She has a patient like Walter Bianco - a 65-year-old woman whose severe liver damage puts her on the edge of liver failure.
Graham believes her patient's best chance at cure lies in the use of both Sovaldi and Olysio. "We have about 160 people who were studied in a clinical trial called COSMOS that showed a very high cure rate - 90 to 100 percent - for even the most difficult-to-treat patients with this combination," she says.
But, as in Bianco's case, the Medicare's drug-benefit contractor that covers this patient has refused to approve payment.
The apparent reason is that the Food and Drug Administration has not yet approved use of the two drugs in combination. (On May 7, Olysio's maker, Janssen Therapeutics, asked the agency for such approval.)
But Graham notes that in the early days of successful antiviral drug treatment for HIV, payers allowed doctors to "mix and match" medications in "off-label" or unapproved combinations as they thought best.
"Medicare has been slower to adopt off-label combinations than most of the other insurance plans," Graham says.
Medicare officials wouldn't comment on coverage of new hep-C drugs. A spokesman wrote in an email that the federal program turns such decisions over to private insurers that administer its drug plan, called Medicare Part D.
However, advocates say Medicare officials are well aware of the program's looming exposure to the enormous costs of treating hep-C. Some say it could run in the tens or hundreds of billions of dollars, though it's not clear over what period of time.
One thing likely to accelerate demand for treatment: Medicare is expected to approve payment for routine blood tests for hep-C infection soon. That will reveal many people who don't yet know they're infected - and spark difficult conversations between patients and doctors on when to use the expensive new medications to clear the virus from their blood.
Many hepatitis specialists and patient advocates are worried that the cost of the drugs will lead payers to limit access to patients who already have advanced liver disease, or even more narrowly, those who are on transplant waiting lists.
"We're very scared that these programs to limit access to treatment could interfere with our goals of trying to find people with hepatitis C," Graham says.
Ryan Clary of the National Viral Hepatitis Roundtable, a patient advocacy group, says public health may be on a collision course with treatment and reimbursement policy.
"On the one hand, we're saying 'Now is the time to be tested for hep-C. There are these promising treatments,'" Clary says. "But on the other hand, we're saying 'You can't have access to these cures. It'll bankrupt the country.' So where's the incentive to test?"
Apart from expensive drug treatment aimed at cure, doctors say there are other good reasons for identifying infected patients. They can be counseled to stay away from alcohol, which accelerates hep-C related liver damage. They can also be told about steps to take to avoid infecting others.
Fri, May 09 2014