HAS -Direction of medical, economic and public health evaluation1

Advice final version

TMO​​​

7 Octo Bre 20 20

Cyproterone androcur 5 0 mg acetate, scored

Revaluation

The essentials:

Favorable opinion for reimbursement in:

• Horsutism only in non-menopausal women in the indication of major female female hirsutisms of non-tumor origin (idiopathic, polycystic ovary syndrome), when they graze seriously on psycho-affective and social life and when the use of drugs based on lower dose cyproterone or other treatment options satisfactory.
• The anti-Androgenic palliative treatment of prostate cancer.

Opinion unfavorable to reimbursement in hirsutism among menopausal women. The medical service provided is now moderate (previously it was important) in the treatment of hirsutism (only for the defined population cf.infra) and in the anti-Androgenic palliative treatment of prostate cancer.

What place in the therapeutic strategy?

Hirsutism

The French Endocrinology Society recommends cyproterone acetate, associated with an estrogen, in treatment of 1st intention in the event of major hirsutism invalidating from non -menopausal women.

Spironolactone ( excluding AMM), under cover of an effective contraceptive, is the treatment of second intention in the event of adverse effects, counter - indication, refusal of the patient or the lack of efficiency of cyproterone acetate in non -menopausal women.

In menopausal women, androcur (cyproterone acetate) is not recommended and non -tumor androgenic ovarian hyperactivity - menopause.

Cosmetic measures allowing prolonged hair removal can be offered in combination with anti - androgens treatments : electrolysis or photoepilation.

Drug place:

The Commission considers that:

- -menopausal women , Androcur (Cyproterone acetate) , subject to compliance with the recommendations issued ( see specific recommendations CI - after) keeps a place in the treatment of major female hirsutisms of non -tumor origin (idiopathic, syn drome of polycystic ovaries), when they seriously sound on psycho - affective and social Batter -dose -based cyproterone acetate drugs obtained satisfactory results.

The Commission has taken into account the significant medical need in the absence of an alternative available for these patients.

- in menopausal women, given on on the one hand increased risk of the occurrence of meningioma highlighted in this population by the available data (risk which increases with age), on the other hand, the risk of breast cancer (in post - menopause under estrogen associated with synthetic progestins) , Androcur (Cyproterone acetate ) in charge of hirsutism.

In the rare case of androgenic ovarian hyperactivity, surgical solutions ( annexectomy ) can be envisaged.

Prostate cancer

According to the recommendations of the National Comprehensive Cancer Network ( NCCN ) of 2020, the anti palliative treatments are intended for patients with life expectancy ≤ 5 years with a high or very high risk of metastases as well as in patients when the disease progresses abstention p - surveillance with symptoms that appear or when PSA Prostate) suggests the imminent appearance of symptoms.

Note that the NCCN recommendations explicitly cite non -steroidal anti -androgen that are nilutamide , flutamide and bicalutamide, but do not mention cyproterone acetate. The recommendations of the European Society for Medical Oncology ( ESMO ) of 2018 do not mention cyproterone acetate in the palliative treatment of prostate cancer. AFU (French Urology Association) in 2018 recommendations underlines that the interest of using cyproterone acetate lies in the management of heat puffs linked to hormone treatment. Only disabling heat puffs should be supported by drug treatment .

Drug place:

The place of Androcur (cyproterone acetate) is today very limited in view of the alternatives available in the palliative anti - androgenic treatment of prostate cancer . The risk of meningioma is very limited with Androcur in this indication possibly due to the shorter exposure time than in women for the treatment of the major invalidating . However , it should be noted that other non -steroidal anti - androgens currently used do not expose this risk. In total, the Commission considers that in the palliative treatment of prostate cancer, cyproterone acetate retains a very limited place only as a treatment for recourse for degable heat puffs linked to hormonal treatment.

Special recommendations:

The commission recalls :

• The importance of good information of patients and health professionals as to the risks of meningiomas concerning the measures to be taken to avoid them, their detection and their management . The annual renewal of the ION information certificate co -signed by the patient and the doctor must be respected.
• The need to carry out the prescription of Androcur 50 mg (Cyproterone acetate) while respecting the summary of the characteristics of the product (RCP), in particular concerning the search for meningiomes before starting treatment and regularly during treatment . In Insi, a brain MRI must be carried out at the start of treatment in order to verify the absence of meningioma. If the treatment is continued for several years, IMRI imaging by MRI will have to be carried out no later than 5 years after the first imagery, then every 2 years if the MRI at 5 years is normal.
• The need to use as much as possible the lowest effective dose of cyproterone , prolonged and high doses being to be avoided ;
• The ssity of definitively stopping the treatment was the discovery of a meningioma .

Read the full review  here

Link to HAS