Reason for request

New indications

Key points

Favourable opinion for reimbursement in the treatment of severe Raynaud's phenomena in patients with progressive trophic disorders.

Unfavourable opinion for reimbursement in the treatment of severe chronic ischaemia of lower limbs in patients in whom revascularisation has failed or is not indicated.

What therapeutic improvement?

No clinical added value in the treatment of severe Raynaud's phenomena in patients with progressive trophic disorders.

Role in the care pathway?

Treatment of severe chronic ischaemia of lower limbs:

ILOMEDINE has no role in the care pathway in severe chronic ischaemia of lower limbs when revascularisation has failed or is not indicated.

Treatment of severe Raynaud's phenomena:

ILOMEDINE is a last-line treatment, in addition to lifestyle and dietary measures, which must be reserved for Raynaud’s phenomenon patients with severe trophic lesions following the failure of oral therapies.


Clinical Benefit

Low

The clinical benefit of ILOMEDINE is low in the indication “Treatment of severe Raynaud's phenomena in patients with progressive trophic disorders”.

Insufficient

The clinical benefit of ILOMEDINE is insufficient to justify its funding by the French national health insurance system in the indication “Treatment of severe chronic ischaemia of lower limbs in patients at risk of amputation, in whom surgical revascularisation or angioplasty has failed or is not indicated, following an interdisciplinary meeting of physicians, surgeons and radiologists”.

 


Clinical Added Value

no clinical added value

ILOMEDINE provides no clinical added value (CAV V) in the care pathway for severe Raynaud's phenomena with progressive trophic disorders.

 


Contact Us

Évaluation des médicaments
All our publications