Fri, May 02 2014
Simple math illustrates the challenge facing U.S. taxpayers, consumers and insurers following the launch late last year of two expensive new drugs to treat hepatitis C.
If all 3 million people estimated to be infected with the virus in America are treated at an average cost of $100,000 each, the amount the U.S. spends on prescription drugs would double, from about $300 billion in one year to more than $600 billion.
That prospect has inspired an unusually blunt public debate: Should expensive treatments – one new drug costs $1,000 a pill -- be limited only to the sickest patients, or is it appropriate to treat all who want the drugs immediately? And should those in taxpayer-funded programs have the same access?
“These are, at their core, ethical fights,” said Arthur Caplan, director of the division of bioethics at New York University Langone Medical Center.
The issues are especially contentious because the drugs, Sovaldi by Gilead Sciences and Olysio by Janssen Therapeutics, are an advance in treatment and offer a cure for many people; they are not just medicines that ease symptoms or extend life for a few months.
“The more definitive the cure, the closer we are to asking, ‘What’s the value of a human life?’” said Tony Keck, director of Medicaid in South Carolina where the treatments are being covered case by case.
This is not an isolated predicament. Already, specialty drugs account for less than 1 percent of all prescriptions but more than a quarter of spending. Other high-cost specialty medicines in the pipeline include treatments for high cholesterol and diabetes, which affect tens of millions of people.
"This is the tip of the iceberg,” said Steven Pearson, president of the nonprofit Institute for Clinical and Economic Review, which analyzes the effectiveness of new treatments. “We have about a year or two as a country to sort this out” before more specialty drugs hit the market.
Different Groups, Different Guidelines
For now, though, the question is how broadly public and private insurers will make the hepatitis drugs available.
As they draft their guidelines, many are considering recommendations from expert groups.
Early this year, a panel from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America said the new drugs should be the preferred treatments for most of those infected with virus. The 28-member group, a majority of whom received drug industry financing directly or through their research institutions, did not set any criteria for which patients should get the treatment first.
“We just put down the best regimen for the individual,” said Gary Davis, a hepatitis expert and panel co-chairman. “We recognize cost issues are really important, but we are clinicians, not the people who should be addressing that.”