- Under new deals with generic drug manufacturers, Médecins Sans Frontières says it can buy copycat versions of Gilead Sciences Inc.'s Sovaldi and Bristol-Myers Sqibb Co.'s Daklinza (daclatasvir) for as little as $1.40 a day.
- The Swiss organization, known as Doctors Without Borders in the U.S., will pay $120 for a 12-week regimen of the hepatitis C medications that just two years ago cost the group between $1,400 and $1,800 through the companies' respective patient access programs, according to an Oct. 31 statement.
- The Food and Drug Administration first approved the combination of Daklinza and sofosbuvir, the active ingredient in Sovaldi, in July 2015 for hep C patients with genotype 3 infections. Both drugs are known as direct-acting antivirals (DAAs) and, although older, have the ability to cure more than nine in ten patients with the liver disease.
Hep C drugmakers have painted themselves into a corner. Increased market competition pushed them to craft better products, but those medicines have gotten so good that they're effectively curing the disease — and thereby slashing the number of patients in the developed world who still need treatment.
Unsurprisingly, Gilead has seen sales of its antiviral products slip in recent years, and company executives expect that decline to continue. While those products still brought in $5.8 billion during the third quarter, Sovaldi (sofosbuvir) sales declined 73% year over year to $219 million.
Yet, in addition to smaller sales, hep C drugmakers remain under pressure to increase access to their drugs. In July, for instance, the World Health Organization urged countries to ramp up capabilities for DAA production.
"The revolution in hepatitis C treatment with DAAs has, for the first time, provided an opportunity for widespread scale-up of curative treatment," Gottfried Hirnschall, Director of WHO’s Department of HIV and Global Hepatitis Programme, said in a July 25 statement.
"DAAs have been proven to be safe and effective in clearing the hepatitis C virus from the body, thus preventing life-threatening complications," he added. "As an organization whose recommendations are based on scientific evidence, we will continue to monitor the latest research and country experiences to see if there is any need to change our recommendations on DAAs. Currently there is not."
For its part, Gilead has in the past inked deals with generics manufacturers to make cheaper versions of its drugs available to people in poorer countries. Back in 2014, the company entered non-exclusive licensing agreements with seven such drugmakers located in India to increase hep C treatment access for patients in developing nations.
"What good is a breakthrough medicine that people cannot afford?" Jessica Burry, pharmacist for MSF’s Access Campaign, said in an Oct. 31 statement. "Pharmaceutical corporations price hepatitis C medicines far out of reach for people paying out of pocket around the world, and also for many governments struggling to provide treatment in the public sectors; but the prices for generic versions keep coming down."
To Burry's point, even with the market competition, falling revenues and patient-focused pricing initiatives, big hepatitis drug developers are making hundreds of millions of dollars a year on their products. Gilead's Harvoni (ledipasvir and sofosbuvir) and Epclusa (sofosbuvir and velpatasvir) respectively raked in $973 million and $882 million during the third quarter, while Bristol-Myers' hep C franchise, which includes Daklinza (daclatasvir), Sunvepra (asunaprevir) beclabuvir and Ximency (daclatasvir, asunaprevir and beclabuvir), fetched $73 million for the same period.
"By the end of 2016, three years after sofosbuvir was launched, only an estimated 2.1 million people globally had been treated with the medicines, leaving 69 million people still without access," MSF said in its Oct. 31 statement.
According to WHO, about 71 million people worldwide have chronic hep C and roughly 400,000 die each year from it. The disease is most prevalent in WHO's Eastern Mediterranean Region, where about 2.3% of the population has it.