Decision to provide CF drugs made without funding agreement

HSE says cost must come from additional Government funding

Campaigner Jillian McNulty, who has cystic fibrosis,   celebrates the news of the funding with Micheál Martin, outside the Dáil. Photograph: Brenda Fitzsimons

Campaigner Jillian McNulty, who has cystic fibrosis, celebrates the news of the funding with Micheál Martin, outside the Dáil. Photograph: Brenda Fitzsimons

 

The Government’s decision to fund two new drugs for up to 600 patients with cystic fibrosis was made in the absence of any agreement on the source of funding for the deal.

The Health Service Executive (HSE) has made it clear to Minister for Health Simon Harris and his officials that it cannot afford to fund the deal to provide Orkambi and Kalydeco, according to well-informed sources. It wants the cost to be met from additional funds from Government.

The Minister has refused to disclose the cost of the agreement, but it is believed to be close to €400 million.

Mr Harris told the Dáil on Tuesday that agreement had been reached in principle with the manufacturer, Vertex Pharmaceuticals, on reimbursing the cost of the drugs. The deal was reached without the matter being approved by Cabinet, as was expected.

The announcement was welcomed by patients with cystic fibrosis, who called off a demonstration planned outside the Dáil for the following day.

The Minister told TDs “we are now in the concluding stages of an agreement” and predicted the matter would be finalised “in the coming days”. He said the cost was not being made public as this was “commercially sensitive information”.

Price drop

The HSE has previously said, when Vertex was seeking €400 million for Orkambi alone over five years, that it could not afford to pay for the drug. Sources estimate that the company dropped its price by about 40 per cent during negotiations, but the inclusion of Kalydeco and as yet undeveloped drugs in the overall deal means the final cost may be about €400 million.

Responding to queries, the Minister’s spokeswoman declined to say whether the deal would be funded by the HSE or from new monies, saying this, too, was commercially sensitive. The agreement was approved by Government, she added, notwithstanding the matter had not yet come to Cabinet. The Department of the Taoiseach and the Department of Public Expenditure were kept “apprised”.

Orkambi protest outside the Dail.

The HSE is unable to afford the cost of these and other new drugs awaiting approval. The 40 other licensed drugs awaiting a reimbursement decision have a combined potential cost of more than €1 billion.

They include Respreeza, a drug for patients with genetic emphysema, 17 of whom are on a trial that is due to end this month. Muscular Dystrophy Ireland has called on the HSE to approve Translarna, another drug awaiting approval that is the first treatment to address an underlying genetic cause of the condition.

Fianna Fáil TD, Marc MacSharry, while welcoming the agreement with Vertex, has expressed concern about the “agreement in principle” referred to by Mr Harris, and has called for clarification that the rollout of the drug will not be delayed.