Costly drugs spark debate on treatment

HEARTFELT: Dr. Steven Fera, cardiologist at South County Hospital, checks equipment inside the Cardiac Catherization Lab. / PBN PHOTO/ MICHAEL SALERNO
HEARTFELT: Dr. Steven Fera, cardiologist at South County Hospital, checks equipment inside the Cardiac Catherization Lab. / PBN PHOTO/ MICHAEL SALERNO

New cholesterol-lowering medications that could help patients lower their risk of developing heart disease and other associated ailments are raising questions within the local health care industry about cardiac-care guidelines.

The Federal Drug Administration approved Praulent, the first of a new class of drugs known as PCSK9s – proprotein convertase subtilisin kexin type 9 – in June.

Praulent works as an antibody that attacks the PCSK9 protein, which stops the liver from intercepting low-density lipoprotein – also known as the “bad cholesterol.” Praulent reduces the number of PCSK9 proteins on the liver, which then allows the liver to lower LDL levels in the blood.

But the drug is expensive, costing about $15,000 per year for one patient, and some say that without changing how patients are selected for prescriptions, insurance companies will be hard-pressed to handle the costs.

- Advertisement -

“We believe that the current guidelines do not provide clarity on how to choose the best evidence-based therapy to achieve cost-effective clinical outcomes,” said Dr. William H. Shrank, senior vice president, chief scientific officer and chief medical officer for provider innovation and analytics at CVS Health Corp., a leading manager of prescription-drug benefits.

“We are encouraging the cardiology community to reconsider the current guidelines, and to provide more clarity for providers to determine the … appropriate use of PCSK9 inhibitors,” he said.

The American College of Cardiology’s guidelines, updated in 2013, recommend that cardiologists treat high-cholesterol patients with high-potency medications, instead of treating patients in order to reach a targeted cholesterol level.

Shrank warns that aggressive treatment plans could push doctors to prescribe PCSK9 inhibitors to patients at a rate that would drive up insurance costs and possibly prevent access to patients who need it the most.

“The current guidelines could potentially result in some scenarios where a prescriber could consider a PCSK9 inhibitor for a low-risk patient. As a result, PCSK9s could be the most costly class of medications we’ve seen thus far,” he said.

But Dr. Steven Fera, a cardiologist with South County Cardiology in South Kingstown, said several factors – including the established guidelines and caution associated with a brand-new drug – most likely will prevent overprescribing.

“Changing the [cholesterol] number doesn’t always change the patient’s prognosis,” Fera said. “What is typical of current guidelines is that patients at the highest risk get the most intensive [treatment].”

Fera said a patient’s heart-disease risk is determined by several factors, including gender, age, blood pressure and smoking status. Low-risk patients are first advised to make lifestyle and diet changes to lower their cholesterol and prescribed statins when and if they are necessary.

Praulent is FDA-approved only for treatment in patients who have maxed out their tolerance or response to statins, a class of cholesterol-lowering drugs that includes Lipitor, and for patients with heterozygous familial hypercholesterolemia and patients with atherosclerotic cardiovascular disease such as heart attacks or strokes.

As such, low-risk patients wouldn’t be eligible to use the drug. However, some patients whose cholesterol levels and lifestyle put them in a low-risk category do have genetic conditions that make it difficult to reduce heart-disease risk through statins and diet. Fera said that those patients – who are not the majority of patients – could be candidates for PCSK9s.

While he believes that a small number of patients will be prescribed Praulent at first, he does see the need for caution in prescribing the medication.

“You want to be sure the patient will have some benefit and there are so many patients who are potential candidates, you want to make sure the patients who get this really need this,” he said.

Insurers also are expressing caution when it comes to approving the drug within a patient’s insurance plan.

Stacy Paterno, assistant vice president of public affairs at Blue Cross & Blue Shield of Rhode Island, said that if Praulent is recommended for a member, the company’s specialty pharmacy would “manage and support that process, including ensuring that existing therapies are being used optimally.”

Aetna Inc. spokeswoman Anjie Coplin said that patients must meet the criteria established by the FDA and must have tried two high-dose statins first.

UnitedHealthcare of New England’s public relations department said the company is still determining coverage policy. •

No posts to display