Government puts new drug approvals back in HSE’s hands

Move seen as a way for Department of Health to distance itself from rows over drug funding

 A protest at the Dáil in March over delays in securing approval for Orkambi drug therapy for people with cystic fibrosis in Ireland. Following the campaign, the Minister approved funding of the drug therapy. Photograph: Alan Betson

A protest at the Dáil in March over delays in securing approval for Orkambi drug therapy for people with cystic fibrosis in Ireland. Following the campaign, the Minister approved funding of the drug therapy. Photograph: Alan Betson

 

The Government has moved to distance itself from recurring rows over its failure to provide the health service with enough money to fund new high-tech medicines.

Instead, it has passed back to the HSE the final responsibility for approving new medicines. However, there is no suggestion that any extra budget will be provided to the HSE to allow it to pay for the drugs.

In a letter to the HSE, sent earlier this week, the Department of Health says that there is no future requirement to send to the Minister for his decision any drug that it feels should be available but is outside the HSE’s current medicines budget.

The move effectively unpicks an agreement reached between the Government and the pharmaceutical sector just over a year ago on the supply and pricing of medicines.

Additional funding

A measure in the agreement provided that, where the HSE approved reimbursement of a new drug but did not have the budget to pay for it, it would be referred to the Minister for Health. He then determines whether to bring it to cabinet with a request for additional funding.

However, this has led to the Minister finding himself at the sharp end of discussions with patients, the HSE and drug companies over where to find the money for these new-generation high-tech drugs. At present, nine drugs for conditions including cancer and heart disease have been stalled in the system awaiting ministerial approval after being approved by the HSE.

The highest-profile medicine to go through this process was the cystic fibrosis therapy Orkambi, which was approved for funding by the Minister after an extensive campaign by patients and their families.

The HSE is understood to be considering the letter and its implications for future drug approvals.

Medicines budget

Given the pressure on the health service’s existing medicines budget, it is likely to need to seek some clarity from the Department of Health on where funding will come from for new medicines.

A spokesman for the Irish Pharmaceutical Healthcare Association, which represents the industry, said it had honoured its obligations under the supply and pricing agreement, and expected the Government to deliver on its side of the deal.

To date, he said, the industry had delivered over €140 million of savings on medicines and was on course to deliver €785 million in savings by 2020.

“Patients have the right to see the agreement implemented and to have access to medicines,” said the spokesman.

The involvement of the Minister is understood originally to have been at the behest of the Department of Public Expenditure and Reform, as part of its efforts to ensure tighter budgetary control.

In a new review of spending, the department says that the savings provided by the agreement with the pharma industry “only deliver headroom to fund a limited level of growth in the existing stock of medicines from 2018 onwards”.