This article is from the source 'nytimes' and was first published or seen on . It last changed over 40 days ago and won't be checked again for changes.
You can find the current article at its original source at http://www.nytimes.com/2016/11/16/health/cholesterol-drugs-pcsk9-inhibitors.html
The article has changed 5 times. There is an RSS feed of changes available.
| Version 1 | Version 2 |
|---|---|
| Study Shows Promise for Expensive Cholesterol Drugs, but They Are Still Hard to Obtain | Study Shows Promise for Expensive Cholesterol Drugs, but They Are Still Hard to Obtain |
| (35 minutes later) | |
| If there is one thing decades of studies with tens of thousands of heart disease patients have revealed, it is that lowering cholesterol can reduce the risk of heart attacks and deaths. Now, with new drugs on the market that can plunge cholesterol levels lower than ever thought possible, researchers are eagerly waiting for an answer to the next question: Is there a limit to the benefits in high risk patients? After a certain point, do benefits level off or even reverse? | If there is one thing decades of studies with tens of thousands of heart disease patients have revealed, it is that lowering cholesterol can reduce the risk of heart attacks and deaths. Now, with new drugs on the market that can plunge cholesterol levels lower than ever thought possible, researchers are eagerly waiting for an answer to the next question: Is there a limit to the benefits in high risk patients? After a certain point, do benefits level off or even reverse? |
| A new study suggests there is no leveling off. But that good news comes in the context of unexpected problems with the new drugs, known as PCSK9 inhibitors. | A new study suggests there is no leveling off. But that good news comes in the context of unexpected problems with the new drugs, known as PCSK9 inhibitors. |
| On Nov. 1, Pfizer, one of three companies developing such drugs, announced it was stopping the project after spending years and huge sums on their drug’s development and after clinical trials with 27,000 patients were well underway. Patients developed antibodies to the drug, which canceled its effects. | On Nov. 1, Pfizer, one of three companies developing such drugs, announced it was stopping the project after spending years and huge sums on their drug’s development and after clinical trials with 27,000 patients were well underway. Patients developed antibodies to the drug, which canceled its effects. |
| And while two other PCSK9 inhibitors approved for sale last year do not have such a problem, they have another issue. With their high price — the Amgen list price is $14,000 a year — insurers are refusing to pay for them. | And while two other PCSK9 inhibitors approved for sale last year do not have such a problem, they have another issue. With their high price — the Amgen list price is $14,000 a year — insurers are refusing to pay for them. |
| For now, the PCSK9 inhibitors, heralded as a triumph of basic research, are turning into expensive headaches. | For now, the PCSK9 inhibitors, heralded as a triumph of basic research, are turning into expensive headaches. |
| The new 18-month study involved 968 heart patients. They were randomly assigned to take a statin or to take a statin plus the Amgen PCSK9 inhibitor, evolocumab. It, like Sanofi and Regeneron’s PCSK9 drug, can drive levels of LDL cholesterol, the dangerous kind, to what Dr. Peter Libby of Harvard calls “subterranean levels.” (Dr. Libby was not associated with the new study.) | The new 18-month study involved 968 heart patients. They were randomly assigned to take a statin or to take a statin plus the Amgen PCSK9 inhibitor, evolocumab. It, like Sanofi and Regeneron’s PCSK9 drug, can drive levels of LDL cholesterol, the dangerous kind, to what Dr. Peter Libby of Harvard calls “subterranean levels.” (Dr. Libby was not associated with the new study.) |
| Researchers used ultrasound to measure the size of patients’ plaques. When those pimple-like growths on the walls of coronary arteries rupture, people can have heart attacks. Research has shown that the smaller the plaques, the lower the heart attack risk. | Researchers used ultrasound to measure the size of patients’ plaques. When those pimple-like growths on the walls of coronary arteries rupture, people can have heart attacks. Research has shown that the smaller the plaques, the lower the heart attack risk. |
