Are New Hepatitis C Drugs Too Expensive?

For millions of Americans the upcoming release of two new hepatitis C drugs, Sovaldi and Olysio, offer an appealing alternative to the current treatment regimen. Chronic hepatitis C infection affects approximately 130 to 150 million people globally and 3.2 million in the United States. Along with excitement over the new releases also comes controversy. The standard hepatitis C treatment plan today costs between $20,000 to $40,000 over a 48 week period. In comparison, a twelve week course of Sovaldi costs roughly $84,000 and a twelve week course of Olysio costs upwards of $66,000. Accordingly, a "firestorm of objection" has arisen in response to the extremely high prices of these potentially life saving new drugs.

According to the World Health Organization, hepatitis C is a liver disease caused by the hepatitis C virus. People most often become infected with the virus through contact with contaminated needles and through unsafe sexual activities. The hepatitis virus can cause both acute and chronic infections. Acute HCV infection is defined as having the infection for less than six months and exhibiting "very mild non-specific" symptoms. On the other end of the spectrum is chronic hepatitis C infection which can be fatal. Between 15% to 20% of people with acute hepatitis C infection are able to rid the virus from their body in less than six months without treatment. The other 80% of infected people go on to develop chronic hepatitis C.

The current standard procedure for treating both chronic and acute hepatitis C infections includes administering the antiviral drugs interferon and ribavirin to patients. Antiviral therapy is successful, meaning that there is no evidence of hepatitis C in lab tests for two years, in 50% to 90% of patients. However, the main drawbacks to treatment using interferon and ribavirin are the side effects and the lengthy process. Many people find it difficult to get through hepatitis C treatment for six to twelve months because of the unpleasant side effects. The most common side effects are anemia, fatigue, headaches, nausea, depression, insomnia, and hair loss.

Numerous patients and doctors alike are optimistic about the significantly shortened treatment course and milder side effects that the new drugs offer. In clinical trials Sovaldi and Olysio have been shown to cure 80% to 90% of the people tested. This is a much higher and narrower range in comparison to that of interferon and ribavirin. Studies have also shown that these new drugs are highly effective in patients who were not cured using other treatment plans. Both drugs have been heavily endorsed by the World Health Organization. In fact, WHO recommends that the 150 million infected people worldwide should all be "assessed" for treatment using the new drugs.

Unfortunately, WHO's worthy goal may not be met. The staggering prices for Sovaldi and Olysio make it difficult for the average person, insurance companies, and developing nations to pay for them. Steven Pearson, President of the Institute for Clinical and Economic

Review, says that the pricing controversy is "a tough ethical and financial quandary." The drug companies have to charge a lot for their products because of the exorbitant costs they have to spend on getting their drugs to market. Jennifer Wall, who works for the Pharmaceutical Research and Manufacturers of America, explains that "on average, to research and develop just one medicine takes 10 to 15 years and more than one billion dollars." The company behind Sovaldi, Gilead, announced that it will charge less for its product in countries outside the United States in response to the growing criticism over cost. Gilead dubs this approach "tiered pricing" and will base the discounted price of the medicine on a targeted country's gross national income and percentage of the population infected with hepatitis C. For instance, in Egypt, which has the highest infection rates in the globe, Solvadi will be sold at a 99% discount; $900 for a twelve week regime instead of $84,000. Gilead is also in talks with several companies in India to produce a generic version of Solvadi for $2,000. Some critics still argue that $2,000 is too much for people to pay. Rohit Malpani of Doctors Without Borders believes that "full hepatitis C treatment needs to be available for no more than $500 per person." On the other hand, Greg Alton of Gilead makes the point that $2,000 for Solvadi is "substantially less" than the current cost of treating hepatitis C in India using less effective drugs. According to Mr. Alton, Solvadi will "be more effective, less toxic and easier to use and without side-effects" than the current antiviral drugs.

Prices for the new drugs may be lowered over time due to competition from other drug companies. Already at least 20 other drugs aimed at curing hepatitis C are in the works. When new drugs are approved by the FDA and made available to the public, then the demand for Solvadi and Olysio will decrease and therefore so too will the price. Another solution to lowering prices that is gaining support is the idea of delinkage whereby governments help fund pharmaceutical research and development for the good of citizens. The drug company in turn will predominantly focus their resources on manufacturing, marketing, and distribution. Pharmaceutical companies will therefore have to spend less on producing their product which should in turn lower the price of the drug they produce. Of course, there are no concrete plans for a system of delinkage to be established anytime soon. In the future it will be interesting to see how the dilemma between profit and ethics pans out.

References:

Brody, J. "Progress Against Hepatitis C, a Sneaky Virus." NY Times. February 24, 2014.

FAQ: The High Cost of Hepatitis C Drugs. WebMD, 2014.

Knox, R. "WHO Calls For High-Priced Drugs For Millions With Hepatitis C." NPR. April 9, 2014.

Knox, R. "Maker Of $1,000 Hepatitis C Pill Looks To Cut Its Cost Overseas." NPR. February 7, 2014.

Loftus, P. "Sales of Johnson & Johnson's New Hepatitis C Drug Soar." Wall Street Journal. April 15, 2014.

Terhune, C. "Prices of new hepatitis C drugs are tough to swallow for insurers." LA Times. March 9, 2014.

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KGH (via Wikimedia Commons).

CDC.