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MISOONE

Surgical termination of pregnancy
Opinions on drugs - Posted on Jun 29 2020

Reason for request

New indication

  • Key points

Favourable opinion for reimbursement in cervix uteri preparation prior to surgical termination of pregnancy during the first trimester.

  • What therapeutic improvement?

No clinical added value in the therapeutic strategy.

  • Role in the care pathway?

In all cases where possible, women must be able to choose the method of voluntary termination of pregnancy (elective abortion), whether medical or surgical, and receive detailed information.

A surgical termination of pregnancy consists of dilation of the cervix and aspiration of the uterine contents under general or local anaesthetic. This method may be offered at any time up to 12 weeks of pregnancy (14 weeks of amenorrhoea) and if the medical method fails. However, the surgical method will be favoured to the medical method from 7 weeks of pregnancy (9 weeks of amenorrhoea).

In a surgical termination, medical or mechanical preparation of the cervix is recommended to facilitate dilation and reduce its complications:

  • Medical preparation is based on the use of an oral antiprogesterone, MIFEGYNE 200 mg (mifepristone) 36 to 48 hours before aspiration, or an oral prostaglandin, GYMISO 200 µg (misoprostol) 3 to 4 hours before aspiration, or CERVAGEME 1 mg (gemeprost) by the vaginal route 3 hours before aspiration.
  • Mechanical preparation of the cervix is based on the use of osmotic dilators (laminaria) or synthetic mechanical dilators.

Role of the medicinal product in the care pathway

MISOONE 400 µg (misoprostol) scored tablets are a therapeutic alternative in the medical preparation of the cervix before aspiration of the uterine contents in the context of surgical termination of pregnancy.

  • Special recommendations

The Committee reiterates that, in accordance with the SPC, MISOONE 400 µg (misoprostol) scored tablets are administered as a single oral dose 3 to 4 hours before surgical aspiration.


Clinical Benefit

Substantial

The clinical benefit of MISOONE 400 µg (misoprostol) is substantial in the MA indication.


Clinical Added Value

no clinical added value

Considering:

  • the known efficacy and safety profile of oral misoprostol 400 µg;
  • the lack of comparative data;
  • the medical need currently met by another medicinal product containing misoprostol;

the Transparency Committee considers that MISOONE 400 µg (misoprostol) scored tablets provide no clinical added value (CAV V) in the management strategy for surgical voluntary termination of pregnancy.


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