The conundrum of hepatitis C is well known. The virus kills more than 20,000 Americans each year, more, according to Centers for Disease Control and Prevention, than the other 60 infectious causes of death combined. A cure is in hand, but is out of reach for many because it costs tens of thousands of dollars per patient. The problem is most acute in state Medicaid programs and prisons, where 700,000 people need treatment but only 20,000 a year will get it. The price controls some have asked for would make treatment affordable, but would also be likely to chill innovation in pharmaceutical companies, the very innovation that benefits society by producing such remarkable drugs.
A recent consensus committee of the National Academies of Sciences, Engineering, and Medicine proposed a novel strategy to improve access to hepatitis C medicines. Their report recommends that the firms producing the hepatitis C treatments compete to license their patent to the federal government for use in neglected patients, such as Medicaid beneficiaries and prisoners. Such a deal would protect the innovator companies’ market share in the lucrative private markets, while allowing the government to save billions of taxpayer dollars and reach more poor patients.
How Would The Deal Work?
Every year roughly 20,000 Medicaid beneficiaries receive hepatitis C treatment. After the mandatory Medicaid discount, these medicines cost about $40,000 per patient. Thus, under the status quo over the next 12 years about 240,000 Medicaid patients will receive treatment, generating roughly $10 billion in revenues for manufacturers. Since these revenues are earned over a 12 year period their worth in today’s dollars is roughly $6.5 billion. Pharmaceutical firms should be indifferent between being paid $6.5 billion today rather than $10 billion over a 12-year period.
A review of recent reimbursement data showed considerable variability in access to direct-acting antiviral therapy based on amount of liver scarring and substance use.
April 20, 2017, Amsterdam, The Netherlands: Data presented today demonstrate that there are considerable restrictions in the reimbursement of direct-acting antiviral (DAA) therapy across European countries, particularly with respect to the severity of liver fibrosis (scarring of the liver) and prescribing by specialists. The study, presented at The International Liver Congress™ 2017 in Amsterdam, The Netherlands, showed that there was evidence that some countries were not following the most recent European HCV treatment guidelines, published by the European Association for the Study of the Liver (EASL) in 2016.
HCV is one of the most widespread transmissible diseases. It can cause both acute and chronic infection, with about 55-85% HCV-infected individuals developing chronic infection. HCV is a leading cause of chronic liver disease, end-stage cirrhosis and liver cancer.4 It is estimated to infect over 71 million people worldwide, of whom 784,000 die each year.5,6 Until the approval of the DAAs, HCV was treated with pegylated interferon and ribavirin, which caused serious adverse effects in more than 80% of patients, and fewer than 50% were able to finish the course of therapy. These new drugs have revolutionised treatment and mean that HCV is now curable, with a cure rate of 95% or higher.7 Although the DAAs are highly effective, they are expensive and unaffordable if prescribed for all patients.1 Most countries therefore limit access to these drugs.
After shooting meth put her in a Missouri hospital with six days of bleeding, Heather Surface stumbled out into the January cold last year, still drug-addicted, homeless and unaware that she had a dangerous liver infection.
Two weeks later at a rehab center, she met Bruce Burkett, a wispy-bearded Army vet who’s part social worker, part public health crusader, and a boon to drugmakers for his work in finding patients who need costly, powerful treatments for the viral liver infection hepatitis C.
Burkett specializes in lining up testing and treatment for patients, and most of his work is funded by companies including Gilead Sciences Inc., AbbVie Inc. and Merck & Co.that have sold almost $50 billion of the new antivirals since they began hitting the market in 2013. Stiff competition has driven prices down and discounts up, and many insured patients have already been treated. That’s been bad news for the market leader, Gilead, which must increasingly find patients through the social service networks that target drug users and the poor. Many patients don’t even know they have the infection, which can take years to show symptoms.
MONTPELIER, Vt. (AP) — The non-profit Vermont Legal Aid is working to make it easier for people suffering from Hepatitis C to get curative treatment under Vermont’s Medicaid system.
Vermont Public Radio reports the legal aid group has taken up the case of a Vermont woman who was denied Hepatitis C treatment under the program because her liver isn’t yet damaged enough. VPR did not use the woman’s name. Vermont legal Aid is helping the woman appeal her coverage denial.
Vermont’s Medicaid program requires people to be in the late stages of liver damage before they qualify for treatment.