Use of medicinal product permitted, if the doctor and patient take full responsibility
On 30 May 2019, the State Agency of Medicines (Agency) suspended marketing authorisation of the medicinal product “Rigvir solution for injections” (hereinafter – Rigvir). Meanwhile, upon request from 38 patients and doctors, the Health Inspectorate (HI) has allowed distribution of one batch of Rigvir only to the patients with melanoma already being treated with this product in accordance with the procedure laid down in Cabinet Regulations stipulating that in exceptional circumstances a medicinal product may be supplied to patients already being treated with the product. This batch of Rigvir (No. B0119R) was manufactured in January 2019 and is compliant with quality requirements as shown by testing results. However, quality control was carried out with a method that has not been appropriately evaluated and validated. Therefore, a decision was made that the use of this batch of Rigvir is permitted only if the doctor and patient assume full responsibility over the choice of continuing treatment with this medicinal product. The cost of Rigvir shall not be covered through the national system for reimbursement of medicinal products.
The regulation regarding distribution and quality control of medicines stipulates that in exceptional circumstances a medicinal product may be supplied to patients already being treated with this medicinal product. 38 patients addressed a request to the Health Inspectorate and the State Agency of Medicines to lift the ban on distribution of batches of Rigvir. A request for permission to make an exception for distribution of Rigvir in accordance with the normative acts was submitted also by 5 healthcare institutions and 16 oncologists, general practitioners, an oncologist-chemotherapist, an immunologist and a dermatologist.
Which patients may use this batch of Rigvir and in which situations this may be done? Is this medicinal product available to all patients?
This batch of Rigvir that may be distributed as an exception, may only be used in patients already undergoing treatment with Rigvir. Treatment with this medicinal product may not be initiated in new patients. The aforementioned batch of medicinal product may be used in treatment of current patients only after careful evaluation of the risk-benefit ratio by the doctor for each individual patient. Prior to prescription of Rigvir, patients should be familiar with the informed consent document and the included warning. The doctor and patient must sign the informed consent document, thus, confirming that they are aware of the risks associated with the use of medicinal products not tested with a method approved in marketing authorisation documentation. Considering the quality non-compliance identified in this medicinal product, patients are entitled to refuse treatment with Rigvir, and the decision regarding treatment should made by the patient and healthcare professional together. Healthcare professionals should review treatment of current patients as soon as possible and should change Rigvir to appropriate alternatives. Healthcare professionals have received the information provided in this article in a Direct Healthcare Professional Communication (DHPC), thas has been also published on the Agency’s website.
What should current patients do?
If you have been using Rigvir until now, please contact your treating physician for information regarding further treatment.
Why was the decision made to suspend the marketing authorisation of Rigvir?
This year, quality deficiencies have been identified in several batches of Rigvir, therefore, distribution of this medicinal product was stopped. LLC “Latima”, the company that authorized Rigvir, has yet to identify a specific, unequivocal cause for the quality deficiency. Furthermore, the company has not complied with the requirements of normative acts during the post-authorisation period and has not updated the marketing authorisation documentation. Therefore, the Agency has suspended the marketing authorisation of this medicinal product until the deficiencies are corrected. At the moment, several conditions have been set for the company to fulfil in order to renew marketing authorisation.