ALTEIS (olmesartan) - Essential hypertension in adults
Reason for request
Maintenance of the unfavourable opinion for reimbursement of ALTEIS (olmesartan) in the treatment of essential hypertension in adults.
Role in the care pathway?
Antihypertensive treatment aims to prevent the cardiovascular complications (death, stroke, myocardial infarction (MI) and dementia) and renal complications (end-stage kidney failure) of hypertension. Cardiovascular risk reduction depends first and foremost on lowering blood pressure (BP), regardless of the class of antihypertensive used; therefore, normalisation of blood pressure must be a goal.
The latest HAS / Société Française d'Hypertension Artérielle (SFHTA - French Hypertension Society) guidelines from 2016 recommend, as a 6-month target objective, a systolic BP of between 130 and 139 mmHg and a diastolic BP < 90 mmHg at the doctor's office, confirmed by home measurements (daytime BP by blood pressure self-monitoring (BPSM) or ambulatory blood pressure monitoring (ABPM) < 135/85 mmHg), including in diabetics and patients with kidney disease. In subjects aged 80 years or over, it is recommended to obtain a systolic BP < 150 mmHg, without orthostatic hypotension (daytime SBP by BPSM or ABPM < 145 mmHg).
According to these national guidelines, the first-line management of hypertension is based on lifestyle and dietary measures, with or without medicinal treatment and on the control of cardiovascular risk factors in all hypertensive patients, irrespective of their blood pressure level. Medicinal treatment is initiated immediately:
- in the event of grade 2 hypertension,
- in the event of grade 1 hypertension in patients at high cardiovascular risk (i.e. those with, in addition to hypertension, target organ damage and/or established cardiovascular disease and/or a concomitant disease increasing the cardiovascular risk [CVR] - diabetes, chronic renal failure - and/or an estimated overall CVR > 20% at 10 years).
When medicinal treatment is deemed necessary, the choice of therapy must be adapted to the pathophysiology and severity of the hypertension, and to the patient's comorbidities. Monotherapy with a thiazide diuretic, calcium channel blocker, ACE inhibitor or angiotensin II receptor blocker (ARB) is recommended as first-line therapy. Beta-blockers can be used as antihypertensive drugs, but they appear to offer less protection than other therapeutic classes against the risk of stroke. Nevertheless, they remain a first-line treatment for secondary prevention in patients with ischaemic heart disease or heart failure. In the event of failure of monotherapy after one month, it is recommended to initiate a preferably fixed-dose dual therapy (combination of two classes from among: ACE inhibitor or ARB, calcium channel blocker, thiazide diuretic). If the blood pressure target is still not achieved, triple therapy is recommended, ideally comprising a combination of an ACE inhibitor or ARB, a calcium channel blocker and a thiazide diuretic at optimal doses. Finally, if blood pressure targets are not achieved within six months with triple therapy, specialist advice is recommended.
In severe cases (grade 2/3 hypertension), the guidelines of the European Society of Cardiology and the European Society of Hypertension (ESC/ESH 2018) recommend treatment with dual therapy from the outset. If the blood pressure target is not achieved with maximum-dose dual therapy, triple therapy should be considered.
The Committee highlights that the thresholds defining hypertension grades are consensus-based but have not been based on conclusive evidence.
Role of the medicinal product:
Olmesartan is one of the seven members of the angiotensin II receptor blocker (ARB or sartan) class.
- demonstration of its efficacy on the reduction of blood pressure values solely,
- the absence of evidence of efficacy in terms of cardiovascular morbidity and mortality,
- the very rare but serious risk of enteropathy, which appears to be more frequent with olmesartan than with the other sartans,
prescribing olmesartan instead of another sartan could result in a loss of opportunity for patients.
Consequently, the Committee considers that, on the basis of currently available data, ALTEIS (olmesartan) has no role in the care pathway for patients with hypertension.
The additional data added to the dossier are not of a nature to alter the conclusion of the last assessment and that the clinical benefit of ALTEIS (olmesartan) remains insufficient to justify public funding in the treatment of essential hypertension in adults in view of the available alternatives.
Clinical Added Value