I work for an EYLEA PSP in Canada. One of our patient's prior authorization requests was denied by their insurer - the denial rational: "Avastin, Byooviz, and Beovu are preferentially reimbursed as first tier anti-VEGF therapy. Reimbursement of alternate anti-VEGF therapy may be considered in patients who have contraindications or intolerances to Avastin, Byooviz and Beovu"

I have written an appeal template draft for denials of this type. The appeal will ideally be able to be used for any DME patient that receives a denial of this type. Please review the draft below and revise as you see fit to produce the strongest, most compelling appeal template possible. please also standarize the citations in APA and include a reference list.

DRAFT:

Dear [Insurance Company],
I am writing to appeal your recent decision to deny coverage for EYLEA as the best course of treatment for [patient's name], who has been diagnosed with diabetic macular edema (DME). The prescribing physician has determined EYLEA to be the most effective treatment option based on their clinical expertise and a thorough evaluation of the patient's medical history, comorbidities, and other factors that may influence their response to treatment. We believe that the physician's clinical judgment should be given the utmost respect and consideration when making decisions about a patient's care.
We strongly disagree with the denial of coverage for EYLEA based on [Insurer’s] preference for lower-cost medications – namely Avastin, Byooviz, and Beovu. Medical necessity and clinical criteria should be the primary considerations when deciding on a patient's treatment options, with the aim of providing the best possible care for the patient – including access to the most appropriate medications. The patient’s physician has determined that EYLEA is the most appropriate medication for [Patient]. The success of [Patient’s] treatment should not be compromised by cost considerations.
EYLEA has been demonstrated to be a highly effective treatment for DME. The VIVID VISTA trial, a phase 3, randomized, double-masked, multicenter study by Korobelnik et al in 2014, showed that EYLEA was superior to ranibizumab in improving visual acuity in patients with DME at 1 year. This study found that EYLEA improved visual acuity by a mean of 10.5 letters compared to 9.4 letters with ranibizumab. Additionally, the VIVID VISTA study demonstrated that a higher percentage of patients receiving EYLEA had a clinically significant improvement in visual acuity compared to those receiving ranibizumab.
Further supporting the efficacy of EYLEA, the VIEW study by Heier et al in 2012 demonstrated that EYLEA was non-inferior to ranibizumab in treating wet age-related macular degeneration. Moreover, the GALILEO study by Holz et al in 2013 showed that EYLEA was effective in treating central retinal vein occlusion (CRVO), and the MYRROR study by Ikuno et al in 2015 found that EYLEA was effective in treating myopic choroidal neovascularization (mCNV). Collectively, these influential studies substantiate the broad efficacy of EYLEA in various ocular conditions, including diabetic macular edema (DME).
EYLEA treatment requires fewer or less frequent injections than other anti-VEGF therapies, resulting in reduced treatment burden and improved patient outcomes. In a study by Wykoff et al in 2018, patients with diabetic macular edema who received EYLEA required significantly fewer injections than those treated with ranibizumab. Therefore, EYLEA is arguably a more cost-effective treatment option than ranibizumab in the long term.
Recent studies have demonstrated that EYLEA is a more effective and safer first-line treatment option than Beovu for the treatment of diabetic macular edema. A randomized, controlled study by Dugel et al. (2021) found that EYLEA provided superior visual acuity improvements and required fewer injections than Beovu in patients with DME. The study concluded that "EYLEA was associated with superior visual acuity outcomes and fewer injections than Beovu in eyes with DME." Additionally, a meta-analysis by Semeraro et al. (2021) concluded that EYLEA had a better safety profile than Beovu, with a lower risk of inflammation and retinal vascular occlusion.
It is also essential to note that while Avastin is commonly used off-label for intravitreal injection, it has not been approved by Health Canada for this indication. The use of off-label medication carries inherent risks, and physicians should be free to choose the medication that they believe to be the most appropriate for their patient's condition. Furthermore, the procedure to withdraw Avastin from its vial amounts to splitting of the medication, which is illegal in the province of Ontario. Byooviz and Beovu are relatively new anti-VEGF medications, and their long-term safety and efficacy data are not yet available. Therefore, they are not comparable to EYLEA in terms of efficacy and safety.
In conclusion, we strongly urge you to reconsider your decision to deny coverage for EYLEA and provide [patient’s name] with the most appropriate and effective treatment for their medical condition. We believe that the assertions and arguments made in this appeal are based on evidence-based medical research and should be given serious consideration in your decision-making process.
Sincerely,
EYLEA Patient Support Program