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Fat Busting: But at What Price?

| 13 Comments
Since the late 1990s, I've been working closely with a great group of activists--Matt Sharp, Jeff Taylor, Nelson Vergel, Jeff Berry, Jules Levin, Lynda Dee, the late Marty Delaney and a handful of others--on a huge advocacy initiative: the approval of a safe and effective treatment for the excessive buildup of abdominal fat being experienced by HIV-positive folks with lipodystrophy. Well, after failing to do this with one drug--EMD Serono's Serostim (recombinant human growth hormone)--we've finally succeeded with another: Theratechnologies' Egrifta (tesamorelin). 

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The drug, which acts on pituitary cells in the brain to stimulate growth hormone production, works relatively well. According to Phase III studies, it reduces the amount of deep belly fat (visceral adipose tissue, or VAT) by 15 to 17 percent. While this won't magically translate into a return to trim physiques for many with lipodystrophy, it will certainly allow for a tightening of the belt by a notch or two. And, as we argued before an FDA review committee in May, the benefits or Egrifta treatment outweigh its risks--certainly much more so than with an earlier contender, Serostim, which presented a significant risk of glucose impairment and diabetes. 

After several years of (sometimes heated) meetings, conference calls and letters with Theratechnologies. EMD Serono and the FDA, we have an approval: the drug was given the green light by the agency on Wednesday, November 10. It has taken more than 12 years of drug research, development and advocacy--it was first suggested that growth hormone might reduce VAT in people with lipodystrophy at the 12th International AIDS Conference in Geneva in 1998--but, yes, we finally have a treatment for this disabling condition. 

Prescriptions for Egrifta will start being filled in January 2011, possibly sooner. And it's EMD Serono that will be marketing and selling the drug in the United States, not Theratechnologies, after both companies entered into licensing agreement in 2008. 

To streamline the prescription process--and to prevent drug counterfeiting and misuse of the drug by those who don't have HIV-associated lipodystrophy--EMD Serono is requiring all prescriptions be processed by a contracted group (The Axis Center: 877-714-2947), which will do a lot of the wrangling with insurers companies, and fulfilled by select mail-order pharmacies. In fact, The Axis Center is already standing by to receive prescriptions and get the ball rolling for people living with HIV and lipodystrophy.

But a central question remains: Will the drug be priced so that it's accessible to everyone who needs it? I strongly suspect that Egrifta won't be cheap. However, will the final price tag be so high that insurers ultimately balk at paying for it, despite the best intentions of The Axis Center and pre-authorization letters written by health care providers?

True, HIV treatment has never been considered inexpensive--ARV regimens are in the ballpark of $20,000 annually--but Egrifta has its own set of unique cost challenges. Whereas ARV therapy has clearly been shown to keep people alive longer and healthier, Egrifta has not. If I was an insurer, operating in this economy while also being instructed to keep my doors open to everyone in need of insurance, all the while facing pressure to keep my premiums as low as possible, I'd probably think twice about paying thousands of dollars for a drug that hasn't been proven to reduce the risk of serious health problems and improve survival. 

There's a lot of hope surrounding Egrifta. Studies have demonstrated that excess VAT is an independent risk factor for cardiovascular disease--no stranger to people living with HIV--and can contribute greatly to things like respiratory problems, difficulty sleeping and a long list of nutritional challenges. The problem is, Egrifta, while we know it reduces VAT and can helps some people with their self-image, hasn't been shown to improve any of these more serious health problems.

When it came time to advocate for Egrifta's approval, one of things I asked for, in a letter written on behalf of the AIDS Treatment Activist Coalition's Drug Development Committee, was a post-approval clinical trial exploring the potential benefits of Egrifta on the risk of cardiovascular complications like heart attacks, strokes or atherosclerosis. The problem is, a massive study--in both size and length--would be needed to address this issue and it became clear that neither Theratechnologies nor EMD Serono had the capital or resources to fulfill this request, which not only would have justified an (anticipated) high price tag for the drug, but also better inform people living with HIV and their health care providers about the need to treat lipodystrophy. 

My ultimate fear is that we will have an approved lipodystrophy drug sitting on pharmacy shelves, collecting dust, because its cost exceeds what the market will bear. While EMD Serono has mapped programs to help defray out-of-pocket costs and for those who don't have adequate insurance, the company is still going to need to sell Egrifta--and plenty of it--in order to keep itself in business. 

I, for one, am glad Egrifta is finally here. Cardiovascular risk issue aside, lipodystrophy is no trivial matter for the thousands of people living with HIV in the U.S. who suffer from it. It is disfiguring. It is disabling. It is stigmatizing. It is physically uncomfortable and painful. This drug is needed and very much wanted by many people still dealing with the untoward effects of lipodystrophy, despite dieting, exercising, switching offending meds--pretty much every approach that's been suggested to work. 

