MEDICINAL PRODUCTS INDICATED IN HORMONAL REPLACEMENT THERAPY FOR THE MENOPAUSE (estradiol, estriol, tibolone, cyproterone acetate, dydrogesterone, levonorgestrel, medrogestone, medroxyprogesterone, norethisterone acetate, progesterone)
Reason for request
Summary of opinion
Favourable opinion for maintenance of reimbursement in:
- “Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in post-menopausal women” for ACTIVELLE (estradiol, norethisterone acetate), CLIMASTON (estradiol hemihydrate, dydrogesterone), CLIMENE (estradiol valerate, cyproterone acetate), DERMESTRIL (estradiol), DERMESTRIL SEPTEM (estradiol), DUOVA (estradiol, medroxyprogesterone acetate), ESTREVA (estradiol), FEMSEPT (estradiol), FEMSEPTCOMBI (estradiol, levonorgestrel), FEMSEPTEVO (estradiol, levonorgestrel), KLIOGEST (estradiol, norethisterone acetate), NOVOFEMME (estradiol, norethisterone acetate), OESTRODOSE (estradiol), OROMONE (estradiol hemihydrate), PROVAMES (estradiol hemihydrate), THAIS (estradiol), THAISSEPT (estradiol) and TRISEQUENS (estradiol, norethisterone acetate),
- “Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products indicated for the prevention of osteoporosis” for ACTIVELLE (estradiol, norethisterone acetate), CLIMASTON (estradiol hemihydrate, dydrogesterone), CLIMENE (estradiol valerate, cyproterone acetate), KLIOGEST (estradiol, norethisterone acetate), NOVOFEMME (estradiol, norethisterone acetate), OESTRODOSE (estradiol), OROMONE (estradiol hemihydrate), PROVAMES (estradiol hemihydrate) and TRISEQUENS (estradiol, norethisterone acetate),
- “Correction of oestrogen deficiency symptoms in natural or artificial primary or secondary ovarian insufficiency, as short-term treatment” for PHYSIOGYNE (estriol),
- “Confirmed menopause (artificial cycle in combination with an oestrogen)” for DUPHASTON (dydrogesterone),
- “Perimenopause, hormone replacement therapy for menopause (as an adjunct to oestrogen)” for UTROGESTAN (progesterone) oral route, vaginal route.
Unfavourable opinion for reimbursement in:
- “Artificial cycle in combination with an oestrogen” for COLPRONE (medrogestone),
- “Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women, more than one year after menopause” for LIVIAL (tibolone).
Clinical Benefit
| Substantial |
The clinical benefit of ACTIVELLE 1 mg/0.5 mg (estradiol, norethisterone acetate), CLIMASTON 1 mg/5 mg, 1 mg/10 mg, 2 mg/10 mg (estradiol hemihydrate, dydrogesterone), CLIMENE (estradiol valerate, cyproterone acetate), DERMESTRIL 25 µg/24h, 50 µg/24h, 100 µg/24h (estradiol), DERMESTRIL SEPTEM 25 µg/24h, 50 µg/24h, 75 µg/24h (estradiol), DUOVA 1 mg/2.5 mg, 1 mg/5 mg, 2 mg/5 mg (estradiol, medroxyprogesterone acetate), DUPHASTON 10 mg (dydrogesterone), ESTREVA 0.1% (estradiol), FEMSEPT 50 µg/24h, 75 µg/24h, 100 µg/24h (estradiol), FEMSEPTCOMBI 50 µg /10 µg/ 24 hours (estradiol, levonorgestrel), FEMSEPTEVO 50 µg/7 µg/ 24 hours (estradiol, levonorgestrel), KLIOGEST 2 mg/ 1 mg (estradiol, norethisterone acetate), NOVOFEMME 1 mg/1 mg (estradiol, norethisterone acetate), OESTRODOSE 0.06% (estradiol), OROMONE 1 mg, 2 mg (estradiol hemihydrate), PROVAMES 1 mg, 2 mg (estradiol), THAIS 25 micrograms/24 hours, 50 micrograms/24 hours (estradiol), THAISSEPT 25 micrograms/24 hours, 50 micrograms/24 hours (estradiol), TRISEQUENS 2 mg/2 mg-1 mg/1 mg (estradiol, norethisterone acetate) and UTROGESTAN 100 mg, 200 mg (progesterone) remains substantial in the MA indication, PHYSIOGYNE 1 mg (estriol) remains moderate in the MA indication.
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| Moderate |
The clinical benefit of ACTIVELLE (estradiol, norethisterone acetate), CLIMASTON 1 mg/5 mg, 1 mg/10 mg, 2 mg/10 mg (estradiol, dydrogesterone), CLIMENE (estradiol valerate, cyproterone acetate), DUOVA 1 mg/2.5 mg, 1 mg/5 mg, 2 mg/5 mg (estradiol, medroxyprogesterone), KLIOGEST (estradiol, norethisterone acetate), NOVOFEMME (estradiol, norethisterone acetate), OROMONE 2 mg (estradiol), PROVAMES 2 mg (estradiol), TRISEQUENS (estradiol, norethisterone acetate) |
| Insufficient |
The clinical benefit of COLPRONE 5 mg (medrogestone) remains insufficient to justify public funding in the MA indication in view of the available alternatives. |
Clinical Added Value
| minor |
DERMESTRIL (estradiol), DERMESTRIL SEPTEM (estradiol), ESTREVA (estradiol), FEMSEPT (estradiol), FEMSEPTCOMBI (estradiol, levonorgestrel), FEMSEPTEVO (estradiol, levonorgestrel), OESTRODOSE (estradiol), THAIS (estradiol) and THAISSEPT (estradiol) provide a minor clinical added value (CAV IV) compared to oral forms. |
| no clinical added value |
ACTIVELLE (estradiol, norethisterone acetate), CLIMASTON (estradiol hemihydrate, dydrogesterone), CLIMENE (estradiol valerate, cyproterone acetate), DUPHASTON (dydrogesterone), DUOVA (estradiol, medroxyprogesterone acetate), KLIOGEST (estradiol, norethisterone acetate), NOVOFEMME (estradiol, norethisterone acetate), OROMONE (estradiol hemihydrate), PHYSIOGYNE (estriol), PROVAMES (estradiol hemihydrate), TRISEQUENS (estradiol, norethisterone acetate) and UTROGESTAN (progesterone) provide no clinical added value (CAV V) in the care pathway. |
| Not applicable |
The clinical benefit of COLPRONE 5 mg (medrogestone) remains insufficient to justify public funding in the MA indication in view of the available alternatives. |