| In the new study, patients taking a statin had LDL levels averaging 93, which is considered excellent. Those taking a statin plus evolocumab had levels averaging 36 and some got their levels down to 10. | In the new study, patients taking a statin had LDL levels averaging 93, which is considered excellent. Those taking a statin plus evolocumab had levels averaging 36 and some got their levels down to 10. |
| A level of 30, said Dr. Elliott M. Antman, a cardiologist at Brigham and Women’s Hospital and a past president of the American Heart Association, is like that of a 6-month-old baby. “In a sense you are turning back the cardiovascular clock,” he said. Dr. Antman was not associated with the new study. | A level of 30, said Dr. Elliott M. Antman, a cardiologist at Brigham and Women’s Hospital and a past president of the American Heart Association, is like that of a 6-month-old baby. “In a sense you are turning back the cardiovascular clock,” he said. Dr. Antman was not associated with the new study. |
| Plaques got smaller in two-thirds of those taking evolocumab but in less than half of those taking a statin alone. And the lower the LDL level for the evolocumab patients went, the more likely it was that plaques would shrink. At the lowest LDL levels — around 24 — 81 percent of patients’ plaques shrank. | Plaques got smaller in two-thirds of those taking evolocumab but in less than half of those taking a statin alone. And the lower the LDL level for the evolocumab patients went, the more likely it was that plaques would shrink. At the lowest LDL levels — around 24 — 81 percent of patients’ plaques shrank. |
| The study was published online Tuesday in JAMA, the Journal of the American Medical Association, to coincide with a presentation at the annual meeting of the American Heart Association. | The study was published online Tuesday in JAMA, the Journal of the American Medical Association, to coincide with a presentation at the annual meeting of the American Heart Association. |
| The results are not proof of benefit, cautioned Dr. Steven Nissen of the Cleveland Clinic, who directed the study. “It’s a signal,” he said. “It suggests these drugs will show benefit.” | The results are not proof of benefit, cautioned Dr. Steven Nissen of the Cleveland Clinic, who directed the study. “It’s a signal,” he said. “It suggests these drugs will show benefit.” |
| What is needed — and will come within months — are the outcomes of large clinical trials investigating whether PCSK9 inhibitors are safe and prevent deaths from heart disease. Maybe then, said Dr. Sean Harper, Amgen’s executive vice president for research and development, insurance companies will more readily approve the drugs. | What is needed — and will come within months — are the outcomes of large clinical trials investigating whether PCSK9 inhibitors are safe and prevent deaths from heart disease. Maybe then, said Dr. Sean Harper, Amgen’s executive vice president for research and development, insurance companies will more readily approve the drugs. |
| “I hope it will make a difference,” he said. | “I hope it will make a difference,” he said. |
| Amgen’s drugs are discounted about 35 percent, Dr. Harper said. Medicaid and the Department of Veterans Affairs get bigger discounts. But of course even with discounts it remains an expensive drug. | |
| Yet even when patients meet all the criteria for a PCSK9 inhibitor, insurers deny 80 to 90 percent of claims at first. In the end, only one in three or one in four qualified patients get the drug, Dr. Harper said. | Yet even when patients meet all the criteria for a PCSK9 inhibitor, insurers deny 80 to 90 percent of claims at first. In the end, only one in three or one in four qualified patients get the drug, Dr. Harper said. |
| Insurers generally require prior authorization before they will pay for the drugs and their decisions usually depend on “whether patients meet specific criteria,” said Kristine Grow, a spokeswoman for America’s Health Insurance Plans, which represents private insurers. But, she added, plans also have “robust appeals processes.” And part of the companies’ hesitation is their wish to see evidence that the drugs actually prevent heart attacks and deaths from heart disease. | Insurers generally require prior authorization before they will pay for the drugs and their decisions usually depend on “whether patients meet specific criteria,” said Kristine Grow, a spokeswoman for America’s Health Insurance Plans, which represents private insurers. But, she added, plans also have “robust appeals processes.” And part of the companies’ hesitation is their wish to see evidence that the drugs actually prevent heart attacks and deaths from heart disease. |
