FLASH: Pharmacy and HCMD List Changes for October 2024

Pharmacy Updates

October 15, 2024

All Plans

 Rare Diseases

 New Drug Reviews/Policies

• Pombiliti (cipaglucosidase alfa-atga) and Opfolda (miglustat)— Treatment of late-onset Pompe disease (lysosomal acid alphaglucosidase deficiency) in adults weighing ≥40 kg and who are not improving on enzyme replacement therapy
  • Formulary placement recommendations
    • Commercial
    • Pombiliti: Non-Preferred Specialty Medical with PA
    • Opfolda: Non-Preferred Specialty Pharmacy with PA and MDL (#120/30)
    • Medicare—Non-Formulary
  • Wainua (eplontersen)— Treatment of the polyneuropathy of hereditary transthyretinmediated amyloidosis in adults
    • Formulary placement recommendations
      • Commercial— Non-Preferred Specialty Pharmacy with PA and MDL (0.8mL/28 days)
      • Medicare—Non-Formulary (Part D)
    • Lenmeldy (atidarsagene autotemcel)— Treatment of presymptomatic late infantile, presymptomatic early juvenile, or early symptomatic early juvenile metachromatic leukodystrophy in pediatric patients ≥8 months of age
      • Formulary placement recommendations
        • Commercial—Non-Preferred Specialty Medical with PA
        • Medicare—Medicare Part B or Non-Formulary (Part D)
      • Xolremdi (mavorixafor)— Treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) in patients ≥12 years of age to increase the number of circulating mature neutrophils and lymphocytes
        • Formulary placement recommendations
          • Commercial— Non-Preferred Specialty Pharmacy with PA and MDL (#120/30)
          • Medicare—Non-Formulary
        • Elevidys (delandistrogene moxeparvovec)— Treatment of Duchenne muscular dystrophy in children age 4+
          • FDA converted approval of Elevidys from accelerated to traditional, which required creation of policy for coverage of ambulatory patients (non-ambulatory are excluded) to comply with IL-mandated coverage of FDA-approved therapies for pediatric neuromuscular disorders
            • Commercial— Non-Preferred Specialty Medical with PA, effective 1/1/2025
            • Medicare—Non-Formulary

Commercial

 Rare Diseases

 Criteria Changes

• Emflaza (deflazacort)
  • Added step through generic product
  • Updated clinical criteria to be consistent with other DMD products
• Sucraid (sacrosidase)
  • Added genetic testing option to confirm diagnosis
• Xuriden (uridine triacetate)
  • Elaborated diagnostic criteria

Miscellaneous Criteria Changes

• Ulcerative Colitis Immunomodulator Therapies policy
  • Added Tremfya to policy
• Voquezna (vonoprazan products) policy
  • Added criteria for GERD without erosive esophagitis
• State of Illinois – Weight Loss Medications policy
  • Added applicable quantity limits aligned with package labels
  • Removed age exclusion

Formulary Changes—Commercial

Positive Changes (effective immediately)

Simlandi (adalimumab-ryvk)—Add to Preferred Specialty Pharmacy

• Additional adalimumab biosimilar option for members
• Most patient assistance available

Negative Changes (effective 1/1/2025)

Oxbryta (voxelotor)—Remove from formulary

• Product discontinued by manufacturer based on new safety concerns
• 2 members currently on therapy
• Other covered therapies include: Adakveo

Tegsedi (inotersen)—Remove from formulary

• Product discontinued by manufacturer based on steady decline in utilization
• No member impact
• Other covered therapies include: Onpattro, Amvuttra

Medicare

Formulary Changes—Medicare Part D

Overview of 2025 formulary changes that have been approved by CMS:

Positive Changes

• 15 formulary additions
• 38 positive tier changes
• 2 quantity limit removals
• 3 prior authorization removals

 Negative Changes

• 186 formulary removals
• 132 negative tier changes
• 10 quantity limit additions
• 23 prior authorization additions

The P&T Committee meets bimonthly, and formulary changes and criteria changes can occur during the meetings. Negative formulary changes are made effective on 1/1 and 7/1, while positive formulary changes are effective immediately to better serve our members and providers. Upcoming negative formulary and criteria changes can be found online at the following website: HealthAlliance.org/Documents/960/2022. Drug coverage and policies in the following categories will be reviewed during the remainder of 2024 and changes may be made:

• December Meeting: Specialty and Medicare.

Updates to High Cost Medical Drugs List

See the table below for changes to the High Cost Medical Drugs List with effective dates.

Note: Medications removed from the High Cost Medical Drugs List may still require prior authorization.

Note: This article/table only applies to our Health Alliance^TM branded Commercial plans. It does not apply to Health Alliance Northwest^TM branded plans.

Note: This article/table does not apply to any of our Medicare plans (no matter what their brand/name).