Spain’s menopause drug shortage spreads to patches and other hormone therapies

Lenzetto disruption shifts demand

A global supply failure affecting Lenzetto, the only estradiol spray available in Spain, is pushing patients and prescribers toward alternative hormone treatments and creating additional pressure elsewhere in the market. Spain’s Agency for Medicines and Health Products, or AEMPS, says the resulting rise in demand has caused intermittent shortages among substitutes, particularly certain transdermal patches.

Diario en Positivo reports that Lenzetto manufacturer Gedeon Richter did not give advance notice of the problems threatening continuity of supply, despite its obligation to report such incidents. The company plans to restart deliveries gradually from November and throughout 2027. AEMPS has cautioned, however, that dates previously supplied by the company have not always proved accurate. Lenzetto’s price had already been increased in an effort to keep the product on the Spanish market.

Patches and gels absorb displaced demand

Other authorised estradiol products can temporarily replace the spray, including transdermal patches and gels. Oral estrogens, used alone or in combination, may also be suitable in some cases. The medicines are used mainly to relieve menopause symptoms and prevent osteoporosis, as well as in gender-affirming treatment for trans women. Any substitution remains a clinical decision because presentations and treatment needs differ.

Evopad, the only patch currently covered by Spain’s National Health System, is due to receive new batches in mid-October, with supply expected to return to normal from November. Estradot’s manufacturer, whose product has a small market share, has announced that it will stop marketing the treatment. Supply of Estraderm, by contrast, is keeping pace with demand. Oestraclin Gel has increased production and maintains stable availability, although public reimbursement was withdrawn at its manufacturer’s request.

Financing discussions expose access gap

Not all alternatives are publicly financed. Some manufacturers previously chose to leave the reimbursement system, while others never applied for inclusion in a market whose use has changed considerably in recent years. The Health Ministry has opened talks with companies producing non-reimbursed hormone treatments to examine their possible inclusion in the National Health System. No company has yet submitted a formal financing application, according to Diario en Positivo.

AEMPS has monitored supply and consumption since March and is asking companies to raise production and bring forward distribution where possible. It has also met scientific societies, pharmacists and patient organisations to exchange information and assess measures to limit the disruption. The General Directorate for the Common Portfolio of Services and Pharmacy has contacted holders of alternative hormone products to gauge their interest in seeking public reimbursement. The shortage extends beyond Spain: France, Italy, Sweden, Norway, the Czech Republic, Portugal, Denmark, Poland, Ireland, Greece and Finland are also affected. The broad geographic impact and the spillover into substitutes show how disruption involving one presentation can strain several products when replacement capacity and reimbursement coverage are limited.