Coverage By Vaccines For Children Program Is Critical For RSV Therapy Access

Recent advances in monoclonal antibody (mAb) technology have yielded significant progress for new infectious disease preventive treatments. Preventive therapies have already been approved for COVID-19, Ebola, respiratory syncytial virus (RSV), and anthrax. New therapies are under development for a variety of infectious diseases including pneumococcal pneumonia, malaria, and HIV. Most notably, two new vaccine-like preventive mAb RSV therapies for infants are slated to gain approval within the next one to three years. Once approved, these therapies will be covered for infants born to low-income families under one of two pathways—either under standard Medicaid drug coverage or under the Vaccines for Children (VFC) program. In this Forefront article, we explore the factors that go into determining which form of coverage will be used and the implications for access to careThe VFC program pathway has clear advantages over the Medicaid drug program for decreasing RSV morbidity and mortality, making it the best choice for coverage. This article was developed by independent consultants who are employees of Health Management Associates (HMA) with the support of Sanofi, one of the manufacturers of RSV mAb therapies pending Food and Drug Administration (FDA) approval.

Serious RSV infections among children have long been a concern, and current disease trends are now testing hospital capacity across the nation. Although the timing is unrelated to this surge, the Centers for Disease Control and Prevention (CDC) is actively evaluating potential RSV prevention products through a workgroup established in late 2021 under the auspices of the Advisory Committee on Immunization Practices (ACIP) to develop guidance and recommendations for their use. The ability for patients to effectively access the new preventive RSV mAbs will be heavily influenced by whether the ACIP votes to include these immunizations in the VFC program, a federally funded program that provides vaccines at no cost to children who have historically been difficult to immunize because of cost barriers.

VFC was created in 1993 to establish an equitable national approach to the coverage of vaccines with widespread population health benefits that surmounted the inherently inconsistent state-by-state Medicaid program approach. A recent Health Affairs Forefront article highlighted VFC as a stable foundation for preventive mAb immunization coverage. For nearly 30 years, VFC has provided the infrastructure for high rates of childhood vaccination in the US and is an ideal delivery mechanism for preventive mAbs to ensure equitable access for the children most affected by RSV hospitalizations. Since its inception, the VFC program has increased immunization levels above 90 percent for many conditions and avoided more than 20 million hospitalizations and 700,000 deaths due to preventable conditions.

Monoclonal Antibodies And RSV Prevention

The development of monoclonal antibodies—human immune proteins that can provide rapid, passive protection against some infectious diseases—is progressing quickly and holds great promise for expanding the public health communicable disease prevention toolkit beyond traditional vaccines.

RSV is the leading cause of lower respiratory tract infection in infants and young children, acute illness visits to clinics, and hospitalizations during the respiratory season. An estimated 9.3 percent of all infant hospitalizations are caused by RSV, making it the most common cause of hospitalization for infants after delivery. The burden of RSV falls disproportionately on the roughly 1.5 million infants born annually with Medicaid coverage, who represent an estimated 62 percent of RSV hospitalizations and 56 percent of emergency department visits. Medicaid-enrolled infants are 91 percent more likely than commercially insured infants to be hospitalized for RSV in their first year. Medicaid pays approximately $709.6 million annually for infant RSV prevention and treatment costs.

In addition to the immediate burden of acute illness, potential hospitalization and emergency visits, RSV infection in the first three years of life has been associated with longer-term respiratory issues including recurrent wheezing and asthma, decreased lung function, and possibly allergic sensitization.

Because the RSV-preventive mAbs expected to gain approval in the coming months offer near-immediate passive immune protection for infants born during RSV season, they are ideally suited to administration in-hospital at the time of birth. If the new mAbs can be delivered routinely to infants before hospital discharge, significant and meaningful reductions in RSV morbidity and mortality are possible. Whether that outcome is achievable will depend on the accessibility of the new mAbs and how they are paid for.

The Medicaid Drug Coverage Pathway For Preventive mAbs

If RSV mAbs are not included in the VFC program, mAbs for the prevention of RSV would likely be treated like other drugs pursuant to the federal Medicaid Drug Rebate Program statute. While the federal coverage requirement is clear-cut and unambiguous, how that coverage is determined would vary state by state, with unavoidable inconsistencies in access. Preventive mAbs would be subject to a variety of state Medicaid and managed care organization (MCO) administrative practices aimed at managing drug costs. For Medicaid coverage to reliably meet the needs of infants at risk for RSV, several factors need to align.

• State and MCO coverage committees will need to review the new mAbs and recommend preferred drug listing status. Pending these reviews, some states may default to prior authorization, likely in advance of the establishment of clear criteria beyond broad medical necessity definitions. Prior authorization requirements may persist beyond initial review depending on how a state assesses risks for overuse of preventive mAbs.
• While manufacturer costs and state budgets will be one consideration for establishing more permanent authorization requirements, criteria for coverage often rely on external recommendations from professional organizations and associations, which can be more restrictive than FDA-approved indications.
• Under prior authorization, the decision of the prescribing physician will be subject to review by the MCO or Medicaid agency utilization management staff, which will involve extra time, submission of documentation, and potential delays resulting from assessment and communications between reviewers and prescribers.
• Outside of prior authorization considerations, states will also need to address how reimbursement is handled for in-hospital administration (typically by diagnosis-related group). These decisions can impact the availability of therapies in hospital settings and may require Centers for Medicare and Medicaid Services approval.

