Patients on hormone replacement therapy (HRT) in England have risen by nearly a third over the most recent financial year, according to data provided to parliament by women’s health strategy minister Maria Caulfield on Monday (December 18).
According tot he data, some 2,344,680 patients were identified as having been prescribed HRT medications that were subsequently dispensed in the community in 2022/23. It marks a 29% increase on 2021/22, when 1,813,228 such patients were identified.
Read more: HRT prescriptions in England spiked almost 50% in a year
The rising rate of HRT use comes as a “breakthrough” treatment for hot flushes and night sweats, Veoza (fezolinetant), was approved by the Medicines and Healthcare products Regulatory Agency (MHRA), also on Monday.
According to the most recent statistics published by the NHS Business Services Authority (NHSBSA) in October, the upward trend in HRT prescribing has held for eight years, with the exception of a dip during the COVID-19 pandemic in 2020/2021.
In all, the number of patients receiving prescription HRT medicines on the NHS in England has more than doubled since 2015/2016, according to NHSBSA.
“First of a new class of treatments”
On Monday, Tokyo-based pharmaceutical company Astellas Pharma announced that it had received UK regulatory approval for Veoza. It described the medicine as a “first-in-class” treatment for “moderate to severe vasomotor symptoms”, better known as hot flushes and night sweats.
Fezolinetant is a non-hormonal medicine, described by Astellas as “the first in a new class of treatments” to receive licensing approval in the UK. Patients prescribed fexolinetant 45mg – which will be available in “mid-January” on private prescription – will take one tablet once a day, according to its package leaflet.
Read more: Manufacturer promises 30% HRT supply boost as new factory opens
According to Dr Timir Patel, medical director of Astellas UK, fezolinetant reduces the “number and intensity” of vasomotor symptoms by preventing the binding of a protein, neurokinin B, to the brain’s temperature control centre.
Astellas said this mechanism signalled “a breakthrough in an area that has seen limited advances in many years”.
Read more: Wholesalers banned from exporting or hoarding progesterone
Julian Beach, interim executive director of healthcare quality and access at the MHRA, said that hot flushes and night sweats had a “significant impact” on women experiencing menopause.
He said that the MHRA was “pleased to have authorised” fezolinetant after the drug met the health regulator’s standards for “safety, quality and effectiveness”.
Menopausal health inequality?
A spokesperson for Astellas confirmed that the manufacturer had applied to the National Institute for Health and Care Excellence (NICE) for the drug’s approval for use in the NHS.
They said that the appraisal was “due to start in mid-2024” and that NICE had not provided an “expected publication date”.
According to the appraisal timeline on the NICE website, in October 2023, Astellas requested to reschedule its NICE appraise to start in "late July 2024" so that it could produce "a suitably comprehensive and robust submission".
Read more: HRT PPC website crashes as more than 37k purchased in first days of scheme
This was the second such rescheduling. In November 2022, Astellas asked to postpone until December 2023, after NICE had been asked by the Department of Health and Social Care (DH) to conduct an appraisal of fezolinetant.
While women who suffer menopausal vasomotor symptoms and can afford to have the drug prescribed privately may welcome a new and effective treatment, NHSBSA data shows that HRT is not dispensed evenly across income groups on the NHS even as its use booms.
HRT is dispensed to patients in England’s wealthiest income quintile more than twice as much as those in its “most deprived” quintile (43 patients per 1,000 people vs 17 per 1,000 people), according to NHSBSA data.
In February, the Royal Pharmaceutical Society (RPS) reported that pharmacists responding to a survey had experienced a rise in patients asking which of their prescription medicines they can “do without” due to affordability issues. At the time, the professional body reiterated its call for scrapping prescription charges.
Earlier this year, C+D reported that the government website offering HRT pre-payment certificates (PPCs), which offers HRT patients a reduced prescription charge, crashed when more than 37,000 certificates were purchased after its launch on April 1.
Read more: UPDATED: Serious shortage protocol issued for HRT drug Utrogestan
Meanwhile, in October, C+D reported that NHS data revealed that the number of HRT items prescribed in England in 2022/23 had increased by almost 50% compared to the previous year.
Throughout the year, HRT products have faced supply issues. In May, the government issued a serious shortage protocol (SSP) for Utrogestan 100mg capsules and then restricted wholesalers from exporting or hoarding progesterone, its active ingredient, as pharmacists faced ongoing shortages of HRT drugs.
