The U.S. Food and Drug Administration (FDA) is approving medications at an accelerated pace. With these rapid approvals, the specialty medication pipeline continues to expand. Some approved medications have limited evidence to support their use, and manufacturers are launching medications with higher price points.
UnitedHealthcare has developed the Review at Launch program for the medical benefit to allow for a proactive response to new medication launches and to better manage client benefits while minimizing disruption for employees. This program enables UnitedHealthcare to ensure access to, and coverage for, the most clinically appropriate medications, while enabling providers to better serve their patients as new medication therapies become available.
Currently, with the Review at Launch program, select newly FDA-approved medications that are administered by a health care professional and covered under the member’s medical benefit are placed on the Review at Launch list during the evaluation period. This allows UnitedHealthcare to review FDA-approved medications for clinical appropriateness. After the evaluation period, these medications are removed from the list and utilization management strategies are implemented (e.g., our standard prior authorization program). Coverage determination will be based on the clients’ benefit plan.
Exclude at Launch builds on the Review at Launch program. It’s a temporary exclusion for newly approved FDA medications, which allow for a comprehensive review of the medication, development and implementation of clinical management strategies, and communication to providers prior to coverage. Once utilization management strategies have been implemented, the medication will move off of the Review at Launch list and be removed from temporary exclusion. Coverage determination will be based on the clients’ benefit plan.
Exclude at Launch, for the medical benefit, is standard for fully insured clients, where state mandates allow, and for self-funded clients with Exclude at Launch language in their Summary Plan Document (SPD) or the Summary Material Modification (SMM) document.
For ASO clients, Exclude at Launch requires the necessary SPD/SMM language. Under Exclusions, Drug Section it should state: New Pharmaceutical Products and/or new dosage forms until the date they are reviewed. Language enhancements are pending and will be communicated once in place.
For ASO clients with a 2018 series SPD, this program was included in the standard language and is effective as of 1/1/18, if accepted by the client.
For ASO clients with a 2007 series SPD, this program was included in the SMM sent 1/1/17 and the program is effective on renewal, if accepted by the client.
For ASO clients with a 2004 series or earlier SPD, the program is not currently in place. The language will be updated upon renewal if accepted by the client.
UnitedHealthcare has worked closely with care providers to ensure they are aware of this policy and to encourage them to request pre-service coverage reviews to determine whether a medication is covered before providing services.
If you have additional questions, please contact your UnitedHealthcare representative.