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Summary

Avalere analysis finds Medicare incurred $106.4 billion in 2016–2018 treating diseases potentially preventable with inline vaccines and select pipeline vaccine candidates. Those diseases also resulted in beneficiary costs of approximately $9.6 billion during the same time period.

Understanding Vaccine Uptake and Vaccine-Preventable Disease Burden

Immunization uptake among the Medicare 65+ population has consistently lagged behind Healthy People 2020 national targets. Disparate coverage of vaccines under Medicare Parts B and D (Table 1) has created access barriers that further hinder vaccine uptake across care settings (e.g., physician office, mass immunization clinics, pharmacy). In particular, cost-sharing for Part D-covered vaccines has been shown to deter beneficiaries from obtaining recommended vaccines, though other systemic barriers, such as physician challenges billing for Part D-covered vaccines, also hamper vaccination efforts, resulting in higher incidence of and therefore a greater Medicare spend on potentially vaccine-preventable diseases (VPDs).

Table 1: Medicare Coverage of Vaccines
Table 1: Medicare Coverage of Vaccines

To better understand vaccine uptake and VPD burden in the 65+ Medicare population, Avalere conducted a claims-based analysis examining uptake levels of routinely recommended inline vaccines and burden of potentially VPDs between 2016 and 2018. This analysis includes 7 disease areas identified as vaccine-preventable since they have inline vaccines routinely recommended for adults age 65+ (e.g., influenza, pneumococcal disease, herpes zoster, pertussis, hepatitis A and B, tetanus). The disease burden analysis also includes 2 disease areas with pipeline vaccine candidates in late stage development (C. diff and RSV). The analysis utilized Center for Medicare and Medicaid Services (CMS)-sourced claims data for Medicare Fee-for-Service (FFS) beneficiaries and Part D enrollees and Medicare Advantage (MA) claims from the Inovalon MORE2 Registry®.

Results: Estimated Medicare and Beneficiary Costs

Between 2016 and 2018, care associated with potentially VPDs cost Medicare an estimated $106.4 billion. This estimate includes the 7 disease areas with inline vaccines routinely recommended for adults age 65+, as well as 2 disease areas with pipeline vaccine candidates in late stage development, C. diff and RSV (Figure 1). C. diff and RSV, for which there are no approved vaccines on the market, accounted for approximately 40% of total estimated Medicare spend among the diseases in this analysis. The analysis also found that beneficiary costs during this time period totaled $9.6 billion (Figure 2). However, actual out-of-pocket costs paid may be lower after coverage from supplemental benefits.

Figure 1: Estimated Medicare Costs on Diseases Preventable by Marketed Vaccines or Advanced Pipeline Vaccine Candidates, 2016–2018
Figure 1: Estimated Medicare Costs on Diseases Preventable by Marketed Vaccines or Advanced Pipeline Vaccine Candidates, 2016–2018
Figure 2: Estimated Beneficiary Costs on Diseases Preventable by Marketed Vaccines or Advanced Pipeline Vaccine Candidates, 2016–2018*
Figure 2: Estimated Beneficiary Costs on Diseases Preventable by Marketed Vaccines or Advanced Pipeline Vaccine Candidates, 2016–2018*

Notes: For Figures 1 and 2, Part D costs represent standard Part D coverage only. Some disease costs are offset by Part B and D premiums and supplemental coverage, respectively. Additionally, influenza and RSV spends are measured across the 2015–2016 and 2017–2018 seasons.

*Diseases preventable by advanced pipeline vaccine candidates are C. diff and RSV.

Results: Understanding Vaccine Uptake in the Medicare 65+ Population

Avalere also examined uptake for marketed vaccines to establish a baseline understanding of current rates in Medicare. Overall, year-over-year uptake of vaccines routinely recommended for the Medicare population stayed relatively steady between 2009 and 2018. Noticeable changes to uptake generally coincided with changes to ACIP recommendations, namely in 2015 for pneumococcal vaccination and 2018 for zoster vaccination (Figure 3).

Annual influenza uptake in the Medicare population failed to reach over 55% for any flu season from 2009–2010 to 2017–2018 (Figure 4). Vaccine uptake for any pneumococcal and shingles vaccines both fall below the Health People 2020 targets of 90% and 30%, respectively. Results also showed an increasing trend for pharmacies rather than physician-based settings as the site of vaccine administration from 2009 to 2018 for the Medicare population, particularly in Part D.

