He Ministry of Health already announced that the National Health System (SNS) would finance the first RNA ‘vaccine’ to lower cholesterol. It is a unique medicine in Europe, which has been developed by the Novartis pharmaceutical with small interfering RNA (siRNA) technology. But, which patients can receive it in public healthcare? The Interministerial Commission on Drug Prices (CIPM) has established three profiles.
With two doses a year, this injection is capable of powerfully and sustainably reducing LDL-C, main type of cholesterol which promotes atherosclerotic cardiovascular disease due to the accumulation of lipids in the inner lining of the arteries. Specifically, inclisiran, the drug’s active ingredient, can reduce low-intensity lipoprotein levels by up to 54 percent, according to studies.
The people who will be eligible for cholesterol treatment through the SNS pharmaceutical benefit are, first of all, those patients with heterozygous familial hypercholesterolemia (HeFH) uncontrolled (defined as LDL-C greater than 100 mg/dl) with the maximum tolerated dose of statins (alone or in combination with ezetimibe).
Second, patients with established cardiovascular disease (ischemic heart disease, ischemic cerebrovascular disease or peripheral arterial disease) (defined as LDL-C greater than 100 mg/dl) with the maximum tolerated dose of statins (alone or in combination with ezetimibe). And, thirdly, those who are intolerant to statins or in whom statins are contraindicated and whose LDL-C is greater than 100 mg/dl will also be included.
As for the authorized therapeutic indicationsthe department led by José Miñones points out that this injection, called Leqvio, It is indicated in adults with primary hypercholesterolemia (familial and nonfamilial heterozygous) or mixed dyslipidemia, such as dietary adjuvant. Specifically, in combination with a statin or a statin and other lipid-lowering treatments in patients who fail to achieve LDL-C goals on the maximum dose of a statin; or alone or in combination with other lipid-lowering treatments in patients who are intolerant to statins, or for those for whom statins are contraindicated.
How does the cholesterol ‘vaccine’ work? According to studies carried out, with only two doses a year, this inoculation potently and sustainably reduces LDL-C, the main type of cholesterol that promotes atherosclerotic cardiovascular disease (ASCVD) due to the accumulation of lipids in the inner lining of the arteries. This reduction would come up to 54 percent.
As indicated by the European Medicines Agency (EMA), the drug will be administered with a single subcutaneous inoculation, after which it will be necessary wait three months to receive the second. Thereafter, injections will be given every six months.
Sales of cholesterol ‘vaccine’
Likewise, the CIPM has agreed on the establishment for this medicine of singular reserves in the SNS with the aim of limiting its dispensation, without the need for a visa, to non-hospitalized patients in the Pharmacy Services of hospitals.
“There will also be a annual sales review and the prices now set, to ensure that they are within the legally established parameters, and if not, proceed to adapt them through the corresponding reduction”, they detail from Health. In fact, the monitoring and control of the expense caused, It will be carried out through the Seguimed computer process, where Novartis will have to communicate each month the information regarding the sales made of the drug.
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2023-11-10 13:20:00
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