September 2025 P&T formulary decisions (partial) — Pharmacy & Specialty Drugs coverage criteria
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Summarizes Pharmacy & Therapeutics Committee decisions on formulary status, new indications, generics, and dosage-form launches for multiple drugs that affect Aspirus Medicare formulary placement and prior authorization/step therapy rules.
New strengths and formulations for Zoryve (roflumilast) were released to support pediatric use and new indications, and were assigned formulary statuses.
New 5 mg and 7.5 mg selumetinib (Koselugo) sprinkle capsules were launched to support pediatric patients ≥1 year; Koselugo listed as Formulary.
New vial size for Krystexxa (pegloticase) — 8 mg/50 mL IV vial — was launched and listed as Non-Formulary.
New Evexithroid (thyroid) tablet strengths (45 mg and 75 mg) were launched and listed as Non-Formulary.
Vyscoxa (celecoxib) 10 mg/mL oral suspension launched and listed as Non-Formulary.
Tonmya (cyclobenzaprine) 2.8 mg sublingual tablet for fibromyalgia launched and listed as Non-Formulary.
Beizray (docetaxel-albumin) 80 mg/4 mL IV vials approved via 505(b)(2) pathway and listed as Non-Formulary.
Keytruda Qlex (pembrolizumab-berahyaluronidase alfa) subcutaneous formulation launched and listed as Non-Formulary.
Formulary Placement & Coverage Decisions
Formulary placement decisions (examples)
P&T recommendations (selected examples from this excerpt):
Non-Formulary status recorded in entries
Formulary decisions vary by product and indication
Effective date for such changes noted as 01/01/2026 in part
The P&T Committee excerpt records multiple products explicitly designated Non-Formulary in the reviewed entries. Examples in this document include expanded-indication listings for Vonvendi (von Willebrand factor [recombinant]) IV vials, certain oncology and specialty agents in combination regimens (e.g., Tecentriq/Tecentriq Hybreza with Zepzelca for ES-SCLC), and newly launched strengths or formulations such as the Krystexxa 8 mg/50 mL IV vial, Evexithroid 45 & 75 mg tablets, Vyscoxa 10 mg/mL oral suspension, Tonmya 2.8 mg sublingual tablet, Beizray 80 mg/4 mL IV vials, and the subcutaneous Keytruda Qlex. These entries are recorded as Non-Formulary unless otherwise noted.
Select items explicitly called out as Non-Formulary in the committee notes include: Vonvendi (650 & 1300-unit IV vials) for expanded prophylactic and perioperative use; Opzelura 1.5% cream for pediatric atopic dermatitis; combination regimens listed as Non-Formulary such as Tecentriq/Tecentriq Hybreza with Zepzelca; Uzedy risperidone prefilled syringes for bipolar I; weight-loss agents for specific indications (e.g., Wegovy for noncirrhotic MASH); newly launched products and strengths recorded as Non-Formulary including Krystexxa 8 mg/50 mL IV vial, Evexithroid 45 & 75 mg tablets, Vyscoxa 10 mg/mL oral suspension, Tonmya 2.8 mg sublingual tablet, Beizray 80 mg/4 mL IV vials, and Keytruda Qlex subcutaneous vials.
Within the provided excerpt there are no sentences that explicitly frame any of these entries using the phrase 'not medically necessary' or present an explicit medical-necessity rationale denying coverage. The document records formulary recommendations (Formulary, Formulary w/PA, or Non-Formulary) and supporting rationale/alternatives for some items (for example, Dexcom G7 rationale and generic alternatives for Vyscoxa), but does not include explicit 'not medically necessary' determination language in the cited passages.
Prior Authorization, Step Therapy & Documentation
Formulary Status & Prior Authorization
Formulary status determines PA requirements: items designated as Formulary w/PA require prior authorization as noted; new formulations or strengths follow the formulary designation for PA needs. Effective date: 01/01/2026 — ensure documentation supports the change and date for any submissions.
- Formulary w/PA = prior authorization required for covered agents and new formulations/strengths.
- Formulary status drives whether a PA is needed for new strengths or formulations (status of the new product controls PA requirement).
- Effective date for formulary changes to New Generics, New Indications and Miscellaneous Previously Reviewed drugs: 01/01/2026.
Non‑Formulary — Denial Risk
Non-Formulary status may trigger denial: items listed as Non-Formulary are at higher risk for coverage denial unless an exception is granted; providers should submit complete supporting documentation.
- Non-Formulary designations commonly result in claim denials without an approved exception or justification.
- When a product is Non-Formulary, include clinical rationale and prior therapies attempted to support any medical necessity request.
