Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Rosacea
Treatment: Soolantra
The insurer denied coverage for Soolantra.
The denial is upheld.

This is a male patient who has rosacea to his cheeks, nose, and forehead. The patient has used triamcinolone, doxycycline, and metronidazole gel. Soolantra was requested. 

Per Rainer, et al, "In mild to moderate disease of rosacea, topical therapeutic approach is considered to be the first-line. Metronidazole 0.75% [percent] (gel, cream, and lotion; twice-daily application), metronidazole 1% (gel and cream; once-daily application), azelaic acid 15% gel (twice-daily application), and ivermectin1% cream (once-daily application) are US FDA [United States Food and Drug Adminitration] approved to treat inflammatory lesions of rosacea, and are generally well tolerated by most patients. According to the current Cochrane review published in 2015, topical metronidazole, azelaic acid, and ivermectin compared with placebo were all associated with improvements primarily for papulopustular rosacea... brimonidine tartrate 0.33% gel (once-daily application) was approved by the FDA as the first medication for the topical treatment of persistent facial erythema associated with rosacea... based on a systematic review, topical brimonidine tartrate gel was associated with two grades of improvement in facial erythema among 114 of 227 participants (50%) compared with 54 of 276 participants... topical brimonidine tartrate gel is generally well tolerated; the most common side effects are skin related, including burning sensation, contact dermatitis, and rebound erythema."

Per Buddenkotte, J., & Steinhoff, M. (2018), "Flushing and erythema: According to recent guidelines, two approved topicals can be used to treat persistent erythema in adults with rosacea: brimonidine (a beta2-adrenergic agonist) and oxymetazoline hydrochloride 1% cream... certain laser therapies can be used, but they should be avoided in pain-sensitized patients. Off-label usage of beta-blockers such as carvedilol or adrenergic receptor modulators (for example, brimonidine) may alleviate these symptoms. In case of pain association, an analgesic therapy with, for instance, lidocaine gel (4%) or polidocanol cream in mild cases and antiphlogistics (for example, ibuprofen), anti-depressants (for example, amitriptyline), or anticonvulsants (for example, gabapentin and pregabalin) in more severe cases may be helpful. Telangiectasia: Only a few options exist for the treatment of telangiectasia, among which physical laser therapy and intravascular aethoxysklerol (0.5%-1%) injections are most commonly used. Papules and pustules: Patients with mild to moderate papules and pustules benefit from topical treatment with ivermectin (1%), metronidazole (1%), azelaic acid (15%), or sodium sulfacetamide sulfur. Off-label therapy with topical erythromycin (2%), isotretinoin, clindamycin, permethrin, doxycycline, minocycline, and oral erythromycin has been reported with good results. Combination therapy often helps to prolong symptom-free periods. In severe or therapy-refractory cases, systemic treatment with metronidazole, clarithromycin, and azithromycin can be conducted. In cases of Demodex infestation, permethrin (off-label) or ivermectin cream and oral ivermectin can improve the therapeutic result."                                                       

The formulary drugs would not be more likely to cause the patient an adverse reaction.   The formulary alternatives Finacea, metronidazole cream/lotion, Mirvaso, and Rosadan have not been ineffective for treating his condition. He has already tried and failed topical metronidazole gel. It is not expected that the cream or lotion formulation would be more effective. There are no head-to-head studies showing that Soolantra would be more effective than Finacea or Mirvaso. Therefore, the requested drug would not be more effective than the formulary drugs Finacea or Mirvaso.

The carrier's denial of Formulary Exception for Soolantra is upheld.