Coding Resource - My Access 360

嚜澧oding Resource

Indications for TAGRISSO

? TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth

factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test

? TAGRISSO is indicated for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following

concurrent or sequential platinum-based chemoradiation therapy and whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21

L858R mutations, as detected by an FDA-approved test

? TAGRISSO is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor

receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test

? TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or

metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test

? TAGRISSO is indicated for the treatment of adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC, as detected by

an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy

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.

National Drug Code (NDC)

10-digit NDC

11-digit NDC

Dosage

Code

Dosage

Code

40 mg TABLETS 每 30 ct BOTTLE

0310-1349-30

40 mg TABLETS 每 30 ct BOTTLE

00310-1349-30

80 mg TABLETS 每 30 ct BOTTLE

0310-1350-30

80 mg TABLETS 每 30 ct BOTTLE

00310-1350-30

Current Procedural Terminology (CPT)1

Code

Description

81235

EGFR (epidermal growth factor receptor) (eg, non-small cell lung cancer) gene analysis, common variants

(eg, exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q)

Healthcare Common Procedure Coding System (HCPCS)2

Code

Description

G0452

Molecular pathology procedure; physician interpretation and report

Personal History of Drug Therapy

Code

Description

Z92.21

Personal history of antineoplastic chemotherapy

Diagnosis Codes3

ICD-10-CM

Description

ICD-10-CM

Description

C34.00

Malignant neoplasm of unspecified main bronchus

C34.32

Malignant neoplasm of lower lobe, left bronchus or lung

C34.01

Malignant neoplasm of right main bronchus

C34.80

C34.02

C34.11

Malignant neoplasm of left main bronchus

Malignant neoplasm of upper lobe, unspecified

bronchus or lung

Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

Malignant neoplasm of upper lobe, left bronchus or lung

C34.90

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

Malignant neoplasm of lower lobe, unspecified

bronchus or lung

C34.91

Malignant neoplasm of lower lobe, right bronchus or lung

C34.92

C34.10

C34.30

C34.31

C34.81

C34.82

Please read Important Safety Information on page 2 and complete

Prescribing Information, including Patient Information.

Malignant neoplasm of overlapping sites of unspecified

bronchus and lung

Malignant neoplasm of overlapping sites of right

bronchus and lung

Malignant neoplasm of overlapping sites of left

bronchus and lung

Malignant neoplasm of unspecified part of unspecified

bronchus or lung

Malignant neoplasm of unspecified part of right

bronchus or lung

Malignant neoplasm of unspecified part of left

bronchus or lung

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Coding Resource

Select Safety Information About TAGRISSO

? There are no contraindications for TAGRISSO

? TAGRISSO, alone or in combination with other treatments, can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. For patients who have not

received recent definitive platinum-based chemoradiation, withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening

of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue if ILD/pneumonitis is confirmed. For

patients who have received recent definitive platinum-based chemoradiation therapy with Grade 1 ILD/pneumonitis, including radiation pneumonitis,

continue TAGRISSO or interrupt and restart, as appropriate. Permanently discontinue TAGRISSO in patients diagnosed with Grade ≡2 ILD/pneumonitis

? TAGRISSO can cause heart rate-corrected QT (QTc) interval prolongation. Monitor patients who have a history or predisposition for QTc prolongation or

those who are taking medications that are known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval

prolongation with signs/symptoms of life-threatening arrhythmia

? TAGRISSO can cause cardiomyopathy, including cardiac failure, chronic cardiac failure, congestive heart failure, pulmonary edema, or decreased ejection

fraction. Cardiomyopathy occurred in patients treated with TAGRISSO monotherapy and in combination with pemetrexed and platinum-based chemotherapy,

some instances of which were fatal. For patients receiving TAGRISSO monotherapy, conduct cardiac monitoring in patients with cardiac risk factors,

including assessment of LVEF at baseline and during treatment. For patients receiving TAGRISSO in combination with pemetrexed and platinum-based

chemotherapy, conduct cardiac monitoring in all patients, including assessment of LVEF at baseline and during treatment. Assess LVEF in patients who

develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO

? Promptly refer patients with signs and symptoms of keratitis to an ophthalmologist

? Withhold TAGRISSO if erythema multiforme major, Stevens-Johnson syndrome or toxic epidermal necrolysis is suspected and permanently discontinue if confirmed

? Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can

be identified, consider permanent discontinuation of TAGRISSO based on severity

? Aplastic anemia, including fatal cases, has been reported in patients treated with TAGRISSO. Inform patients of the signs and symptoms of aplastic anemia.

If aplastic anemia is suspected, withhold TAGRISSO and obtain a hematology consultation. If aplastic anemia is confirmed, permanently discontinue

TAGRISSO. Perform complete blood count with differential before starting TAGRISSO, periodically throughout treatment, and more frequently if indicated

? Verify pregnancy status of women prior to use. Advise women to use effective contraception during treatment with TAGRISSO and for 6 weeks after the last

dose. Advise men to use effective contraception during treatment with TAGRISSO and for 4 months after the last dose

? Advise women not to breastfeed during treatment with TAGRISSO and for 2 weeks after the last dose

? Most common (≡20%) adverse reactions, including laboratory abnormalities, were:

o

TAGRISSO monotherapy: leukopenia, lymphopenia, thrombocytopenia, anemia, diarrhea, rash, musculoskeletal pain, neutropenia, nail toxicity, dry skin,

stomatitis, and fatigue

o

TAGRISSO monotherapy following platinum-based chemoradiation therapy: lymphopenia, leukopenia, ILD/pneumonitis, thrombocytopenia,

neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough and COVID-19

o

TAGRISSO in combination with pemetrexed and platinum-based chemotherapy: leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash,

diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine

Please see complete Prescribing Information including Patient Information.

For more information, call AstraZeneca Access 360? at 1-844-ASK-A360, Monday through Friday, 8 am 每 6 pm ET.

1-844-ASK-A360 (1-844-275-2360)

1-844-FAX-A360 (1-844-329-2360)



Access360@

One MedImmune Way, Gaithersburg, MD 20878

You may report side effects related to AstraZeneca products. ?

References: 1. American Medical Association. CPT? 2024 Professional Edition. Chicago, IL: American Medical Association; 2024. 2. Centers for Medicare & Medicaid

Services. HCPCS Release & Code Sets. . Accessed September 25, 2024.

3. Centers for Medicare & Medicaid Services. 2023 ICD-10-CM. Accessed September 25, 2024.

TAGRISSO is a registered trademark and AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies.

?2024 AstraZeneca. All rights reserved. US-87243 Last Updated 9/24

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