For the best uptake of preventive mAbs, prior authorization and payment factors need to align within a given state and sometimes across both fee-for-service and managed care delivery systems. The alignment problem is further compounded by variation across the 50 states, the District of Columbia, and territorial programs.

The Vaccines For Children Program Access Pathway

In contrast to the Medicaid drug coverage pathway, ACIP-recommended vaccines are covered under the national VFC program. VFC establishes a consistent, nationwide vaccine coverage pathway for children and youth younger than age 19 years, including Medicaid-eligible children, the uninsured or underinsured, and Native American/Alaskan Native children.

Once the ACIP issues a VFC resolution, the CDC negotiates contracts for the purchase of recommended vaccines with manufacturers, which are then funded via congressional appropriation by the CDC. Vaccines are then distributed to grantees, such as health departments and public health agencies, that deliver them at no cost to registered VFC physician and clinic providers for administration free of charge to families.

The ACIP’s RSV work group is currently evaluating the new mAb therapies and is expected to make evidence-based recommendations based on their efficacy, safety, and cost-effectiveness relative to the epidemiology and burden of RSV. If approved, they would be the first mAbs to undergo ACIP review and be added to the VFC program.  Recommendations would include guidelines for who should receive the vaccine.

Unlike the Medicaid program, VFC does not require prior authorization for administration, instead relying on enrollment screenings, site visits, and audits to ensure that providers are prescribing and administering vaccines appropriately. VFC itself is subject to audit by the Office of Inspector General, as are other federal agencies and state Medicaid agencies. While this approach has its own pros and cons, it avoids the friction of prior authorization processes employed by Medicaid agencies or MCOs that can constrict access as well as the 50-state variability inherent in Medicaid drug coverage.

Cost Considerations For Coverage Under VFC And Medicaid Drug Coverage Pathway

Both state and ACIP decisions for coverage will take cost into account. The RSV work group is explicitly tasked with reviewing “efficacy, immunogenicity, safety, and cost-effectiveness of RSV vaccine(s) and newly developed immune globulin products.” Medicaid drug rebate programs have been mandated since 1993 to conduct drug utilization review under section 1927(g) of the Social Security Act including consideration of “billing practices that indicate abuse or excessive utilization” in addition to foundational general requirements for utilization management for Medicaid programs to safeguard against unnecessary use of care and services under section 1902(a)(30).

One specific cost consideration for RSV mAbs involves hospital payments if RSV mAbs are covered under the Medicaid drug benefit. From a public health point of view, in-hospital administration during the RSV season is an outstanding opportunity to deliver preventive therapy without requiring an additional visit from the family and to maximize early protection. However, administering mAbs in-hospital would mean that the preventive RSV mAb would need to be covered under the hospital payment rather than a payment for a drug therapy. Any additional cost associated with the RSV mAb would be surplus to the established payment structure, at least in the short to medium term. If mAbs are part of the VFC program, this barrier would be removed for the majority of newborns.

While there are ways programs can work around these issues, they require additional administrative actions on the part of the state that complicate coverage considerations. Given the challenges already faced by Medicaid programs and MCOs, clearing these payment barriers to ensure access will be difficult for many states to accomplish in a timely manner and negative impacts to access will result.

Policy Directions And Considerations

While coverage pathways are important for coverage efficiency and administrative burdens for government and providers, the most critical question to consider is how decisions impact families seeking to protect their newborns against the risks of RSV infection. As exhibit 1 shows, the differences for family experience and vaccine uptake are stark.

Exhibit 1: Impact of coverage pathway on beneficiary experience and access

Source: HMA analysis of state Medicaid drug coverage policies and VFC program structure.

Equitable access to and uptake of mAbs, particularly in Medicaid where the impact of RSV falls disproportionately on low-income children, will be best achieved by coverage in the VFC program. Without VFC designation, the road to access becomes more difficult and more state specific, with Medicaid drug coverage making mAbs subject to varying utilization management strategies, reimbursement complexities, and state budgetary pressures.

The VFC program bridges coverage categories and attempts to cover all children whose families may not otherwise be able to afford vaccines. Including monoclonal antibodies in the VFC regulatory framework would put these therapies on a stronger footing for the attention from states and Medicaid managed care plans that is a prerequisite for equitable access. Given the urgent unmet public health need to prevent RSV, the advent of mAbs for prevention of RSV is a major breakthrough for young children. To realize the full intent of the VFC program and avoid the access pitfalls it was designed to prevent, RSV mAbs should be fully recommended and funded like a vaccine to maximize equity and access for all infants. We recommend swift consideration of newly approved RSV mAbs by the ACIP and alignment across the Department of Health and Human Services agencies to establish access to Medicaid beneficiaries through VFC, ensuring broad-based, equitable access on a national level.

Authors’ Note

This article was developed by independent consultants who are employees of Health Management Associates (HMA) with the support of Sanofi, one of the manufacturers of RSV mAb therapies pending FDA approval. HMA is an independent, national research and consulting firm specializing in publicly funded health care and human services policy, programs, financing, and evaluation. We serve government, public and private providers, health systems, health plans, community-based organizations, institutional investors, foundations, and associations. Every client matters. Every client gets our best. With offices in more than 20 locations across the country and more than 500 multidisciplinary consultants coast to coast, HMA’s expertise, services, and team are always within client reach.