Study Evaluating Recombinant Zoster Vaccine (RZV) and the Risk of New Dementia

Cohort #1 – CMS >=65 Years of Age Population Inclusion Criteria

• Receipt of 2 doses of RZV for the exposed and at least 1 preventive care visit with no prior RZV for the RZV unvaccinated comparator.

The index date will be set to the second claim for RZV or the preventative care visit for the RZV unvaccinated comparator.

• >=65 years on the index date.
• Continuously enrolled in Medicare FFS Parts A, B, and D for at least 365 days preceding the index date. Continuous enrollment is determined by Medicare enrollment in the month of the RZV Dose 2 vaccination or preventative care visit and enrollment in at least 11 of the 12 preceding months, i.e., allowing a maximum of one calendar month gap in enrollment.
• Original reason for entitlement to Medicare is based on Old Age and Survivor’s Insurance. Cohort #2 – Immunocompromised (IC) or Autoimmune disease (AID) Population Inclusion Criteria
• Receipt of 2 doses of RZV for the exposed and at least 1 preventative care visit with no prior RZV for the RZV unvaccinated comparator.

The index date will be set to the second claim for RZV or the preventative care visit for the RZV unvaccinated comparator.

• >=65 years on the index date.
• Continuously enrolled in Medicare FFS Parts A, B, and D for at least 365 days preceding the index date. Continuous enrollment is determined by Medicare enrollment in the month of the RZV Dose 2 vaccination or preventative care visit and enrollment in at least 11 of the 12 preceding months, i.e., allowing a maximum of 1 calendar month gap in enrollment.
• Evidence of IC status or AD during the 12-month baseline period preceding the index date, defined as:

Patients with autoimmune diseases (e.g., Crohn’s disease, ulcerative colitis, inflammatory bowel disease, multiple sclerosis, psoriasis, psoriatic arthritis, rheumatoid arthritis, or systemic lupus erythematosus). Cohort #3 – Herpes Zoster (HZ) Population Inclusion Criteria

• Evidence of an HZ event defined as >=1 diagnosis code for HZ in any position with a claim for HZ-specific antiviral using national drug codes (NDCs) within 7 days of diagnosis.

The index date will be set to the earliest claim for HZ.

• >=65 years on the index date.
• Continuously enrolled in Medicare FFS Parts A, B, and D for at least 365 days preceding the index date. Continuous enrollment is determined by Medicare enrollment in the month of the RZV Dose 2 vaccination or preventative care visit and enrollment in at least 11 of the 12 preceding months, i.e., allowing a maximum of one calendar month gap in enrollment.

U.S. Medicare beneficiaries who are continuously enrolled only in Medicare Part C in the 365 days (i.e., baseline period) preceding the index date.

• Evidence of any dementia (including Lewy Body dementia and age-related cognitive decline), VD, AD, or mild cognitive impairment (MCI) in the available claims history preceding the index date. The available claims history dating back to October 2015 will be used to detect any evidence of a diagnosis on any of the claims files or an AD-related medication dispensing in the Part D claims.