Figure 3: Uptake for Non-Seasonal Vaccines, 2009–2018
Figure 3: Uptake for Non-Seasonal Vaccines, 2009–2018

PCV: Pneumococcal Conjugate Vaccine; PPSV: Pneumococcal Polysaccharide Vaccine

*Defined as the number of beneficiaries who receive the vaccine within a year divided by the number of beneficiaries who had not previously received the vaccine

**The ACIP recommended routine PCV-13 vaccination for adults 65+ in 2014.

Figure 4: Seasonal Influenza Vaccine Uptake, 1+ Doses, 2009–10 to 2017–18
Figure 4: Seasonal Influenza Vaccine Uptake, 1+ Doses, 2009–10 to 2017–18

Discussion

In 2016–2018, diseases preventable by inline and pipeline vaccines accounted for a sizable portion of Medicare and beneficiary costs. The analysis found that costs were largely attributable to respiratory diseases, including diseases without a marketed vaccine, indicating that advanced pipeline candidates have the potential to shift the landscape of vaccine preventable diseases. Increasing uptake of routinely recommended inline vaccines in the Medicare population also holds potential to reduce Medicare expenditures on VPDs.

As more vaccines come to market in the near future, addressing known barriers that hinder beneficiary access is an important step to reaching national uptake targets. A recent Avalere analysis of 2020 Part D plans found that plans require copayments for Part D-covered vaccines 87% of the time, and allow $0 cost-sharing for select Part D vaccines only 4% of the time, whereas Part B vaccines are not subject to cost-sharing. The recent inclusion of future COVID-19 vaccines under Medicare Part B further underscores the inconsistencies in vaccine coverage and access for the Medicare population. These existing barriers, coupled with the emergence of COVID-19 and advanced pipeline candidates, highlight an opportunity to examine vaccine access for seniors.

Funding for this research was provided by the Biotechnology Innovation Organization. Avalere Health retained full editorial control.

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Methodology

For the cost of VPD analysis, Avalere utilized CMS-sourced Medicare FFS enrollment, medical, and pharmacy claims to identify beneficiaries age 65 and older who experienced an episode of a VPD over the time period analyzed. VPDs of interest included influenza, pneumococcal disease, herpes zoster, pertussis, hepatitis A and B, tetanus, RSV, and C. diff. Most VPDs were analyzed over the 2016–2018 period, but influenza and RSV spend was calculated between the 2015–2016 and 2017–2018 respiratory virus seasons.

To be included in the cohort, the beneficiary had to be continuously enrolled in Parts A and B for the full season (12 months). For a second cohort, patients were also required to be continuously enrolled in Part D for the full season. Avalere calculated costs over episodes triggered by the presence of relevant ICD-9-CM and ICD-10-CM diagnosis codes in any position on 1 or more medical claims in any setting of care. The C. diff disease burden analysis was replicated for an at-risk cohort limited to immunocompromised and immunocompetent patients.

The unadjusted proportion of beneficiaries with each type of VPD was compared with estimates from the published literature and adjusted as appropriate to correct for potential underdiagnosis in the medical claims. To estimate VPD-attributable costs, medical claim records having a VPD diagnosis or its related complication in the primary diagnosis position were considered VPD-attributable claims, and corresponding Medicare payments and beneficiary payments were considered VPD-attributable costs to Medicare/beneficiary. Among pharmacy claim records, claims with medications for direct treatment of the VPD were captured as VPD-attributable. These VPD-attributable payments for all beneficiaries during a given season (for RSV and influenza) or calendar year (for the other VPDs analyzed) were summed up to calculate overall disease burden. Avalere’s observed rates of disease prevalence were compared with CDC estimates and extrapolated if required to adjust for underdiagnosis using published literature (such as for RSV and influenza ). To obtain the combined disease burden for FFS and MA, the FFS disease burden was extrapolated to the MA population using a season-specific multiplication factor based on Medicare enrollment.

Vaccine uptake in Medicare FFS Parts B and D between 2009 and 2018 was measured using a 20% random sample of CMS-sourced Medicare FFS enrollment, medical, and pharmacy claims for beneficiaries age 65 and older. Similarly, vaccine uptake in MA was measured using the Inovalon MORE2 Registry®. Inline vaccines for the following therapeutic areas were captured: influenza, pneumococcal disease, herpes zoster, pertussis, hepatitis A and B, and tetanus.

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