6 inches wide x 8 inches high when folded. 12 inches wide x 8 inches high when spread.
CODING RESOURCE
Our programs are designed to help qualifying people without insurance, those in Medicare Part D, and those who receive their medications through participating healthcare facilities.
ZOLADEX® (goserelin acetate implant) works by blocking the production of sex hormones, including estrogen in women and testosterone in men.
Please feel free to call us at 1-800-AZandMe (292-6363), Monday through Friday, 8:00 AM - 6:00 PM ET with any questions you have about our programs, the eligibility requirements, or the application process. We are here to help.
ZOLADEX in Prostate Cancer
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ZOLADEX (3.6 mg and 10.8 mg) is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate and for the palliative treatment of advanced carcinoma of the prostrate.
Access 360™ offers a variety of financial support services that can help patients get the medicine they need.
ZOLADEX in Breast Cancer and Benign Gynaecology • F or the management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy • F or use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding • F or use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women Contraindications: • P atients with a known hypersensitivity to GnRH, GnRH agonist analogues or any of the components in ZOLADEX • P atients who are pregnant unless ZOLADEX is being used for palliative treatment of advanced breast cancer. ZOLADEX can cause fetal harm when administered to a pregnant woman Please see accompanying Full Prescribing Information. ZOLADEX® (goserelin acetate implant) — Coding Resource
CONTACT INFORMATION
ZOLADEX (3.6 mg) is indicated:
844-ASK-A360 (844-275-2360)
844-FAX-A360 (844-329-2360)
One MedImmune Way Gaithersburg, MD 20878
MyAccess360.com
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ZOLADEX® (goserelin acetate implant) Coding Resource
Diagnosis Codes
National Drug Code (NDC)
When filing claims, providers often indicate a diagnosis code reflecting the patient’s condition. Based on the indications for ZOLADEX, examples of diagnosis codes that may be appropriate are listed below.
NDC
Generic Name
Brand Name
Mfg/Labeler
Strength
00310096130
Goserelin Acetate
ZOLADEX
ASTRAZENECA LP
10.8 MG
00310096036
Goserelin Acetate
ZOLADEX
ASTRAZENECA LP
3.6 MG
It is important to note that the codes identified below are examples only. Each provider is responsible for ensuring all coding is accurate and documented in the medical record based on the condition of the patient. The use of the following codes does not guarantee reimbursement. International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification = ICD-9-CM/ICD-10-CM
Current Procedural Terminology (CPT) Submitting accurate codes and claims is important to ensure proper reimbursement of services. The chart below lists the potential Common Procedural Terminology (CPT) code for your reference when submitting claims for your ZOLADEX patients.
Provider administration of ZOLADEX
Code
Description
96372
Therapeutic, prophylactic or diagnostic injection (specify substance or drug); subcutaneous or intramuscular
ICD-9-CM
ICD-10-CM
Description
C61
Malignant neoplasm of prostate
(STAGE B2-C) PROSTATIC CARCINOMA 185
198.82
03
Description
233.4
Malignant neoplasm of prostate Secondary malignant neoplasm of genital organs {Secondary malignant neoplasm of prostate} Carcinoma in situ of prostate
C79.82
Secondary malignant neoplasm of genital organs {Secondary malignant neoplasm of prostate}
D07.5
Carcinoma in situ of prostate
(STAGE B2-C) ENDOMETRIOSIS
Healthcare Common Procedure Coding System (HCPCS)
617.0
Endometriosis of uterus
N80.0
Endometriosis of uterus
617.1
Endometriosis of ovary
N80.1
Endometriosis of ovary
NDC
Generic Name
Brand Name
Mfg/Labeler
Strength
617.2
Endometriosis of fallopian tube
N80.2
Endometriosis of fallopian tube
J9202
Goserelin Acetate
ZOLADEX
ASTRAZENECA LP
3.6 MG
617.3
Endometriosis of pelvic peritoneum
N80.3
Endometriosis of pelvic peritoneum
617.4
Endometriosis of rectovaginal septum and vagina
N80.4
Endometriosis of rectovaginal septum and vagina
617.5
Endometriosis of intestine
N80.5
Endometriosis of intestine
617.6
Endometriosis in scar of skin
N80.6
Endometriosis in cutaneous scar
617.8
Endometriosis of other specified sites
N80.8
Other endometriosis
617.9
Endometriosis, unspecified site
N80.9
