HSE's change of policy on stroke drug

SOME STROKE risk patients, switched to a new drug said to be safer and more effective than the widely used warfarin have been unnecessarily switched back to warfarin because of confusion over communications from the HSE on funding.

Pradaxa, a prescription blood-thinner, was authorised for the prevention of clotting in hip and knee replacement patients in Ireland in 2008.

Since August, however, the Irish Medicines Board has also cleared it for use in some patients with atrial fibrillation or an irregular heartbeat, a condition that affects 1 per cent of the population, rising to 10 per cent in people over the age of 80. The condition increases the risk of stroke by a factor of five.

Pradaxa is claimed to be safer and more effective for many patients with atrial fibrillation than the widely used warfarin.

In a clinical trial of more than 18,000 people, Pradaxa 150mg capsules reduced the risk of stroke 35 per cent more than warfarin.

With warfarin interacting badly with some other drugs, and some foods and with patients requiring regular blood tests and adjustment of their dosage to prevent excessive bleeding, Pradaxa is also easier for patients to take.

Though some Irish clinicians switched their atrial fibrillation patients to Pradaxa from September this year, subsequent communications from the HSE about the funding of the drug have created widespread confusion.

Spokesman for the Irish College of General Practitioners, Dr John Ball, said the first communication received from the HSE “about a month ago” was about funding for medical card holders and the drug payment scheme, saying “patients would be issued with one more month but after that, it wasn’t going to be covered”.

Dr Ball said he only realised that those already switched to Pradaxa would continue to be funded to remain on it when he saw a later statement on the HSE website, dated November 23rd. “I only heard that because I went onto the HSE website.

“We actually haven’t had a letter yet. We actually haven’t had official communication yet.”

Meanwhile, Irish Pharmaceutical Union president Darragh O’Loughlin described the situation as “a communications mess”.

Speaking last Thursday, Mr O’Loughlin said his understanding from the HSE was “if someone was commenced on the drug before November 9th, it will be funded for them, but only for a fixed, limited period of time”.

He said he understood that where doctors prescribed it after November 10th “for anything other than post-surgery implications, they were not going to fund it”.

In a statement to The Irish Timeslast Thursday, however, the HSE said that patients who have already been switched to Pradaxa do not have to move back to warfarin and will be reimbursed under the GMS scheme.

“Patients who are stabilised already could remain on these treatments and do not have to switch back to warfarin,” it said.

According to the the statement, patients already prescribed Pradaxa for atrial fibrillation “can continue to receive it and their pharmacists will be reimbursed as per the GMS scheme”.

Mr O’Loughlin, however, has said the HSE “seem to be making up their policy about the medicine on the hoof”.

“Their policy on this particular medicine has changed over the past couple of weeks. They are reacting to circumstances.”

He said that poor communication by the HSE to pharmacists and doctors meant, “many patients were getting caught”.

The Irish Timeshas been made aware of a number of stroke risk patients who were switched from warfarin to Pradaxa and who, due to confusion about funding, were unnecessarily switched back to warfarin.

Calls by patients to the HSE helpline have also yielded conflicting answers.

On contacting the HSE helpline on November 21st, the daughter of one patient says she was told that the Pradaxa drug to which her father, a medical card patient, had been switched a month earlier would no longer be funded by the HSE.

In an apparent volte face, however, on a call to the helpline on December 1st, she was told patients who had been switched to Pradaxa could remain on it, funded by the HSE, and that pharmacists had been sent a memo to that effect. As of December 1st, however, the patient’s pharmacist had not received the memo and would not dispense the drug without payment.

In the interim, the stroke-risk patient has had to pay for the Pradaxa himself at a cost of €100 for 10 days’ supply until the matter is clarified.

The Irish Timeshas heard of a number of patients put on the new drug who, because of lack of clarity from the HSE on funding, have been unnecessarily switched back to warfarin.

Mr O’Loughlin said the price paid by the HSE to the manufacturer of Pradaxa for each capsule was “about €3”, which, he said, was “approximately 100 times the price of warfarin”.

As a result of the cost, the HSE statement advises GPs and pharmacists not to prescribe the drug for new atrial fibrillation patients until the HSE assesses the “availability of resources in 2012”.

Meanwhile, president of the Irish Medical Organisation, Dr Ronan Boland, called for the results of the HSE cost-benefit analysis to be made available to clinicians. “GPs and consultants are going to come under significant pressure from patients – patients read newspapers and they are on the internet and I, as a clinician, am going to have to be able to explain to patients.

“It won’t be enough for me to say that the State isn’t willing to pay for this drug.”

He says in making the assessment, the HSE should be recognise that “warfarin is not just about the cost of the drug, it’s about the provision of warfarin phlebotomy services around the country and the cost to the State in transporting patients to those services, and that’s not to mention the cost and inconvenience to patients themselves.”

Stephen McMahon of the Irish Patients’ Association said: “We would have grave concerns that medicines are being pulled not because of their ineffectiveness but purely for financial reasons.

“We’d have further concerns that if this is allowed to develop, there could be other treatments that are equally effective that might be simply pulled due to cost.”

Regarding patients already started on Pradaxa who were moved back to warfarin by their doctors on the belief that Pradaxa would not be funded, he said: “That is extremely stressful for a patient. You are told you are getting something better that will not have the same side effects and then you are told they are taking it away from you – that is a natural upset.”

* In a clinical trial of more than 18,000 people, Pradaxa 150mg capsules reduced the risk of stroke 35% more than warfarin