Medical Policy

Effective Date:01/01/2012 Title:Inlyta (Axitinib)
Revision Date:06/01/2019 Document:BI361:00
CPT Code(s):None
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)    Inlyta (axitinib) requires prior authorization.

2)    Inlyta is used to treat advanced renal cell cancer.

3)    Inlyta is covered under the pharmacy benefit as a specialty drug.

Medical Statement

Inlyta (Axitinib) is considered medically necessary for adult patients who meet the following criteria:

1)    Diagnosis of advanced renal cell carcinoma;  AND

2)    Patient has failed at least one prior systemic therapy (e.g. cytokines, sunitinib, bevacizumab, sorafenib, temsirolimus) OR

3)    As first-line therapy with Keytruda (pembrolizumab) in advanced renal cell carcinoma.

Intentially left empty

1)    Inlyta Product Information.  Pfizer.  April 2019

2)    Clinical Pharmacology.  Inlyta.  Accessed online May 2019.

3)    Rini BI, Escudier B, Tomczak P, Kaprin A, et al.  Comparative effectiveness of Axitinib versus sorafenib in advanced renal cell carcinoma (AXIS):  a randomized phase 3 trial.  Lancet 2011 Dec3:378(9807); 1931-9. Epub 2011 Nov 4.

4)    NCCN Drugs & Biologic Compendium. Accessed online 5/14/19.

Application to Products
This policy applies to all health plans 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) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, 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.