Foster City-Based Gilead's Breakthrough Hepatitis Drug Costs $1,000 Per Pill
FOSTER CITY (KPIX 5) - Doctors are calling a newly-approved drug a " revolution" in treating the most common blood-borne infection in the United States. But patient advocates warn how those who need it may not be able to afford it; and noisy protests from Paris to San Francisco are trying to drive the displeasure over the price into the open.
Sovaldi is a breakthrough drug used in the treatment for hepatitis C. The medication was approved by the Food and Drug Administration in December 2013. The wholesale price for the recommended once-a-day, 12 week treatment is $84,000. That works out to be $1,000 a pill.
"The thought of dropping one on the floor and not being able to find it, you know, is very scary," said Dr. Diane Sylvestre, an internist and addiction specialist at the Oasis Clinic in Oakland.
Health experts call Sovaldi a game-changer. Most of the people who take this treatment can expect to be cured, said Sylvestre.
In a study published in the New England Journal of Medicine, the drug produced a sustained virologic response, or cure, in 90% of patients infected with genotype 1, the most common and difficult to treat strain of the liver-destroying virus that causes hepatitis C.
Bill Remak is Chairman of the California Hepatitis C Task Force and a longtime patient advocate. He was infected with hepatitis C as a child and is thrilled to hear about the approval of the new drug.
"I've had two liver transplants and I still have the virus and this offers me the possibility to actually be free of this illness," said Remak.
By many accounts from the experts with whom KPIX 5 spoke, the benefits of Sovaldi are remarkable: when compared to conventional treatment, Sovaldi cuts treatment time in half, has fewer side effects, and in some cases, eliminates the need to inject interferon, a drug with debilitating side effects.
"The results were spectacular," said Dr. John McHutchison, a top specialist in liver diseases and Senior Vice-President overseeing liver disease at Foster City-based Gilead Sciences the maker of Sovaldi.
"We're being able to cure many more people with very simple, very short durations of therapy," said McHutchison.
But even though Sovaldi is made by a U.S. company, Americans are likely to pay the highest price for the medication.
Prices in Europe will be lower: the cost for treatment in the United Kingdom is about $57,000; in Germany, the wholesale price is $66,000.
In India, while not yet finalized, the prices are expected to be tiered. Gilead told KPIX 5 that $2,000 is being considered for 24 weeks of therapy for Genotype 3 for public hospitals, community clinics and NGOs.
The price differences and the wholesale price in the U.S. are upsetting to patient advocates in the Bay Area.
"The price is staggering," said pharmacist Steve Bacon.
"Who can really afford to pay for this and will the insurance companies put it on their formularies," said pharmacist Fred Mayer, president of the Pharmacists Planning Service, Inc.
As many Americans are now painfully aware, many insurers now require patients to shoulder higher costs for specialty drugs. Sovaldi is a specialty drug, and that could mean big out-of-pocket expenses and co-payments.
Patients may also be forced to try less optimal treatments first, according to Professor David Magnus, Director of the Stanford Center for Biomedical Ethics.
"That's very frustrating for patients: they've got insurance. They've got a network that's agreed to carry the insurance. They have a disease and it's clear what's the best treatment, but they might not get it thanks to the exorbitant cost," said Magnus.
Gilead believes the pricing for Sovaldi is fair, considering the immense benefits of the drug.
Gilead says Sovaldi may prevent liver cancer, as well as the need for expensive transplants - and that saves money in the long run.
The company also offers financial assistance for patients in need in the form of coupons and also helps connect patients with the Patient Access Network Foundation.
"Very glad my insurance picked it up - man!," said Tom Espinosa.
For Espinosa, Sovaldi may be his last chance. His liver disease is advanced and currently very active. Dr. Sylvestre, who is Espinosa's doctor, said she had to jump through hoops and file mounds of paperwork just to get him the drug.
Because the medicine is so expensive, at this point she'll only prescribe it to patients like Espinosa who have advanced liver disease. If it were cheaper, she would absolutely prescribe it to every one of her Hepatitis C patients, Sylvestre told KPIX 5.
"It's appalling in many ways, but the cost of many medications is appalling." said Sylvestre.
With a free market economy, that won't change anytime soon - no matter how loud the protest.
Baby boomers - Americans born between 1945 and 1965 - are five times as likely to be infected with the virus. Why this is is not completely understood, according to the Centers for Disease Control and Prevention. Many could have gotten infected from contaminated blood and blood products before the widespread screening of the blood supply which began in 1992, the CDC said.
All baby boomers are urged by the CDC to get screened for the hepatitis C virus at least once in their life. Many could be infected and not even know it.
As for specialty drugs, a new report from Express Scripts is sobering: while currently used by 1% of Americans, they account for 25% of all prescription drug costs in the U.S. Experts predict that will soar to 50% in just 5 years.
