HSE approves seven life-enhancing medicines

• New drug approvals to treat rare but debilitating conditions
• Antimicrobial infections, aggressive cancer, and post-menopausal osteoporosis are to be tackled with new additions to HSE lists

Osteoporosis, antimicrobial-resistant infections and several types of cancer are among the ailments that will be tackled by seven drugs newly approved by the HSE. These seven new life-enhancing drugs will be funded from the €20 million funding recently allocated for new medicines in 2024.

Dr Colm Henry, Chief Clinical Officer, HSE, said:

“These newly approved drugs will have a profound impact on those who need them. With these seven drugs, we hope to be able to continue to support people to live healthier, happier lives in the future.

“The approved medicines will be available under the Community Drugs Schemes and other arrangements, ensuring equitable access for those whose treatment requires them. The HSE has a robust assessment in place for approving medicines, with decisions based on several factors, including clinical need, efficacy and effectiveness. Many of the newly approved drugs are responding to a previously unmet need. They will target conditions that existing approved medications cannot treat, such as infections caused by multidrug-resistant (MDR) bacteria.”

“Cefiderocol (Fetcroja®) has been approved for the treatment of adults who have antimicrobial-resistant infections. In these cases, no other medication has been effective. Cefiderocol presents a new opportunity to treat extremely vulnerable patients, for whom medication options are limited.

“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,” Dr Henry explained.

Postmenopausal women, with severe osteoporosis who have had a major osteoporotic fracture (within the previous year and who are at imminent risk of another fragility fracture) will benefit from the approval of Romosozumab (Evenity®).

There were approximately 32,000 new fragility fractures diagnosed in Ireland in 2019, with annual figures expected to increase to 51,000 by 2034 as Ireland’s population ages. Osteoporotic fractures are associated with substantial pain and disability; they can result in an older person needing long-term care and, can ultimately result in earlier deaths.

"This reimbursement agreement will target a very specific, at-risk, subgroup of postmenopausal women," said Dr Henry. "It's a first-in-class medication and could prevent these women from requiring additional care. It's also 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."

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

"NSCLC is known to have a high rate of tumour recurrence post-surgery. However, these new medicines can prevent recurrence and potentially prolong a patient's chance of survival post-treatment," Dr Henry noted.

Another group of vulnerable people to benefit from this round of approvals is transplant patients. “Transplant patients are immunosuppressed to reduce the risk of organ rejection. This, however, leaves them susceptible to other infections, such as cytomegalovirus (CMV). Maribavir (Livtencity®) treats CMV and will reduce the risk of infection and illness for patients.”

Finally, through Ireland’s participation in the Beneluxa Initiative, a collaboration between Belgium, the Netherlands, Luxembourg, Austria, and Ireland, Atidasagene autotemcel (Libmeldy®) was 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.