Filenews 25 June 2025
Greater importance in the documentation of the doctor's opinion and greater flexibility and speed in the completion of the procedures, are given by the new criteria decided by the Health Insurance Organization for the examination of nominal requests submitted for the administration of specialized treatments to patients/beneficiaries of the General Health System.
Five months after the transfer of all specialized medicines to the GHS and the operation of the Committee for Nominal Requests for Medicines by the HIO, the Organization proceeded with the first revision of criteria with the aim of increasing patients' access to them. The new, more relaxed criteria, in fact, have already been approved by the Organization's board of directors, while the System's doctors were also informed about the changes last Monday.
Based on the new design, the opinion of the doctor who submits the request on behalf of his patient acquires particular importance. That is, the documentation of the request by the doctor himself based on the available literature will be accepted, provided that, as the HIO states in its relevant announcement to doctors, it comes from reliable sources and ensures that the procedure remains scientifically rigorous.
Furthermore, the criterion of "additional clinical benefit" is put on another basis, and this is perhaps the most important change in the design of the HIO. Until now, in order for a medicine that is not included in the list of pharmaceutical products of the GHS to be approved and given through the nominated request process, it was necessary to prove that this preparation has an "additional benefit" for the patient than another medicine already provided by the System. With the new design of the HIO, other criteria will be taken into account, which will be based, to a greater extent, on the severity of the disease, international and scientific recommendations and the documentation of each request by the doctor who submits it.
A key feature of the new criteria is the right given to the doctor to ensure treatment for his patient, regardless of the clinical benefit, when he presents to the HIO correct and sufficient documentation for his decision to choose the specific drug for the specific patient.
The criteria also include a provision for children, according to which in cases where a preparation can be taken in an easier way (less inconvenience) compared to another corresponding medicine that is included in the GHS (pill or injectable/intravenous drug) and there is again correct documentation by the doctor, the Commission will be able to approve the request before it.
The changes to the criteria, as stated by the HIO in its relevant briefing to doctors, were made after consultation with the Cyprus Oncology Society, since most of the requests submitted to the Nomination Requests Committee concern oncology drugs.
Analytically:
> A major change concerns the approval of medicines for serious or rare diseases. A drug will now be able to be approved if it has a scientific recommendation of category 1 or 2A, in accordance with international guidelines for cancer management. On this basis – even for rare diseases – it will be possible to accept even a request for treatment with a lower rating, as long as the need for it is adequately documented to the patient.
> With the new data, there will also be the possibility to approve a request even when there is another similar treatment in the GHS list of pharmaceutical products. This will be done when the attending physician, who also submits the relevant request, can document the reason why the medicine available on the list is not the most suitable for his patient. Particular emphasis will be given to cases where there are side effects, contraindications or interactions with another treatment that make a drug unsuitable for the specific patient. In such cases, the Commission will be able to approve the request for an off-list alternative treatment if it considers that the documentation is medically adequate and well-founded.
> In addition, in cases where there are no international guidelines, the competent HIO committees will be able to base their decision on recognised scientific studies and publications, provided that such documentation is sufficient and comes from reliable sources.
> Finally, specific reasons related to the form of the drug are taken into account. For example, when a formulation is easier to use (such as syrup instead of pill), particularly in children under 18 years of age or other vulnerable populations. That is, in cases where there are different forms of the same or equivalent drug, e.g. pill, syrup, injectable or intravenous, priority will be given to the less invasive and easier to use form, when this facilitates patient compliance and improves their quality of life. This provision is of particular importance for children under 18 years of age, since doctors will be able to request the administration of treatment that best meets the needs of the child, adequately documenting and justifying this choice.
Administration of treatments with apparent efficacy for the patient
The changes, as pointed out in the HIO's briefing to doctors, are expected to increase patients' access to treatments outside the Pharmaceutical Products List and at the same time reduce the rejections of requests and the delays that, in some cases, were observed in the evaluation process and have been of concern to the public.
The purpose of the HIO is to maintain strict scientific control in the evaluation of requests regardless of the changes that have been decided, which in fact constitute a relaxation of the criteria, so that the treatments are administered safely and with apparent effectiveness for the patient.
Of course, the ultimate goal of the HIO is to develop and update as many protocols as possible in order to include medicines in the GHS List of Pharmaceutical Products and thus to reduce the requests to the Committee for Nominal Medicines Requests, whose responsibilities will be limited to exceptions and patients will be able to receive their medicines quickly and seamlessly without additional procedures.
