'Hugely expensive' cholesterol drug prescribed on NHS does not prevent fatal heart attacks or strokes, say experts

But it is guaranteed to work or your money back.

New deals for drugs: No heart attack or your money back

'Hugely expensive' cholesterol drug prescribed on NHS does not prevent fatal heart attacks or strokes, say experts

Repatha, or evolocumab, has been available on the NHS since 2016 Credit: Robert Dawson/Amgen

• Henry Bodkin
• Justin Stoneman

6 May 2017 • 10:00pm

A new “hugely expensive” cholesterol drug does not improve overall survival chances for patients with heart disease and should be withdrawn from use, experts have said.
A coalition of doctors last night called on patients to be told that evolocumab, which was hailed as  a “game changer” and “better than statins”, does nothing to prevent fatal heart attacks and strokes.

Fresh analysis of data shows the injectable medicine is costing the NHS more than £645,000 for every minor heart attack or stroke it delays, however a trial conducted by Amgen, which manufacturers the drug under the name Repatha, also showed a higher death rate among those taking it than in the placebo patient group.

 

Amgen says the 5 per cent higher death rate, which is not technically “statistically significant”, is explained by the relatively short duration of the trial - 2.2 years - and that a longer study would have shown a survival benefit.
But campaigners argue it is precisely because the death rate was higher among Repatha patients that the trial was wound up early.
Rival pharma company Pfizer abandoned its trial of a similar PCSK9 inhibitor drug last year, conceding it was “not likely to provide value to patients”.

Dr John Abramson, an expert in healthcare at Harvard Medical School, said: “In terms of the effect of these drugs on UK citizens, there is no evidence on this data that there is a death benefit in people at high risk of cardiovascular disease. “I think people should know that - it’s a hugely expensive drug.”

The injectable medicine, which is prescribed for people with a high cholesterol for whom statins are not working, costs £4,400 per patient per year.
Unlike statins, which slow the production of cholesterol, drugs like evolocumab block a protein which hampers the liver's ability to clear cholesterol from the blood.
The Amgen-sponsored trial of 27,000 people found it could lower cholesterol by almost 60 per cent compared with existing treatments.
Despite this, the NHS, which was told it should provide evolocumab by the National Institute for Health and Care Excellence (NICE) last year, would have to treat 74 people for two years with the drug to delay a single stroke or heart attack. These could be very minor events.
Sir Richard Thompson, former President of the Royal College of Physician and physician to the Queen, said: “You have to contrast the enormous expense and the difficulty of injecting this medicine with an amazingly small benefit to patients.

“Is it really worth it?” Amgen said Repatha decreases low-density lipoprotein, or “bad”, cholesterol to “unprecedented low levels” and that there was a “well established relationship between LDL-C reduction and cardiovascular events”.
There is, however, a controversy over the extent to which LDL cholesterol contributes to cardiovascular ill health. One of those campaigning against the orthodox view of a causal link is NHS Consultant Cardiologist Dr Aseem Malhotra.
“NICE needs to urgently revise its recommendations on the prescription of the drug to include information that the drug will not prevent a fatal heart attack or increase a patient’s lifespan by one day,” he said.

British researcher  Dr Zoe Harcombe said it would have been a “disaster” for Amgen if the trial had continued and the higher death rate among the evolocumab cohort had reached statistical significance.
As well as an absent mortality benefit, researchers have said that the Amgen trial, which used participants in a range of countries, showed evocolumab did not benefit the European patients.
Professor Sherif Sultan, President of the International Society of Vascular Surgeons, said there was “no evidence  of benefit to UK patients”, describing the NICE guidelines as “crazy”.
However, a spokesman for Amgen disagreed, saying: “We remain confident that Repatha is a clinically effective and cost-effective treatment in the very high risk patient group stipulated by NICE."
A spokesman for NICE, which claims to enjoy an unspecified commercial discount from evolocumab, said the organisation could not comment because of the general election campaign.

New deals for drugs: No heart attack or your money back

Does your doctor and hospital offer a guarantee that you won't have another stroke? WHY NOT?
http://abcnews.go.com/Business/wireStory/deals-drugs-heart-attack-money-back-47181258?yptr=yahoo

Warranties and money-back guarantees, long used to entice buyers of products like hand tools and kitchen gadgets, are now being used to sell something more crucial: pricey new-generation drugs for diseases like rheumatoid arthritis and cancer.

Deals being negotiated between drugmakers and the insurers who buy medicines now sometimes include extra rebates — or even full refunds — if drugs don't help patients as expected.

It's part of an effort driven by insurers and government health programs to align the cost of care with the quality of care, and slow the relentless growth of prescription drug costs.

"We're spending less money on drugs that are less effective," said Dr. Michael Sherman, chief medical officer for the not-for-profit insurer Harvard Pilgrim, which has several of these deals and is negotiating more. Sherman says one-fourth of every dollar it spends on patient care goes to prescription drugs.

For the patient, it doesn't mean a check in the mail if cancer comes back after a round of treatment. But it does mean patients could get a drug that an insurer might otherwise be unwilling to pay for and that might help them. And insurers, who now can track how patients fare through electronic medical records, will be reducing wasteful spending and making at least a dent in overall health care costs.

