How long does it take for the gratuity to become effective? And which contraceptives will be reimbursable and which will not?
On Friday Giovanna Scroccaro, the president of the Prices and Reimbursement Committee of AIFA, the commission of the Italian Medicines Agency which evaluates and expresses opinions on the classification of drugs for reimbursement purposes, anticipated that part of the hormonal contraceptives currently available on the market will become reimbursable : paid by the national health service and therefore free for women of all age groups. All you need is a prescription from your general practitioner and the contraceptives identified by AIFA will be delivered to the pharmacy.
To make the decision effective, there is still one step missing and what is not yet clear is which contraceptives will become free and which will not: it seems, however, that “contraceptive drugs” will be reimbursable, as Scroccaro said. But among contraceptive drugs it is not clear whether only oral ones will be included, i.e. the pill, or also hormonal patches and vaginal rings. Instead, it seems that coils and subcutaneous devices will be excluded, as well as the so-called barrier methods (male and female condoms, and diaphragm), which are not considered drugs.
The AIFA Technical-Scientific Commission (CTS), the one that evaluates and expresses opinions on the classification of drugs for reimbursement purposes, had given its opinion in favor of free female contraception already some time ago. However, the decision was blocked last October due to problems with the CPR’s definition of drug prices. When a drug becomes reimbursable, its price must be negotiated with the manufacturing company because the price applied to citizens is different, and usually higher, than that applied to the health system. On Friday, as anticipated, the CPR arrived at a solution.
However, the decision of the AIFA Board of Directors and then the publication of the decision in the Official Gazette are missing to make the decision on reimbursement effective. The Board of AIFA is made up of the president, indicated by the Ministry of Health, and four members: two indicated by the Minister of Health and two by the State-Regions Conference. Since January 2023, the new president of AIFA has been Giorgio Palù, in the League.
A RepublicFrancesco Trotta, one of the managers of AIFA, explained that after the favorable decisions of the CTS and CPR, the passage to the Board of Directors “is only formal”. And he declared that “it will arrive shortly”, even if AIFA let the Post that, for now, “it is not possible to know the times” of these passages.
Scroccaro spoke a little more precisely about the times, explaining that the technicians of the AIFA committees wanted to complete the decision on contraception before the expiry of their mandate, scheduled for the summer, when the reform should become effective of AIFA. The AIFA reform provides for the repeal of the general manager, the unification of many functions in the figure of the president, who is politically appointed, and the establishment of a single commission to replace the CTS and the CPR. The reform was wanted by the new government of Giorgia Meloni and has been much criticized by the opposition, but not only, because it will make the agency more dependent on the current government.
Times aside, it is not even clear which contraceptives will be paid for by the national system and which ones will not, because the definitive list of reimbursable drugs will be published by AIFA only after the passage to the Board of Directors.
Giovanna Scroccaro, in her anticipation, however named “contraceptive drugs” saying that the Commission divided them into three categories recommending that some of them be made free of charge for each category, those for which the lowest price was negotiated. AIFA clarified to the Post that “the categories considered are second, third and fourth generation drugs”, that is, a part of oral contraceptives which, over time, have been made more effective and with fewer possible side effects.
Contraceptives can be hormonal or barrier.
Hormonal contraceptives provide a minimal dose of hormones similar to those produced during pregnancy. Among hormonal contraceptives, in turn, we can distinguish combined ones (which contain progesterone and estrogen) and progestin ones. Some hormonal contraceptives are considered medicines, and therefore are included in AIFA decisions, and others are not, and therefore are excluded.
Among the combined hormonal contraceptives there are the estrogen-progestogen pill, the hormonal patch and the vaginal ring: they are “taken” in different ways, but they all act in the same way. And they are considered drugs. However, for some women, who have problems related to headache or blood clotting, for example, combined hormonal contraceptives are contraindicated precisely because they contain estrogen. And therefore there are contraceptives without estrogen: the so-called minipill (POP), which is considered a drug.
The subcutaneous implant and the hormonal spiral as well as the non-hormonal copper spiral, on the other hand, are not considered drugs, but devices, and this is why they probably will not be included in the AIFA decisions.
Barrier contraceptives will also be completely excluded, which act mechanically by preventing the spermatozoa from going back up to the uterus: male condom, female condom and diaphragm.
Marina Toschi, a gynecologist who sits on the board of the European Society of Contraception and Reproductive Health and who is a member of Pro-Choice, the Italian contraception and abortion network, says that from the brief statements made by Scroccaro one can understand how AIFA has identified for the refundability first of all the combined. But it is not clear whether in their various forms of intake or only those taken orally: therefore only the pill, with the exclusion of vaginal patches and rings, or the pill, patches and rings. According to Toschi, the progestin pill should also be included in the list. Most likely, however, the copper IUD, hormonal IUDs, and subcutaneous devices, which are not considered drugs, will be left out.
Spirals (hormonal or copper) and subcutaneous devices are called LARCs, long-acting reversible contraceptives (from the English “Long Acting Reversible Contraception”). The World Health Organization, says Toschi, «claims that the best contraceptives are precisely the LARCs. The spirals offer excellent coverage, have few side effects and, in general, a low cost. Those with progesterone, the most expensive, are therapeutic for endometriosis or the development of fibroids. Copper spirals are also the “greenest”, because they do not pollute». The latest AIFA annual report on the use of drugs shows that, in 2021, coils and contraceptives with subcutaneous implants increased significantly compared to the previous year: +25.8 and +45.3 percent. But out of the total, the most used contraceptives are confirmed as the fourth generation estrogen-progestogen oral contraceptives.
Welcoming AIFA’s decision very positively, Toschi underlines however that some contraceptives will continue to remain out of the reimbursement, despite the guarantee of free, accessible contraception in all its forms has been provided for by law since the 1970s: law number 405 of 1975, which establishes the consultors, then taken up by law 194 on abortion of 1978.
However, from the 1970s to today, free and accessible contraception has not been guaranteed in Italy. Over time there have been protests, petitions, signatures collected and discussions with the institutions and AIFA carried out by feminist movements, committees or associations to be able to obtain the application of the law. Without success. On the contrary. In 2017, when Beatrice Lorenzin was Minister of Health, AIFA had reclassified the latest hormonal contraceptives that were still paid by the national health service from band A (and therefore reimbursable) to band C (and therefore paid by people). The decision had caused a lot of controversy especially since the class A pills were prescribed for therapeutic purposes or to the most vulnerable people, women with low incomes or migrant people.
Often the free contraception depended on the good will of health agencies, hospitals, consultants and regions. But with strong limitations. The regions which to date actually provide for some form of free contraception distributed in counseling clinics, for specific categories of people, are Emilia-Romagna, Tuscany, and Puglia. In 2022 Lazio was also added to the list, but only for the pill for minors.
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