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Content for access and reimbursement - inpatient - before accordion

Pfizer Oncology Together wants to help you and your staff find solutions for access and reimbursement issues that may arise. We assist with handling benefits verification, offering prior authorization and appeals assistance, and coordinating with specialty pharmacies.
Select Clinical Setting

Inpatient

BILLING AND CODING ASSISTANCE

See below for codes you may need when coding for BESPONSA in an inpatient setting.*

National Drug Code (NDC)

Product Name

BESPONSA

(inotuzumab ozogamicin)

NDC (11-digit format)

NDC 00008-0100-01

Description

0.9 mg single-dose vial

Route of Administration

Intravenous infusion

Accordion for Inpatient

Code
Description
J9999
Not otherwise classified (NOC), antineoplastic drugs
J3490
Unclassified drugs
J3590
Unclassified biologics
C9399 (Medicare)
Unclassified drugs or biologics
Code
Description
0636
Drug requiring detailed coding (Medicare or if required by payer)
0260
General Classification (IV Therapy)
0280
General Classification (Oncology)
Code
Description
3E0330M
Introduction of Monoclonal Antibody into Peripheral Vein, Percutaneous Approach
3E0430M
Introduction of Monoclonal Antibody into Central Vein, Percutaneous Approach
3E03305
Introduction of Other Antineoplastic into Peripheral Vein, Percutaneous Approach
3E04305
Introduction of Other Antineoplastic into Central Vein, Percutaneous Approach
Code
Description
C91.00
Acute lymphoblastic leukemia not having achieved remission
C91.01
Acute lymphoblastic leukemia, in remission
C91.02
Acute lymphoblastic leukemia, in relapse
Z51.11
Encounter for antineoplastic chemotherapy

Content for access and reimbursement - inpatient - after accordion

*The information provided here is intended for informational purposes only, and is not a comprehensive description of potential coding requirements for BESPONSA. Coding and coverage policies change periodically and often without warning. The healthcare provider is solely responsible for determining coverage and reimbursement parameters and accurate and appropriate coding for treatment of his/her own patients. The information provided in this section should not be considered a guarantee of coverage or reimbursement for BESPONSA.

DOWNLOAD THE SAMPLE UB-04/CMS-1450 FORM FOR HOSPITAL INPATIENT USE

ORDERING BESPONSA (inotuzumab ozogamicin)

Pfizer has made BESPONSA available through a network of specialty distributors and one specialty pharmacy.

Specialty Distribution Partners
Customer Service Number
Website
Item Number
ASD Healthcare
Item Number : 49307
Biologics Specialty Pharmacy
Item Number : --
Cardinal Health Specialty Solutions
Item Number : 5390364
McKesson Plasma and Biologics
Item Number : 3700093
McKesson Specialty Health Solutions
Item Number : 5007354
Oncology Supply
Item Number : 49307
Smith Medical Partners
Item Number : 5680723

FIELD REIMBURSEMENT SUPPORT

If you need additional assistance or support in your office, we can put you in touch with a local Pfizer Field Reimbursement Manager (FRM) who is trained to address specific access and reimbursement issues.

(Monday–Friday 8 am–8 pm ET)

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Content for access and reimbursement - outpatient - before accordion

OUTPATIENT or PHYSICIAN's OFFICE

BENEFITS
VERIFICATION

We Help determine available coverage Pfizer Oncology Together can conduct a benefits verification to determine your patient's health insurance coverage, including co-pay responsibility and other out-of-pocket costs for BESPONSA.

Enrollment form
Fax a completed enrollment form to 1-877-736-6506

PRIOR
AUTHORIZATION

We assist with understanding insurance authorization Pfizer Oncology Together will coordinate with the insurer to determine all prior authorization requirements, where and how to submit requests and typical turnaround times. We will also follow up with the payer on behalf of the patient—and track the process until a final outcome is determined.

APPEALS
ASSISTANCE

WE OFFER APPEALS ASSISTANCE If your patient's claim is denied, Pfizer Oncology Together can work with you to review the reason for the denial and help you better understand the appeals process. Once the appeal is submitted, we will follow up with the payer on behalf of the patient—and track the process until a final outcome is determined.

Pfizer and its representatives cannot make any guarantees about the outcome of appeals assistance.

(Monday–Friday 8 am–8 pm ET)

BILLING AND CODING ASSISTANCE

See below for codes you may need when coding for BESPONSA in an outpatient or physician’s office setting.

