Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  Post Surgical Corneal Ectasia.
Treatment:  Topography-Guided Corneal Collagen Crosslinking.
 
The insurer denied the Topography-Guided Corneal Collagen Crosslinking.  The denial is upheld. 

The patient is a female.  She has a diagnosis of corneal ectasia as a result of hyperopic LASIK (laser-assisted in situ keratomileusis).  Request is made for coverage of Topography Guided UV (ultraviolet)-Corneal Crosslinking.  The patient has needed phototherapeutic keratectomy to treat recurrent corneal erosions.  

Per exam note, the patient complains of difficult time with her vision with her contact lenses; visual acuity is 20/25 right eye and 20/40 left eye; corneal exam with flap stable, clear cornea.  Assessment is high hyperopia, with difficulty finding scleral rigid gas permeable contact lenses fit - referral is made to consider topography guided PRK (photorefractive keratectomy).  

No, the health plan should not cover the Topography-Guided Corneal Collagen Crosslinking.

The Topography-Guided Corneal Collagen Crosslinking is considered to be experimental/investigational.

The articles submitted by the Provider also state that more studies are needed:

Sakla et al. article provided states, "Future studies with larger cohorts of patients and longer follow-up periods are needed to determine that the safety and efficacy are maintained, as the keratoconus patient ages."  

No, the Topography-Guided Corneal Collagen Crosslinking has not been shown to be more beneficial than standard corneal cross-linking.

Per the American Academy of Ophthalmology:  "As keratoconus usually presents in late childhood or adolescence, early diagnosis is very important.  The greater the delay of diagnosis, the higher the risk of greater vision loss and of the patient requiring a cornea transplant.  Once progression is observed early detection and prompt treatment with corneal cross-linking (CXL), can reduce or stop keratoconus progression and preserve good visual acuity with eyeglasses and/or contact lenses."  

As of 04/18/2016, the FDA has approved a riboflavin ophthalmic solution (Photrexa, Avedro) for treatment of progressive keratoconus with CXL.

Progressive keratoconus or corneal ectasis is defined as one or more of the following:  1) An increase of 1D (diopter) in the steepest keratometry value, 2) An increase of 1D in regular astigmatism evaluated by subjective manifest refraction, 3) A myopic shift (decrease in the spherical equivalent) of 0.50 D on subjective manifest refraction, or 4) A decrease greater than or equal to 0.1 mm in the back optical zone radius in rigid contact lens
wearers where other information was not available.

Wittig-Silva and colleagues reported the refractive, topographic, and clinical outcomes three years after CXL in eyes with progressive keratoconus.  A prospective randomized controlled trial included 100 eyes with progressive keratoconus randomized into the CXL treatment or control groups.  The authors concluded that, at 36 months, there was a sustained improvement in Kmax (maximum simulated keratometry value), UCVA (uncorrected visual acuity), and BSCVA (best spectacle-corrected visual acuity) after CXL, whereas eyes in the control group demonstrated further progression.

Hersh and colleagues evaluated the safety and efficacy of corneal collagen crosslinking (CXL) for the treatment of progressive keratoconus in a prospective randomized multicenter controlled clinical trial involving 205 patients. Patients were identified as having progressive keratoconus if they demonstrated one or more of the following changes over a period of 24 months:  1) an increase of 1.00 D or more in the steepest keratometry measurement, 2) an increase of 1.00 D or more in manifest cylinder, or 3) an increase of 0.50 D or more in manifest refraction spherical equivalent

The treatment group underwent standard CXL, and the sham control group received riboflavin alone, without removal of the epithelium.  In the CXL treatment group, the maximum keratometry value decreased by 1.6 diopters (D) from baseline to 1 year, whereas keratoconus continued to progress in the control group.  In the treatment group, the maximum keratometry value decreased by 2.0 D or more in 28 eyes (31.4%) and increased by 2.0 D or more in five eyes (5.6%).  The CDVA improved by an average of 5.7 logarithm of the minimum angle of resolution (logMAR) units.  Twenty-three eyes (27.7%) gained and five eyes lost (6.0%) 10 logMAR or more.

The UDVA improved 4.4 logMAR. Corneal haze was the most frequently reported CXL-related adverse finding.  There were no significant changes in endothelial cell count one year after treatment.  The authors concluded that CXL was effective in improving the maximum keratometry value, corrected distance visual acuity, and UCVA in eyes with progressive keratoconus one year after treatment, with an excellent safety profile.

Although corneal cross-linking is shown to be beneficial for patients with corneal ectasia/keratoconus, the data on simultaneous topography-guided photorefractive keratectomy is limited.  This newer treatment has not been shown to be more beneficial in improving net health outcomes compared to standard corneal cross-linking.  Therefore, recommendation is made for non-certification of the proposed treatment.