Newly Marketed and Specialty Prescription Drug Coverage and Utilization Controls
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Governance of coverage, prior authorization, quantity limits, limited distribution designation, and preferred specialty pharmacy arrangements for newly marketed and specialty prescription medications for Florida Blue members; affects prescribers, pharmacies, and members covered by Florida Blue plans.
No material clinical or coverage changes in this revision.
Coverage Criteria and Drug Listings
Coverage criteria and utilization controls
Coverage status and utilization management for listed specialty and newly marketed drugs.
Coverage exceptions and exclusions
- Some listed drugs are explicitly marked NOT COVERED; coverage varies by drug and by plan — claims for NOT COVERED drugs are subject to denial
Coverage Indicators and Not Covered Items
Drugs are listed with indicators showing whether they are limited distribution, require prior authorization, have quantity limits, and whether they are covered or not covered under the pharmacy benefit.
Examples of covered or subject-to-controls
- tadalafil (for PAH) — PA, QL
- Xolair — LDD, PA, QL
- Yutrepia — LDD, PA, QL
- Zarxio — PA
Examples of drugs marked NOT COVERED
- Gilenya — LDD, PA, QL, NOT COVERED
- Gleevec — PA, QL, NOT COVERED
- Abrilada — PA, QL, NOT COVERED
- Xyrem — LDD, PA, QL, NOT COVERED
- Xeloda — NOT COVERED
Drug Designations and Plan Indicators
| LDD | Limited Distribution Drug (Dispensing pharmacy can be found here: Limited Distribution Drugs) |
| PA | Prior Authorization |
| QL | Quantity Limit |
| LDD | Limited Distribution Drug |
| PA | Prior Authorization |
| QL | Quantity Limit |
Provider Responsibilities, Prior Authorization, and Pharmacy Access
Prior authorization and limited distribution guidance
Prior Authorization requirements vary by plan; determine PA enrollment and coverage by consulting the member contract benefit and the Prior Authorization Program Information and Forms. Certain specialty drugs may be Limited Distribution Drugs and are only available from specific specialty pharmacies (see Limited Distribution Drugs for dispensing pharmacy locations).
- Check member contract benefit for PA program inclusion.
- Use Prior Authorization Program Information and Forms to determine coverage.
- If drug is LDD, confirm designated dispensing pharmacy from the Limited Distribution Drugs resource.
Cost share and preferred pharmacy
Member cost share may be higher when self-administered specialty drugs are not obtained from an in-network specialty pharmacy. CVS/Caremark is identified as the preferred in‑network specialty pharmacy for hemophilia products.
- Advise members about potential higher cost share for out-of-network specialty pharmacy dispensing.
- Use CVS/Caremark for hemophilia specialty products when appropriate to align with preferred in-network arrangements.
Prior Authorization and Quantity Limits Apply
Many specialty drugs listed require Prior Authorization (PA) and are subject to Quantity Limits (QL); some listed products are designated Limited Distribution Drugs (LDD) and must be dispensed from specified pharmacies.
- Verify PA and QL requirements for each drug prior to prescribing or dispensing (examples in drug lists show PA and QL flags).
- If a drug is labeled LDD, arrange dispensing through the designated specialty pharmacy.
Denial risk for NOT COVERED drugs
Drugs marked NOT COVERED in the listings indicate a coverage exclusion or risk of claim denial if coverage criteria are not met; confirm plan-specific coverage before prescribing or dispensing.
- Do not assume coverage for medications flagged NOT COVERED; obtain PA only when applicable and verify benefit inclusion.
- Contact Customer Service (number on member ID card) for plan-specific coverage questions or to confirm alternatives.
Abbreviations and Definitions
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