Solvaldi (sofosbuvir) was introduced by Gilead Sciences in December as a breakthrough treatment for Hepatitis C with the capability to cure more individuals in a shorter period of time. However, U.S. legislators and insurance companies are expressing concern over the cost of treatment pegged at $84,000, a cost most companies and government programs will not cover.
There are approximately 3.2 million individuals afflicted with Hepatitis C (HCV) in the United States, and Sovaldi was heralded as their answer. HCV is a contagious disease that attacks the liver and is not detectable in most. However, those 75-85% of patients who subsequently develop chronic Hepatitis C are more susceptible to cirrhosis and cancer of the liver, both life-threatening diseases. The new drug is so encouraging since it is tolerable to a much broader range of patients, some who are not able to tolerate other treatments and some whose disease returns after initial treatment.
Other available treatments have cure rates of 65 and 75%, while Sovaldi has a success rate of 90% and higher, depending on other components of the treatment.
To determine pricing, Gilead Sciences chose a tiered approach based on per capita gross national income of each country. Pricing is lowest in Egypt where rates of HCV are highest at $900 per course of treatment, while the UK, Germany, and United States are priced at $57,000, $66,0000 and $84,000 respectively.
The high price spurred Democrats from the House Energy & Commerce Committee to write a letter of concern to Gilead, citing worry that price may negatively affect national public health if no one can afford access to the treatment. “Our concern is that a treatment will not cure patients if they cannot afford it. The costs are likely too high for many patients, both those with public insurance and private insurance,” said the letter to Gilead. “The extraordinarily high cost of your drug raises additional concerns because of the role of the federal government in speeding up its approval.”
Sovaldi was granted FDA approval after an expedited process because of its “breakthrough therapy” designation. It is the first treatment to address HCV without the interferon injections that caused so many patients debilitating side effects like anemia, insomnia, fatigue, depression, and rashes. Sovaldi in combination with an older treatment called ribavirin have only fatigue and headache as potential side effects.