Tuesday, 2 October 2018

These Cholesterol-Reducers May Save

These Cholesterol

These Cholesterol-Reducers May Save Lives. So Why Aren’t Heart Patients Getting Them?

Heart disease runs in Mackenzie Ames’s family.

Her grandfather had a fatal heart attack at age 30 while dancing together with her grandmother at the Elks occupy Bath, N.Y. Her mother had a quadruple bypass when she was 42.

When Ms. Ames was just 9 years old, her LDL cholesterol level (the bad kind) was 400 mg/dL, about fourfold above it should have been.

Diet and exercise did not help. Ms. Ames tried every cholesterol-lowering drug available, but nothing could get her LDL below 100 mg/dL.

Her problem may be a genetic condition, heterozygous hypercholesterolemia (F.H.), that results in high cholesterol levels and heart attacks at a young age. It affects 1.3 million Americans.

In theory, there's an answer — a replacement class of medicine, called PCSK9 inhibitors, that slash cholesterol levels, reduce the danger of heart attacks and strokes and save the lives of people like Ms. 

Ames, who lives in Raleigh, N.C. According to the Food and Drug Administration, patients with F.H. are eligible for the new drugs. But she can’t get them. Two insurers have turned her down.

“I have followed every rule, and that I still can’t get access,” Ms. Ames said.

“My doctor can’t get a straight answer.”

Like many similar patients, she has gotten caught within the crossfire of a marketplace battle between insurers, providers of prescribed drugs and therefore the makers of those drugs.

Drug companies gave the PCSK9 inhibitors exorbitant price tags — the list figure was as high as $14,600 per annum, although payers generally negotiate much lower prices.

But insurers balked at the prices and questioned the effectiveness of the new drugs.

Access is starting to ease now, with some unusual new agreements between the manufacturers, insurers, and pharmacy benefit managers who act as intermediaries.

Still, these drugs offer a cautionary tale, whilst pharmaceutical manufacturers bring back market costly new treatments for common diseases like migraine, nonalcoholic liver disease and severe dermatitis.

Unlike expensive drugs for cancers or rare inherited diseases, the PCSK9 inhibitors were aimed at large numbers of individuals — as many as 10 million Americans, a variety that includes not just people with F.H. but also people with heart condition and stubbornly high cholesterol levels.

For the foremost part, few of these patients were ready to get the medications.

In one study, 80 percent of patients who tried to urge the powerful cholesterol-lowering drugs were met with initial rejections by insurers; only 50 percent eventually received approval after appealing.

The drugs arrived just after what was called “the hepatitis C debacle” by Jalpa A. Doshi, a health economist at the University of Pennsylvania — the introduction of medicines that cured the disease but cost $84,000 or more for a course of treatment.

Stunned by those costs, insurers and other payers “were scanning the horizon to see what else was approaching the market,” she said.

The PCSK9 inhibitors, they learned, could cost the state anywhere from $21 billion to $113 billion a year.

And unlike hepatitis C medications, the new cholesterol-lowering drugs would be taken for a lifetime.

“The science behind these drugs is astonishing, but the worth is additionally astonishing,” said Dr. Steven Miller, a chief medic at Express Scripts, the most important pharmacy benefit manager in the United States.

(It is being acquired by Cigna, the health insurer.) Until recently, there have been no studies showing the drugs did anything except lower cholesterol levels, Dr. Miller added.

Payers resisted in part because of the manufacturers needed to point out that PCSK9 inhibitors also prevented heart attacks and strokes and save lives.

And given the expense, doctors needed to point out that patients really needed these powerful drugs and not cheaper alternatives. “Statins cost around $250 a year,” Dr. Miller said.

Dr. Michael Sherman, a chief medic at Harvard Pilgrim, which provides health insurance plans echoed those concerns.

“People get very angry when their deductibles go up, or when their premium or cost the share goes up,” Dr. Sherman said. But the worth of pricy drugs “is beginning of somewhere.”

The companies that make the drugs, Amgen and Regeneron, note the asking price of medicine is always above the worth insurers comply with pay.

Regeneron, the first to market (in collaboration with Sanofi), set its asking price to permit substantial discounting when its competitor, Amgen, got its drug approved, a spokeswoman said.

As for Amgen, whose drug was the second PCSK9 inhibitor to be approved, the drug’s price “was set to be competitive within posh health care the system,” said Tony Hooper, Amgen’s executive vice president.

Both companies say they deplore the next lack of access to their drugs.

Insurers insisted doctors fill out pre-authorization forms describing why their patients needed the drugs, Dr. Doshi said.

The practice isn't unusual for expensive treatments — but within the case of PCSK9 drugs, the forms attended be byzantine, inordinately long and complicated.

And while pre-authorization forms for many other drugs require only the doctor’s verification of a patient’s medical record, the PCSK9 inhibitor forms usually required proof, including long medical records that always had to be faxed.

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