National Drug Code (NDC)

Product Name

BESPONSA

(inotuzumab ozogamicin)

NDC (11-digit format)

NDC 00008-0100-01

Description

0.9 mg single-dose vial

Route of Administration

Intravenous infusion

Code type

Accordion for outpatient

Code
Description
J9999
Not otherwise classified (NOC), antineoplastic drugs
J3490
Unclassified drugs
J3590
Unclassified biologics
C9399 (Medicare)
Unclassified drugs or biologics
Code
Description
0636
Drugs requiring detailed coding (Medicare or if required by payer)
0260
General Classification (IV Therapy)
0280
General Classification (Oncology)
Code
Description
96413
Chemotherapy administration, intravenous infusion technique, up to 1 hour; single or initial substance/drug
96415
Chemotherapy administration, intravenous infusion technique: each additional hour (list separately in addition to primary procedure)
Code
Description
C91.00
Acute lymphoblastic leukemia not having achieved remission
C91.01
Acute lymphoblastic leukemia, in remission
C91.02
Acute lymphoblastic leukemia, in relapse
Z51.11
Encounter for antineoplastic chemotherapy

Content for access and reimbursement - outpatient - after accordion

CPT® is a registered trademark of the American Medical Association.

The information provided here is intended for informational purposes only, and is not a comprehensive description of potential coding requirements for BESPONSA. Coding and coverage policies change periodically and often without warning. The healthcare provider is solely responsible for determining coverage and reimbursement parameters and accurate and appropriate coding for treatment of his/her own patients. The information provided in this section should not be considered a guarantee of coverage or reimbursement for BESPONSA.

DOWNLOAD THE SAMPLE UB-04/CMS-1450 FORM FOR HOSPITAL OUTPATIENT USE

DOWNLOAD THE SAMPLE CMS-1500 FORM FOR PHYSICIAN OFFICE USE

ORDERING BESPONSA (inotuzumab ozogamicin)

Pfizer has made BESPONSA available through a network of specialty distributors and one specialty pharmacy.

Specialty Distribution Partners
Customer Service Number
Website
Item Number
ASD Healthcare
Item Number : 49307
Biologics Specialty Pharmacy
Item Number : --
Cardinal Health Specialty Solutions
Item Number : 5390364
McKesson Plasma and Biologics
Item Number : 3700093
McKesson Specialty Health Solutions
Item Number : 5007354
Oncology Supply
Item Number : 49307
Smith Medical Partners
Item Number : 5680723

FIELD REIMBURSEMENT SUPPORT

In the event you need additional assistance or support in your office, we can put you in touch with a local Pfizer Field Reimbursement Manager (FRM) who is trained to address specific access and reimbursement issues.

(Monday–Friday 8 am–8 pm ET)

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Bepsonsa hcp in content isi

Important Safety Information and Indication for BESPONSA (inotuzumab ozogamicin)

WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST–HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY (NRM):

  • Hepatotoxicity, including fatal and life-threatening VOD, occurred in patients who received BESPONSA. The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment. Consider identified risk factors. Monitor closely for signs and symptoms of VOD
  • There was a higher post-HSCT non-relapse mortality rate in patients receiving BESPONSA, resulting in a higher Day 100 post-HSCT mortality rate

Hepatotoxicity, Including VOD: Hepatotoxicity, including fatal and life-threatening VOD, occurred in patients who received BESPONSA. The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment. The use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin ≥ the upper limit of normal (ULN) before HSCT were significantly associated with an increased risk of VOD. Other risk factors for VOD in patients treated with BESPONSA included ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of BESPONSA treatment cycles. Grade 3/4 increases in aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin have occurred.

Monitor closely for signs and symptoms of VOD; these may include elevations in total bilirubin, hepatomegaly (which may be painful), rapid weight gain, and ascites. Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA. Permanently discontinue treatment if VOD occurs. If severe VOD occurs, treat according to standard medical practice.

Increased Risk of Post-HSCT Non-Relapse Mortality: There was a higher post-HSCT non-relapse mortality rate in patients receiving BESPONSA, resulting in a higher Day 100 post-HSCT mortality rate. In the BESPONSA arm, the most common causes of post-HSCT non-relapse mortality included VOD and infections. Monitor closely for toxicities post HSCT, including signs and symptoms of infection and VOD.

Myelosuppression: Myelosuppression, and severe, life-threatening and fatal complications of myelosuppression, including hemorrhagic events and infections, have occurred with BESPONSA. Thrombocytopenia, neutropenia, and febrile neutropenia were reported.

Monitor complete blood counts prior to each dose of BESPONSA and monitor for signs and symptoms of infection, bleeding/hemorrhage, or other effects of myelosuppression during treatment and provide appropriate management. As appropriate, administer prophylactic anti-infectives during and after treatment with BESPONSA. Dose interruption, dose reduction, or permanent discontinuation may be required.

Infusion-Related Reactions: Infusion-related reactions have occurred in patients who received BESPONSA. Premedicate with a corticosteroid, antipyretic, and antihistamine prior to dosing. Monitor patients closely during and for at least 1 hour after the end of the infusion for the potential onset of infusion-related reactions. Interrupt the infusion and institute appropriate medical management if an infusion-related reaction occurs. For severe or life-threatening infusion reactions, permanently discontinue BESPONSA.

