Dendreon Corporation (NASDAQ:DNDN) recently announced the Centers for Medicare and Medicaid Services (CMS) updated their coverage policy to cover infusion costs associated with administration of the company’s flagship product, PROVENGE® (sipuleucel-T). This additional billing authorization should help get doctors on board with prescribing the company’s product.
Physician acceptance of Provenge® has been slower than Dendreon First expected and this has hampered the company’s ability to obtain cash flow breakeven. Dendreon has had to lay off 500 workers nationwide and slow production until physician demand catches up with production capacity.
A doctor’s ability to get paid for the drug, as well as for costs of its administration through infusion therapy, has been a hold back on the company’s ability to gain widespread acceptance of the product. This latest government billing authorization, which is retroactive to June 2011, should allow the company to promote further sales of Provenge®, and move even closer to long term success through creation of positive cash flow.
Dendreon’s ability to generate positive cash flow is essential for the survival and future growth of the Seal Beach facility. About 70 staffers were recently laid off at their Seal Beach plant. As doctor acceptance of the product picks up steam, local production can ramp up.
As production expands, the furloughed workers can be rehired. Eventually, increases in product demand will lead to new local jobs.
See related articles below for OC180NEWS continuing coverage of Dendreon Corporation. The remainder of this article is from a company statement, which is solely responsible for the jargon and industry-speak wording.
From a Company Statement:
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.
To fulfill a post marketing requirement and as a part of the company’s ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.
For more information on PROVENGE, please see the full prescribing information at http://www.provenge.com or call 1-877-336-3736.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon’s first product, PROVENGE® (sipuleucel-T), was approved by the FDA in April 2010. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. The Company is headquartered in Seattle, Washington and is traded on the NASDAQ Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com.
(No Ratings Yet)
Loading …
About Dolores Barr, Publisher
Dolores Barr has lived in Rossmoor since 1992 and has created this site to provide local news for the people of Los Alamitos, Seal Beach, Rossmoor, Leisure World, Sunset Beach, and Surfside, California. My husband and I have had two students graduate from the Los Alamitos Unified School District and currently our Grandson, Ricky Apodaca, grade 3 at Weaver Elementary, is actively involved in youth baseball through LAYB and youth football through FNL.
In 
