The Washington Post this week wrote again about the Centers for Medicare & Medicaid Services review of whether the federal government insurance program will reimburse patients who receive Provenge -- and if so under what circumstances and for how much. The national coverage review has been controversial since it was announced -- as patient advocacy groups for prostat cancer have repeatedly pointed out that Medicare is not supposed to take cost into consideration when determining coverage.
As a reminder, Provenge was approved for use in late stage prostate cancer patients by the FDA in April. Provenge costs $93,000 per patient treated and on average is expected to extend survival by 4 months. Therefore, Provenge has a QALY (quality of life for 1 year) of $272,000 - the 4th highest among cancer drugs. Drug companies and cancer experts are concerned that if Medicare makes an independent decision on which drugs will be used after FDA approval - it will effectively amount to a "second approval" that drug companies need to navigate. This may cause drug firms to shy away from the cancer area with new innovative therapies. Private insurers tend to follow Medicare's lead so the Medicare decision can have a huge impact on a drug's availability based on the reimbursement policy adopted.
The counter argument is that society can't pay for everything and that choices need to be made. The fear is that if we keep paying for high priced treatments with marginal clinical benefit (and we can debate what 4 months is worth to a dying man or woman), then we won't be able to afford health care. The debate rages on and the Provenge decision by Medicare needs to be closely watched.
Fierce Biotech reports today that Bavarian Nordic is close to announcing that it's found a "big pharma" partner to fund phase III clinical trials for its prostate cancer vaccine called Prostvac. Analysts have pegged Prostvac as a potential strong competitor with Dendreon's Provenge. The Bavarian Nordic drug more than doubled Provenge's survival rate in phase II trials (only phase II though), and also bettered survival with J&J's abiraterone by 3.9 months on average. Bavarian Nordic may be able to cash in with a royalty stream in excess of 25% with its partner. Bavarian Nordic has experienced a very tough revenue year so they could use the success.
Posted by Bruce Lehr November 9th 2010.
That's sad news for those who are using the same treatment mentioned above. Thanks for the information though.
Posted by: treat prostate cancer naturally | 11/11/2010 at 10:28 PM
It's interesting, I listened to the same webcast live early this morning.
While the company did indeed say that they were talking to potential partners, including some in Top 10 pharma, that is never any guarantee that a deal will be made in the near term.
There is no guarantee that promising phase II results will translate to positive phase III data either, especially in oncology.
What Bavarian Nordic do potentially offer over Dendreon's Provenge in the long run is a more streamlined mass market manufacturing process and a global phase III program. They suggested this morning that the new trial potentially starting in 2011 (assuming SPA agreement from the FDA is forthcoming) will be 60:40 for ROW:US, thus broadening access and appeal for a global company interested in active partnering.
Posted by: Account Deleted | 11/09/2010 at 03:11 PM