New prior authorization requirements for Mepolizumab (Nucala)

Date: December 21, 2020Attention: Allergists & Immunologists, Pulmonologists Effective Date: February 1, 2021Call to action: Texas Children’s Health Plan (TCHP) is aligning prior authorization criteria for mepolizumab (Nucala), J2182, with the Texas Medicaid Provider Procedures Manual (TMPPM). Mepolizumab (Nucala) is a clinician administered drug indicated for members with severe asthma with an eospinophilic phenotype. Mepolizumab (Nucala) is also indicated as a steroid sparing agent for certain types of hypereosinophilic syndrome (HES) and eosinophilic granulomatosis with polyangiitis (EGPA). Below are the new prior authorization criteria for TCHP members effective 2/1/2021. For initial therapy, ALL of the following criteria must be met:

Only for members 6 years old and older
Treatment of mepolizumab may not be used concurrently with omalizumab or any other interleukin-5 or interleukin-4 antagonist.
Procedure codes J0517, J2357, and J2786 may not be billed in any combination for the same date of services by any provider.
Providers may not bill for an office visit if the only reason for the visit is a mepolizumab injection.

Documentation supporting medical necessity for treatment of asthma with mepolizumab must be submitted with the request and must indicate the following:

Symptoms are inadequately controlled with use of one of the following combination therapies:
12 months of high-dose inhaled corticosteroid (ICS) given in combination with a minimum of 3 months of additional controller medication (either a long-acting beta2-agonist [LABA], leukotriene receptor antagonist [LTRA], or theophylline), unless the individual is intolerant of, or has a medical contraindication to these agents; or
6 months of inhaled corticosteroid (ICS) with daily oral glucocorticoids given in combination with a minimum of 3 months of an additional controller medication (a LABA, LTRA, or theophylline), unless the individual is intolerant of, or has a medical contraindication to these agents.
Pulmonary function tests (spirometry) must have been performed within a three-month period and be documented.

Note: Exceptions may be considered with documentation of medical reasons explaining why pulmonary function tests cannot be performed.

Client is not currently smoking, using electronic cigarettes, or heat-not-burn (IQOS) inhaled nicotine delivery devices.
One of the following blood eosinophil counts in the absence of other potential causes of eosinophilia, including, neoplastic disease, and known or suspected parasitic infection:
Greater than or equal to 150 cells/microliter within 1 month prior to initiation of therapy; or
Greater than or equal to 300 cells/microliter within 12 months prior to initiation of therapy

Note: 1 microliter (ul) is equal to 1 cubic millimeter (mm3)For renewal or continuation of therapy, evidence of clinical benefit after a 12-month trial can include:

Reduced asthma symptoms
Improved Asthma Control Test (ACT) score
Improved lung function (spirometry)
Lack of severe adverse effect (such as anaphylaxis)

How this impacts providers: Providers who believe mepolizumab is medically necessary for the member but does not meet criteria must submit a letter of medical necessity to be reviewed by a Medical Director. Providers should adjust their prescribing patterns accordingly and communicate these changes to their staff. Next steps for providers: Prior authorization requests for J2182 must be submitted with a Special Medical Prior Authorization (SMPA) Request Form. The completed Special Medical Prior Authorization (SMPA) Request Form must be maintained by the provider in the member’s medical record and is subject to retrospective review. Providers should communicate these changes to their staff. If you have any questions, please email Provider Network Management at: providerrelations@texaschildrens.org.For access to all provider alerts,log into: www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers