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PROLIA - OPM

Opinions on drugs - Posted on Oct 02 2020

Reason for request

Reevaluation

 Key points

Favourable opinion for maintenance of reimbursement in the treatment of postmenopausal osteoporosis in women patients at high risk of fractures, only as second-line therapy as follow-on treatment after bisphosphonates.

Unfavourable opinion for reimbursement in other situations.

What therapeutic improvement ?

No clinical added value in the therapeutic strategy.

Role in the care pathway ?

PROLIA (denosumab) is a second-line therapy as follow-on treatment after bisphosphonates in women patients with postmenopausal osteoporosis at high risk of fractures.

Special recommendations

The Committee would like to reiterate that :

  • treatment with PROLIA (denosumab) should be reserved for women patients at high risk of fractures,
  • prior exposure to bisphosphonates appears to limit the rebound effect on vertebral fractures. Treatment with denosumab is therefore a second-line therapy to be used as a follow-on treatment after bisphosphonates,
  • the optimal duration of PROLIA treatment is not known. When discontinuation of denosumab is envisaged, it appears to be essential to plan anti-resorber treatment to prevent bone remodelling rebound following discontinuation of denosumab,
  • compliance with osteoporosis treatment is essential for optimal efficacy.

Clinical Benefit
Substantial

The Committee deems that the clinical benefit of PROLIA (denosumab) remains substantial in the treatment of postmenopausal osteoporosis in women patients at high risk of fractures only as second-line therapy as follow-on treatment after bisphosphonates. Women patients at high risk of fractures are defined as :

  • women patients having had a fracture due to bone weakness,
  • in the absence of a fracture, women with a marked reduction in bone density (T score < -3) or with a T score ≤ -2.5 combined with other fracture risk factors, in particular age > 60 years, previous or current systemic corticosteroid therapy at a dosage ≥ 7.5 mg/day of prednisone equivalent, a body mass index < 19 kg/m², a history of femoral neck extremity fracture in a first-degree relative (mother), an early menopause (before the age of 40 years).
Insufficient

The Committee deems that the clinical benefit of PROLIA (denosumab) is insufficient to justify public funding cover in all other clinical situations.

Clinical Added Value
no clinical added value

The Committee considers that PROLIA (denosumab) provides no clinical added value (CAV V) in the treatment of postmenopausal osteoporosis in women patients at high risk of fractures as second-line therapy as follow-on treatment after bisphosphonates.

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