Medicare to Cover Infusion for Dendreon's Provenge

Dendreon Corporation DNDN +1.72% today announced the Centers for Medicare and Medicaid Services (CMS) updated their coverage policy to now cover the infusion costs associated with the administration of PROVENGE(R) (sipuleucel-T). With this decision, the coverage of PROVENGE is now consistent with all other infused biologics.


CMS has issued two new transmittals that instruct the local Medicare Administrative Contractors (MACs) that the costs associated with administering PROVENGE will now be covered and can be billed separately. Additionally, the CMS decision will retroactively cover claims for costs associated with the administration of PROVENGE effective for dates of service on or after June 30, 2011, allowing physicians to collect for all previous infusions.


CMS issued a final National Coverage Decision (NCD) for PROVENGE on June 30, 2011, requiring Medicare contractors to cover the use of PROVENGE for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. The NCD standardized coverage processes across the country for all Medicare patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer and provided the local Medicare Administrative Contractors (MACs) specific criteria, consistent with the label, on how PROVENGE should be covered.


Since the issuance of the final NCD and the activation of a PROVENGE specific Q-code, which accelerates electronic adjudication of claims, the reported average time to payment for physicians is approximately 30 days.


Physicians with questions regarding securing payment related to past PROVENGE infusions can contact the PROVENGE call center, Dendreon ON Call, at 1-877-336-3736 for additional information.


PROVENGE Indication and Safety PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.


PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.


The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence greater-than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.


The Seattle-based company said that under the updated coverage policy, the costs associated with administering Provenge can now be billed separately.


Provenge costs about $93,000 for a standard course of treatment. Physicians are reimbursed $125 per infusion, on average, for biologic drugs, depending on geographic location and the length of the infusion, said Katherine Stueland, a spokeswoman for Dendreon.


The CMS decision covers claims for infusion costs of Provenge retroactive to June 30.


Provenge is a new type of cancer treatment that uses cells from a patient's own body to treat the disease.