Examples of Non‑Formulary Items at Risk for Denial
Specific Non-Formulary items called out in the P&T notes may be denied: examples include Krystexxa 8 mg/50 mL vial, new Evexithroid strengths (45 mg, 75 mg), Vyscoxa oral suspension, and Tonmya sublingual tablets — plan accordingly.
- Krystexxa (pegloticase) 8 mg/50 mL IV vial — Non‑Formulary and may be denied.
- Evexithroid (thyroid) 45 & 75 mg tablets — Non‑Formulary and may be denied.
- Vyscoxa (celecoxib) 10 mg/mL oral suspension — Non‑Formulary and may be denied.
- Tonmya (cyclobenzaprine) 2.8 mg sublingual tablet — Non‑Formulary and may be denied.
Cost & Lower‑Cost Alternative Context
Cost/context notes — include pricing and lower‑cost alternatives when available to support step or exception requests.
- Vyscoxa 473 mL bottle WAC = $2,895.49; generic celecoxib capsules with MAC pricing (~$0.15 to ~$1.10) are preferred lower‑cost alternatives.
- Tonmya maintenance dosing cost example: approximately $1,860 per month; consider generic cyclobenzaprine formulations when clinically appropriate.
Preferred Generic Alternatives
Preferred generic alternatives: when generics exist (e.g., celecoxib capsules), prefer those lower‑cost options and document why a brand or novel formulation is necessary if requesting coverage.
- If a generic alternative is available and clinically appropriate (for example, generic celecoxib capsules), the generic should be used or documented rationale provided for the brand/special formulation.
- Opening generic capsules and administering with food (e.g., applesauce) may be a clinically appropriate, cost‑effective alternative to oral suspensions in some patients.
Step Therapy Note
Step therapy referenced in the P&T key (ST = Step Therapy); specific step rules may exist elsewhere in the policy — check plan-specific step therapy criteria when submitting authorizations.
- ST in the key indicates step therapy may apply; consult the detailed step therapy rules (not included in this excerpt) for agent‑specific requirements.
Documentation Required for PA/Exceptions
Documentation reminder: include clinical history, prior therapies tried, and dates to support PA or exception requests; reference the effective dates and pricing context when relevant.
- Provide prior treatment history and rationale for use of Non‑Formulary or high‑cost formulations.
- Reference effective dates (e.g., 01/01/2026 for many formulary changes) in requests to align with P&T decisions.
Step Therapy & Preferred-Drug Sequencing
| Agent | Coverage Status | Prior Authorization (PA) Required | Step Therapy / Notes |
|---|---|---|---|
| Avmapki Fakzynja (avutometinib/defactinib) | |||
| Formulary w/PA | |||
| Yes — Formulary w/PA designation indicates PA required | |||
| May be subject to step therapy per plan-specific rules; specific ST not enumerated in excerpt |
| Agent | Coverage Status | Prior Authorization (PA) Required | Step Therapy / Notes |
|---|---|---|---|
| Vyscoxa (celecoxib) 10 mg/mL oral suspension | |||
| Non-Formulary | |||
| PA likely required for Non-Formulary products unless separate policy applies | |||
| Preference for lower-cost generic celecoxib capsules (can be opened and mixed) referenced; generics may be preferred prior to covering branded suspension |
Administration Site & Provider-Administered Formulations
New IV vials and autoinjectors noted — site‑specific rules not detailed
Several new IV vial and autoinjector formulations were noted (e.g., new Krystexxa vial size, new branded autoinjectors), but site‑of‑care or infusion‑center specific rules were not specified in the provided excerpt.
Keytruda Qlex SC is provider‑administered over 1–2 minutes — site‑of‑care implications
Keytruda Qlex is a new subcutaneous, provider‑administered formulation that can be given over approximately 1–2 minutes instead of a 30‑minute IV infusion; providers should note site‑of‑care implications for administration scheduling and billing.
- Keytruda Qlex (pembrolizumab‑berahyaluronidase alfa) SQ allows administration over 1–2 minutes but remains healthcare provider administered.
Abbreviations & Notable Product Notes
Policy Context & Scope
This record documents the Pharmacy & Therapeutics Committee review process and its recommendations related to formulary placement, new indications, newly launched generics and dosage forms, and related dosing or age-expansion considerations. Committee entries identify which products should be placed as Formulary, Formulary w/PA, or Non-Formulary, and note effective dates, age or indication expansions, and when lower-cost generics are preferred—information intended to guide subsequent prior authorization, step therapy, and coverage implementation decisions.
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