Spain short of menopause hormone therapies since March as drugmakers resist public funding terms

Spain has been facing shortages of hormone replacement therapy (HRT) products since March, with supply gaps across six medicines leaving patients moving from pharmacy to pharmacy in search of their usual treatment, according to reporting by El País and Diario de Sevilla. The Spanish Agency of Medicines and Medical Devices (Aemps) has registered supply problems affecting HRT drugs used in menopause, premature ovarian failure, ovarian removal or dysfunction, and by trans women. Around 400,000 women in Spain currently use these therapies, according to Mercedes Herrero, a gynaecologist at Gine4.

A spray fault that spread to patches

The disruption began with Lenzetto, an estradiol spray that started running short in March because of a problem with its diffuser. Aemps expects supply to return to normal during November. While the agency works to increase the number of available units, users can turn to the Oestraclin gel or to several patch formats, Diario de Sevilla reported.

That substitution has produced a chain reaction. The additional demand created by the Lenzetto shortage has ended up affecting the availability of some presentations of the Evopad patches — the only ones financed by the public health system — and of Estradot, adding pressure to a market that was already strained.

A production halt and a global withdrawal

Bijuva, a combination of 17β-estradiol and progesterone, has been missing since July and is expected to remain unavailable until 30 November, following the suspension of all manufacturing, packaging and marketing activities. Production has since stabilised, but the accumulated backlog of orders is causing restrictions in all markets. The product can be replaced with separate combinations of its active ingredients.

Climodien is a different case. It has stopped being sold worldwide at the request of the manufacturing laboratory. No major impact is expected from the withdrawal, since alternative estrogen and progestogen tablets are available. Its market share is just 14%, below that of three of its available substitutes.

Reimbursement at the centre of the dispute

According to El País, the medicines agency says several companies refused to include their treatments in public funding. That leaves the Evopad patches as the only publicly financed option among the products concerned, concentrating demand on a single reimbursed item whenever other presentations fail. Scientific societies were due to meet the regulator on Friday to discuss the situation, El País reported.

Aemps sources attribute the current supply problems to a combination of factors. Herrero points to steadily rising demand, noting that these treatments have shed the stigma they carried after an older study wrongly linked them to a higher cancer risk, a finding since disproved by subsequent research.

Treatment interruptions and patient pressure

Herrero stressed that clinical alternatives exist: “The transdermal spray can be replaced by the patch or the cream, also administered through the skin. We even have natural estradiol tablets that could work for a woman, unless she cannot use oral treatment.” She added, however, that “the fact that there are options does not mean we are not facing a problem,” warning that “therapeutic adherence is fundamental for a treatment to be effective. When a drug is missing, it is very common for treatments to be interrupted.” Repeated gaps can also generate distrust among patients and health professionals, making some clinicians wary of prescribing these therapies.

Patient pressure is building. Rebeca Martín, a 49-year-old woman on HRT, has launched a change.org campaign that has already collected more than 20,000 signatures, demanding preventive action against possible supply problems and accessible alternatives when a medicine is missing. Diario de Sevilla described individual cases: one patient postponed starting Lenzetto until November after failing to find a diffuser across several pharmacies, while another, aged 44, switched to a therapy she found less convincing rather than repeat the search every month. Pharmacies have been using Farmahelp, a platform that helps them locate medicines with supply problems.