| In the meantime, insurers have been forcing doctors to send in extensive documentation about a patient’s need for the drug and then denying appeal after appeal, Dr. Harper said. | In the meantime, insurers have been forcing doctors to send in extensive documentation about a patient’s need for the drug and then denying appeal after appeal, Dr. Harper said. |
| “What they’ve done is make it so administratively onerous for doctors’ offices that they hit fatigue,” Dr. Harper said. “Some physicians feel so passionately that they are willing to work full time, but sometimes after doing all that their patients face a very high co-pay and abandon the scrip,” he added. | “What they’ve done is make it so administratively onerous for doctors’ offices that they hit fatigue,” Dr. Harper said. “Some physicians feel so passionately that they are willing to work full time, but sometimes after doing all that their patients face a very high co-pay and abandon the scrip,” he added. |
| Dr. Seth Baum, a cardiologist and heart researcher in private practice in Boca Raton and president of the American Society for Preventive Cardiology, has numerous stories of frustrating dealings with insurers over PCSK9s. | Dr. Seth Baum, a cardiologist and heart researcher in private practice in Boca Raton and president of the American Society for Preventive Cardiology, has numerous stories of frustrating dealings with insurers over PCSK9s. |
| One of his patients, Mahendra Mahabir, 41, of Margate, Fla., said he had his first heart attack at age 17, another at 23, and has had two more since. He has had stents implanted to prop his arteries open and had a bypass operation in 2004. His father, uncles, and aunts all died of heart disease at young ages. | One of his patients, Mahendra Mahabir, 41, of Margate, Fla., said he had his first heart attack at age 17, another at 23, and has had two more since. He has had stents implanted to prop his arteries open and had a bypass operation in 2004. His father, uncles, and aunts all died of heart disease at young ages. |
| He takes the maximum doses of a statin and two other less effective cholesterol-lowering drugs, but even so, he and Dr. Baum said, his LDL level bounces around in the 200s, sometimes reaching 300. Without the drugs his LDL is 500. | He takes the maximum doses of a statin and two other less effective cholesterol-lowering drugs, but even so, he and Dr. Baum said, his LDL level bounces around in the 200s, sometimes reaching 300. Without the drugs his LDL is 500. |
| So when the PCSK9 inhibitors were approved, Dr. Baum was sure Mr. Mahabir would get them. “It should be a slam dunk,” he said. | So when the PCSK9 inhibitors were approved, Dr. Baum was sure Mr. Mahabir would get them. “It should be a slam dunk,” he said. |
| He said he applied in June to Mr. Mahabir’s insurer but the request was denied. He appealed, and it was denied again. Dr. Baum said he submitted three appeals but every time, he said, there was another reason for the denial. | He said he applied in June to Mr. Mahabir’s insurer but the request was denied. He appealed, and it was denied again. Dr. Baum said he submitted three appeals but every time, he said, there was another reason for the denial. |
| Contacted by The New York Times, the insurer, United Healthcare, said it would review the case but could not comment immediately. | Contacted by The New York Times, the insurer, United Healthcare, said it would review the case but could not comment immediately. |
| Finally, on a call with a doctor at the insurance company, Dr. Baum was encouraged. But the next day, he found out that his appeal was denied again. The insurer wanted the man to have a 12-week trial of a statin. | Finally, on a call with a doctor at the insurance company, Dr. Baum was encouraged. But the next day, he found out that his appeal was denied again. The insurer wanted the man to have a 12-week trial of a statin. |
| “He’s been taking a statin for 25 years,” Dr. Baum said. | “He’s been taking a statin for 25 years,” Dr. Baum said. |
| Dr. Baum appealed again. Mr. Mahabir finally got approved on Monday. | Dr. Baum appealed again. Mr. Mahabir finally got approved on Monday. |
| He does not yet have the drug — it has to come from a special pharmacy. | He does not yet have the drug — it has to come from a special pharmacy. |
| “When I can pick up the medicine, then I will believe it,” Mr. Mahabir said. | “When I can pick up the medicine, then I will believe it,” Mr. Mahabir said. |