Medicines reimbursed in Poland

Due to emerging doubts regarding the interpretation of the scope of indications covered by the reimbursement for Prolia (denosumabum), the Minister of Health, after consulting the Team of Osteoporosis Experts operating at the National Consultant in the field of rheumatology, indicates that the following interpretation of individual criteria for this indication:

Postmenopausal osteoporosis (T-score less than or equal to -2,5, as measured by DXA). – diagnosis of postmenopausal osteoporosis, documented in the patient's medical history and confirmed by the assessment of bone mineral density (BMD) expressed with a T-score value less than or equal to -2,5 and measured by the DXA method in the central location, i.e.: the proximal end of the femur (neck, total) or in the area of ​​the lumbar spine (section L1-L4), however, the occurrence of a value of -2,5 is required as diagnostic confirmation at the time of diagnosis, and subsequent BMD measurements - regardless of their value - are used to monitor treatment;

For women over 60 years of age - 60 years of age from the date of birth;

Osteoporotic fracture. – low-energy fracture, disproportionate to the forces causing it, i.e. a fall from one's own height or spontaneous fracture. Osteoporotic fractures include fractures of the proximal end of the femur (femoral neck, transtrochanteric or subtrochanteric fractures) and vertebrae, ribs, humerus, radius or tibia, pelvis, and pathological fractures and atypical femoral fractures are not included in the above indication;

Failure of treatment with oral bisphosphonates or contraindications (intolerance) to their use:

            - Failure of oral bisphosphonate therapy (alendronate or risedronate or ibandronate) - new low-energy fracture or fall from baseline in BMD at 12-month follow-up during treatment with therapeutic doses of bisphosphonates for more than 12 months by a value greater than the smallest significant change (4,5% - in the case of the femoral neck or 3.4% in the case of the lumbar vertebrae), measured in the same place and with the same DXA technique.

            – Contraindications to treatment with oral bisphosphonates – active gastric ulcer, dysphagia, active gastroesophageal reflux disease, gastrectomy, inability to stand or sit for at least 60 minutes, drug allergy or other patient condition that precludes regular oral bisphosphonate intake, and other contraindications listed in the Summary of Product Characteristics.

            – Intolerance to bisphosphonate therapy – gastrointestinal disturbances severe enough to warrant discontinuation of treatment.

It should be noted that the attending physician, acting on the basis of his or her best knowledge, states the presence or absence of contraindications or intolerance to oral bisphosphonates.

By authority of the Minister of Health
Undersecretary of State
Igor Radziewicz-Winnicki

Announcement of the Minister of Health on the reimbursement of denosumab: http://www.archiwum.mz.gov.pl/

A specialist treating a patient over 75 for osteoporosis may provide information on indications for the use of the drug to a primary care physician, on the basis of which the primary care physician will issue a prescription for free drugs. There is no binding, official form of information for a primary care physician, however, according to the regulations, this certificate must contain the following data²:
- diagnosis
– prognosis
– Information on prescribed drugs, foodstuffs for particular nutritional uses in the period of their use and dosage
– information about the method of treatment
– information on scheduled control visits

Prolia, which has so far been used mainly by specialists in the treatment of osteoporosis, is now also prescribed by general practitioners as part of the 75+ programme. The lack of knowledge of this drug sometimes raises concerns about the possibility of subcutaneous injection in primary care practice.

The administration of Prolia is no different from other subcutaneous injections given to patients in primary care. According to the product characteristics, the drug is administered by subcutaneous injection once every 6 months in the thigh, abdomen or arm by a person trained in subcutaneous injection³, i.e. it can be administered by a doctor or nurse in the treatment room.

2 Announcement of the Minister of Health of 11 July 2016 on the announcement of the consolidated text of the Regulation of the Minister of Health on the general terms and conditions of contracts for the provision of healthcare services, Journal Laws of 2016, item 1146
https://osteoporoza.pl/wp-content/uploads/2016/10/2376_2.-Rozporzadzenie-w-sprawie-ogolnych-warunkow-zawierania-umow.pdf