Diagnosis: Myopic Choroidal Neovascularization.
Treatment: Lucentis 0.5MG Inj.
The insurer denied the Lucentis 0.5MG Inj.
The denial is upheld.

The patient is a male with myopic choroidal neovascularization OD (right eye) status post refractive surgery (LASIK) for whom coverage of Lucentis for dates of service is the subject of review.

Coverage was previously denied by the health plan, as it was not identified that the patient had tried or had a poor response to medications on the preferred drug list including Avastin, Mvasi, or Zirabev. On appeal, the provider states that while Lucentis has been FDA (United States Food and Drug Administration)-approved for the patient's diagnosis, Avastin has not been shown to be effective for the patient's diagnosis, and the provider was not willing to jeopardize the patient's vision.

No, the requested medication (intravitreal Lucentis) is not established medically necessary over the formulary alternatives, including bevacizumab (Avastin).
According to the American Academy of Ophthalmology, intravitreal anti-vascular endothelial growth factor (anti-VEGF) is considered as mainstay of therapy in myopic CNVM (choroidal neovascular membrane). The REPAIR and RADIANCE studies showed efficacy and safety of ranibizumab in this condition. The pro-re-nata (PRN) dosing of ranibizumab was found to be superior to PDT (photodynamic therapy) in the RADIANCE study. MYRROR study for aflibercept in myopic CNV (choroidal neovascularization) in Asian population has found it to be safe and effective. Bevacizumab is also used to treat myopic CNVM (choroidal neovascular membrane), but its intraocular use is not Food and Drug Administration (FDA)-approved.

Loutfi et al performed a meta-analysis of published literature comparing intravitreal ranibizumab with intravitreal bevacizumab for the treatment of myopic choroidal neovascularization. Early evidence suggested that intravitreal injections of ranibizumab are comparable to intravitreal injections of bevacizumab in the treatment of myopic choroidal neovascularization. Both treatments result in a statistically significant increase in visual acuity with high numbers of patients maintaining stable vision.

Similarly, Wang et al performed a retrospective and comparative study to compare the efficacy of intravitreal aflibercept and bevacizumab for patients with myopic choroidal neovascularization. They concluded that both aflibercept and bevacizumab can effectively treat choroidal neovascularization in high myopes. Intravitreal aflibercept had similar efficacy but less treatment number than bevacizumab for mCNV (myopic choroidal neovascularization) during 12-month period.

Therefore, as there as a review of the peer reviewed medical literature does not establish ranibizumab as being safer or more effective than bevacizumab in the treatment of the patient's condition, Lucentis is not established as medically necessary over the formulary alternatives.

Yes, the health plan acted reasonably, with sound medical judgement and in the best interest of the patient.