Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Bilateral Aphakia with Esotropic Nystagmus

Treatment: Combigan 0.2-0.5% (percent) OP (ophthalmic) SOLN (solution)

The insurer denied coverage for Combigan 0.2-0.5% OP (ophthalmic) SOLN (solution)

The denial is upheld.

The doctor reports that the patient has bilateral aphakia with esotropic nystagmus and bilateral retinal detachments alongside chronic open-angle glaucoma. The patient's visual acuity has been maintained at 20/100 given progressive glaucoma monitoring and treatment. The patient has developed allergies to multiple glaucoma drops and has had the best clinical response to Combigan. There is a clinical encounter provided by the treating provider that the intraocular pressure was 16 bilaterally. A large angle exotropia was seen. The patient was aphakic bilaterally, and his pressure was controlled on Combigan. The provider asserts in previous encounters that the intraocular pressure was controlled with generic timolol and brimonidine but that the patient does better with Combigan. It is difficult to ascertain what better means. The intraocular pressure control was reasonably similar between the generic versus the brand when evaluating the clinical encounters. It is possible that tolerability was a factor, though documentation of this is not present.

In order for Combigan to be approved, intolerance to the generic brimonidine and timolol must be documented, and as such, the claim was denied. The provider asserts medical necessity as the rationale for the appeal however there is no documentation of intolerance or side effects with the use of the generic equivalent. The documentation must include information on how the patient is intolerant to the generic formulation and/or what side effects the patient has on the generic formulation. None of this is provided. Thus, Combigan is not considered medically necessary.

"In this study, we observed that use of generics was associated with comparable clinical outcomes to use of brand-name products. These results could help in promoting educational interventions aimed at increasing patient and provider confidence in the ability of generic medicines to manage chronic diseases." (Desai et al., 2019).

"Providers encounter barriers to using generic medications. Some eye-care providers are concerned about the efficacy of generic ophthalmic medications because the Food and Drug Administration (FDA) does not require most generic medications to undergo efficacy testing in clinical trials.1719 The FDA requires systemic generic medications to demonstrate pharmaceutical and bioequivalence to the parent drug, but topical generic drugs need to demonstrate pharmaceutical equivalence, not bioequivalence. The purpose of this FDA policy is to lower regulatory burden and thus to promote generic ophthalmic medication development.  Demonstrating topical (and intraocular) bioequivalence is complex and would greatly limit the number of generic equivalents that could come to market. Pharmaceutical companies have argued for the necessity of both pharmaceutical and bioequivalence likely to limit the number of available generics. However, the FDA has held their position that bioequivalence testing is not required. Despite the more lenient policy by the FDA, eye care providers may believe that generic medications are less effective than brand medications, a frequent argument presented in the lay literature." (Newman-Casey et al., 2018).

The health plan acted reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for the Combigan 0.2-0.5% OP SOLN is upheld. Medical Necessity is not substantiated.