Endometriosis, unspecified
236.0
Neoplasm of uncertain behavior uterus (Endometriosis, stromal)
D39.0
Neoplasm of uncertain behavior uterus (Endometriosis, stromal)
N89.7
Hematocolpos
N92.5
Other specified irregular menstruation
N93.8
Other specified abnormal uterine and vaginal bleeding
DYSFUNCTIONAL UTERINE BLEEDING
For more information on ICD-10-CM codes or other reimbursement information, call AstraZeneca Reimbursement Services at 1-877-674-7140, Monday through Friday, 8:00 AM to 6:00 PM ET. Please see accompanying Full Prescribing Information. ZOLADEX® (goserelin acetate implant) — Coding Resource
626.8
Disorders of menstruation and other abnormal bleeding from female genital tract, Other
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Diagnosis Codes ICD-9-CM
Description
Diagnosis Codes ICD-10-CM
Description
(ADVANCED) BREAST CANCER, FEMALE
173.50
174.0
174.1
Unspecified malignant neoplasm skin of trunk, except scrotum (Malignant neoplasm mastectomy site {skin})
Malignant neoplasm of female breast, nipple and areola
Malignant neoplasm of female breast, central portion
05 174.2
174.3
174.4
Malignant neoplasm of female breast, upper-inner quadrant
Malignant neoplasm of female breast, lower-inner quadrant
Malignant neoplasm of female breast, upper-outer quadrant
ICD-9-CM
Description
ICD-10-CM
Description
(ADVANCED) BREAST CANCER, FEMALE (Continued from previous page)
C44.501
Unspecified malignant neoplasm of skin of breast
174.5
(Malignant neoplasm mastectomy site {skin})
Malignant neoplasm of female breast, lower-outer quadrant
C50.011
Malignant neoplasm of nipple and areola, right female breast
C50.012
Malignant neoplasm of nipple and areola, left female breast
C50.019
Malignant neoplasm of nipple and areola, unspecified female
C50.111
Malignant neoplasm of central portion, right female breast
C50.112
Malignant neoplasm of central portion, left female breast
C50.119
Malignant neoplasm of central portion, unspecified female breast
C50.211
Malignant neoplasm of upper-inner quadrant, right female breast
C50.212
Malignant neoplasm of upper-inner quadrant, left female breast
C50.219
Malignant neoplasm of upper-inner quadrant, unspecified female breast
PRE- AND PERI- MENOPAUSE*
C50.311
Malignant neoplasm of lower-inner quadrant, right female breast
256.31
Premature menopause
627.0
Premenopausal menorrhagia
C50.312
Malignant neoplasm of lower-inner quadrant, left female breast
C50.319
Malignant neoplasm of lower-inner quadrant, unspecified female breast
C50.411
Malignant neoplasm of upper-outer quadrant, right female breast
C50.412
Malignant neoplasm of upper-outer quadrant, left female breast
C50.419
Malignant neoplasm of upper-outer quadrant, unspecified female breast
Please see accompanying Full Prescribing Information. ZOLADEX® (goserelin acetate implant) — Coding Resource
174.6
174.8
174.9
Malignant neoplasm of female breast, axillary tail
Malignant neoplasm of female breast, other specified sites
Malignant neoplasm of female breast, unspecified
C50.511
Malignant neoplasm of lower-outer quadrant, right female breast
C50.512
Malignant neoplasm of lower-outer quadrant, left female breast
C50.519
Malignant neoplasm of lower-outer quadrant, unspecified female breast
C50.611
Malignant neoplasm of axillary tail, right female breast
C50.612
Malignant neoplasm of axillary tail, left female breast
C50.619
Malignant neoplasm of axillary tail, unspecified female breast
C50.811
Malignant neoplasm of overlapping sites, right female breast
C50.812
Malignant neoplasm of overlapping sites, left female breast
C50.819
Malignant neoplasm of overlapping sites, unspecified female breast
C50.911
Malignant neoplasm of unspecified site, right female breast
C50.912
Malignant neoplasm of unspecified site, left female breast
C50.919
Malignant neoplasm of unspecified site, unspecified female breast
E28.310
Symptomatic premature menopause
E28.319
Asymptomatic premature menopause
N92.4
Excessive bleeding in the premenopausal period
*Adjunct diagnoses for palliative treatment of advanced breast cancer in pre- and peri- menopausal women.
Potential ICD-10-CM Impact on Clinical Documentation Many of the diagnosis examples listed contain a one-to-one match from ICD-9-CM to ICD-10-CM. It is important to note the additional specificity may be required when assigning carcinoma codes. This set of codes may require provider documentation detail containing gender and laterality.
