Synagis

Human Respiratory Syncytial Virus (RSV) causes respiratory tract infections and serious lung disease in infants and children. Synagis (palivizumab) is available for children with high risk of infection.

2021-22 RSV Assessment and Synagis Authorization

The recent summertime resurgence in respiratory syncytial virus (RSV) activities in Texas resulted in HHSC’s decision to gradually open all DSHS regions allowing all children who meet prior authorization criteria to receive monthly doses Synagis (palivizumab). To address concerns for the appropriateness of giving additional doses or starting new therapy during the fall and winter seasons, providers will be required to re-assess the need for prophylaxis therapy for the children in their regions. A new prior authorization for all children is required beginning October 1, 2021.

As of Sept. 1, it is not possible to anticipate if RSV activity will continue to spread equally in all regions or if it will increase to levels of activity typically seen during the fall and winter months. As new developments arise, it may be necessary to close certain regions based on the latest RSV activity reports. HHSC will continue to monitor atypical RSV activity and provide further guidance as the traditional 2021-22 RSV season progresses.

Formulary Coverage

  • Synagis is a year-round benefit for Medicaid, CHIP, and CSHCN Services Program to allow for consideration of off-season requests. NDCs for Synagis will remain active on the formulary year-round.
    • RSV illness may occur at any time during the year, but most cases occur in a season from late autumn to early spring, peaking in mid-winter. VDP coverage for the series of 5 once-monthly doses of Synagis prophylaxis for RSV is based on this season. The fall and winter season schedule for each of the 11 Texas Health Service Regions will be available for reference.
    • HHSC in coordination with the RSV Taskforce determines the beginning and end of the season in each region by reviewing the percentage of positive reported RSV tests as they rise and fall with disease activity. The task force relies on both RSV antigen testing and PCR testing to make that determination.
  • Synagis for children in CHIP is a pharmacy benefit and not available as a medical benefit. The Medicaid prior authorization criteria also apply to CHIP and align coverage as a pharmacy benefit for both programs.
  • Prior authorization approval for children with RSV infection risks not identified on the Medicaid or CSHCN RSV prior authorization forms may be eligible for approval on a case-by-case basis and may require additional supporting documents, such as pertinent diagnostic, lab tests, or medical records.

Forms and Submission Instructions

Prescribing providers must both complete the Texas Standard Prior Authorization Form for Prescription Drug Benefits (TDI Form NOFR002) and HHS Form 1321 for traditional Medicaid. The provider submits the form as instructed on the form.

Prescribing providers must both complete the Texas Standard Prior Authorization Form for Prescription Drug Benefits (TDI Form NOFR002) and HHS Form 1325 for CSHCN Services Program. The provider submits the form as instructed on the form.

Providers must contact the patient’s MCO for prior authorization forms and instructions. Medicaid managed care and CHIP require NORFR002 and may provide additional information with the specific MCO addendum form or via phone call. Each MCO’s prior authorization form reflects the appropriate MCO contact information and reconsideration request process. Contact information is available on the Prescriber MCO Assistance Chart, or providers can refer to the MCO Resources for links to each MCO’s clinical prior authorizations.

Allow up to two weeks for prior authorization processing and shipping.

Criteria

The prior authorization criteria used for this season are the same as the 2020-21 season.

Pharmacy Information

Any specialty pharmacy enrolled with HHSC may provide Synagis. A pharmacy must enroll in the CSHCN Services Program to provide services to children in the program.