Filenews 13 January 2023 - by Marilena Panayi
Dozens of innovative medicines have made their way to joining the GHS by the end of the month. If the representatives of the pharmaceutical industry accept the proposal put before them yesterday by the Minister of Health and the Health Insurance Organization, in the coming months almost all the treatments currently administered to patients will be included in the System through the time-consuming procedures of the Ministry of Health and the Nominal Requests Committee.
Specifically, and according to the official data of the HIO, by the end of January, the evaluation for 92 out of 126 formulations currently administered through the Ministry of Health will be completed since they have not yet joined the GHS.
For 68 of the 92 formulations, the competent Committee of the HIO has completed the process and has already gradually begun informing the suppliers about their initial purchase price. For 44 of the 68 formulations, the relevant letters have already been sent and in some of them the supplying companies have already responded positively to the proposal put before them.
Therefore, according to the HIO's calculations, these 68 medicines, if the suppliers fully adopt the proposal of the Minister of Health and the Organization, will join the GHS by January 31st. These formulations include treatments for Multiple Sclerosis, lung cancer, asthma, ulcerative colitis, arthritis and other rheumatic diseases and Crohn's disease.
Another 24 (out of 92) drugs are estimated to be included in the System before the end of the current quarter and then the procedures for the remaining 34 drugs (out of 126) for which the evaluation has not yet begun will be forwarded.
During a meeting held yesterday at the Ministry of Health, Minister Michalis Hatzipantelas presented to the suppliers a proposal on the basis of which each preparation will be evaluated by the Advisory Scientific Committee and immediately after the completion of its evaluation will be included in the GHS on the price base preliminarily set by the HIO. The companies will then negotiate the prices within the Medicines Compensation Advisory Committee and the final reimbursement price of the formulations will be determined.
Before the representatives of the Cyprus Association of Pharmaceutical Research and Development Companies and the Association of Pharmaceutical Companies of Cyprus, an economic proposal was put forward which includes the formula on the basis of which the calculation of the preliminary price of each preparation will be made. Although the representatives of KEFEA and SΦΕΚ expressed some reservations, there is optimism that they will be overcome. Despite the fact that they submitted an alternative proposal, the Minister of Health has put on the table an incentive that provides for the satisfaction of a long-standing request of suppliers for the establishment and operation of a Medicines Review Council to which they can turn when the negotiation in the SEAF does not result in an agreement and therefore the consultation has probably been put on track to reach an agreement.
As the Minister of Health Michalis Hadjipantela said in his statements to "F", "at the moment the ball is with the suppliers. If they accept our proposal, then patients will have 68 innovative treatments available through the GHS by the end of the month."
"We made a very big effort to speed things up. We have presented a comprehensive proposal that is to the benefit of all and we are committed to the creation of the Medicines Review Council. We expect that we will have a positive outcome and certainly (we have also pointed this out to the suppliers) we have no intention of leaving any preparation outside the General Health System", he stressed.
On his part, the Deputy Director of the HIO, Athos Tsinontidis, explained that "the procedure that has been proposed will function as a transitional stage until we manage with summary procedures to include in the GHS medicines that are currently not integrated but citizens need them and contact the Ministry of Health to secure them. We expect that we will have a positive response from the suppliers to move on to the rest, which will work for the benefit of both patients and the GHS and the importers of medicines themselves."
Proposal for a Drug Review Board
To date, the compensation prices of medicines by the HIO are determined following a negotiation conducted between suppliers and the Pharmaceutical Compensation Advisory Committee. Then, SEAF submits a proposal to the HIO Board of Directors which gives the final approval for the inclusion of the drug in the GHS. In case there was no agreement during the negotiation, SEAF came up with a proposal for the rejection of the drug by the Board of Directors of the Agency. With the operation of the Medicines Review Council, in cases where no agreement is reached in the SEAF, suppliers will have the right to appeal for a review of their case. As mentioned during yesterday's meeting, in case an agreement is reached, the HIO will prepare the Regulations for the operation of the Medicines Review Board within the next ten days.
Regarding the proposal put before the pharmaceutical suppliers, it briefly provides that the innovative and other treatments currently administered to patients through the procedures of the Ministry of Health, will be included in the GHS immediately after the procedures of the SEAF (evaluation and update of protocol) so that they are made available to patients earlier. Specifically, the proposal provides that, immediately after the preparation of the relevant protocol, and before the inclusion of the preparation in the System, the HIO will determine (without negotiation), an initial (temporary) compensation. It will inform the importer/Representative accordingly and if he does not object, then the medicine will be included in the GHS and at the same time the procedures for negotiation between the Agency and the pharmaceutical company will be promoted in order to determine the final price. The negotiation will take place in the same way as it is currently conducted, while for cases where the holder of a marketing authorization of the preparation will not accept the application of a special agreement, then the negotiation will precede the accession, with all that this will of course entail for the introduction of the drug into the System.
The pending issue that currently exists between the Minister of Health, the HIO and suppliers concerns the way in which the preliminary reimbursement price of medicines is calculated. Michalis Hatzipantela and HIO expect that in the coming days KEFEA and SFEK will proceed to their final placement.
INTERVENTION
Let there be no more delay
Let us hope that this time an agreement will be reached and that innovative and other treatments that seriously concern patients will finally be integrated into the GHS. Some say that patients have them available to them anyway through the procedures of the Ministry of Health. These people do not think that a cancer patient who needs such a specialized treatment may not have the luxury of the time it takes to submit a request to the Ministry of Health, the approval of the request by the competent Committee and the purchase of the drug by the Directorate of Purchases and Supplies of the Ministry of Health. Rather, we should all start putting the interests of patients first and foremost.
