Patients waiting over 1,000 days for access to high-tech drugs, TDs told

Delays in access to innovative treatments to lengthen next year due to lack of dedicated funding, industry says

Patients are being forced to wait an average of over 1,000 days for access to innovative new high-tech medicines, TDs have been told.

A lengthy and complicated approvals process leads to patients waiting years for access to drugs that are already available in many other European countries, according to the Irish Pharmaceutical Healthcare Association.

One cancer drug not yet approved in Ireland is already available in 14 other comparable countries in Europe, it points out, while two others are available in 12.

These lengthy wait times risk becoming even longer due to the absence of any dedicated funding for new medicines next year, IPHA said in an Oireachtas briefing on Wednesday.

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The Government’s decision not to provide funding for new drugs in Budget 2024 may interrupt the flow of innovative therapies for patients, according to the pharmaceutical manufacturers’ representative body.

The Government has promised to make savings in the drugs budget, which will be reinvested in new drugs, but IPHA says sick patients “may not have the time” before these savings are found.

There are up to 30 stages in the approval process for new medicines, including cost-effectiveness assessments and price negotiations. This make the process one of the most robust assessments of investment in the health service, the industry maintains.

“The availability of medicines in the provision of healthcare is a crucial and integral part of ensuring universal health coverage. Medicines are key to healthy ageing and, given the demographic trends of the Irish population, timely access to medical innovation needs to be a priority,” said IPHA chief executive Oliver O’Connor.

With private health insurers now funding the cost of these drugs on the basis of a case made by a patient’s consultant, IPHA says there is a risk of an “increasing two-tier gap” with public patients unable to access the same treatments.

Savings of €400 million have already been made in the first two years of its agreement with the Department of Health and the HSE, industry says.

Irish patients continue to fall behind those in other European countries, Mr O’Connor told TDs. “As per the agreement, Ireland is referenced against 14 basket countries, and we have identified medicines that are currently available in all or in most of these countries but not here for Irish patients.

“These are medicines which can improve the health outcomes of patients and make a significant difference to their quality of life.”

The average time for approval of a drug requiring a high technology assessment is estimated by IPHA at 1,026 days. For orphan medicines, the average time for approval is 758; for oncology medicines, 656 days; and for rapid review medicines, 400 days.

For one drug, Luxturna, used to treat a genetic eye condition, approval took almost four years.

“To align Ireland with peer countries who adopt medicines faster, we need a continuous and a faster flow of new medicines which will raise the standards of care and health outcomes for Irish patients.” Mr O’Connor said.

The industry is calling for more resourcing for agencies involved in assessing new drugs, as well a pilot scheme under which patients could access a treatment for a temporary price, pending completion of the reimbursement process.

Paul Cullen

Paul Cullen

Paul Cullen is Health Editor of The Irish Times