Appeal type: Step Therapy
Decision: Upheld

Diagnosis:  Severe Proliferative Diabetic Retinopathy, Diabetic Macular Edema
 
Treatment:  Lucentis

The insurer denied the Lucentis.  The denial was upheld.   

This is a female patient with a medical history of severe bilateral proliferative diabetic retinopathy and diabetic macular edema.  The patient underwent an injection of Lucentis in her left eye and treatment with panretinal photocoagulation without complications.  It was reported that the patient had severe disease with many dot/blot hemorrhages.  Documentation revealed the patient had arteriovenous (AV) crossing changes bilaterally with venous tortuosity.   There were scattered dot/blot hemorrhages bilaterally to the macula and periphery and macular edema.  Additionally, she was counseled on proper diet control, exercise and hypertension control. 

Avastin and Mvasi are the same drug - namely bevacizumab: as per lexicomp:
"humanized monoclonal antibody which binds to, and neutralizes, vascular endothelial growth factor (VEGF), preventing its association with endothelial receptors, Flt-1 and KDR. VEGF binding initiates angiogenesis (endothelial proliferation and the formation of new blood vessels). The inhibition of microvascular growth is believed to retard the growth of all tissues (including metastatic tissue)."

Lucentis is ranibizumab: as per lexicomp:
"a recombinant humanized monoclonal antibody fragment which binds to and inhibits human vascular endothelial growth factor A (VEGF-A). Ranibizumab inhibits VEGF from binding to its receptors and thereby suppressing neovascularization and slowing vision loss."  The formulary, step therapy options and the requested drug act against VEGF.

There is no suggestion that Avastin or Mvasi would cause physical or mental harm to the patient.  There are no contraindications in the documentation that would put the patient at risk for adverse reactions.  This patient has a diagnosis of maculopathy.  Avastin and Mvasi have been shown to be helpful with this condition.  There is nothing in the patient's history to suggest that this medication would not effectively treat the patient's condition.  The patient has not tried and failed treatment with Avastin or Mvasi.

Lucentis is FDA approved for intravitreal injection with the same mechanism of action.  Off label use of Avastin or Mvsai could be considered an alternative. 

There are few head-to-head trial data to guide selection of an individual VEGF inhibitor [37].  In the only comparison trial, all three drugs had similar efficacy when visual acuity was better than 20/50 (approximately +8 letters at one year), but when the baseline visual acuity was 20/50 or worse, aflibercept improved visual acuity more than the other two drugs (+19 versus +12 letters with bevacizumab and +19 versus +14 letters with ranibizumab) [38].  There was no difference in improvement in visual acuity between ranibizumab and bevacizumab."  It should be noted that this patient's visual acuity is 20/25- and 20/25- as per her most recent visit note .
The documentation provided did not indicate that there were any barriers that would cause a worsening condition or non-compliance from the patient utilizing the insurer's option of Avastin or Mvasi.  There is no indication that utilizing Avastin would cause non-compliance, likely worsen a co-morbid condition or decrease the patient's ability to achieve or maintain functional ability in performing daily activities.  Based on her active treatment with PRP along with only 2 injections of Lucentis to date, it cannot be said that the Lucentis has had a material effect on her status and that the use of Avastin would have a different result.

Based on the above, the insurer's denial of Lucentis is upheld.