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Effective July 15, 2025: Pharmacy and Biopharmacy Policies

Date: 05/14/25

Superior HealthPlan has added, updated or retired certain pharmacy and biopharmacy policies to ensure medical necessity review criteria is current and appropriate for members and the scope of services provided. As a result, the following policies are effective on July 15, 2025 at 12:00AM.

POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

Delandistrogene moxeparvovec-rokl (Elevidys) (CP.PCH.56)

Ambetter

Policy includes:

  • Initial criteria
    • Elevidys is considered experimental and investigational and not medically necessary for the treatment of Duchenne muscular dystrophy patients at least 4 years of age who are ambulatory or non-ambulatory for the following reasons:
    • Elevidys does not have proven efficacy in the treatment of Duchenne muscular dystrophy for ambulatory patients.
    • The phase III EMBARK [NCT05096221] confirmatory trial, which evaluated patients aged 4 to 7 years, failed to meet its statistical primary endpoint of improvement versus placebo in the North Star Ambulatory Assessment (NSAA) total score.
    • Study 102 Part 1 [NCT03769116], which evaluated patients aged 4 years to 7 years, failed to demonstrate a statistically significant change in NSAA from baseline to week 48 after treatment. Data showed no clear association between expression of Elevidys micro-dystrophin and change in NSAA total score.
    • Elevidys does not have proven efficacy in the treatment of Duchenne muscular dystrophy for non-ambulatory patients.
    • The phase I ENDEAVOR - Study 103 [NCT04626674] was the only study that contained data on non-ambulatory patients with Duchenne muscular dystrophy. Study 103 was not designed to demonstrate clinical efficacy and there was no data to support effectiveness for non-ambulatory patients with Duchenne muscular dystrophy.

Delandistrogene moxeparvovec-rokl (Elevidys) (CP.PHAR.593)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy Updates include:

  • Removed HIM and Commercial line of business (refer to CP.PCH.56)
  • Clarified age restriction to age to 4 years and < 6 years.

 

To review all policies, please visit Superior’s Clinical, Payment & Pharmacy Policies webpage.

Prior to updates, pharmacy and biopharmacy clinical policies are reviewed and approved by the Pharmacy and Therapeutics (P&T) Committee.

For questions or additional information, please contact Superior’s Pharmacy Department at 1-800-218-7453, ext. 22272.