Hepatitis drug Sovaldi $1,000 per tablet, lawmakers scrutinize

Gilead Sciences’ new hepatitis drug Sovaldi (sofosbuvir), at $1,000 per tablet or $84,000 for a course of treatment, has attracted the attention of US lawmakers.

Congress Democrats have written to the biotech company asking why the new medication has such a high price tag.

The letter was sent by three members of the House Energy and Commerce Committee – Diana DeGette of Colorado, Frank Pallone Jr. of New Jersey, and Henry Waxman of California.

The lawmakers wrote

“Our concern is that a treatment will not cure patients if they cannot afford it.”

Industry experts believe the current scrutiny will soon blow over. The three members of Congress who signed the letter are Democrats in a Republican-controlled House.

Private and state insurers balking at Sovaldi’s price

Hepatitis drug Sovaldi is facing strong resistance from state Medicaid programs and health insurers. News that the new drug’s price is being scrutinized pushed Gilead shares down 6% on Friday.

Other major biotech companies also saw their share value drop as investors wondered whether the pricing of new medicines may affect future overall profits. Celgene Corp fell 3.7%, Amgen Inc. slid 3% and Biogen Idec declined 8% on Friday.

Despite Sovaldi’s proven success in curing patients with hepatitis C, health insurers, including the state’s Medicaid program for lower income people, are so far reluctant to authorize its use for their patients.

There three to four million people in the US live with hepatitis C, if a large proportion of them are treated with Sovaldi the annual costs would run into several billion dollars.

Sovaldi sold more cheaply abroad

Gilead has agreed to supply Sovaldi in Egypt at $900 for a 12-week course of treatment, approximately one-hundredth of the price it sells for in the US. Egypt has the highest rate of hepatitis C in the world, a consequence of contaminated needle usage 40 years ago.

Gilead aims to price Sovaldi according to each country’s income per capita. In Germany a course of treatment costs $66,000, while in the UK it has been set at $57,000.

Sovaldi is a breakthrough in the treatment of hepatitis. Trials have demonstrated its ability to cure a significantly higher percentage of patients than older medications, and with fewer side effects. When taken with two older medications, Sovaldi has an 80% cure rate within a 12-week period.

However, a growing number of people are questioning the price tag of $1,000 for each tablet if the drug is relatively easy to manufacture.

Gilead responded by email, saying it has been working with US state and federal officials, and expects to meet with lawmakers in Congress to answer questions regarding Sovaldi.

Sovaldi works out cheaper, says Gilead

According to Gilead, the current prices offered globally are the best they could manage for Sovaldi. Gregg Alton, executive vice-president for corporate and medical affairs said Gilead is willing to meet with members of Congress.

The New York Times quoted Alton, who said “We think the price is fair, it will save the system money long term.”

When the lower cure rates of other medications plus their side effects are taken into account, Gilead says Sovaldi actually works out less expensive per patient cured.

Gilead’s new drug’s high cure rate could attract many patients with hepatitis C and no symptoms. The majority of individuals with hepatitis C never have serious liver disease. How many of them would be treated, even though they would have lived normally without taking the medication?

HIV medications cost about $30,000 per year, while several cancer drugs cost over $100,000 per year and only add a few months to the patient’s life. In most cases, hepatitis patients take just one 12-week course of Sovaldi.

Sovaldi might become a record-breaking blockbuster

Sovaldi is expected to rank among the top blockbusters in pharmaceutical history. It was approved by the Food and Drug Administration on December 6th, 2013. Industry experts predict 2014 sales in just the US of between $3 billion and $10 billion, which would be a world record for any first-year sales.

Some doctors are combining Sovaldi with Olysio (Johnson & Johnson), another newly approved medication. A course of treatment with the two-drug combination costs $150,000.