorrhoidal disease.

Conclusion

In its statement, SÚKL states that drugs containing MPFF or micronized diosmin are essentially interchangeable and belong to the group of active substances used in chronic venous disease – bioflavonoids. This group includes drugs containing the active substance diosmin (ATC group C05CA03), fixed combinations of diosmin and hesperidin (C05CA53), and fixed combinations of Rusci extractum siccum/hesperidin-methyl chalcone/ascorbic acid (C05CA51).

(lexi)

Sources:
1. SÚKL. 1st evaluation report on the determination of the amount and conditions of reimbursement for Diozen. Administrative procedure ref. no. SUKLS308034/2021. State Institute for Drug Control, December 17, 2021.
2. SÚKL. Decision, ref. no. sukl7419/2022. Administrative procedure ref. no. SUKLS308034/2021. State Institute for Drug Control, January 11, 2022.
3. MZ ČR. Decision, ref. no. MZDR 23415/2021-16/PRO. Ministry of Health of the Czech Republic, October 25, 2021.