17 Feb 2016

Patients left in lurch as free drug pulled

8:55 am on 17 February 2016

Fifteen hundred patients with blood-related problems have been left in the lurch by a big pharmaceutical company pulling a free anti-coagulant drug.

A logo of German pharmaceutical giant Bayer appears on an overpass at its Berlin headquarters July 24, 2013.

Photo: AFP

Bayer withdrew Xarelto when it failed to get a state subsidy - an unprecedented step for the company in New Zealand. The change poses health risks for patients who have to switch back to other drugs.

It has infuriated Masterton hospital doctor Niels Dugan, who broke with his principle of never switching a patient onto a non-funded drug when a Pharmac-funded one was available after hearing from Bayer sales representative Richard Buddle.

"We were given assurances that it [Xarelto]... had worked its way through the various Pharmac committees and it was just a matter of time before approval would come through," Dr Dugan said.

"I had no reason not to believe the representative of Bayer. It was only when they pulled the plug that I was upset by this and I started looking into the publicly available documents on the Pharmac website, which told quite a different story. There was nothing to suggest that it was nearing approval."

Pharmac's clinical committees had looked at Xarelto and did recommend funding it, with varying levels of priority from low to high, as recently as last year - though a rival drug, apixaban, still had the edge.

However, the Crown drug-buying agency said companies such as Bayer were well aware such recommendations were no guarantee of ultimate funding, and it had parked Xarelto because it would cost too much.

Bayer gave three months warning then withdrew free supplies to the 1500 patients in December.

A doctor holds an elderly woman's hand

About 1500 patients in New Zealand had been using Xarelto (file). Photo: 123RF

Since then, Dr Dugan and other doctors have been switching people back to the two Pharmac-funded anti-coagulants, as sticking with Xarelto would cost perhaps $200 a month.

"These are potentially very dangerous drugs," Dr Dugan said. "When you switch from one to the other, there's a period of risk."

He had not heard of any blood clots or strokes or haemorrhaging that could be linked to forced switches off Xarelto.

His point, though, was whether Bayer's marketing strategy should have exposed people to that risk.

"I can only guess that Bayer actually did know what the status of their medication was in Pharmac at most times."

Bayer responds

Bayer's stance is that this was a typical decision for a drug firm, balancing "compassionate access" with hard-headed proft and loss - and that, after three-and-a-half years negotiating with Pharmac over Xarelto, it was simply unsustainable to carry on what was meant to be just 12 months of free access.

"Imminent might have been the wrong word to use but when we set the programme up we certainly believed that funding was only a matter of a fairly short amount of time," said Dr Jan Twomey, Bayer's medical director for Australia and New Zealand, who is based across the Tasman.

"The information that was given to doctors, which was clearly not that it was guaranteed funding because we would never say that, but that at the time when we set this up ... we were representing accurately what we understood to be the case."

What about what Mr Buddle may have told Dr Dugan?

"I have actually spoken to the individual representative who deals with this doctor who believes he did not represent at all that it was a certainty that Xarelto would be funded," Dr Twomey said.

Xarelto was the only drug Bayer had withdrawn in this way in New Zealand, though Dr Twomey said this kind of thing happened in Australia.

Pharmac said when companies supplied medicines for free, they had an ethical obligation to carry that on as long as a patient was benefiting.

George Laking, a senior Auckland oncologist who advises Pharmac, said with cancer drugs that was standard practice, and he knew of dozens of drugs where free supply carried on even though a subsidy did not come through.

The Xarelto case was the first he'd come across being pulled "in that sort of surprising way".

"Speaking from my experience in oncology where these projects have happened, once people are able to go on the drug they are able to stay on the drug as long as it's helping them."

Next steps

From Bayer, an underlying theme emerges of Pharmac's funding becoming more restrictive.

That was echoed by Eileen Merriman, who was on an advisory board to Bayer that in 2012 urged it to get Xarelto into New Zealand.

Dr Merriman, a lead thrombosis clinician at North Shore Hospital, said Bayer had done nothing wrong, and Xarelto was so much better for some patients that it took no persuading doctors to switch them to it.

The drug's withdrawal struck her two ways.

"Yes, it's inconvenient for the patient and for the doctors who are trying to decide what to put their patients on, many of whom weren't happy to be on warfarin or were poorly controlled on warfarin," Dr Merriman said.

"I guess the other side of the coin is Pharmac has been stalling this decision for a very long time, which is very frustrating, and perhaps if the compassionate programme has ended, then that might help push them towards making their decision because at the moment it doesn't seem to them to be a high priority."

If Bayer had a fall-back position, to supply for free to create a Xarelto-friendly lobby group of doctors and patients who might put pressure on Pharmac, it wouldn't be the first time big pharma had tried something similar here.

Bayer would not comment directly on that.

It said some doctors had raised the cases of individual patients they did not want to switch back to the funded drugs, and Bayer would consider, case-by-case, keeping them on Xarelto for free.

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