Coverage Policies

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If not specified in a QualChoice coverage policy (Benefit Interpretation), QualChoice follows care guidelines published by MCG Health.

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Effective Date: 07/01/2016 Title: Tagrisso (Osimertinib)
Revision Date: 03/01/2019 Document: BI512:00
CPT Code(s):
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Tagrisso (Osimertinib) requires prior authorization.

2)    Tagrisso is used to treat a particular type of lung cancer.

3)    Tagrisso is an oral specialty medication covered under the Rx benefit.  It must be obtained through a contracted specialty pharmacy.

Medical Statement

Tagrisso (Osimertinib) is considered medically necessary when ALL of the following criteria are met:

1)    Diagnosis of metastatic EGFR T790M mutation positive non-small cell lung cancer (NSCLC), as detected by an FDA approved test, after progression on or after EGFR tyrosine kinase inhibitor therapy (e.g. Tarceva, Gilotrif, Iressa)  OR

2)    Diagnosis of metastatic EGFR (exon 19 deletion or exon 21 (L858R) substitution) mutation-positive non-small cell lung cancer (NSCLC)  AND

3)    Measurement of left ventricular ejection fraction (LVEF) has been obtained AND

4)    In members with congenital long QTc syndrome, congestive heart failure, electrolyte disturbances, or taking medications that can prolong the QTc interval, an ECG has been performed and the QTc interval is less than 470 milliseconds AND

5)    Contraceptive counseling has been provided.


Re-authorization can be provided when the following criteria are met:

1)    No evidence exists of development of interstitial lung disease or pneumonitis while on Tagrisso AND

2)    No evidence of symptomatic congestive heart failure exists AND

3)    LVEF has been measured within the past 3 months and LVEF is greater than 50% or LVEF is less than 50% but has declined less than 10% from baseline AND

4)    No evidence of life-threatening arrhythmia with prolonged QTc interval exists.


1)    As an oral specialty medication, Tagrisso is limited to no more than a 30 day supply per fill.

2)    Tagrisso is limited to 30 units per 30 day supply.


1)    NCCN Drugs & Biologics Compendium. Accessed online 02-04-2019.

2)    Tagrisso Product Information.  Astra Zeneca. Wilmington, DE.  November 2015.

3)    Clinical Pharmacology. Accessed online 02-04-2019.

Application to Products

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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