At its meeting on 21 April, the price and reimbursement committee (CPR) of the Italian Medicines Agency (Aifa) approved the free use of the contraceptive pill for all women of all age groups. A news that has bounced on all the national media, gathering opposing and favorable opinions, both from political parties and from scientific associations and societies. Like the Italian Society of Gynecology and Obstetrics (Sigo), which brings together all the components of Italian, university, hospital and territorial gynecology, which learned with satisfaction the novelty, but wishing to put some clarifications on paper, which it hopes will be taken considered by the Italian agency.
Reimbursability soon
It should be remembered that the decision of the Cpr, led by Joanna Scroccaro – anticipated to Quotidiano Sanità on the same day as the session – before being definitively approved, it will have to be examined by the Aifa Board of Directors. A “usually only formal passage” he explained to Repubblica Francesco Trottadirector of Hta and drug economy of Aifa, which should arrive shortly, already within a week.
Contraceptive pills are currently included in the WHO list of essential medicines and were already partially paid for by the Italian NHS until 1993, to then pass into category C for citizens. Except in some Italian regions, such as Puglia, Emilia Romagna, Piedmont, Tuscany as well as the Autonomous Province of Trento, where they are still prescribed free of charge for girls under 25 years of age.
The selection of products
However, not all birth control pills available on the market today will be free, but only those established by the CTS after months of work. As the president of the Committee explained again, in fact, all the contraceptives available to date were analyzed by progestogen component belonging to three different categories and divided by “generation”. The least expensive products of each generation have been recommended for reimbursement, guaranteeing a certain overlap.
The cost to the State has been estimated at around 140 million euros per year. According to Scroccaro, a necessary price to guarantee access to contraception even to those women who “considered the cost of contraceptive pills too high and for this reason did not use them”. “Moreover, it is difficult to say – he adds – since there has been no price negotiation for these products, that a 25 euro pill is better than those that cost 10 euros”.
Expanding the audience of contraceptive methods
Sigo also enters into the merits of the choice of contraceptive methods, recalling how hormonal contraception today is not only made up of the “pill” but also of long-acting contraceptives (medicated IUD and subcutaneous implant) which would play a greater role in reducing voluntary interruptions of pregnancy (IVG), because they are more indicated in that segment of the population who is not very receptive to daily contraception and therefore more at risk of unwanted pregnancies. This is why it requests that all contraceptives, both daily and depot, be made free of charge by the NHS, in order to allow the choice of the most suitable contraceptive system for each individual woman.
Personalized medicine
The scientific society also points out that the estrogen-progestogen formulations are now highly differentiated in the type and dosage of estrogen and progestogen. This allows for the choice of contraceptive to be personalized on the basis of the woman’s characteristics. Without forgetting that the estrogen-progestogen also has a therapeutic function in the case of numerous gynecological pathologies (Pcos, endometriosis, hirsutism, chronic pelvic pain) in which a careful choice of the type of product to be taken is necessary.
More support for women
For this reason it recommends that women who decide to use it always rely on a specialist, in order to choose the most suitable contraceptive for each one. In support of this, an information and training campaign on “responsible sexuality” and counseling structures should therefore be implemented and finally public family planning clinics should be made free so that women can easily find a specialist ready to advise them on the most suitable contraceptive.
Last in “ranking”
Sigo also points out that Italy is today the European country with the lowest use of elective contraception. Among the major determinants of this situation are not the economic aspect, but also the fear that hormones are harmful. This leads to a substantial reluctance to take them and a preference for less safe natural methods, which expose to a greater number of risky relationships and unwanted pregnancies. The demonstration is given by the significant increase of emergency contraception in Italy.
Reimbursed also the Prep
In the same session on Friday, the Cpr of Aifa also gave the go-ahead for the reimbursement of PReP, pre-exposure prophylaxis, a pharmacological intervention put in place to prevent contagion in people negative for the HIV virus and at risk of becoming infected. A decision that had been long overdue and that Aifa had already postponed. The drug – in particular we are talking about Mylan’s emtricitabine / tenofovir / disoproxil mix – is now included in band A, therefore reimbursable by the National Health Service.
Full charge
Bruno Marchini, president of Anlaids Onlus commented: “The reimbursement of PrEP is an important step forward in the prevention of HIV infection, since it makes the drug usable by all people. However, taking the drug is part of a process which, in addition to the prescription, includes periodic screening for sexually transmitted infections (STI), which at the moment, in most Italian regions, is still the responsibility of the user. We hope that the process will be fully taken over to ensure effective prevention and complete awareness”.
Before the reform
Both issues had been in the attention of the agency for some time as recalled by Scroccaro, who also underlines the desire to complete them before the expiry of the mandate and the arrival of the reform of the Agency, expected for the summer.