Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Lupus 

Treatment: Herpes zoster (shingles) vaccine

The insurer is denied coverage for herpes zoster (shingles) vaccine. The denial is overturned. 

The patient has a history of lupus, treated with methotrexate. She was evaluated by infectious disease for an episode of cryptosporidium, successfully treated, and was advised to get the Shingrex injection for prevention of recurrent reactivation of herpes Zoster. 

Peer-reviewed literature as well as recommendations by one of the major scientific rheumatologic societies, EULAR (2011), recommends the shingles vaccine in patients with autoimmune diseases, such as lupus, who are treated with immunosuppressive medications, such as methotrexate. 

Per Chakravarty E. F. (2017), "Herpes zoster is the reactivation of latent varicella zoster virus usually occurring decades after initial exposure, and manifesting as a painful vesicular rash occurring along one or more dermatomes. Zoster incidence increases with age as cell mediated immunity against latent virus wanes. Epidemiological evidence suggests that individuals with underlying rheumatic diseases are at increased risk for zoster. 

Per Papp, K. A., Haraoui, B., Kumar, D., Marshall, J. K., Bissonnette, R., Bitton, A., Bressler, B., Gooderham, M., Ho, V., Jamal, S., Pope, J. E., Steinhart, A. H., Vinh, D. C., & Wade, J. (2019), "Several immunosuppressive therapies attenuate vaccine response. Thus, vaccines should be administered before treatment whenever feasible. Inactivated vaccines can be administered without treatment discontinuation. Similarly, evidence suggests that the live zoster vaccine is safe and effective while on select immunosuppressive therapy, although use of the subunit vaccine is preferred. Caution regarding other live vaccines is warranted. Drug pharmacokinetics, duration of vaccine-induced viremia, and immune response kinetics should be considered to determine appropriate timing of vaccination and treatment (re)initiation. Infants exposed to immunosuppressive therapies through breastmilk can usually be immunized according to local guidelines. 

Per Maltz, F., & Fidler, B. (2019), "In two phase 3 trials, Hz/su significantly reduced the development of herpes zoster in adults aged 50 and older, and of herpes zoster and PHN in adults aged 70 and older.9,10 Because of its superior efficacy over ZVL, HZ/su is now recommended by ACIP as the preferred vaccine for adults aged 50 and older for the prevention of herpes zoster and PHN.5 An additional phase 3 trial showed that Hz/su elicited a strong immune response in patients who were previously vaccinated with ZVL.11 Therefore, ACIP recommends that all adults 50 and older should
receive HZ/su regardless of previous ZVL vaccination.5 It is important to note that HZ/su is a two dose vaccine, with injections given two to six months apart. Because of the great economic and public health burden caused by herpes zoster and PHN, all immunocompetent adults aged 50 and of herpes zoster in adults aged 50 and older, and of herpes zoster and PHN in adults aged 70 and older.9,10 Because of its superior efficacy over ZVL, HZ/su is now recommended by ACIP as the preferred vaccine for adults aged 50 and older for the prevention of herpes zoster and PHN. 

Therefore, the requested service, Herpes zoster (shingles) vaccine is likely to be more beneficial than any of the standard treatments/procedures for this patient.

Based on the above, the insurer's denial of herpes zoster (shingles) vaccine is overturned.