Specialty medical injectable drug program updates – Amondys-45™, Xiaflex® and more
New specialty medical injectable guidelines and requirements announced.
- All states
Please review the following information to determine changes to our specialty medical injectable drug programs.
Specialty medical injectable drugs added to review at launch
|Drug Name||UnitedHealthcare Commercial||Treatment Uses|
|Amondys-45™ (casimersen)||X||For the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping.|
|Evkeeza™ (evinacumab-dgnb)||X||Add-on treatment for patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH), a genetic condition that causes severely high cholesterol.|
To view the UnitedHealthcare Commercial Plan Review at Launch Medication List.
Updates to drug program requirements and drug policies
|Drug Name||Effective Date||UnitedHealthcare Commercial||Treatment Uses||Summary of Changes|
|Xiaflex®||Apr. 1, 2021||X||
Treatment of Dupuytren’s contracture
UnitedHealthcare will honor all approved prior authorizations on file until the end date on the authorization or the date the member’s eligibility changes. Providers don’t need to submit a new notification/prior authorization request for members who already have an authorization for these medications on the effective date noted above. Upon prior authorization renewal, the updated policy will apply.
Administrative Guide medication sourcing requirement for Xiaflex – April 1, 2021
As a reminder, the 2021 Care Provider Administrative Guide includes information on medication sourcing requirements for in-network providers. The sourcing requirement for some specialty medications apply to all outpatient care providers (referred to as Medication Sourcing) while other sourcing requirements only apply to outpatient hospital providers (referred to as Medication Sourcing Expansion). Xiaflex will be placed under the Medication Sourcing Program that applies to all outpatient care providers, effective April 1, 2021.
We have contracted specialty pharmacies for the distribution of these specialty medications. Our participating specialty pharmacy providers give fulfillment and distribution services to meet the needs of our members and our care providers. Effective April 1, 2021, a provider must acquire Xiaflex from US Bioservices, unless otherwise authorized by us. The requirement does not apply when Medicare or another health benefit plan is the primary payer and we are the secondary payer.
Note: Certain specialty medical injectable drug programs and updates will not be implemented at this time for providers practicing in Rhode Island, with respect to certain commercial members, pursuant to the Rhode Island regulation: 230 -RICR-20-30-14. UnitedHealthcare encourages providers practicing in Rhode Island to call in to confirm if prior authorization is required. This exception does not apply to Medicaid and Medicare.
UnitedHealthcare commercial plan outpatient medical benefit injectable medication prior authorization process change for Erythropoiesis Stimulating Agents
Beginning April 1, 2021, the prior authorization reviews for Erythropoiesis-Stimulating Agents, drugs such as Retacrit and Aranesp, will move to the Specialty Guidance Program for all non-oncology and non-end stage renal disease (ESRD) diagnoses. The new process is designed to ease the administrative burden of obtaining a prior authorization while also reducing the turnaround time for a determination.
Providers should continue to request notification/prior authorization for oncology diagnoses, ESRD diagnoses, and for UnitedHealthcare Oxford and UMR members through the existing processes until future notice.
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