Medicare Already Paying for Provenge for Some Patients

National coverage analysis still important

Nick Mulcahy

January 06, 2011

January 6, 2011 — Back in the fall of 2010, the Centers for Medicare and Medicaid Services (CMS) had a problem: their phone lines for an important presscast were at full capacity.

As a result, there was a waiting list of 40 journalists who wanted to listen to the presscast of a federal panel's review of data on Provenge, the prostate cancer vaccine known generically as sipuleucel-T (Dendreon).

Provenge was approved by the US Food and Drug Administration (FDA) in the spring of 2010 for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer. However, CMS has not finally determined if, and to what extent, CMS will pay for its use nationally.

Treatment with Provenge costs a reported $93,000, an eye-popping number, especially in an age of heightened scrutiny of federal spending. But it is also a number that is line with other high-cost — some say unsustainably expensive — cancer treatments with comparable survival benefits. Hence, the CMS panel's review of Provenge sparked widespread media interest.

The panel, known as the Medicare Evidence Development and Coverage Advisory Committee (MedCAC), met on November 17 and voted on the quality of the evidence supporting the novel therapy. In the end, the committee gave what amounted to a middling vote of confidence for the on-label use of Provenge and a rejection for off-label use.

The 40 or so journalists shut out of the day-long presscast received a fast email from CMS afterward, with a tally of the MedCAC votes, and therefore were able to report on this step of the CMS coverage review of Provenge.

However, what did not make any headlines that day was this: CMS had already agreed to pay for Provenge.

That is, local Medicare Administrative Contractors had already made coverage determinations about Provenge. All of the 15 contractors, which establish regional Medicare payment policies, and review and pay out claims, have policies on Provenge, according to a spokesperson for Dendreon. However, the company did not say how many of the 15 are actually paying out claims at this point. But the company did confirm that Medicare has paid and is paying for Provenge.

Clinicians Pursuing Provenge

The CMS National Coverage Analysis, which the MedCAC review is a part of, will eventually override these regional decisions, according to a CMS spokesperson. In other words, there will eventually be a single Medicare policy about Provenge.

In the meantime, clinicians can approach their local Medicare Administrative Contractor to learn about its policy.

Medscape Medical News found out, for example, that Highmark Medicare Services, which covers Delaware, the District of Columbia, Maryland, New Jersey, and Pennsylvania, provides coverage for Provenge. The coverage is "limited to men whose clinical condition conforms to the FDA coverage definition of documented hormone-refractory disease, and whose records demonstrate an absence of symptoms related to the patient's documented metastatic disease." Their full coverage policy is online.

Whether or not there are payment limitations for Provenge, the vaccine is still in the early stages of coming to market and has limited availability, according to company material.

When it was approved by the FDA in 2010, Dendreon said that they could only treat 2000 men in the first year because of manufacturing limitations.

Provenge, which is designed to induce an immune response targeted against antigen expressed in most prostate cancers, has a recommended course of therapy of 3 complete doses, given at intervals of approximately 2 weeks. However, there is a multistep process that involves the patient in the manufacture of the vaccine.

On day 1 of the manufacturing process, a patient has blood drawn at a clinic, and autologous antigen-presenting cells are obtained using a standard leukapheresis procedure. The antigen-presenting cells are then couriered to the manufacturing facility.

On day 2 or 3, the antigen-presenting cells are cocultured with a recombinant fusion protein containing prostatic acid phosphatase, and the resulting Provenge is then couriered back to the clinic.

On day 3 or 4, the patient is infused with the therapy, which "can potentially stimulate a T cell response against prostate cancer cells," according to the company.

Not a Home Run

At the time of Provenge's FDA approval, Medscape Medical News spoke with prostate cancer expert Richard Greenberg, MD, who was less than overwhelmed with Provenge.

"It's not a home run," said Dr. Greenberg, who is chief of urologic oncology at the Fox Chase Cancer Center in Philadelphia, Pennsylvania.

Dr. Greenberg did not find the improvement in survival to be dramatic. "The median improvement in survival was about 4 months, compared with placebo. That's not insignificant, but it's not a big change in the treatment of metastatic prostate cancer."

The survival benefit with Provenge is not that much greater than that with the most frequently used treatment in this setting, docetaxel (Taxotere, Sanofi-Aventis), he pointed out. Docetaxel and prednisone provided a 2.4-month survival advantage, compared with mitoxantrone and prednisone, in men with metastatic castrate-resistant prostate cancer (N Engl J Med. 2004;351:1502-1512).

On the positive side of things, Dr. Greenberg noted that Provenge is less toxic than the other treatment option for this group of men — chemotherapy.

The best candidates for treatment are "appropriately selected" men — those with "good performance status" and a "low volume of bone involvement," he explained. "Those are the patients who do best with this treatment."

"Not every patient with metastatic castration-resistant prostate cancer needs to be on Provenge," he pointed out.