"It's going to be part of the solution" to soaring drug prices, predicts Roger Longman, CEO of Real Endpoints, an analytics company that assesses the value of medicines for drugmakers, insurers and other clients.

Many new drugs now top $100,000 per year or course of treatment, even though their benefits are unclear or only marginally better than cheaper, older drugs. Buyers of those new drugs, usually insurance companies, are hesitant to pay without assurance the drugs will help patients. Not only is that bad for patients, it makes insurers spend even more on complications and hospital stays if the drugs don't work.

As a result, insurers often restrict access to expensive new drugs. Sometimes that's achieved by making patients pay more out of their own pockets, or making doctors wade through red tape to get authorization for a patient's medicine. Sometimes patients have to try cheaper drugs first, and only when they fail — and the patients' health has deteriorated — are they allowed to get the pricey new drug.

Pharmaceutical companies have an incentive here, too: These deals may help them sell more of the new drug they've spent hundreds of millions of dollars or more developing.

For example, a new generation of injected cholesterol drugs does an impressive job of reducing so-called bad cholesterol. But the drugs, Amgen's Repatha and Sanofi's Praluent, cost $14,000 a year, while cheap generic pills do a good job of lowering cholesterol for most people for $300 a year or less.

Predictably, insurers often reject prescriptions for these drugs.

So Amgen, trying to boost disappointing sales for a drug expected to be a huge seller, is offering full refunds to insurers if patients have a heart attack or stroke while taking its drug. On Tuesday, Amgen announced its first deal to do so, with Harvard Pilgrim. Sanofi has a contract with insurer Cigna to pay extra rebates if patient cholesterol doesn't fall as much as expected.

"It demonstrates the fact that we are standing behind the value the product has, and we're willing to put some money behind it," said James Borneman, Sanofi's head of strategic pricing.

Some insurers are now demanding these deals, which are expected to become standard for some drugs: super-expensive medicines for cancer and rare diseases, and others that are used widely enough to cost insurers millions. In addition, the drugs must have a benefit that's easy to measure, such as keeping kids with asthma out of the emergency room or preventing growth of cancerous tumors for a certain period.

Cigna has been pursuing more of these types of deals after finding that some of its earlier efforts "met or exceeded expectations in terms of benefit to our customers, patients," said Chris Bradbury, who heads Cigna's prescription benefit program.

One of its early deals, with drugmaker Merck for its diabetes pills Januvia and Janumet, dates to 2009, with rebates pegged to how much patients lower blood sugar.

"We keep re-signing that agreement, so I think they're pretty satisfied," said Bob McMahon, head of U.S. marketing at Merck, which also has such contracts with insurers and hospital systems covering an asthma medicine and is negotiating contracts for an infection drug.

Other companies with such deals for one or more medicines include drugmakers Eli Lilly, Johnson & Johnson, Novartis, Novo Nordisk and Roche's Genentech unit; insurers Aetna and Priority Health, and prescription benefit manager Express Scripts.

On their own, these deals are unlikely to reverse the persistent rise in medical spending, experts say. But they improve the chance that the money will at least go to treatments that work best — by making sure insurers and drug companies have something at stake along with the patient.

"There's a risk on both sides with these contracts," said Dr. Mark Fendrick, director of the University of Michigan's Center for Value-Based Insurance Design. "Both want to make sure they'll get the outcome they want."

———

Follow Linda A. Johnson at https://twitter.com/LindaJ—onPharma .

Experimental cholesterol drugs cut heart risk, but questions remain

Big F*CKING WHOOPEE
Replacing one class of cholesterol lowering drugs with another is pure stupidity. They aren't even addressing the correct problem. Inflammation! If there was no inflammation it wouldn't grab the cholesterol out of the bloodstream and pack it into plaque. Do these people never read research? Or understand anything about cause and effect? Leaders would tackle the hardest problems. Alas, we have no leaders in stroke. Kiss your neurons goodbye if you have a stroke.
Statins cause enough problems without going to a new drug that might rarely cause
neurocognitive problems.
You can see a video of how plaque forms here:
Inflammation In Atherosclerotic Plaque Formation  

 Experimental cholesterol drugs cut heart risk, but questions remain 
Studies of a new class of experimental cholesterol-lowering drugs signal that they may reduce by half the risk of heart attack and other major cardiovascular problems compared to standard treatment alone.

Doctors at the annual meeting of the American College of Cardiology, where the studies were presented, called the results "encouraging," but said larger, controlled trials were needed to fully understand the drugs, known as PCSK9 inhibitors.

An analysis of about 4,500 patients who continued treatment for nearly a year after completing earlier trials of Amgen Inc's Repatha, also known as evolocumab, found that 0.95 percent of patients given the drug and standard therapy suffered a cardiovascular event, compared with 2.18 percent of the group receiving standard treatment, which ranged from dietary changes to drugs such as statins.

Amgen defined "event" in the study as death, heart attack, stroke or "mini-stroke," unstable chest pain or heart failure requiring hospitalization, or the need for a procedure to restore bloodflow to the heart.

Side effects more frequent, but still rare, in patients treated with Repatha included neurocognitive problems - something the U.S. Food and Drug Administration has said should be monitored closely.

More at link.