Friday, May 30, 2014

Sovaldi : A medical breakthrough actually worth paying for

Joel W. Hay: A medical breakthrough actually worth paying for
By JOEL W. HAY / Contributing Writer
Published: May 29, 2014 Updated: 5:55 p.m.

“Are you experiencing ‘Restless Eyebrow Syndrome?’ Ask your doctor if Firmbrowlta is right for you.”

Pharmaceutical companies are often criticized for charging high prices for medications that add negligible benefits and sometimes for even concocting questionable new conditions and syndromes just to sell their latest drug. There is, however, a new class of drugs entering the market that represents a major breakthrough in treating and even curing a disease plaguing tens of millions of patients worldwide.

Hepatitis C, or HCV, is responsible for more deaths in the United States than HIV/AIDS and Hepatitis B combined. It is also the leading cause of liver cancer, as well as the No. 1 reason for liver transplants in the U.S. Some 3.2 million individuals in the U.S. are infected with HCV, close to five times the number who have HIV. Given the nature of HCV, often referred to as the “silent killer,” only half of these individuals have been tested and know their status, about a third have been referred to care, and only 5 percent to 6 percent have been successfully treated.

On top of these sobering statistics, the existing treatment options for individuals with hepatitis C are, literally, nauseating. The current standard of care for HCV patients is a cocktail of three drugs, one being interferon, which must be administered in weekly injections and is often accompanied by unendurable side effects of anemia, rash, depression, and flu-like symptoms. These side effects can persist throughout the entire 48 weeks required by current treatments.

However, there’s light at the end of the tunnel for Americans suffering from the disease. There are currently a host of new oral, injection-free, interferon-free treatments in clinical trials. This is very big news for those currently infected with HCV.

It is expected that a large portion of the patients that were previously referred for care, but unsuccessfully treated, will now have a better (and far more pleasant) chance at being cured.

Of course, these new breakthrough treatments will come at a price, and a very high one at that. In fact, the cost of these all-oral treatments is expected to be around $150,000 for a 12-week regimen. Sovaldi, the first of the new class of HCV drugs to be approved by the FDA, costs $1,000 per pill.

So is this yet another case of Big Pharma holding patients hostage with their colossal prices? Not quite. If price is truly a reflection of value (as it should be), then it should come as no surprise that these new oral treatments hit the market at a higher price than their clinically inferior predecessors.

After all, the new therapies are proving to have substantially higher efficacy, with shorter treatment duration, and fewer undesirable consequences than the interferon-based therapies. We conducted an economic analysis showing that these drugs actually deliver excellent health care value despite their high cost, because they prevent liver disease, liver failure, cancer and premature death.

However, the value of these new drugs doesn’t stop at the patient level. A recent study in the Journal of Hepatology estimated the total cost of HCV in the United States to be $6.5 billion, which is expected to rise to $9.1 billion by 2024. Much of this cost is due to infected individuals foregoing (or failing) the treatments, and consequently transitioning into very costly health states such as cirrhosis, liver cancer, and eventual liver transplants.

This new generation of treatments will therefore not only have an unprecedented impact on patient health, but in the long run also help tackle the enormous economic and medical burden associated with HCV.

Moreover, with a large percentage of infected Americans being institutionalized, or on some type of government program, including Obamacare, this is something every taxpayer should appreciate.

The arrival of this new class of drugs cannot come soon enough, and, apparently, Medicare agrees. In a statement last week, Medicare officials embraced the guidelines laid out by the American Association for the Study of Liver Diseases, which recommend the use of these new oral therapies – even though the FDA has not yet approved most of the drugs.

We shouldn’t let price sticker shock distract us from the true value of new HCV drugs, as they could very well eradicate hepatitis C entirely. Yes, these drugs are expensive but much less expensive than treating progressive liver disease for a lifetime. If we don’t give reasonable economic rewards to pharmaceutical companies when they invent genuine breakthrough products they’ll go back to concocting treatments for silly things like “restless eyebrow syndrome.”

Joel W. Hay is a professor at the USC Schaeffer Center for Health Policy and Economics.

Related: Reducing the cost of new hepatitis C drugs 
An index of articles pointing the reader to current information and controversy over the high price of Solvadi -
Why does Gilead's Sovaldi cost $84K in the U.S. and $57K in Britain?
At $1,000 per pill, new Hepatitis C drug has insurers and CCOs scratching their heads
The Price is Right: New Hepatitis C Drug is Really a Priceless Breakthrough....

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