Hepatitis C is a contagious, bloodborne viral infection that causes inflammation in the liver. Many people with Hepatitis C are unaware of their infection because they can remain asymptomatic for years. However, if left untreated, a chronic Hepatitis C infection can cause severe scarring of the liver – called cirrhosis – liver cancer or death. The Centers for Disease Control and Prevention estimate that approximately 3.5 million Americans are infected with Hepatitis C, and global cases are estimated between 130-150 million persons chronically infected.
Chronic Hepatitis C infections are the leading cause of liver transplantation, cirrhosis and liver cancer in the U.S., and the total cost associated with chronic HCV infection is estimated at $6.5 billion. Traditionally, the drugs used to treat Hepatitis C required patients to take numerous pills per day for 24-48 weeks, and they caused a range of severe side effects such as anemia, depression and liver and kidney damage. Overall efficacy of treatment with these drugs averaged at only around 50% due to poor patient compliance or stoppage of treatment by physicians due to harsh side effects.
The recent introduction of direct acting antiviral drugs (DAAs) onto the market, such as Harvoni by Gilead Sciences and Viekira Pak by AbbVie has allowed for most patients with Hepatitis C to be essentially cured of the disease after 12 to 24 weeks of drug treatment. These new treatments require taking fewer pills and cause much milder side effects than previous Hepatitis C treatment regimens, thus allowing for greater patient compliance and significantly higher efficacy rates. DAAs have an overall efficacy rate between 90-97% in patients who complete treatment. “Cure” of the infection is determined by whether the patient’s sustained virologic response (SVR) – the level of Hepatitis C virus (HCV) in their bloodstream – remains undetectable three months after treatment has ended. These treatments can rid many people with chronic HCV infections of an illness that could have severely reduced their quality of life.
It seems perfectly logical to think that the U.S. is on the brink of virtually eradicating Hepatitis C infections within the next few decades. Those infected will just be prescribed these treatment drugs and will clear the infection. No brainer. However, there has been a lot of controversy and barriers to access to these drugs for many patients in the U.S. since they came to the market in 2014. The reason: cost. The drug companies have set exorbitant prices for these breakthrough treatments. The market price for a course of treatment for these drugs can range between $83,000-$153,000 per patient. The wholesale price per dose of Harvoni is $1,125 per pill. Even though most insurers negotiate lower bulk prices with pharmaceutical companies to somewhat reduce this price, treating Hepatitis C patients with these new drugs has been incredibly costly to health insurers. Government funded health providers such as the Veterans Administration, Medicaid and Medicare were hit quite hard with this cost burden as well.
In order to control the cost of treatment of persons with HCV, many insurers have imposed limitations on access to DAA drugs. Some insurers require that a patient already have mild to moderate liver scarring before receiving DAA treatment. Others require that HCV patients with alcohol or substance abuse problems show sustained sobriety for a period of time before qualifying for treatment. These limitations go against the U.S. recommendations that all infected persons should receive treatment. In November 2015, the Centers for Medicare and Medicaid Services (CMS) issued a formal letter to states that instructed them to remove these and any other “unreasonable” limitations to DAA drug treatment for the HCV patients insured under Medicaid. Many states have responded and have removed the liver damage or sobriety pre-requisites. However, private insurers have been slower to remove such limitations. The pharmaceutical companies have worked with government and private insurers to negotiate lower prices for the drugs, and slowly there is an alleviation of the access problem being seen in the U.S. However, the cost of the treatment for the low-income uninsured is still an insurmountable obstacle.
The high cost of healthcare and pharmaceuticals in the U.S. is not new information to any of us. Barriers to healthcare access is one of the principal issues we address here at the O’Neill Institute. However, the U.S. still has many more resources to serve the healthcare needs of its citizens than do many other countries. In a poor country like Egypt, which is faced with an epidemic rate of HCV infections, these market prices for treatment drugs would be prohibitive for nearly the entire population.
The pharmaceutical companies that developed these HCV treatments are making nearly all of their profits from sales in the U.S. and western Europe, because those countries have more economic means to pay retail for the drugs. Even though this poses an economic strain on many in those countries, there is actually a positive consequence to this arrangement that many in the U.S. and Europe consider to be “price gouging” (every cloud has a silver lining). Securing profits from sales in these countries makes the pharmaceutical companies more amenable to providing these drugs at significantly lower costs to citizens of poor countries. The greatest example of this can be seen in Egypt, where 9 million people, or 10 percent of the population, are infected with Hepatitis C. Egypt has the highest per capita rate of Hepatitis C infection in the world due to the spread of the virus during a decades-long mass vaccination program against the parasitic disease schistosomiasis, where several people were given injections using the same needle without proper sterilization between doses. Gilead has offered to charge the Egyptian government just $14 per day per patient for Harvoni, and AbbVie is providing Viekira Pak for $13 a day, or about 1 percent of the cost of the drug in the U.S.
The widespread availability of these drugs in Egypt has offered a second chance to many people who saw their Hepatitis C infection as the death sentence it had been for many of their relatives and neighbors. The deal struck between the pharmaceutical companies and the government allows the Egyptian health ministry to distribute the treatment to patients for free. The program in Egypt is only a year old, but it holds great promise of significantly decreasing rates of the disease, and serving as a model for other countries dealing with high Hepatitis C rates.
The potential to significantly reduce worldwide Hepatitis C rates with these new drugs is a public health game changer. Governments and health administrators are still trying to figure out the best strategies to balance the treatment needs of citizens with economic concerns. However, despite the current challenges, it seems likely that Hepatitis C will go from a pervasive and deadly illness to a rare and easily treatable disease within our lifetime. That is a beautiful thing.
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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.