Omega-3 reimbursability: the opinion of the medicines evaluation committee
Published on 7/3/2013
Clarifications from the Technical-Scientific Advisory Committee for the evaluation of medicines (CTS) regarding certain doubts over the interpretation of Note 13.
Bearing in mind that Note 13 is currently under revision in light of the ongoing scientific debate, the Technical-Scientific Advisory Committee for the evaluation of medicines (CTS), at its meeting of 6 and 7 December 2011, deemed it appropriate to clarify certain interpretative doubts for which specific requests for clarification had been received.
Reimbursability of omega-3
Note 13 concerns medicines for the treatment of hyperlipidaemias and therefore does not apply to the prescribability of omega-3 for the indication "secondary prevention in subjects with previous myocardial infarction". Therefore, for this specific indication alone, currently reimbursed by the National Health Service (SSN), omega-3 may be prescribed outside the scope of the note, requiring no specification by the doctor on the prescription.
Ezetimibe as monotherapy
It is specified that, in patients intolerant to statins, ezetimibe is reimbursable as monotherapy.
Fixed combination of ezetimibe + statin
Where indicated, the ezetimibe + statin combination is reimbursed both in extemporaneous form and in fixed-combination formulations.
Fibrates in chronic renal failure: for this indication, fibrates are not reimbursed.
The inconsistency in the citation in the explanatory text will be corrected during the revision. What is written in the box therefore prevails. Omega-3 in drug-induced hyperlipidaemias: in this case too, what is written in the box prevails.
Classification of familial dyslipidaemias: the inconsistency will be corrected during the revision.
For the time being, it is clarified that the treatment is in any case the same both for hypercholesterolaemias (whether autosomal dominant or recessive) and for monogenic familial hypercholesterolaemia.
Definition of moderate risk
It is specified that this category includes hypercholesterolaemic patients presenting 2 or more major risk factors (table 1 prevails). Aorto-coronary bypass: the "coronary disease" category must also include aorto-coronary bypass.
source AIFA