Baby boomers and HCV screening

harvoni and hcv screeningDon’t get health advice from commercials!

While nursing my cold last weekend, I was watching TV and one prescription drug commercial caught my eye. (One of oh so many. FTC—please make these go away!)

Actually, the ad didn’t mention any drug by name, but it was sponsored by Gilead Sciences, the makers of the new hepatitis C drug, Harvoni.

The commercial was aimed at baby boomers, who were advised to get tested for the hepatitis C virus (HCV).

One in 30 baby boomers could have HCV and not know it, the voice over said, “…because Hep C can hide in your body silently for years, even decades, without symptoms.”

To scare people even more, the commercial compared HCV to the AIDS virus, HIV.

But, the ad continued more optimistically, if you are found to have HCV, “It can be cured.”

How safe and effective is Harvoni?

The cure, of course, is Harvoni (ledipasvir and sofosbuvir), one of a new class of direct-acting antivirals.

One of the reasons I noticed this particular commercial was that I had just read about a report that highlighted safety concerns for Harvoni and other direct-acting antiviral drugs.

The costly new drugs, which have been lauded for their ability to cure hep C, could be associated with severe side effects such as liver failure, according to an analysis by the Institute for Safe Medication Practices (ISMP).

While not definitive, the report said the data “show the need for further investigation into the negative consequences of these expensive and important new drugs.”

Harvoni is considered safer and more effective than older HCV treatments (interferon). It does offer a cure for some. That’s the good news.

The bad news is that it’s very expensive. A 12-week course of treatment costs roughly $100,000.

And because it’s a relatively new drug (since 2014), it has a very short track record for safety. That’s a problem with lots of new-to-market drugs. Harmful side effects only become apparent after many people have taken the drugs for many years.

According to the patient drug information website, Informulary:

Short track record means that new, unexpected side effects may emerge. Harvoni was approved by FDA in 2014 based on studies where about 1,100 people took the drug for up to 6 months. As with all new drugs, rare but serious side effects may emerge after Harvoni is on the market when larger numbers of people—with other conditions and on other medications—have used the drug.

HCV screening recommendations

I usually agree with the screening recommendations from the Centers for Disease Control (CDC) and the United States Preventive Services Task Force (USPSTF).

Both these agencies recommend baby boomers (born between 1946 and 1964) get screened for HCV.

But I don’t agree with this particular screening recommendation, and most doctors I’ve talked to don’t, either.

I explained my reasoning in a previous post about HCV screening.

The CDC and USPSTF updated their recommendations just before Harvoni was approved by the Food and Drug Administration (FDA). That’s not a coincidence. Harvoni has justly been called a “game changer” in the treatment of HCV.

However, Harvoni is not risk free.

First, it’s incredibly expensive, so many insurance companies are rationing who can get it.

Second, as I already mentioned, there may be a higher incidence of serious side effects than first thought.

About 30% of patients may carry the hepatitis C virus but it will never make them sick. If they are screened and found to be HCV positive, and do not have any sign of liver damage, their insurance company may refuse to pay for the expensive drug because it’s not yet “medically necessary.”

On the flip side, insurance may not pay if there is too much liver damage, either.

And while Harvoni works on the most common strain or genotype of HCV, others don’t respond as well and patients will not be “cured.”

Baby boomers—talk to your doctors

Rather than getting a blood test for HCV based on a birth date alone, talk to your healthcare provider about your personal risk, and whether being screened for HCV is a good idea.

Also talk to your insurance company to find out what they would pay, and when, if you test positive.

Here are the questions I would ask myself or my healthcare provider before getting screened for HCV:

  • Other than age, what are my risk factors? What is the statistical likelihood that I will test positive for HCV?
  • Will my insurance cover the cost of the screening? Because the screening test was given a “B” rating by the USPSTF, it should be covered with no cost sharing per the Affordable Care Act (ACA) rules. There are different levels of testing; some tests can cost upwards of $400, so know before you get tested!
  • If I were to test positive, does my insurance company demand prior approval for treatment? Is there a waiting period? What is considered “medically necessary?” Would I have to wait for months or years, knowing I was HCV positive, before getting treated?
  • How are expensive specialty drugs covered by my plan? Every company will deal with these high-cost drugs differently. Know your plan!
  • I have one of the high-deductible health plans. I have to pay over $10,000 before my insurance will cover anything. Can I afford that?
  • Can I wait until I’m symptomatic (if ever) to get tested? How would that affect my chance of being “cured”?

Gilead’s commercial used all the typical tropes (nature shots, healthy and attractive actors, pleasant music) to make it seem like getting screened for HCV is not a big deal because there is a “cure.”

Maybe, maybe not. All drugs have risks, and the benefits of treatment must outweigh those risks.

Don’t get your health advice from a commercial. If you’re a baby boomer concerned about HCV, talk to your healthcare provider, talk to your insurance company.

Get informed before you get screened.

Sláinte,

Frugal Nurse

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Comments

Baby boomers and HCV screening — 2 Comments

  1. The test and follow up with expensive, aggressive treatment mentality has a checkered past. Remember when every man over age 40 was advised to have his PSA checked as a screening tool for prostate cancer? Surgical intervention and hormonal agents likely caused more deaths from complications, diabetes, and cardiovascular disease than prostate cancer.

    These drug company promotions seem to be cyclic. Those get tested for Low “T” ads were everywhere a few months ago. Testosterone replacement fuels prostate cancer and contributes to strokes and heart attacks. I don’t even think the long term effects are known.

    It would be much more effective to develop strategies to define and delineate risk than to advocate widespread screening for these problems.

    • Yeah, there are many advocates in the healthcare system that are attempting to control the American trend of overscreening. The public perception is that any screening test that can “catch” cancer or other disease “early” can only be good. Sadly, that’s often not the case. Overtreatment adds billions to our healthcare costs, not to mention added emotional stress.

      Other countries with regulated healthcare costs do as you suggest, and offer screenings on individual basis of risk/need. They spend less than we do, and the results are the same regarding death rates.

      As long as we have a fee-for-service system, though, financial incentives will always support overscreening and overtreating.

      Thanks for the comment! FN

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