The government is expected to introduce two significant new policies this week in emerging areas of health care, one on whether Medicare will pay for a $93,000 cancer drug treatment, and the other on rules that may affect hospitals, insurers, doctors and patients in accountable care organizations set up under the new health care law.
The cancer drug in question is Provenge, from Dendreon, a vaccine that stimulates the body’s immune system to attack cancer cells. It was proven to extend the lives of some advanced prostate cancer patients by a median of 4.1 months, to 25.8 months.
Dendreon has priced the drug at $93,000 for three infusions, which it says is in line with other cancer drugs per month of added life. The Centers for Medicare and Medicaid Services is scheduled to announce by Wednesday its coverage.
Medicare could limit uses of Provenge to only those patients that the company has proved would benefit and refuse to pay for broader, so-called off-label uses. The drug is proven in men with advanced prostate cancer who do not respond to hormone treatment but who have minimal or no symptoms.
Medicare is due to reveal its proposed decision by Wednesday, with a final ruling to come by June 30. Some private insurers have already agreed to pay for the vaccine, which was approved by the Food and Drug Administration in April, 2010.
This decision has broader implications as Medicare decides how to pay for very high priced drugs for older Americans, and also because Provenge is the first in a new class of drugs known as active cellular immunotherapies.
The rules for Medicare accountable care organizations, or A.C.O.’s, have no definite deadline. They have been delayed since January.
But on March 11, Kathleen Sebelius, secretary of health and human services, told reporters the draft rules would be announced within two weeks — a period that ends Friday.
A.C.O.’s would provide joint responsibility for patient health to teams of doctors and hospitals and share the financial benefits of good treatment. But those incentives pose complex issues. The government may have to revise fraud and antitrust laws to allow hospitals, insurers and doctors some pricing flexibility. There will be a long period for public comment after draft rules are published.
And there is some possibility the budget battle on Capitol Hill will delay the rules further.
Congress returns to work this week amid talk of wars and spending cuts. Medicare and Medicaid are being discussed in closed-door negotiations between Democrats and Republicans as Congress faces the threat of an April 8 government shutdown if a spending plan is not agreed by then.
In other political news, the health and oversight subcommittees of the House Ways and Means Committee have scheduled a hearing Friday over AARP’s insurance business. AARP, formerly known as the American Association of Retired Persons, plays a big role lobbying over government policies and also obtains much of its budget from insurance it recommends to older Americans.
“This hearing is about getting to the bottom of how AARP’s financial interests affect their self-stated mission of enhancing seniors’ quality of life,” Wally Herger, the California Republican who chairs the health subcommittee, said in a statement. “It is important to better understand how AARP’s insurance business overlaps with its advocacy efforts and whether such overlap is appropriate.”
Wednesday marks the start of the annual meeting of the European Association for the Study of the Liver, in Berlin. The investment house Leerink Swann said in a note to investors on Monday that important results are expected for Bristol-Myers Squibb’s interferon-free and ribavirin-free direct antiviral agent, which “could greatly expand the market for agents for hepatitis C. “
There are no F.D.A. advisory committee meetings this week related to drugs or medical devices. There is a meeting on Wednesday and Thursday on the effect of food color additives on children’s behavior.
Let us know anything important we may have missed for the week ahead.
