Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Type 2 diabetes mellitus. 
Treatment: Formulary Exception for metformin extended release (ER) (generic Fortamet). 

The insurer is denied coverage for Formulary Exception for metformin ER (generic Fortamet). 

The denial is overturned. 

This is a female patient who has a history of Type 2 diabetes mellitus and depression. The patient presented to an office visit for a 6 week follow-up visit. The visit notes state that the patient has been struggling with depression and has issues complying with treatment recommendations. Per the Prior Authorization form, the patient is unable to comply with twice daily dosing of metformin 500 milligrams (mg), and the patient's compliance would be better with once daily dosing, resulting in better outcomes. They are requesting coverage of metformin extended release (ER) (generic Fortamet). 

In the documentation given for review, it is noted that this patient is having issues with depression and cannot reliably take multiple medications throughout the day. The office note from the treating provider states that the patient is better with taking Metformin on once daily ER formulation. It is also noted the patient's hemoglobin A1c (HbA1c) has reduced from the previous visit. 

Stated by Christofides E. A. (2019), "Strict self-management of type 2 diabetes is required throughout a patient's lifetime to maintain blood glucose levels as close to normal as possible and to reduce the risk of long-term diabetes-related complications affecting the heart, circulatory system, eyes, nerves, and kidneys ...Adherence to and persistence with prescribed diabetes medications are strongly influenced by the class of medication prescribed. Metformin was recently shown to be associated with a higher level of persistence than other classes of oral antidiabetic drugs, but persistence with metformin therapy remains less than optimal. In one study, only 58.6% of patients had good persistence with metformin, defined as compliance with medication purchase for at least 9 months ...Prescribing the most appropriate metformin formulation may be an effective means of improving adherence in specific situations. The newer ER and delayed-release formulations of metformin offer the potential to improve adherence through better gastrointestinal tolerability and simplified regimens for many patients." 

According to Derosa, G. et al. (2017), "Prescribing the most appropriate metformin formulation may be an effective means of improving adherence in specific situations. The newer ER and delayed-release formulations of metformin offer the potential to improve adherence through better gastrointestinal tolerability and simplified regimens for many patients ...Compared to conventional IR [immediate release] formulation, the [ER] offers some advantages. The [ER] formulation has been designed to allow a more gradual release of the drug in the main absorption site...thus improving its tolerability and improving patients' compliance due to a reduction in the frequency of administration and a decrease in adverse events." 

The formulary drugs are likely to cause the patient an adverse reaction. It is documented that the patient has been struggling with her depression, and is struggling with compliance, of the medications that are dosed to be taken multiple times per day, such as the formulary alternatives. The patient should be given a drug that she takes once a day to increase compliance. It is noted the patient has had success with the once daily regimen, with missing less doses, and having a decreased A1C result. The requested drug, metformin ER, is more effective than the formulary options. As it has once daily dosing it will help with compliance, in comparison to the formulary options that require dosing multiple times per day to be effective. 

The insurer's denial of Request for Formulary Exception for metformin ER (generic Fortamet) is overturned.