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We could certainly have dreamed of a better ministerial launch. Invited dawn of November 27, on France Inter, Agnès Buzyn had a great scoop in his luggage solidarity and sanitary. Unfortunately, shaken by a thousand and one daily political urgencies, the minister has missed her effect: she simply "Forgot the name of the brand" -The lubricated male condom that will soon be reimbursed by Health Insurance.
A brand that will soon enjoy strong publicity: EDEN, first "medical device" latex reimbursed by the Health Insurance. An event since never Social Security, in charge of therapy, had been brought to such preventive care. And since the emergence of the AIDS epidemic, no government had wanted to raise the issue of reimbursement of the male condom while the health authorities were inciting to its use.
From the 10th of December
The Minister of Solidarities and Health having "forgotten" the name of the brand, the firm concerned ensures communication: "Majorelle, the 1st citizen laboratory ". This company was created in 2012 in the wake of the business of third-generation pills, with the development of a new range of female contraceptives. In 2014, it markets the first reimbursed pill with no "Venous thromboembolic over-risk". In 2015, Majorelle launched the "First treatment of erectile dysfunction in the form of cream". Then, in 2017, a media campaign to publicize its medical device indicated in the home treatment of urinary leakage.
And today, fully in tune with the government and health insurance, here is the announcement of the first "Condom reimbursable on prescription". And this "To provide an effective response to a major public health issue: the prevention of badually transmitted infections" (HIV / AIDS, viral hepatitis B and C, syphilis, gonorrhea, chlamydia, etc.).
In practice, as of December 10, 2018, EDEN will be covered by the Health Insurance. This care will concern both women and men. The delivery, in the form of boxes of six, twelve or twenty-four condoms, will be made in pharmacies on presentation of a prescription from a doctor or a midwife. Premium quality condom, EDEN will benefit from a 60% reimbursement rate based on a selling price of € 1.30 including tax a box of six (also available in size XL), 2, 60 € TTC the box of twelve and 5,20 € TTC the box of twenty-four.
The cost for health insurance
It remains to shed light on the politico-economic aspects of this decision. The firm explains that it was, initially, addressed to the High Authority of Health (HAS). His file was then studied by the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). According to the June 12 commission's announcement, the condoms in question are manufactured by Okamoto Rubber Products Co., Ltd. (Thailand); and two models are available: EDEN, lubricated condoms (clbadic size) and EDEN XL, lubricated condoms (size XL).
"Indications retained: in the general population over the age of 15, prevention of the following eight badually transmitted infections:
– Human immunodeficiency virus (HIV);
– Herpes simplex virus (HSV-2);
– Papillomavirus (HPV);
– Hepatitis B;
– Syphilis;
– Chlamydia;
– Gonorrhea;
– Trichomonas. "
For CNEDiMTS experts, the expected service is qualified as "sufficient" because of the interest in terms of prevention of STIs and "Taking into account the effectiveness of condoms, used correctly and systematically as part of a comprehensive prevention strategy".
One can also find in the release these encrypted elements of contextualization:
IMPACT
EDEN responds to a need covered by all male condoms available through various commercial distribution channels (of the order of 110 million units per year) or subject to free delivery programs (approximately 6 million units). Interventions to improve the availability and accessibility of condoms are among the strategies considered effective in improving STI prevention. According to the two surveys provided by the applicant, the price would be a barrier to the use enjoyed differently according to the populations interviewed: 11% in the LGBT survey and up to 38% in a survey conducted in French Polynesia. However, no conclusive studies on the public health impact of community care are available.
TARGET POPULATION
The data available to estimate the target population of condoms are extremely limited, especially in the indication of prevention of STIs. More than 100 million units are sold or distributed each year in France, but the number of users and the purpose of the use (contraception or prevention of STIs) can not be deduced. The population aged 15-75, selected as being likely to be badually active, represents 50 million people, all of whom are not concerned by the prevention of STIs. No data are available to estimate the proportion at risk of exposure. […]
Regarding the use of condoms by homobadual men, the applicant [Majorelle] estimates at 232,000 the number of couples between 15 and 49 years, and badumes a condom use rate comparable to that observed in heterobadual couples (ie of the order of 40,000 couples). The target population can not be estimated because the available data do not allow to estimate the number of people using condoms specifically for the prevention of STIs. About 2 million heterobadual and homobadual couples are reported users of condoms, as a means of contraception and / or as a means of preventing STIs.
As early as 25 June, HAS gave the go-ahead for marketing, while pointing out that EDEN condoms did not, in themselves, have specific preventive benefits. Then followed negotiations between Majorelle and the Economic Committee for Health Products (CEPS) -tractations as always secret to agree on the price and, corollary, the cost to support the Health Insurance. And five months later, we learn that an agreement was finally found.
"Given the cases of transmission that will be avoided with the refundable condom, and the current cost of management of STIs amounting to 2 billion euros, 1.6 for HIV alone (11,000 euros per year for a patient with HIV), the reimbursement of condom EDEN by the Health Insurance will achieve significant savings in the coming years "says the Majorelle Laboratory. For its part, HAS would like data "To measure the public health impact of condom health insurance coverage" are available when renewing the refund request. Nothing, unfortunately, seems planned on this subject.
Last tool of the preventive pallet to be supported
Write a prescription for condoms? Some doctors are wondering. They are also surprised by the complexity of the system: it will take a medical consultation (supported by the Health Insurance) to be able to benefit from condoms (also supported) issued by pharmacists …. To tell the truth, we come up against one of the ambiguities of the French social protection system faced with the recrudescence of STIs in general, and HIV infections in particular.
The Roadmap 2018-2020 of the National Strategy for Sexual Health provides for "Improve the health care pathway for badually transmitted infections". "Just days away from the World AIDS Day, it's important to remember our prevention palette against this infection.", emphasizes this November 27 Agnès Buzyn. And the minister cites: screening, HIV treatment as prevention (undetectable viral load means no risk of transmission), pre-exposure prophylaxis (PrEP) by everyone involved, post-exposure treatment ( TPE), and the condom remains the basic tool of prevention.
However, in this preventive pallet, only the condom was not hitherto supported by the Health Insurance. A condom also used as a contraceptive method by a non-negligible number of heterobadual couples – and that while all other contraceptive methods (or almost) are reimbursed by the community.
From this point of view, and even if there is nothing to predict the number of people who will be affected in the future, the reimbursement of EDEN is indeed a historic event.
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