Assessment of Pragmatism in Recently Published Randomized Clinical Trials

Discussion | The recommendation by the ACIP was informed by the Centers for Disease Control and Prevention model, which assumed a high probability of postherpetic neuralgia and 100% adherence. 1In this modeling study, we found that neither ACIP recommendation would be cost-effective, unless adherence to the 2-dose regimen approached 100%.Using a more realistic estimate, we found it cost-effective to begin vaccination at 55 years of age and offer ZVL recipients a booster after 5 years.This discrepancy highlights the cautions required in interpreting costeffectiveness findings and the importance of scrutinizing underlying assumptions.Adherence of 100% is unlikely for several reasons.The coverage of single-dose ZVL was only 30% in 2015, partly owing to cost. 5 At $280 for the series, RZV is now the most expensive adult vaccine.Reimbursement will also be an issue, especially in people 65 years or older, because Medicare covers zoster vaccine under part D with substantial copayments. 6The 2-dose regimen will require an additional office visit, potentially resulting in extra work loss.Finally, the 6% of patients with a severe local reaction after the first dose may be particularly hesitant to return. Conclusions |The new recommendations of the ACIP for RZV do not appear to be cost-effective unless 100% of patients receive both doses.Given our best estimates, vaccination with RZV at 55 years of age and a booster at least 5 years after ZVL would offer better value.Clinicians may consider vaccination earlier for patients who are very likely to comply with a second dose.In all cases, efforts should be made to enhance compliance with the full series.