Crucial Medicines - ‘Compassion’ plea to cancer drug companies

Minister for Health Simon Harris yesterday appealed to the manufacturers of two cancer drugs to show “compassion” by continuing to provide the medicines, while they are under review, to patients who need them.

A HSE taskforce is likely to decide by this Thursday whether or not to approve paying out for Nivolumab and Pembrolizumab.

Speaking to the media, Mr Harris said that as part of the last Budget, the Department of Public Expenditure and Reform had ruled that drugs above a certain threshold would have to be sanctioned by the Government.

That would appear to give his department more power when it comes to a final decision, but the minister said he would wait until the HSE had completed its considerations on the merits of the drugs before taking the next step.

“I’ve spent most of the weekend liaising with the HSE,” said Mr Harris. “My primary concern is for the patients affected, and patients, who their clinicians believe could benefit from these drugs. I have spoken to the HSE several times over the weekend.

“I have been made aware that the HSE will be meeting to consider these drugs this week and I have been asked that I be advised of their recommendation this week, so that I can then decide how best to proceed.”

He then made a direct appeal to the manufacturers “to show some compassion”.

“They previously had ran a Compassionate Access Programme, which a number of Irish patients had benefited from, and I’m sure they’re extraordinarily grateful for,” he said. “That programme has closed now and what I would respectfully ask the drug manufacturers this afternoon is to reopen that Compassionate Access Programme, whilst this approval process is ongoing.”

Mr Harris also said there needed to be “a serious look at public policy” in relation to the purchasing of new medicines, saying it needed “a really mature and informed discussion”.

“Is it right that a minister for health or any other minister need to make a recommendation to Government about whether to fund a drug, when I believe we should be led on these matters by clinicians?”

The manufacturer of Pembrolizumab — Merck Sharp and Dohme — said it had been continuing to provide the drug to approximately 100 patients, who had been on the Compassionate Access Programme up to when it ceased earlier this year, and this would continue.

However, it is understood around 30 new patients, who have not been able to access the drug, are awaiting the decision of the HSE later this week.

The drug has already been deemed cost-effective by the National Council of Pharmoeconomics.

Representatives of Bristol-Myers Squibb, manufacturer of Nivolumab, were unavailable for comment, as it was a bank holiday in the UK yesterday.

Will ‘compassionate’ plea be listened to?

Q. What’s going on here exactly?

A. Last week Prof John Crown, oncologist and former senator, claimed patients could die due to new cancer drug delays and they have to take a less effective medication that is just as expensive.

Q. What drugs are we talking about?

A. The HSE has been assessing the cost of providing two cancer drugs — pembrolizumab (pembro) and nivolumab (nivo) — to determine value-for-money and patient benefits.

Q. What’s the problem?

A. Where do you want to start? Prof Crown said up to 150 people die from melanoma every year and there is good evidence some of those people could live a lot longer and others could be cured with treatment, but cost is an issue. These two drugs are not cheap.

Q. How expensive are they?

A. One estimate was the initial pricing for pembro at €134,000 per patient per year.

Q. Can’t the minister for health just make the HSE pay out for the drugs?

A. This is as clear as mud. The granting of approval for a new medicine is a comprehensive process, involving consideration by the National Council for Pharmoeconomics as part of that assessment. There was an overarching agreement with drugs manufacturers on the cost of medicines but that lapsed last October. As yet a fresh agreement to replace it has not materialised. In any event, for any drug priced at more than €45,000 per patient per year the HSE negotiates directly with the drug manufacturer. On Sunday evening the HSE also reminded everyone that while it makes decisions in relation to new medicines, “decisions that would have a substantial budget impact for the HSE also require approval by the appropriate departments in consultation with Government”.

Q. So the ball is back in Minister Simon Harris’s court then?

A. Possibly, but he is asking the HSE to speed up its review of the drugs in question and yesterday called on the drugs manufacturers to re-engage with a Compassionate Access Programme, which is now closed. He called on the companies to restart it.

Q. OK then — will they?

A. Who knows — the offices of Bristol-Myers Squibb, which manufactures nivo, were closed yesterday due to a bank holiday in the UK, and MSD (Merck Sharp & Dohme), manufacturer of pembro, said the programme was continuing while the review process was ongoing.


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