Newly Marketed and Self‑Administered Specialty Drugs — Coverage List and Prior Authorization Requirements
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Lists newly marketed prescription and specialty medications with prior authorization (PA), quantity limits (QL), and limited distribution drug (LDD) designations; informs providers and pharmacies about coverage requirements and dispensing channels for Florida Blue members.
No material clinical or coverage changes in this revision.
Coverage Determinations and Listings
Newly Marketed Drugs Review
Coverage determination and listing rules
Providers should check the 'New to Market Drug' list for current status and formulary tiering.
Plan-specific Coverage and PA
Coverage requires plan-specific checks
Prior Authorization requirements may vary by plan; certain specialty drugs may not be covered by certain plans. Member cost share may be higher for self-administered specialty drugs not obtained at in-network specialty pharmacies (Accredo or CVS/Caremark Specialty Pharmacy).
Use the Limited Distribution Drugs list to identify the appropriate dispensing pharmacy.
Provider Contact Center: 1-800-727-2227; Customer Service number is on the back of the member's ID card.
Some specialty medications listed in this document may not be covered for all members. Refer to the member contract benefit and the Prior Authorization Program Information and Forms guide to confirm whether a specific drug is included in the member's plan and PA program. Coverage rules, including PA requirements and available dispensing channels, can vary by plan; providers should verify plan-specific coverage before dispensing.
Drugs that appear in the “Self‑Administered Specialty Drugs that are NOT Covered*” lists and are explicitly labeled NOT COVERED are excluded from payment and will be denied if submitted for coverage. Examples appear throughout the NOT COVERED lists (e.g., Abrilada, Amjevita, Gleevec, Tecfidera, Xyrem, Zytiga and many others); providers should not submit claims for medications shown as NOT COVERED for the member’s plan.
Provider Requirements and Impact
Prior Authorization Required
Prior Authorization Required for Listed Drugs — Many drugs in the lists are designated as requiring Prior Authorization (PA). Providers must obtain PA per the member's plan before dispensing. Coverage may be denied if PA is not obtained.
- PA designations are shown next to drug names (PA).
- Some drugs are Limited Distribution Drugs (LDD) — dispensing pharmacy information available via the Limited Distribution Drugs link.
- Quantity Limits (QL) also apply to many listed drugs.
Prior Authorization Required for Specialty Drugs
Prior authorization is required for many listed specialty drugs prior to coverage. Providers should confirm PA requirements for the specific member plan and for specialty products that may be excluded from some plans.
- Specialty drugs marked with PA must have authorization prior to claim submission.
- Some drugs are covered as self-administered or provider-administered specialty pharmacy drugs as noted in footnotes.
- CVS Caremark is the preferred in‑network pharmacy for hemophilia products for applicable items.
Step Therapy Advisory
Step therapy requirements may vary by plan and are not fully specified in these lists. Providers should consult the member contract and the Prior Authorization Program Information and Forms guide for any step-therapy or step-edit requirements that apply.
- Step edits, if applicable, will be enforced per the member's benefit plan.
- Refer to plan-specific PA guides for details on required trials or alternatives.
Provider Documentation and Contact
Provider documentation and contact — Providers must refer to the member contract benefit and the Prior Authorization Program Information and Forms guide to determine PA program inclusion and coverage details. If questions remain after consulting the table and guides, contact the Provider Contact Center.
- Provider Contact Center: 1-800-727-2227 (health care providers and office staff only)
- Customer Service phone number is on the back of the member's insurance card
- Use the Limited Distribution Drugs resource to identify the appropriate dispensing pharmacy for LDD products.
Prior Authorization and Plan Exclusions
Prior authorization and plan exclusions — Coverage may be denied if a medication is subject to PA and PA is not obtained. Certain specialty drugs may not be covered by certain plans; providers should verify coverage before prescribing or dispensing.
- Medications labeled NOT COVERED in the lists will be denied if submitted for coverage.
- Some products are not covered for certain plan types; consult the member's contract for exclusions.
- Even when PA is obtained, noncoverage designations (NOT COVERED) override PA approval.
Not Covered Drugs — Denial Risk
Not covered drugs — denial risk — Drugs explicitly listed as NOT COVERED are not eligible for payment and will be denied if submitted for coverage. Providers should identify alternate, covered therapies and confirm benefit specifics with the member's plan before dispensing.
- Multiple self-administered specialty drugs in the lists are labeled NOT COVERED — these will be denied.
- NOT COVERED status applies regardless of PA status; do not submit claims for payment for these products.
Document Purpose and Scope
This section functions as an index-style listing of newly marketed and specialty medications that may require Prior Authorization (PA), be designated as Limited Distribution Drugs (LDD), or have Quantity Limits (QL). It identifies drugs with coverage designations (LDD, PA, QL), indicates preferred in-network specialty pharmacies for certain products, and directs providers to check the member contract and PA program guides or contact the Provider Contact Center for plan‑specific requirements.
Key Terms and Designations
Step Therapy Requirements
| Step | Requirement | Notes |
|---|---|---|
| 1 | Step therapy may be required per plan | Refer to the member contract benefit and the Prior Authorization Program Information and Forms guide for specific step edits; requirements vary by plan and by drug. |
Quantity Limit Notes
Specialty Pharmacy and Dispensing
Use Preferred In‑Network Specialty Pharmacies When Required
Certain specialty drugs are preferred to be obtained from in‑network specialty pharmacies (Accredo or CVS/Caremark Specialty Pharmacy); obtain member drugs per site-of-care preferences to avoid higher member cost share.
- CVSICaremark is the preferred in-network pharmacy for hemophilia products.
- Member cost share may be higher for self-administered specialty drugs not obtained at in-network specialty pharmacies.
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