CurrentAnthemPolicy N/A

Request for Prior Authorization: Muscular Dystrophy Agents

A PA request form and criteria checklist for muscular dystrophy agents (Agamree/vamorolone, Duvyzat/givinostat, Emflaza/deflazacort/Jaythari) for Indiana lines of business (Hoosier Healthwise, Healthy Indiana Plan, Hoosier Care Connect, Indiana PathWays for Aging). It specifies member age, confirmed DMD diagnosis, prior trial requirements, baseline testing, dosing limits, reauthorization documentation, and directs use of state FFS form for certain exon-skipping agents.

Policy Summary

PayerAnthem Blue Cross and Blue Shield (Indiana)

PolicyRequest for Prior Authorization: Muscular Dystrophy Agents

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete the PA form in its entirety and fax to the Prior Authorization of Benefits Center; all sections must be completed or the request will be returned.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes noted in this update.

3In-form PA drugs

4State carve-out exon-skipping

2Minimum eligible ages noted

Coverage Summary

This is the Indiana Medicaid prior authorization (PA) request form and criteria checklist for muscular dystrophy agents covering Anthem’s Indiana lines of business (Hoosier Healthwise, Healthy Indiana Plan, Hoosier Care Connect, and Indiana PathWays for Aging). It outlines covered with criteria requirements for Agamree (vamorolone), Duvyzat (givinostat), and Emflaza (deflazacort, Jaythari).

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Medical Necessity Criteria (by agent)

Agamree (vamorolone) - Initiation

Covered when ALL of the following are met:

ALL of the following

Member is ≥ 2 years of age
Diagnosis of Duchenne muscular dystrophy (DMD) confirmed by genetic testing (please include documentation)
Prior trial
- Member has had a previous trial-and-failure history of at least 90 days of therapy with Emflaza (deflazacort, Jaythari)
- If no prior trial with Emflaza, prescriber must provide medical justification for use of Agamree over Emflaza
Prescriber has conducted testing to determine current clinical status and submitted with PA request (for example, Brooke Score, six-minute walk test, pulmonary function tests)

Agamree (vamorolone) - Dosing Note

Dose will be approved for 6 mg/kg/daymax: 300 mg/day or two bottles every 25 days

Rounded to the nearest tenth of a milliliter of oral suspension

Duvyzat (givinostat) - Initiation

Covered when ALL of the following are met:

ALL of the following

Member is ≥ 6 years of age
Diagnosis of Duchenne muscular dystrophy (DMD) confirmed by genetic testing (please include documentation)
Prior trial
- Member has a previous trial-and-failure history of at least 90 days of therapy with Agamree (vamorolone) as single agent therapy
- Member has a previous trial-and-failure history of at least 90 days of therapy with Emflaza (deflazacort, Jaythari) as single agent therapy

Duvyzat (givinostat) - Dosing Note

Dose will be approved for up to 53.2 mg twice dailythree bottles/35 days

Emflaza (deflazacort, Jaythari) - Initiation

Covered when ALL of the following are met:

ALL of the following

Member is ≥ 2 years of age
Diagnosis of Duchenne muscular dystrophy (DMD) confirmed by genetic testing (please include documentation)
Prescriber has conducted testing to determine the current clinical status and submitted it with the PA request (for example, Brooke Score, six-minute walk test, pulmonary function tests)

Reauthorization for any specified muscular dystrophy agent

For reauthorization, ALL of the following must be submitted:

Prescriber has submitted documentation (such as current and previous chart notes) explicitly supporting improvement (including disease stabilization) in current clinical status

Examples: four-stair climb time, North Star Ambulatory Assessment (NSAA), six-minute walk test

Other agents - Exon-skipping drugs

Amondys 45, Exondys 51, Viltepso, and Vyondys 53 are state carve-out drugs

Use the muscular dystrophy agents prior authorization form on the FFS website for these drugs

Provider Actions & Prior Authorization Steps

Prior Authorization

Submit completed PA form

Complete the PA form in its entirety and fax to the Prior Authorization of Benefits Center at 844-864-7860 (retail) or 888-209-7838 (medical injectable). All sections must be completed or the request will be returned.

