Lothians patients denied life-saving heart drug

Bill Whyte with his daughter Vicki. Picture: contributed
Bill Whyte with his daughter Vicki. Picture: contributed
7
Have your say

HEALTH bosses have been accused of putting lives at risk by refusing to offer a groundbreaking drug to thousands of Lothian heart attack patients.

Ticagrelor, which has been proven to prevent potentially deadly blood clots which can cause further heart attacks or strokes, has been hailed by experts as a significant medical advancement after a study showed fewer patients died after being put on the medication, compared with older ­alternatives.

But despite it being widely available in other parts of Scotland and being deemed to offer “value for money” by the Scottish Medicines Consortium (SMC), the more ­expensive treatment is being denied to all but a tiny proportion of heart attack patients in the Lothians.

The health board said that the drug was made available to the most at-risk patients, but it is estimated that just 220 every year out of around 3000 who are discharged following a heart attack annually will receive it. It is understood that cardiologists in the region are becoming increasingly unhappy with the health board’s stance, which they believe means they are not able to offer the most effective treatment to their patients while counterparts in most of ­Scotland are able to prescribe the drug far more freely.

A senior NHS Lothian source said: “All the evidence suggests that this treatment is better than existing ones – fewer people die if they’re on this drug.

“The remarkable thing is that this is one of the very few drugs to be launched recently that actually saves lives. A lot come along to ­reduce ­hospitalisation, but this reduces the risk of death. It’s a remarkable ­product that can prevent blood clots and another heart attack.

“But in Edinburgh and the Lothians, a handful of patients are getting it. The number getting this life-saving treatment is very low and verbally, it’s admitted that it’s purely down to cost. Overall, it would cost several thousand pounds a year and NHS ­Lothian are trying to save money every which way they can.

“In Glasgow, if you have a heart ­attack you will get access to this drug but the chances are if you’re from Lothian, you won’t. It’s postcode 
prescribing.”

Although ticagrelor has been approved by the SMC, it is up to regional committees to decide on how drugs will be used in each ­particular area.

The drug was accepted by the ­Lothian Joint Formulary last summer, but it was decided that despite the SMC guidance, its use would be restricted to a “more limited ­subgroup of patients”.

It was claimed that the ­decision had been taken “not only for ­financial reasons”, but also to ­enable the ­prescribers to build up their ­experience with its use.

In Glasgow, heavy restrictions were initially in place over the use of the drug, although they were relaxed in December and it is now far more widely available. Across Scotland, nine of the country’s 14 health boards prescribe the drug in line with the SMC’s advice.

The restrictions in Lothian come despite health chiefs reporting ­substantial savings on drugs in the 2012-13 financial year, spending more than £6 million less than they had forecast.

The savings were reinvested in other areas and finance bosses had previously claimed they had been made due to the SMC not approving a series of drugs that had been expected to be waved through. However, the latest revelations are likely to lead to fears that even drugs that have been deemed by the expert panel to provide value for money are being denied to Lothian patients in a bid just to save cash.

Labour MSP and former Lothian consultant Dr Richard Simpson called for ticagrelor to be made ­available equally throughout ­Scotland and said it was no exaggeration to say restrictions were costing lives in the region.

Dr Simpson, the shadow minister on public health, said: “This drug has been approved by the SMC.

“There is no evidence of any ­validity for a restriction on ­clinical grounds. It appears to have ­significant advantages over the older and cheaper alternative.

“If a new and innovative drug comes out to save lives and it’s recommended then it should be brought in. Use of this drug should be encouraged rather than discouraged.

“I have been advocating strongly that if the SMC says it has significant advantages then boards should accept it as soon as clinically possible.”

The drug, an antiplatelet medicine, is seen as an advancement on ­clopidogrel, a cheaper alternative which was approved by the SMC ­almost a decade ago.

Ticagrelor, also known as Brilique, is usually taken as a pill twice a day for a year with aspirin. It costs around £55 per month to prescribe, while 28 days’ worth of clopidrogrel costs less than £3.

In Lothian, ticagrelor is only made available to patients aged 75 and younger, as older patients are at higher risk of bleeding, and those with a high risk of having another heart attack.

It has been claimed that the health board has been deliberately imposing a high threshold to restrict access to the drug and save cash.

A review into access to newly ­licensed medicines is currently ­ongoing at Holyrood, following fears that Scotland was lagging behind other countries in the availability of innovative medicines.

The Scottish Government’s Health and Sport Committee will be told this week that despite the volume of medicines being prescribed increasing by a third between 2005 and 2012 in the NHS in Scotland, spending on medicines has fallen in real terms by 11 per cent.

It is believed that nationwide just 74 per cent of drugs approved by the SMC make their way into use in health boards, due to decisions taken by local committees.

It is estimated that spending per head on drugs across the UK is around 50 per cent lower than in cash-strapped countries including Greece, Spain and Italy.

