Appeal type: Step Therapy
Decision: Upheld

Diagnosis:  Asthma.
Treatment:  Dupixent.

The insurer denied the Dupixent.  The denial is upheld. 

The patient is a female, who was diagnosed with asthma.  The pulmonary function tests demonstrate that both the forced expiratory volume over one second (FEV1) and the forced vital capacity (FVC) are reduced, but the FEV1 to FVC ratio is normal.  Though the patient did demonstrate a significant post bronchodilator response in the volume of FEV1 and FVC, the current guidelines for the diagnosis of obstructive airway disease require that the FEV1 to FVC ratio be less than 70% in adults.  In this case, the patient's FEV1 to FVC ratio was normal.  Testing does not suggest that this patient has severe bronchial asthma.  

Based on the clinical notes, the patient's symptoms are under good control.  The patient was not complaining of any respiratory symptoms, and the clinical examination was unremarkable from a respiratory perspective.  The patient has been on high-dose inhaled corticosteroids along with long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) agents.  The patient is also on low-dose prednisone.  There has been no documentation provided about the previous use of medications like Fasenra and Nucala.  The patient has been requested to use Dupixent for the management of her bronchial asthma.

No, the proposed Dupixent is not medically necessary.

Based on the clinical information provided, the requested service is not medically necessary over the health plan's preference.  The patient is defined as having bronchial asthma, and she is on multiple bronchodilator therapy; the patient's clinical condition is reported to be under control as of the last follow-up note.  The patient's pulmonary function tests suggest a restrictive defect rather than an obstructive defect.  The clinic and post bronchodilator response are of unclear nature, and the patient could be defined as having mild persistent asthma.  

Though the guidelines for the requested service, approved by the Food and Drug Administration (FDA) and recommended by the Global Initiative for Asthma (GINA), recommend that Dupixent be used in individuals who have the diagnosis of severe eosinophilic asthma, severe asthma can be defined by the FEV1 to FVC ratio of less than 70% along with FEV1 less than 80% with persistent symptoms of uncontrolled asthma despite adequate conventional management including high-dose inhaled corticosteroids along with long-acting beta agonist and long-acting muscarinic antagonist inhalers.  In addition, there should be documentation provided that the patient's symptoms are poorly controlled despite adequate use of these medications, along with failure of a formulary biologic agent, such as Fasenra and Nucala.  The failure of these biologic agents should be either due to severe adverse effects or contraindication.  There should be adequate documentation of appropriate compliance with the management of bronchial asthma.  

In this case under review, the patient's pulmonary function tests do not suggest that the patient has severe asthma.  Additionally, the patient's clinical notes suggest that her symptoms are under good control, and there was no documentation provided regarding the failure of the formulary biologic agents as mentioned above.  Therefore, medical necessity for the requested Dupixent has not met.

Based on the clinical information provided, the patient's pulmonary function tests suggest that she has a combination of a mild restrictive defect with an occult obstructive component.  The patient's FVC and FEV1 both are reduced, but the ratio of FEV1 to FVC is above 70%, suggesting that the patient has a restrictive lung defect.  Further looking at the lung volumes, the patient's total lung capacity was 78% of predicted with preserved diffuse capacity of the lungs for carbon monoxide (DLCO) and a forced expiratory flow (FEF) [25-75 L/s], suggesting the presence of an occult obstructive component.  

The clinical notes provided suggest that the patient's symptoms are under good control with current conventional management.  In addition, there was no documentation provided showing whether the formulary biologic agents, such as Fasenra and/or Nucala, had been tried and failed due to adverse events or contraindication.  In light of this information, medical necessity is not met for Dupixent.