Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Acne, rosacea, and pityrosporum folliculitis 
Treatment: Formulary Exception for Ivermectin 1% cream 

The insurer denied coverage for Formulary Exception for Ivermectin 1% cream. The denial is upheld. 

This patient is a female with a history of acne, rosacea and pityrosporum folliculitis. An office visit note indicated that the patient continued to use Metronidazole every night but doubted she received any benefit. Metronidazole was stopped and the patient was instructed to start Soolantra (Ivermectin) cream. 

"Ivermectin  1%  cream  (Soolantra();  Rosiver;  Izefla())  is  a  novel  topical  agent  indicated  for  the  once-daily treatment of inflammatory lesions of rosacea. Ivermectin is a derivative of the avermectin family of macrocyclic lactone parasiticides. It displays anti-inflammatory properties as well as broad-spectrum anti-parasitic activity, both of which may contribute to its efficacy in treating rosacea. In phase III trials of 12 or 16 weeks' duration in adults  with  moderate  to  severe  papulopustular  rosacea,  once-daily  ivermectin  1%  cream  improved  the symptoms of rosacea (as per Investigator Global Assessment and inflammatory lesion count) and health-related quality of life versus vehicle, and was more effective than twice-daily metronidazole 0.75% cream in terms of these measures. Ivermectin 1% cream continues to provide benefit for up to 52 weeks of treatment, according to extension  studies,  and  is  well  tolerated,  with  the  most  common  treatment-related  adverse  events  (skin  burning sensation, pruritus, dry skin and skin irritation) each occurring with low incidence (<2%). Thus, ivermectin 1% cream is an effective and well tolerated option for the topical treatment of inflammatory lesions of rosacea, with the convenience of once-daily application" (Deeks, E. D. 2015). 

"Rosacea is a common chronic skin condition that manifests as recurrent inflammator lesions. Long-term treatment is required to control symptoms and disease progression, with topical treatments being the first-line choice. Ivermectin 1 % cream is a new once-daily (QD) topical treatment for the inflammatory lesions of rosacea, and it is important  to compare the efficacy, safety, and tolerability of ivermectin with other currently available topical treatments" (Siddiqui, K. et al. 2016). 

In a Cochrane database review they concluded that "There was high quality evidence to support the effectiveness of topical azelaic acid, topical ivermectin, brimonidine, doxycycline and isotretinoin for rosacea."  The Rosco panel in their algorithm for treatment similarly recommend doxycycline or ivermectin (Schaller et al.). 

There is no indication that the formulary medications will cause an adverse effect.  There is no indication that the formulary medications have been ineffective for the patient. Oral doxycycline 40 mg or 100 mg have been found to be extremely effective for the treatment of rosacea.  In individuals not allergic to sulfa medications, topical  sodium sulfacetamide has been effective in control of rosacea. The documentation does not indicate that these alternatives have been tried. Therefore, the requested drug will not be more effective than the formulary drug. 
                                                       
Based on the above, denial of Formulary Exception for Ivermectin 1% cream is upheld.