WASHINGTON (Reuters) ? The Medicare and Medicaid federal health insurance programs will fully cover Provenge, Dendreon Corp's expensive treatment for advanced prostate cancer, U.S. regulators said.
The U.S. Centers for Medicare and Medicaid (CMS) ruled on Thursday that there is adequate evidence to pay for Provenge and it is "reasonable and necessary" for treating men with advanced prostate cancer whose disease has spread.
Medicare coverage of Provenge, a novel cancer vaccine that costs $93,000 for a course of treatment, is of critical importance since the disease strikes mostly older men.
The Medicare federal health insurance program covers those aged 65 and older along with the disabled, and about 40 percent of its 46 million enrollees are men. Medicaid covers the poor and disabled.
Shares of Dendreon rose to $40.89 after hours after the CMS confirmed its March proposal to fully cover the drug. The stock closed at $39.44 on Nasdaq.
The agency also said there is "insufficient evidence" for so-called "off-label" use of the vaccine treatment, but it left the final decision on such coverage to its local Medicare insurance companies. Off-label refers to uses not approved by the Food and Drug Administration.
Provenge, which in clinical trials extended median survival by 4.1 months, is currently being studied in patients with earlier-stage prostate cancer.
Analysts have said they expect Medicare's decision to help streamline the reimbursement process for the vaccine, which right now varies region to region.
Sales of Provenge have been held back by supply contraints. That problem should be alleviated by the FDA approval on Wednesday of a Los Angeles manufacturing plant, which follows an April decision to approve expanded capacity at Dendreon's New Jersey facility.
A third plant in Atlanta is expected to get a regulatory nod later this year.
A nationwide payment policy will offer the company and investors some certainty when it comes to reimbursement issues. And Medicare coverage also could encourage more private insurers to follow suit.
Aetna Inc, Humana Inc and other health insurers already have agreed to pay for the vaccine, which does not prevent cancer but stimulates a patient's immune system to fight the tumors.
The insurance decision also could eventually affect rivals that are developing other therapeutic cancer vaccines.
The U.S. Food and Drug Administration approved Provenge, also known as sipuleucel-T, last year for certain men with advanced prostate cancer, and a CMS panel recommended the drug for coverage in November.
Dendreon has said Provenge's high price tag reflects a unique manufacturing process where patient tumor cells have to be extracted then sent to the company to incorporate them into a vaccine.
Provenge could generate more than $2 billion in global sales by 2015, according to analyst forecast data from Thomson Reuters.
Nearly 218,000 U.S. men will be diagnosed with prostate cancer this year, according to the National Cancer Institute, although not all those men will either qualify for Provenge or be enrolled in Medicare.
(Reporting by Anna Yukhananov; additional reporting by Bill Berkrot in New York; editing by Carol Bishopric)
the strokes pearl harbor periodic table finding nemo amy smart act test speed tv
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.