The Centers for Medicare and Medicaid Services may consider setting formal parameters around Medicare coverage for Dendreon's ground-breaking prostate cancer vaccine Provenge next year following a national coverage analysis.

Provenge (sipuleucil-T) was approved by FDA in late April for asymptomatic or minimally symptomatic prostate cancer that is metastatic and resistant to standard hormone treatment. The vaccine is the first approval in a new class of autologous cellular immunotherapy treatments.

In an unusual move for a newly-approved drug, the agency announced a national coverage analysis June 30. The analysis is scheduled to be completed June 30, 2011. From there, CMS will decide whether to proceed to a national coverage determination that would set a uniform Medicare coverage policy, potentially with some restrictions, for Provenge. NCDs are binding on all local Medicare carriers and other fiscal intermediaries.

MedCAC Meeting In 2010

As part of the coverage analysis, CMS is requesting public comments on the effects of Provenge on health outcomes in patients with prostate cancer. The agency will also commission an outside technology assessment and a review by the Medicare Evidence Development and Coverage Advisory Committee. The MedCAC meeting will be held in 2010.

CMS does not specify its reasons for opening the NCA, but notes it has received "informal inquiries" - reportedly from local carriers - "for a national coverage determination for autologous cellular immunotherapy treatment for prostate cancer. This interest arose upon the recent FDA approval" of Provenge.

"We are opening this national coverage analysis to determine whether or not autologous cellular immunotherapy is reasonable and necessary" treatment for Medicare patients, the agency states.

The announcement was surprising to many analysts given the vaccine's strong endorsement by the National Comprehensive Care Network in its clinical standards guidelines. NCCN recommends Provenge as a salvage therapy in patients with castration-resistant, recurrent prostate cancer. The therapy received the organization's highest rating - Category 1 - which signifies uniform agreement among experts based on a high level of evidence (Also see "Provenge Poised For Broad Insurance Coverage, Despite Grumbles On Price" - Pink Sheet, 24 May, 2010.).

That $93,000 Price Tag

Although the cost effectiveness of therapy is not supposed to be part of the "reasonable and necessary" determination for Medicare coverage, there is widespread speculation that the vaccine's unexpectedly high cost is of concern to CMS. Provenge is priced at $93,000 per patient per year, which exceeded analysts' predictions Also see "Dendreon Readies For Next Provenge Hurdles: Supply And Reimbursement" - Pink Sheet, 3 May, 2010.). The price is based on the survival benefit offered by the treatment, according to the company.

In the pivotal clinical study supporting the drug's approval, known as IMPACT, median survival for those receiving Provenge was 25.8 months, compared to 21.7 months in the control group. Dendreon used that 4.1 month survival benefit as the basis of the price, which the company has claimed is comparable to other late-stage oncology treatments.

In Medicare-age study subjects (older than 65), the survival benefit was even longer - 6.1 months.

Dendreon has also pointed out that unlike other cancer treatments, additional costs for supportive care are minimal with Provenge. Including related costs, Sanofi-Aventis' Taxotere , the standard of care, costs $60,000 per patient but offers only a 2.9 month survival benefit, according to the firm.

The safety of Provenge is not viewed as a major concern, though Dendreon has committed to a post-market surveillance registry of 1,500 patients to evaluate the potential for an increased risk of stroke associated with the vaccine. In clinical trials on the therapy, cerebrovascular events were found in 3.5 percent of patients in the treated group, versus 2.6 percent in the control arm.

In a statement on the NCA, Dendreon said it "welcomes this opportunity to continue our discussions with CMS about how Provenge will be provided to Medicare beneficiaries, particularly given the survival benefit and safety profile" of the therapy. "We plan on continuing to work closely with CMS during this process to ensure patients with advanced prostate cancer have broad access."

In the first day following the CMS announcement, more than 80 comments had been filed by patients and health care providers in support of broad access to Provenge under Medicare. The deadline for comments is July 30. CMS will release a proposed decision memo by March 30, 2011.

- Cathy Kelly (c.kelly@elsevier.com)

Is Provenge "Reasonable And Necessary"? CMS Analysis For Medicare Coverage Seeks To Find Out

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