Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Vision/Glaucoma
Treatment: Pharmacy/Prescription Drugs/Vysulta
The health plan denied the requested medication, Vysulta as not medically necessary. 
The health plan's determination is overturned.

The patient is a woman with open angle glaucoma oculkous uterque (ou) of both eyes. She has been treated with bilateral selective laser trabeculoplasty (SLT), Latanoprost, Latanoprost/netarsudil (Rocklatan), Brinzolamide/brimonidine (Simbrinza), and Bimatoprost and has not had her intraocular pressure (IOP) adequately controlled. She developed dizziness on Timolol and has asthma, which is a contraindication to this medication. Her ophthalmologist started her on Latanoprostene (Vyzulta) to attempt to get her IOP closer to her goal on < 16. Per the notes, this medication brought her closer to her IOP and she is not experiencing side effects from it.
At issue is the medical necessity for the requested medication, Vyzulta.

The health plan's determination of medical necessity is overturned, in whole.

Yes. The patient has tried and failed all formulary alternatives. The patient has glaucoma, a potentially blinding disease, which has not been adequately treated by formulary medications. The alternative is glaucoma surgery which has increased risk and cost associated with it.
The patient was denied because she had not been specifically on a formulary alternative, Brimonidine. However, she had been tried on Brimonidine in a combination preparation with Brinzolamide, known as Simbrinza, which contains the same dose of Brimonidine as stand alone Brimonidine drops.
This patient has tried and failed or been intolerant to all the alternative therapies.
The only proven treatment for open angle glaucoma is lowering IOP. IOP may be lowered by medical therapy (patient has tried many), laser therapy ( patient has undergone selective laser trabeculoplasty) and surgical procedures. There is no strong evidence supporting which of medical, laser or surgical therapy should be given initially. The most efficacious class of drops is the prostaglandin analogues. They are also the most convenient drops with once nightly dosage. This patient tried Latanoprost and did not get an acceptable reduction in her IOP while using it. The second most efficacious class of drops is the beta-blockers, which this patient can't use due to her asthma. Many other topical drops as well as SLT have failed. Therefore, it is reasonable to use a non-formulary drug for this patient with glaucoma. The only other option is surgery which has many more costs and risks associated with it.
Latanoprostene Bunod (Vyzulta) is a unique nitric oxide (NO) donating Prostaglandin F2 alpha analogue. It is metabolized in Latanoprost and NO. NO causes vasodilation and smooth muscle cell relaxation in schlemm's canal and the trabecular meshwork, thereby increasing trabecular outflow. This is in addition to the increased outflow of the uveoscleral pathway provided by Latanoprost.
The VOYAGER study found that Vyzulta provided a greater mean decrease in IOP at day 28 than Latanoprost alone. The constellation had similar findings when comparing Vyzulta to Timolol. It is Food and Drug Administration (FDA) approved and has been for far longer than the 6 moths, required by the insurance carrier.