We need to make sure that insurers understand the seriousness of lipodystrophy and fully appreciate the need for treatment--health care providers, lipodystrophy experts and people dealing with this syndrome will ultimately need to make their voices heard in this regard. Well, the same goes for EMD Serono and Theratechnologies: fair pricing isn't just good for people living with HIV and lipodystrophy, it is good for business as well. 

13 Comments

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Comments on Tim Horn's blog entry "Fat Busting: But at What Price? "

Tim,

As usual your comments are insightful and meaningful. But as you well know from our discussion (personal and professional) I do believe there is a health benefit that is possibly being overlooked at the beginning of the Egrifta conversation (Hoping that is what it will be and not a "heated debate"!) The disfigurement that comes with long term ART use, and I am saying this as front line AIDS clinician and a man living with virus, is horrific. The physical pain is something that many clinicians never bother to address in HIV itself, let alone when a person's body morphs and wastes and turns on them. There is real physical pain that is associated with wasting and body habitus changes. The mental health issues cannot be overstated. I see hundreds of patients break down in tears over how they look (no, this is not about being a "pretty"; this is about stigma). They know they are "marked”. We know we look difference. Many of my fragile patients with substance use issues have frequently returned to the use of injecting, smoking or whatever coke, meth, heroin, booze, etc to "escape". We cannot let this drug become a "cosmetic" football. The pain of disfigurement is real and we need therapies that can assist with it.

As I like to always point out. Living on lifelong ART is nothing short of being on chemotherapy for the rest of your life. It is time to hammer that home. HAART is not a damn "cocktail"; it is a toxic, yet life saving chemo, that needs to be taken daily for the entire life of those of us living with HIV/AIDS. Pretty has nothing to do with it.

Ric--

Oh, I totally agree. Physical discomfort -- pain, really -- is a huge issue for many people with lipodystrophy. This is yet another "endpoint" that would have been beneficial in the Phase III clinical trials, yet it wasn't included in the protocols, nor is it discussed in any of the data analyses.

This is unfortunate, to say the least. Of course, it will be good for health care providers to note physical pain when jumping through the (inevitable) pre-authorization hoops -- I just hope insurers recognize pain reduction as a valid reason for covering the drug in the absence of any such mention of this in the published data.

But you've just inspired me to take up the critical issue with EMD Serono. The company is going to be conducting an observational safety study as a part of Theratech's post-marketing commitment and I honestly think the company should include some sort of pain/discomfort parameter in its data collection.

We won't get something if we don't ask for it, right?

If I have "inspired" Tim Horn then the world is off kilter. It should be the (and is) the other way around. However, before we gush any further… I come from working with patients that most clinicians run from since they are from the streets, actively using, and many times threatening to me (I have learned to block a sucker punch better than most.) But pain (physical and mental) in the population I am privileged to work with will only likely lead to one thing...INCREASED drug use or RELAPSE - both of which will potentially spread the virus (and other diseases) to others. I am not saying it is time to "think outside the box"; I am say there ISN'T any damn box. It is time to think about what is right.

people with AIDS have suffered enough!!!!! we should not have to pay anything for this new drug. i have lypo-disfiguring to the body. i dont take showers at the gym. never take off all my clothes when i am in bed with someone. its embarassing.

What is lipodystrophy? What does it look like, and people HIV+ that have large abdominal areas. Will Egrifta be wise for us to use? Also, someone without insurance, and been rejected for Medicaid / Medicare twice. Some of the meds/ointments that I have, are out of pocket. Is there an insurance that I can get to cover all, + hospitalization, among other health issues? I would appreciate any info given. Thanks in advance.

Just wanted to add that it is good to know that something is been done medically about lipodystropy. Though you mentioned that Egrifta would help with this problem it only mentions belly fat lipodistrophy reduction but makes no mention of the so called "elephant hump" lipodystropy problem which a lot of HIV+ people also experience. Since there is no mention of this problem in the article, does Egrifta help this condition or not. I would like to hear about any inforamtion on this issue in any available article on whether there is any hope for those of us who suffer from this particular condition.

Tim, thank you for covering and caring about this issue. I appreciate your work.

I know lipdystrophy affects a relatively small number of people, but I'm one of those people. I care. I was thrilled when Egrifta (tesamorelin) was FDA approved. I see Egrifta as one important option in a armamentarium available to physicians and patients, like me.

Unfortunately, here's what's happening post approval: private health insurers (e.g., Blue Cross/Blue Shield) are denying reimbursement on the basis that Egrifta is "cosmetic." In contrast, Medicare is paying for Egrifta.

