Liver Meeting '15: AASLD calls out payers on HCV med coverage; WHO's plan to wipe out hep C & B by 2030
SAN FRANCISCO, CA—AASLD's annual Liver Meeting is beginning to wind down. We'll have a final slew of updates for you tomorrow. But in the meantime, here are the biggest and most interesting takeaways from Monday's panel sessions and presentations.
A Gilead/Bristol-Myers combo shows promise in hardest-to-treat HCV patients
Since Gilead changed the game for HCV treatment in 2013, a bevy of pharma companies have been testing out cocktails of their own next-gen hep C medications, often in combination with Gilead drugs Sovaldi and Harvoni.
Bristol-Myers Squibb announced that a combination of its drug Daklinza (daclatasvir) plus Sovaldi and ribavarin produced promising results in a phase 3b study assessing the combo's efficacy in particularly hard-to-treat patients. The study participants were infected with genotype-3 HCV and had advanced fibrosis or liver cirrhosis.
The results? 88% of patients treated with the combo had a sustained virologic response 12 weeks after receiving treatment with the combo. Furthermore, every participant with advanced fibrosis was cured (including those treated for 12 weeks and 16 weeks).
AASLD to payers: Cover every patient's access to next-gen hep C meds
Insurers in the private sector and government payers alike have been waging a pricing battle with companies such as Gilead and AbbVie over the exorbitant prices of their hepatitis therapies. These insurers claim that the price of the drugs place an undue burden on health systems; drugmakers respond that the burden would be much higher over the long run once patients progress to liver failure or cancer.
But the American Association for the Study of Liver Diseases made clear on Monday where it stands on hepatitis drug access: Expand coverage to every single patient, and end the stratification of the afflicted by disease type.
"Over the past 2-plus years, the Food and Drug Administration has approved multiple new treatments for hepatitis C virus (HCV) that offer nearly universal cure rates with minimal side effects," said AASLD in a statement. "It is a remarkable success story for medical science. Unfortunately, many insurers—both private and public—are delaying access to new HCV treatments to patients until their disease has progressed and the liver is further damaged. There is no medical evidence to justify that position and much to justify treating all patients."
The imperative for expanding access isn't necessarily limited to just medical evidence, either. As BioPharma Dive reported earlier this month, federal officials from the Department of Health and Human Services have sent state Medicaid directors letters warning them against blocking access to next-gen therapies like Sovaldi, Harvoni, and Viekira Pak.
HHS asserted that limiting the drugs to those who have proven to abstain from alcohol or progressed to advanced liver disease may, in fact, be illegal under federal law, which requires Medicaid to cover "medically necessary treatments" cleared by regulators.
The WHO plots an ambitious path to near-eradication of hepatitis C and B by 2030
During a presentation and subsequent plenary session on Monday, the World Health Organization's Dr. Stefan Wiktor made a bold claim: That excitement over major recent advances in hepatitis C treatment were beginning to "spill over" into hepatitis B. In fact, the WHO is already preparing plans to try to eliminate viral hepatitis throughout the world by 2030.
The WHO's plan centers on aggressive testing, preventive measures such as vaccinations, and (in middle- and higher-income nations) lowering the cost barriers to next-gen treatments. Wiktor also pointed out that this is a critical mission since the number of deaths from viral hepatitis has reached new highs. The reason? Patients who contracted the virus decades ago are progressing to the final and most deadliest stages of liver disease.
Yet again, cost came up as the primary barrier to eliminating hepatitis in the developed world. And barring more robust patient access programs, there may not be significant progress on that front until 2029, when Sovaldi will finally lose patent protection in the U.S.