Dr David Farquharson, NHS ­Lothian’s medical director, said that the health board ran a “robust and transparent” system for assessing new drugs, through the Lothian Joint Formulary Committee.

He added: “Specialist clinicians use their expertise to consider the benefits and risks to patients, whilst taking account of the latest clinical evidence available at the time.

“We currently prescribe ticagrelor to patients with specific acute heart problems deemed to be at the highest risk of further events and where the risk of side effects are lower.

“Current evidence, based on one clinical trial, suggests that these ­patients have most to benefit from the use of the drug.

“We continually monitor and review our prescribing decisions and take into account our own experiences and any new evidence we receive.”

FOCUSES ON PLATELETS

TICAGRELOR works by targeting cells in the blood called platelets.

The very small blood cells help stop bleeding by clumping together to plug tiny holes in blood vessels that are cut or damaged.

However, platelets can also form clots inside diseased blood vessels in the heart and brain.

This can be very dangerous as it can lead to the blood being cut off to the organs. When this happens, it can cause a heart attack or stroke. If platelets partly plug a vessel to the heart, it can cause painful angina.

Ticagrelor helps stop the clumping of platelets.

This reduces the chance of a blood clot forming that can reduce blood flow.

After considering the cost of the drug as well as its effectiveness, the SMC accepted it for use in patients with acute coronary syndromes.

The body said a study has shown fewer patients given ticagrelor with aspirin had a heart attack or stroke, or died from clots in the blood vessels, compared with patients given another antiplatelet medicine with aspirin.

While the main side effect of concern with antiplatelet medicines is the risk of bleeding, the SMC said ticagrelor did not cause a significant increase in major bleeding compared with the other antiplatelet medicines being used.

In its advice on ticagrelor, the SMC said cheaper antiplatelet medicines were available, but added: “When the balance of costs and benefits are considered it offers value for money.”

POLICY DIFFERS ACROSS SCOTLAND

We asked every health board in Scotland to explain their policy on the use of ticagrelor.

NHS Ayrshire and Arran

Prescribed to patients who meet criteria set by the SMC.

NHS Borders

Prescribed to patients who meet criteria set by the SMC.

NHS Dumfries and Galloway

Prescribed to patients who meet criteria set by the SMC.

NHS Fife

“Ticagrelor is approved for use in Fife. Following recommendations from our specialists, prescribing is restricted to individuals who are considered high

risk.”

NHS Forth Valley

Prescribed by initiation of cardiologists to clopidogrel intolerant patients and for patients who have had stent thrombosis.

NHS Grampian

Prescribed to patients who meet criteria set by the SMC.

NHS Greater Glasgow and Clyde

Prescribed to patients who meet criteria set by the SMC.

NHS Highland

Prescribed to patients who meet criteria set by the SMC.

NHS Lanarkshire

“The use of ticagrelor depends on the type of Myocardial Infarction [heart attack] a patient has. Ticagrelor is the preferred drug used for STEMI (ST segment elevation myocardial infarction) patients.For non-STEMI patients the preferred drug is clopidogrel. However if they are on clopidegrol and have had a further event while on this they will then receive ticagrelor. These patients would also be given ticagrelor if they are allergic to clopidegrol or if for some other reason clopidegrol is unsuitable for them.”

NHS Lothian

Ticagrelor has been approved for use in patients aged 75 and younger, with a non-ST segment elevation myocardial infarction and a GRACE (Global Registry of Acute Coronary Events) score equal or greater than 140. The GRACE score is a way of identifying risk of further events.

NHS Orkney

Prescribed to patients who meet criteria set by the SMC.

NHS Shetland

Prescribed to patients who meet criteria set by the SMC.

NHS Tayside

“There are restrictions to its use based on the clinical advice of local clinicians.”

NHS Western Isles

Prescribed to patients who meet criteria set by the SMC.

‘If it saves one life, I think it’s paid for itself’

BILL Whyte thought he had aggravated an old shoulder injury while carrying shopping back to his home in Portobello. In fact, he was suffering a potentially fatal heart attack.

After trying to ignore the pain, he phoned NHS 24 and was sent to the Royal Infirmary. There, he went under the knife and had a stent fitted after doctors broke the shock news of his condition.

That was in 2008 and after being discharged days after the operation and receiving excellent treatment from doctors and support from the British Heart Foundation, council employee Bill, now 62, has made a superb recovery.

He was prescribed clopidogrel but he said that if a better drug is now available, it should be given to all patients who could benefit.

He said: “I am concerned if it’s the case that people aren’t getting it. I will never knock NHS Lothian – if it wasn’t for them I wouldn’t be here today.

“But if there’s an advancement in medicine that drug should be used, whether it’s for cardiology, cancer or whatever.

“Anything that gives someone a better chance of life has got to save money for the NHS and everybody else concerned if it keeps people out of hospital in the future.

“If it saves one life, I think it’s paid for itself.”