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IMPORTANT SAFETY INFORMATION ABOUT ZOLADEX® (goserelin acetate implant) Specific to the male indications: • A naphylactic reactions to ZOLADEX have been reported in the medical literature. ZOLADEX is contraindicated in patients who have a known sensitivity to GnRH, GnRH agonist analogues, or any of the components in ZOLADEX
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• T ransient worsening of tumor symptoms, or the occurrence of additional signs and symptoms of prostate cancer, may occasionally develop during the first few weeks of treatment with ZOLADEX. Some patients may experience a temporary increase in bone pain. Monitor patients at risk for complications of tumor flare. As with other GnRH agonists, isolated cases of ureteral obstruction and spinal cord compression have been observed. If spinal cord compression or renal impairment secondary to ureteral obstruction develops, standard treatment should be instituted and in extreme cases, an immediate orchiectomy • H yperglycemia and an increased risk of developing diabetes or worsening of glycemic control in patients with diabetes have been reported in men receiving GnRH agonists like ZOLADEX. Monitor blood glucose levels and glycosylated hemoglobin (HbA1c) periodically and manage according to current clinical practice • Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists like ZOLADEX in men. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice • H ypercalcemia has been reported in patients with bone metastases. Patients should be monitored and managed appropriately. There have been postmarketing reports of osteoporosis, decreased bone mineral density, and bony fracture in men treated with ZOLADEX
Please see accompanying Full Prescribing Information. ZOLADEX® (goserelin acetate implant) — Important Safety Information
• T he most commonly observed adverse reactions during ZOLADEX treatment for prostatic carcinoma were due to the expected physiological effects from decreased testosterone levels. The most common adverse reactions (incidence of >5% in prostate clinical trials) were: — F or ZOLADEX 3.6 mg - depot - hot flashes (62%), sexual dysfunction (21%), decreased erections (18%), lower urinary tract symptoms (13%), lethargy (8%), pain (worsened in the first 30 days) (8%), edema (7%), upper respiratory infection (7%), rash (6%), and sweating (6%). — F or ZOLADEX 10.8 mg - depot - hot flashes (64%), pain (general) (14%), gynecomastia (8%), pelvic pain (6%), and bone pain (6%) • In the locally advanced carcinoma of the prostate clinical trial, additional adverse event data were collected for the combination therapy with radiation group during both the hormonal treatment and hormonal treatment plus radiation phases of this study. Adverse experiences (incidence >5%) in both phases of this study were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%). Treatment with ZOLADEX and flutamide did not add substantially to the toxicity of radiation treatment alone Specific to the female indications: • A naphylactic reactions to ZOLADEX have been reported in the medical literature. ZOLADEX is contraindicated in patients with a known hypersensitivity to GnRH, GnRH agonist analogues, or any of the components in ZOLADEX • Z OLADEX is contraindicated during pregnancy unless used for palliative treatment of advanced breast cancer. ZOLADEX can cause fetal harm when administered to a pregnant woman. If used during pregnancy, the patient should be apprised of the potential hazard to the fetus. There is an increased risk for pregnancy loss due to expected hormonal changes that occur with ZOLADEX treatment. ZOLADEX should not be given to women with undiagnosed abnormal vaginal bleeding • P regnancy must be excluded for use in benign gynecological conditions. Women should be advised against becoming pregnant while taking ZOLADEX. Effective nonhormonal contraception must be used by all premenopausal women during ZOLADEX therapy and for 12 weeks following discontinuation of therapy
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• T ransient worsening of tumor symptoms, or the occurrence of additional signs and symptoms of breast cancer, may occasionally develop during the first few weeks of treatment. Some patients may experience a temporary increase in bone pain. Monitor patients at risk for complications of tumor flare
INDICATIONS
INDICATIONS
ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.
ZOLADEX 3.6-mg depot is indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. Experience with ZOLADEX for the management of endometriosis has been limited to women 18 years of age or older treated for 6 months.
ZOLADEX is indicated for the palliative treatment of advanced carcinoma of the prostate.
ZOLADEX 3.6-mg depot is indicated for use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding.
• H ypercalcemia has been reported in some breast cancer patients with bone metastases. Patients should be monitored and managed appropriately • Z OLADEX may cause an increase in cervical resistance. Therefore, caution is recommended when dilating the cervix for endometrial ablation • T reatment with ZOLADEX may be associated with a reduction in bone mineral density over the course of treatment. Data suggests a possibility of partial reversibility. In women, current available data suggests that recovery of bone loss occurs on cessation of therapy in the majority of patients • T he most frequently reported adverse reactions were related to hypoestrogenism. The adverse reaction profile was similar for women treated for breast cancer, dysfunctional uterine bleeding, and endometriosis
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Complete Prescribing Information is contained in the pocket above.
Specific to the female indications (continued):
• T he most commonly reported adverse reactions with ZOLADEX in clinical trials for endometriosis were: hot flashes (96%), vaginitis (75%), headache (75%), decreased libido (61%), emotional lability (60%), depression (54%), sweating (45%), acne (42%), breast atrophy (33%), seborrhea (26%), and peripheral edema (21%) • T he most commonly reported adverse reactions with ZOLADEX in clinical trials for endometrial thinning were: vasodilation/hot flashes (57%), headache (32%), sweating (16%), and abdominal pain (11%) • T he most commonly reported adverse reactions with ZOLADEX in breast cancer clinical trials were hot flashes (70%), decreased libido (47.7%), tumor flare (23%), nausea (11%), edema (5%), and malaise/fatigue/lethargy (5%). Injection site reactions were reported in less than 1% of patients
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. Please see accompanying Full Prescribing Information. ZOLADEX® (goserelin acetate implant) — Important Safety Information
Specific to the male indications:
Specific to the female indications:
ZOLADEX 3.6-mg depot is indicated for use in the palliative treatment of advanced breast cancer in premenopausal and perimenopausal woman. The estrogen and progesterone receptor values may help predict whether ZOLADEX therapy is likely to be beneficial.
ZOLADEX is a registered trademark of the AstraZeneca group of companies. 3048806
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