Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Congenital Glaucoma.
Treatment: Formulary exception for Lumigan, Pre-service.

The insurer denied the Formulary exception for Lumigan, Pre-service.  The denial is overturned. 

The patient is a male for whom coverage of Lumigan is the subject of review.  Reportedly, the patient has been on Lumigan continuously for several years, and his intraocular pressures are well-controlled on this medication.  The provider states that it is medically necessary for the patient to continue with current regimen to avoid loss of vision or future surgery.

Coverage was previously denied, as it was not identified that the patient had tried and had an inadequate treatment response or intolerance to the required number of formulary alternatives per policy (formulary alternatives include latanoprost and travoprost).

An exam documents the patient using Lumigan drops with intraocular pressures measuring 16 mmHg (millimeters of mercury) OU (both eyes).   An exam documents the patient using Lumigan with intraocular pressures of 16 mmHg OD (right eye) and 15 mmHg OS (left eye). An exam documents the patient as having juvenile open angle glaucoma, for which the patient was using Lumigan. By history, maximum tonometry readings had been 29 mmHg OD (right eye) and 30 mmHg OS (left eye). On exam, intraocular pressures were 19 mmHg OU (both eyes) following dilation. Cup/disc ratios were 0.5 by 0.4 OD (right eye) and 0.45 OS (left eye).

Yes, the health plan should cover the Formulary exception for Lumigan.
It is medically necessary, as supported by current medical literature, that the requested drug be covered instead of the available products on the plan's formulary.

Li et al. assessed the comparative effectiveness of first-line medical treatments in patients with POAG (primary open-angle glaucoma) or ocular hypertension through a systematic review and network meta-analysis, and to provide relative rankings of these treatments: The mean reductions (95% credible intervals) in IOP (intraocular pressure) in millimeters of mercury at three months ordered from the most to least effective drugs were as follows: bimatoprost 5.61 (4.94; 6.29), latanoprost 4.85 (4.24; 5.46), travoprost 4.83 (4.12; 5.54), levobunolol 4.51 (3.85; 5.24), tafluprost 4.37 (2.94; 5.83), timolol 3.70 (3.16; 4.24), brimonidine 3.59 (2.89; 4.29), carteolol 3.44 (2.42; 4.46), levobetaxolol 2.56 (1.52; 3.62), apraclonidine 2.52 (0.94; 4.11), dorzolamide 2.49 (1.85; 3.13), brinzolamide 2.42 (1.62; 3.23), betaxolol 2.24 (1.59; 2.88), and unoprostone 1.91 (1.15; 2.67).

Tang et al. subsequently evaluated and compared the efficacy and safety of three prostaglandin analogues (0.005% latanoprost, 0.004% travoprost, and 0.03% bimatoprost) in treatment of primary open-angle glaucoma (POAG) or ocular hypertension (OHT). They found, "0.03% bimatoprost appears more effective following long time use (3 and 6 month post-treatment) for IOP [intraocular pressure] control compared to 0.005% latanoprost, and is more effective compared to 0.004% travoprost after being used for a certain period of time (3 months post-treatment)."

Given the above, the formulary alternatives, latanoprost and travoprost, are less effective at lowering intraocular pressures than the requested Lumigan, which the patient has successfully used for several years. The provider states that changing medication places that patient at risk for vision loss and future surgery. Therefore, the medical necessity of continued Lumigan therapy is established per standard of care as supported by current medical literature.