ICER Watch: Insurance, regulatory practices overriding doctor treatment decisions

ICER Watch: Who should make your treatment decisions?

Every day, insurance companies and regulators are overriding doctors’ treatment decisions and blocking patients from getting the treatments they need.

That’s the message from our policy director and co-founder Jonathan Wilcox in his latest piece published at The Huffington Post. He warns that the Institute for Clinical and Economic Review is one of the primary culprits in “health care’s secret scandal.”

“The increasingly frequent use of restrictive formularies, clinical pathways and value frameworks that focus on drug cost first and patient access far later,” he explains.

Patients with high cholesterol are the latest group of patients to see a medical breakthrough withheld by insurance companies. Last summer, the FDA approved two new medications for treatment of advanced high cholesterol called PCSK9 inhibitors. These medicines specifically target millions of patients diagnosed with a disease called Familial Hypercholesterolemia (FH), a life-threatening genetic disorder that causes high cholesterol starting at birth.

Yet, the insurance-funded non-profit ICER has offered up a manual for rejecting coverage.

“Just after approval of these advanced high cholesterol medications, ICER released a step-by-step manual on tactics insurers can deploy to deny patient access,” Wilcox writes. “These documents illustrate the preferred ways to deny patients and, revealingly, utilize guidelines released within weeks of FDA approval of PCSK9 inhibitors by some of the nation’s largest health insurers, including Anthem and United HealthCare.”

What is Familial Hypercholesterolemia?

Familial Hypercholesterolemia, known simply as FH, is an inherited disorder that leads to aggressive and premature cardiovascular disease. An estimated 1.3 million American patients suffer from FH — with about 1 in 250 people worldwide. Patients can suffer from problems like heart attacks, strokes, and even narrowing of our heart valves

“For individuals with FH, although diet and lifestyle are important, they are not the cause of high LDL,” notes the FH Foundation, a patient-centered nonprofit organization dedicated to education, advocacy, and research of the disease. “In FH patients, genetic mutations make the liver incapable of metabolizing (or removing) excess LDL. The result is very high LDL levels which can lead to premature cardiovascular disease (CVD).”

What are PCSK9 inhibitors?

“PCSK9 inhibitors are a new class of lipid-lowering medications that are administered as monthly or bimonthly subcutaneous injections,” according to MedScape.com.

Dr. Scott Wright, Professor of Medicine at the Mayo Clinic College of Medicine, says that these treatment innovations have two big advantages over statins.

  1. “They promote the modulation of the receptor that clears cholesterol—if you give the drug, you prolong the receptor and clear more cholesterol; you don’t block synthesis, you block clearance.”
  2. “They’re injectable. So instead of taking a pill every day like a statin, you take an injection of these drugs every 2 to 4 weeks.”

PCSK9 inhibitors remove the bad cholesterol that contributes “to plaque deposits in blood vessels, which can lead to heart attacks and strokes.”

How to Fight Back: What to Do If You’re Denied Coverage for PCSK9 inhibitors

What can patients and their families do when insurance companies deny coverage of PCSK9 inhibitors?

Health advocate Seth D. Ginsberg, who is co-founder of CreakyJoints, offers helpful advice for patients that have been denied coverage of PCSK9 inhibitors. With the help of Matthew Stryker, a pharmacist who works in the Albany Medical Center, GInsberg has identified several ways for patients to fight back.

1. Document everything.

“For example, if you’re intolerant of a statin, make sure your doctor indicates which statin, the dosage, how often it was taken and the specific side effects or reason you can’t take it anymore,” Ginsberg says. “Also make sure your doctor has a detailed family history of any type of heart disease, as this will make a stronger case for your appeal. Once an appeal is made, touch base with your doctor’s office periodically to check on the status, understanding that they’re working on your behalf – so while it’s important to be persistent, also be polite.”

2. Become an advocate: “Advocating can be scary if you’ve never done it, but getting involved is crucial, because if patients don’t, nobody else will.”

Finally, as a last option, Ginsberg recommends placing a call to your state insurance commissioner. Although as we noted earlier this week, a majority of state insurance regulators are heavily influenced by insurance companies with dinners, gifts and junkets.

 

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