PROVENGE Experience

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). It is the first FDA-approved immunotherapy for prostate cancer.

PROVENGE is made by culturing a patient’s own immune cells with a recombinant antigen^a that is prostate specific. When infused into the patient, PROVENGE activates T cells to target and attack prostate cancer cells.

^aThe recombinant antigen used to make PROVENGE is called PAP-GM-CSF. It consists of prostatic acid phosphatase (PAP), an antigen expressed in more than 95% of prostate cancers, and granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune cell activator.

Reference: PROVENGE [prescribing information]. Seal Beach, CA: Dendreon Pharmaceuticals LLC; 2017.

In mCRPC patients who are asymptomatic or minimally symptomatic, clinicians may offer sipuleucel-T. In sequencing agents, clinicians should consider prior treatment and consider recommending therapy with an alternative mechanism of action (Evidence Level: Grade B).

Reference: Cookson MS, Roth BJ, Dahm P, et al. Castration-resistant prostate cancer: AUA guideline. J Urol . 2013;190(2):429-438. doi:10.1016/j.juro.2013.05.005

The current evidence-based recommendation for the use of sipuleucel-T (PROVENGE) in the management of mCRPC in asymptomatic or minimally symptomatic patients is supported by Level A evidence from randomized trials and meta-analyses. Sipuleucel-T (PROVENGE) may achieve greater benefit among mCPRC patients treated earlier in the course of the disease.

Reference: McNeel DG, Bander NH, Beer TM, et al. The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of prostate carcinoma. J Immunother Cancer . 2016;4:92. doi:10.1186/s40425-016-0198-x

The US Food & Drug Administration approved PROVENGE on April 29, 2010.

PROVENGE is manufactured by Dendreon Pharmaceuticals, LLC, headquartered in Seal Beach, California. Dendreon is a commercial-stage biopharmaceutical company and pioneer in the development of treatments that harness the power of the immune system to extend life. Dendreon’s flagship product, PROVENGE^® (sipuleucel-T), was the first FDA-approved immunotherapy to be made from a patient’s own immune cells. Nearly 40,000 men with advanced prostate cancer have been prescribed PROVENGE in the United States since 2010. For more information, please visit www.dendreon.com.

Immunotherapy is a treatment that empowers the immune system to identify and fight foreign substances such as cancer and other diseases. PROVENGE is a personalized immunotherapy for men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). PROVENGE is made by culturing a patient’s own immune cells with a recombinant protein that is prostate specific. When infused into the patient, PROVENGE activates resting T cells to target and attack prostate cancer.

Reference: PROVENGE [prescribing information]. Seal Beach, CA: Dendreon Pharmaceuticals LLC; 2017.

On this website, you can find information about PROVENGE survival data, mechanism of action, and safety profile.

A PROVENGE treatment brochure and video were created for men who are considering treatment with PROVENGE. Your patients may find it helpful to review the brochure with you or a member of your staff. You may also direct your patients to the PROVENGE website for patients.

DOWNLOAD THE PROVENGE TREATMENT GUIDE

PROVENGE has been clinically proven to extend life for certain men with mCRPC and data suggests that men who receive PROVENGE when their PSA level is low may live even longer.

The most common side effects of PROVENGE are generally mild to moderate and well tolerated. In IMPACT, the pivotal clinical trial, 1.5% of patients discontinued treatment with PROVENGE due to adverse events.¹

IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.¹

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.¹

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.¹

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE have not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.¹

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.¹

^{Adverse events experienced by patients receiving PROVENGE can generally be managed in the outpatient setting. PROVENGE does not require dosage adjustments, monitoring of liver/kidney functions, or concomitant steroids.}

Reference: 1. PROVENGE [prescribing information]. Seal Beach, CA: Dendreon Pharmaceuticals LLC; 2017.

Leukapheresis is a cell-collection procedure performed at a local blood center. During a leukapheresis procedure, blood is drawn from a patient and is passed through a machine that removes a small portion of immune cells, along with some platelets and red blood cells. The machine returns the rest of the blood to the patient.

Prior to the first leukapheresis procedure, a venous assessment must be conducted by the prescribing practitioner to determine whether the patient’s veins can accommodate the procedure. If they cannot, placement of a central venous catheter (CVC) may be necessary. In IMPACT, the pivotal clinical trial for PROVENGE, 23% of patients received CVCs. ¹

Following leukapheresis, the immune cells will be sent to a Dendreon manufacturing facility to be made into a dose of PROVENGE for the patient. Once the personal dose of PROVENGE is completed, it is transported to the patient’s local infusion center and infused back into the patient.

