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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J2000-55

Original Effective Date: 03/15/16

Reviewed: 02/10/16

Revised: 00/00/00

Next Review: 08/09/17

Subject: Osimertinib (TagrissoTM)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates    
           

DESCRIPTION:

Osimertinib (Tagrisso), a kinase inhibitor that targets epidermal growth factor receptor (EGFR), was approved by the U.S. Food and Drug Administration (FDA) in November 2015 treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR TKI therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response.

The safety and efficacy of osimertinib were established in two multicenter, single-arm, open-label clinical trials, AURA extension (n=201) and AURA2 (n=210), in patients with metastatic EGFR T790M mutation-positive NSCLC who had progressed on prior systemic therapy, including an EGFR TKI. The objective response rate was 57% for AURA extension study and 61% for AURA2 study. The most common adverse events (AEs) were diarrhea, rash, dry skin, and nail toxicity. Dose interruptions, dose reductions and treatment discontinuations with osimertinib 80 mg due to AEs were reported for 18.7%, 4.4%, and 5.6% of patients, respectively.

National Comprehensive Cancer Network (NCCN) Guidelines for Non-Small Cell Lung Cancer (Version 4.2016) recommend osimertinib as subsequent therapy after afatinib, erlotinib, or gefitinib for EGFR-positive recurrent or metastatic disease.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

Initiation of osimertinib (Tagrisso) meets the definition of medical necessity when ALL of the following criteria are met:

1. Member is diagnosed with non-small cell lung cancer (NSCLC)

2. Member’s disease is metastatic

3. Member’s disease has an epidermal growth factor receptor (EGFR) T790M mutation as detected by an FDA‐approved test

4. Member has failed treatment with afatinib (Gilotrif), erlotinib (Tarceva), or gefitinib (Iressa)

5. Osimertinib will be used as monotherapy

6. The dose does not exceed 80 mg daily – dosage will be achieved using the fewest number of tablets per day

Duration of approval: 6 months

Continuation of osimertinib (Tagrisso) meets the definition of medical necessity when ALL of the following criteria are met:

1. Authorization/reauthorization has been previously approved by Florida Blue or another health plan in the past two years, OR the member has previously met all indication-specific initiation criteria

2. Member’s disease has not progressed during treatment with osimertinib

3. Osimertinib is used as monotherapy

4. The dose does not exceed 80 mg once daily – dosage will be achieved using the fewest number of tablets per day

Duration of approval: 6 months

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

• 80 mg orally once daily, with or without food

Dose Adjustments

• Recommendations for dose modifications due to adverse reactions are provided in FDA-approved Prescribing Information

Drug Availability

• Tablets: 80 mg and 40 mg

PRECAUTIONS:

Boxed Warning

• None

Contraindications

• None

Precautions/Warnings

• Interstitial Lung Disease (ILD)/Pneumonitis

• QTc Interval Prolongation

• Cardiomyopathy

• Embryo-Fetal Toxicity

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J8999

Prescription drug, oral, chemotherapeutic, Not Otherwise Specified

C9399

Unclassified drugs or biologicals (Hospital Outpatient Use ONLY)

ICD-10 Diagnoses Codes That Support Medical Necessity (Effective 10/01/15)

C33

Malignant neoplasm of trachea

C34.00 – C34.92

Malignant neoplasm of bronchus and lung

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) or Local Coverage Determination (LCD) were found at the time of the last guideline review date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Afatinib (Gilotrif) Tablets, 09-J2000-06

Erlotinib (Tarceva®) Tablets, 09-J1000-44

Gefitinib (Iressa), 09-J2000-44

OTHER:

None

REFERENCES:

  1. AstraZeneca Pharmaceuticals. Tagrisso (osimertinib) tablet. 2015 [cited 2016-01-27]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7/.
  2. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2015 [cited 2016-01-27]. Available from: http://www.clinicalpharmacology.com/.
  3. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2016-01-27]. Available from: http://clinicaltrials.gov/.
  4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2016-01-27]. Available from: http://www.thomsonhc.com/.
  5. National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Non-small cell lung cancer, v. 4.2016 [cited 2016-01-27]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  6. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2015 [cited 2016-01-27]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  7. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2015 [cited 2016-01-27]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 2/10/16.

GUIDELINE UPDATE INFORMATION:

3/15/16

New Medical Coverage Guideline.

Date Printed: August 21, 2017: 07:49 PM