QT Interval Prolongation: Increases in QT interval have occurred. Administer BESPONSA with caution in patients who have a history of or predisposition to QTc prolongation, who are taking medicinal products that are known to prolong QT interval, and in patients with electrolyte disturbances. Obtain electrocardiograms and electrolytes prior to treatment and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

Embryo-Fetal Toxicity and Nursing Mothers: BESPONSA can cause embryo-fetal harm. Advise males and females of reproductive potential to use effective contraception during BESPONSA treatment and for at least 5 and 8 months after the last dose, respectively. Advise women against breastfeeding while receiving BESPONSA and for 2 months after the last dose.

Adverse Reactions: The most common (≥20%) adverse reactions observed with BESPONSA were thrombocytopenia, neutropenia, infection, anemia, leukopenia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia, transaminases increased, abdominal pain, gamma-glutamyltransferase increased, and hyperbilirubinemia.

The most common (≥2%) serious adverse reactions were infection, febrile neutropenia, hemorrhage, abdominal pain, pyrexia, VOD, and fatigue.

Indication

BESPONSA is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Please see full Prescribing Information, including BOXED WARNING for BESPONSA (inotuzumab ozogamicin).

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Important Safety Information and Indication

Important Safety Information and Indication for BESPONSA (inotuzumab ozogamicin)

WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST–HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY (NRM):

  • Hepatotoxicity, including fatal and life-threatening VOD, occurred in patients who received BESPONSA. The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment. Consider identified risk factors. Monitor closely for signs and symptoms of VOD
  • There was a higher post-HSCT non-relapse mortality rate in patients receiving BESPONSA, resulting in a higher Day 100 post-HSCT mortality rate

Hepatotoxicity, Including VOD: Hepatotoxicity, including fatal and life-threatening VOD, occurred in patients who received BESPONSA. The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment. The use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin ≥ the upper limit of normal (ULN) before HSCT were significantly associated with an increased risk of VOD. Other risk factors for VOD in patients treated with BESPONSA included ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of BESPONSA treatment cycles. Grade 3/4 increases in aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin have occurred.

Monitor closely for signs and symptoms of VOD; these may include elevations in total bilirubin, hepatomegaly (which may be painful), rapid weight gain, and ascites. Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA. Permanently discontinue treatment if VOD occurs. If severe VOD occurs, treat according to standard medical practice.

Increased Risk of Post-HSCT Non-Relapse Mortality: There was a higher post-HSCT non-relapse mortality rate in patients receiving BESPONSA, resulting in a higher Day 100 post-HSCT mortality rate. In the BESPONSA arm, the most common causes of post-HSCT non-relapse mortality included VOD and infections. Monitor closely for toxicities post HSCT, including signs and symptoms of infection and VOD.

Myelosuppression: Myelosuppression, and severe, life-threatening and fatal complications of myelosuppression, including hemorrhagic events and infections, have occurred with BESPONSA. Thrombocytopenia, neutropenia, and febrile neutropenia were reported.

Monitor complete blood counts prior to each dose of BESPONSA and monitor for signs and symptoms of infection, bleeding/hemorrhage, or other effects of myelosuppression during treatment and provide appropriate management. As appropriate, administer prophylactic anti-infectives during and after treatment with BESPONSA. Dose interruption, dose reduction, or permanent discontinuation may be required.

Infusion-Related Reactions: Infusion-related reactions have occurred in patients who received BESPONSA. Premedicate with a corticosteroid, antipyretic, and antihistamine prior to dosing. Monitor patients closely during and for at least 1 hour after the end of the infusion for the potential onset of infusion-related reactions. Interrupt the infusion and institute appropriate medical management if an infusion-related reaction occurs. For severe or life-threatening infusion reactions, permanently discontinue BESPONSA.

QT Interval Prolongation: Increases in QT interval have occurred. Administer BESPONSA with caution in patients who have a history of or predisposition to QTc prolongation, who are taking medicinal products that are known to prolong QT interval, and in patients with electrolyte disturbances. Obtain electrocardiograms and electrolytes prior to treatment and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

Embryo-Fetal Toxicity and Nursing Mothers: BESPONSA can cause embryo-fetal harm. Advise males and females of reproductive potential to use effective contraception during BESPONSA treatment and for at least 5 and 8 months after the last dose, respectively. Advise women against breastfeeding while receiving BESPONSA and for 2 months after the last dose.

Adverse Reactions: The most common (≥20%) adverse reactions observed with BESPONSA were thrombocytopenia, neutropenia, infection, anemia, leukopenia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia, transaminases increased, abdominal pain, gamma-glutamyltransferase increased, and hyperbilirubinemia.

The most common (≥2%) serious adverse reactions were infection, febrile neutropenia, hemorrhage, abdominal pain, pyrexia, VOD, and fatigue.

Indication

BESPONSA is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Please see full Prescribing Information, including BOXED WARNING for BESPONSA (inotuzumab ozogamicin).