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Effective antiosteoporotics from the aminobisphosphonate group can finally be prescribed by general practitioners from January 2024

12. 12. 2023

Osteoporosis represents a serious societal problem generating numerous health and social complications as well as considerable economic costs. In the Czech Republic, it is estimated to affect 500−750 thousand people, or 5−7% of the population. From January 1, 2024, the prescription restriction for the indication and reimbursement conditions for the medicinal products Osagrand (ibandronic acid) and Risendros (risedronic acid) will be lifted, allowing general practitioners to prescribe them as well, under the prescription conditions listed below.

Greater involvement of first-line doctors in the prevention and treatment

General practitioners and gynecologists are, according to the proposed prevention methodology, expected from this year to utilize the FRAX questionnaire (Fracture Risk Assessment Tool), a standardized tool for assessing fracture risk, every 2 years alongside the collection of anamnestic data during preventive check-ups of indicated patients. This preventive procedure applies to all women one year after menopause, up until 59 years old. For men, the relevant age group is 65−69 years. 

Subsequently, the risk of an osteoporotic fracture or a fracture of the proximal femur will be evaluated. If it is higher than the age limit, the doctor should refer the patient for an examination using whole-body bone densitometry (DXA) or perform it themselves if they are contracted to do so. If osteoporosis is confirmed (T-score ≤ −2.5 SD), the patient will start standard treatment (see below). Otherwise, the patient returns to the FRAX regime within the framework of biennial preventive check-ups.

Women aged 60 and over and men aged 70 and over should be automatically referred to DXA in connection with preventive check-ups. Some health insurance companies additionally offer an expanded option to participate in osteoporosis prevention programs − for example, OZP covers DXA examinations once every 2 years for all its insured persons over 50 years old.

Therapeutic indications of aminobisphosphonates

Alendronic acid, risedronic acid, and ibandronic acid (at a strength of 150 mg in one tablet) are reimbursed for patients with osteoporosis proven by whole-body densitometry (T-score ≤ −2.5 SD) or osteoporotic pathological fracture. The treatment is long-term, lasting at least 2 years. Treatment longer than 2 years is reimbursed only for patients with demonstrable bone mass loss.

The therapeutic indication for ibandronic acid is osteoporosis in postmenopausal women with an increased risk of fractures. When identifying women at increased risk of osteoporotic fractures, independent risk factors such as low bone density (BMD), age, the presence of previous fractures, family history of fractures, rapid bone turnover, and low body mass index (BMI) should be considered. When this treatment is administered, a reduction in the risk of vertebral fractures has been demonstrated; efficacy on femoral neck fractures has not been established.

The therapeutic indications for risedronic acid are postmenopausal osteoporosis (reducing the risk of vertebral fractures and fractures of the proximal femur) and osteoporosis in men with a high risk of fractures. Postmenopausal osteoporosis is associated with several risk factors, including lower bone mass, low BMD, early menopause, history of smoking, and family history of osteoporosis. The risk of fractures due to osteoporosis increases with the number of risk factors. The effect of risedronic acid in the form of increased BMD and decreased bone turnover markers (BTM) is the same for men as for women. Therefore, a clinically equivalent reduction in fracture risk for both men and women is presumed.

(pr)



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