I'm sure EMD Serono wouldn't have pursued a distribution contract with Theratechnologies if Serono wasn't guaranteed coverage from Medicare. We already know Serono likes to push Serostim onto Medicare patients. It's easy money for Serono.

Now, Serono distributes Egrifta in the U.S. Apparently, the Serono marketing push again is only for Medicare patients.

Three years ago, I qualified for the phase III clinical trials. I know the benefits of Egrifta firsthand. Amazing, at least for me. But then, I'm a highly motivated patient who cares.

Now, with FDA approval, my doctor prescribed Egrifta for me. I got one month's supply and then my health insurer denied to pay further. My doctor was clear, he did not want to deal with the hassles of securing reimbursement. He said, that's the job of Serono's Axis Center. Let's be clear, the Axis Center and Serono are the same.

At first, when my insurance appeared to cover Egrifta, the Axis Center was awesome: follow-up phone calls, great service etc. But once my insurance denied to pay, the customer service stopped abruptly. Jessica at the Axis Center was great -- until reimbursement stopped. Now I can't even get one return phone call.

My doctor doesn't want to deal with reimbursement issues. Axis/Serono doesn't return calls now that my private insurance denies coverage. And yet, all my unemployed Medicare friends are now getting Egrifta, no questions asked.

As a hardworking taxpayer who cares about rising healthcare costs, do I want to pay taxes so other people can get Egrifta when I can't get it? Private healthcare deems Egrifta cosmetic, while public healthcare deems it medically necessary? Huh?

I know many HIV-positive people depend on Medicare. Fine. But I also know that some HIV-positive Medicare patients work the system. HIV has created a suspicious class of "welfare queens."

I suspect many on Medicare will take Egfita for a few months, stop taking it, and start reselling it the black market -- just as they did with Serostim. It's a scam and Serono knows it.

Now, who truly deserves Egrifta? HIV-positive people care about rising healthcare costs, who deeply care about their own health, longevity, don't smoke cigarettes, eat healthy, and exercise all in a larger effort to reduce cardiovascular risk factors?

Or, HIV-positive Medicare welfare queens who, simply by not working, who probably smoke, who probably eat junk, and probably have no conscious about collective healthcare costs, these queens now get access to Egrifta?

I suspect in Serono's marketing world, the answer is: Get any and all Medicare patients on Egrifta and don't waste your time with people with private health insurance.

Something's wrong with this picture. And I care.
Brett Grodeck
Twitter: @Brett_Grodeck

But what good are these drugs if the majority of people cannot afford them and insurance says that won't pay for it??

I am amazed that Medicare pays for Egrifta, yet people not on disability can't get it without fighting their insurance carrier. Can anyone give me an update on this situation? It's December 2011. Is Egrifta being covered more by insurance? My carrier is paying for Serostim, yet I am afraid to switch to Egrifta, even though it appears to be a safer product.

Hello,

My HMO, Healthnet has denied Egrifta because they say it is "cosmetic". Even the IMR agreed, However I see many comments that the drug has other benefits. How do I go back to my insurance company with a statement that others have found works?

Any help would be appreciated.

My insurance company, Sharp Community Healthcare Plan are denying coverage. Any ideas on how to get them to pay for this prescription?? Any help or advice would be appreciated.

Thank you,

In this day and age, why is Egrifta not able to be administered using either an epipen type injection, a forced air delivery system or better yet, a skin patch? Seems like so many meds that involve delivery through the skin can eliminate the use of needles and the biohazards associated with them.

Just curious.

As a doctor living and practicing in San Francisco, I am greatly disappointed in the number of insurance companies denying Egrifta coverage on the basis of its use being "cosmetic". We clearly understand the impact of excess visceral body fat on cardiovascular health. And mental health issues remain medical! That's why antidepressants and anxiolytics ARE covered by insurance companies. Lipodystrophy can cause mild distress to severe anguish in sufferers and should be treated. I can't change the insurance or the pharmaceutical industry, but I do offer my patients an option. Most people don't know that there is a generic option to Egrifta that is also bio-identical (that is, identical to the growth hormone releasing hormone normally produced in the human body). Serono made this bio-identical product first, but when they lost their patent, they changed it slightly and re-released it as the much more expensive "Egrifta". Luckily, the original drug can still be found! Treatment still isn't cheap, but it is much more affordable. Generally, treatment runs around $200-250 per month. Egrifta can cost several times that amount. Look into the alternatives and good luck to all of you! Warmly, Dr. Power, Youth Renewal Center

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This page contains a single entry by Tim Horn published on November 12, 2010 10:30 AM.

The Drama is Too Damn High was the previous entry in this blog.

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