The autologous treatment cycle occurs 2 additional times over the course of about a month.

Reference: Data on file. Dendreon, LLC.

PROVENGE is widely covered by Medicare and by private insurance.

^aYour Dendreon Reimbursement Account Manager can offer support via submission of a Letter of Medical Necessity to help override restrictions.

In addition, Dendreon provides support services to help facilitate treatment with PROVENGE. These services focus on patient assistance, supporting the reimbursement process, and product support.

Dendreon On Call (DOC) is a resource for healthcare professionals seeking to use PROVENGE for their patients. DOC reimbursement coordinators and Dendreon Corporate Account Managers provide support with the reimbursement process, and local Reimbursement Account Managers are available.

• Patient enrollment, to ensure accuracy and minimize delays
• Benefits verification
• Prior authorization criteria support
• Claims appeal support

Learn more about PROVENGE reimbursement resources here, or call Dendreon On Call at 877-366-3736.

References:

1. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Autologous Cellular Immunotherapy Treatment (110.22). Accessed May 11, 2020. https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx?
2. Data on file. Dendreon Pharmaceuticals, LLC.

Dendreon is committed to helping every patient who is eligible for treatment with PROVENGE.

Contact Dendreon On Call to learn more about:

• Valuable patient assistance programs
• Support for patients covered by Medicare
  • Refers patients to an appropriate independent foundation that may provide support for a range of financial needs<sup>a
    
    Eligibility is determined by the individual foundation</sup>
• Co-pay assistance
  • Commercially insured patients may be eligible to access PROvide^TM, which provides coverage of up to $10,000 for treatment with PROVENGE<sup>b
    
    Eligibility for PROvideTM commercial co-pay assistance is determined by Dendreon. Check with individual foundations for eligibility criteria</sup>
• Support for uninsured or rendered uninsured patients^c
  _{Eligibility criteria are determined by Dendreon}

^a Co-pay and travel assistance foundations provide assistance regardless of the choice of medicine, and decisions are based on financial need and according to criteria established by the individual foundations. Dendreon On Call can provide a list of independent organizations. Dendreon cannot guarantee that patients will be eligible for or receive assistance after referral. Dendreon does not have control or managerial influence over these independent organizations.

^bThe PROvide^TM Commercial Co-pay Program provides flexible coverage of up to $10,000 over 3 PROVENGE treatments for co-pays, co-insurance, and deductible costs. Eligibility criteria can be changed or program can be discontinued at any time at the sole discretion of Dendreon. Patients with government-funded insurance including Medicare, Medicare Part C, Medicaid, or TRICARE are not eligible for the PROvide^TM Program. Additional terms and conditions apply.

^cContact Dendreon On Call at 877-336-3736 for eligibility criteria. Uninsured patient assistance program eligibility criteria can be changed or program can be discontinued at any time at the sole discretion of Dendreon.

^dIn the event an eligible patient’s claim for coverage for PROVENGE is denied by his payer after all appeals, the cost of the drug may be covered by Dendreon’s patient assistance program.

Once you initiate enrollment, Dendreon On Call will complete benefits verification and patient assistance eligibility checks within 48 business day hours.^a

^aMissing information may delay the 48-hour turnaround.

Help your patients in their fight against advanced prostate cancer by becoming a PROVENGE Treatment Center and that can administer PROVENGE treatments to patients.

When you become a PROVENGE Treatment Center, Dendreon, the makers of PROVENGE, will:

• Provide comprehensive support services throughout the course of therapy for you, your practice, and your patients
• Help support the insurance and reimbursement process
• Assist with scheduling procedures
• Provide detailed training and ongoing product support

Visit Dendreon On Call online or call 877-336-3736 to learn more.

PROVENGE is indicated for men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).¹

Consider PROVENGE if your patient¹:

1. Has progressed below testosterone levels of >50 ng/dl
2. Has confirmed metastatic disease
3. Does not take narcotics for cancer-related pain

References:

1. PROVENGE [prescribing information]. Seal Beach, CA: Dendreon Pharmaceuticals LLC; 2017.

PROVENGE works differently from other cancer treatments such as chemotherapy or hormone therapy. Unlike other treatments, PROVENGE may not lower PSA level.

Reference:

1. PROVENGE [prescribing information]. Seal Beach, CA: Dendreon Pharmaceuticals LLC; 2017.

Treatment with PROVENGE can be completed in 6 appointments over the course of about 1 month.