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The drugs will target conditions that existing approved medicines cannot treat EAMONN FARRELL/PHOTOCALL IRELAND
new medicines

HSE approves seven ‘life-enhancing’ medicines for rare but debilitating conditions

Dr Colm Henry said the new drugs ‘will target conditions that existing approved medications cannot treat’.

SEVEN NEW DRUGS have been approved by the HSE which will target conditions that existing approved medicines cannot treat.

These seven new life-enhancing drugs will be funded from a €20 million allocation for new medicines that was announced by Health Minister Stephen Donnelly in December.

Osteoporosis, antimicrobial-resistant infections, and several types of cancer are among the conditions that will be tackled by the newly approved drugs.

Dr Colm Henry, chief clinical officer with the HSE, said he hopes the approval will “support people to live healthier, happier lives in the future”.

Dr Henry added that the medicines will be available under the Community Drugs Schemes and other arrangements, which will “ensure equitable access for those whose treatment requires them”.

He also remarked upon the HSE assessment for approving medicines and said such decisions are based on several factors, including clinical need, efficacy and effectiveness.

“Many of the newly approved drugs are responding to a previously unmet need,” added Dr Henry.

“They will target conditions that existing approved medications cannot treat.”

The newly approved medicines

Cefiderocol (Fetcroja®) has been approved for the treatment of adults who have antimicrobial-resistant infections.

In these cases where no other medication has been effective, Cefiderocol presents a new opportunity to treat extremely vulnerable patients, for whom medication options are limited.

However, Dr Henry cautioned that “given the growing issue of antimicrobial resistance, it will be important to limit the use of this drug to cases that are otherwise beyond help”.

Elsewhere, Romosozumab (Evenity®) has been approved for the treatment of postmenopausal women, with severe osteoporosis, who have experienced a major osteoporotic fracture within the previous two years and who are at imminent risk of another fragility fracture.

Dr Henry described this as a “first-in-class medication” that could “prevent these women from requiring additional care”.

He added: “It’s been shown that severe fractures in older age can result in morbidity within one year. Providing these medications could have a significant benefit for this population in the future.”

Meanwhile, three medications [Osimertinib (Tagrisso®); Atezolizumab (Tecentriq®); and Atezolizumab (Tecentriq®)] to treat adults with non-small cell lung cancer (NSCLC) have also been approved.

NSCLC has a high rate of tumour recurrence post-surgery, but Dr Henry said these new medicines can prevent recurrence and potentially prolong a patient’s chance of survival post-treatment.

Another group to benefit from these newly-approved medicines are transplant patients.

“Transplant patients are immunosuppressed to reduce the risk of organ rejection,” said Dr Henry.

“This leaves them susceptible to other infections, such as cytomegalovirus (CMV).”

Maribavir (Livtencity®) has been approved to treat CMV and reduce the risk of infection and illness for patients.

And as a result of Ireland’s participation in the Beneluxa Initiative, a collaboration between Belgium, the Netherlands, Luxembourg, Austria, and Ireland, Atidasagene autotemcel (Libmeldy®) has been approved to treat metachromatic leukodystrophy (MLD).

MLD is a rare genetic disease and Libmeldy is a one-time therapy designed to correct this gene mutation.

A HSE spokesperson said that “confidential pricing agreements” mean it is not possible to provide a breakdown of costs for each newly approved drug.

Last year, close to €3 billion was spent on medicines.

The Department of Health said this represented nearly €1 in every €8 of public funding being spent on health.

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