Documentation Required

Include diagnostic confirmation

Include documentation of Duchenne muscular dystrophy (DMD) diagnosis confirmed by genetic testing with the PA request.

Documentation Required

Provide prior therapy dates or justification

For agents that require a prior trial, submit start and stop dates for prior 90-day trials. If no prior 90-day trial was done, provide a medical justification for use of the requested agent instead of the preferred agent(s).

Documentation Required

Baseline and ongoing lab monitoring for givinostat

Obtain baseline platelet count and triglycerides prior to initiating Duvyzat (givinostat), attest baseline platelet count is 150 x 10^9/L or greater, and continue to monitor platelet count and triglycerides and adjust dosing per the prescribing information.

Documentation Required

Submit clinical status tests

Submit results of clinical assessments to document current status (examples: Brooke Score, six-minute walk test, pulmonary function tests). For reauthorization, include measures showing improvement or stabilization (for example, four-stair climb time or North Star Ambulatory Assessment).

Brooke Score
Six-minute walk test
Pulmonary function tests
Four-stair climb time (reauthorization example)
North Star Ambulatory Assessment (NSAA) (reauthorization example)

Billing Rule

State carve-out agents

Amondys 45, Exondys 51, Viltepso, and Vyondys 53 are state carve-out drugs; use the muscular dystrophy agents prior authorization form on the FFS website for these agents.

Background

This document is a PA request form tailored to Indiana Medicaid-managed lines and must be completed in full by the prescribing provider; all sections must be completed or the request will be returned. Completed forms are to be faxed to the Prior Authorization of Benefits Center per the instructions on the form.

Required documentation and attestations include confirmation of DMD diagnosis by genetic testing, submission of baseline and ongoing clinical status assessments (for example, Brooke Score, six-minute walk test, pulmonary function tests), and, where applicable, prior trial documentation with start and stop dates for at least 90 days or medical justification if no prior trial.

Prescriber attestations and monitoring requirements are required for specific agents: for Duvyzat prescribers must attest baseline platelet count and triglycerides were obtained and that baseline platelet count is at least 150 x 10^9/L, and must agree to continue monitoring and adjust dosing per labeling. Dosing approvals are specified on-form (for example, Agamree 6 mg/kg/day; max 300 mg/day or two bottles every 25 days; Emflaza 0.9 mg/kg/day; Duvyzat up to 53.2 mg twice daily with three bottles/35 days).

For reauthorization, prescribers must submit documentation explicitly supporting improvement or stabilization in clinical status (examples: four-stair climb time, NSAA, six‑minute walk test).

State carve-outs: Amondys 45, Exondys 51, Viltepso, and Vyondys 53 are handled through the state FFS process — use the FFS muscular dystrophy agents prior authorization form for those drugs.

Covered lines of businessHoosier Healthwise; Healthy Indiana Plan; Hoosier Care Connect; Indiana PathWays for Aging

Policy subjectPrior authorization requirements for muscular dystrophy agents (Agamree/vamorolone, Duvyzat/givinostat, Emflaza/deflazacort/Jaythari)

Prescriber attestations

Member is ambulatory before initiation of therapy
Prescriber must attest Yes/No
Prescriber has obtained baseline platelet count and triglycerides before initiating therapy
Prescriber must attest Yes/No
Baseline platelet count is 150 x 10^9/L or greater
Prescriber must attest Yes/No
Prescriber will continue to monitor platelet count and triglycerides and adjust dosing per the prescribing information
Prescriber must attest Yes/No

OpenPayer

Request for Prior Authorization: Muscular Dystrophy Agents

Coverage Summary

Medical Necessity Criteria (by agent)

Referenced Drugs and Coding

Provider Actions & Prior Authorization Steps

Background

Revision History

Agamree	vamorolone
Duvyzat	givinostat
Emflaza	deflazacort
Jaythari	deflazacort brand
Amondys 45	casimersen (exon 45 skipping) - state carve-out
Exondys 51	eteplirsen (exon 51 skipping) - state carve-out
Viltepso	viltolarsen (exon 53 skipping) - state carve-out
Vyondys 53	golodirsen (exon 53 skipping) - state carve-out