Prior Authorization : Services Requiring Prior Authorization

Spinal Muscular Atrophy Drugs

Clinical PA is required for all SMA drugs.

ForwardHealth does not cover treatment with more than one SMA drug at a time. If a member is transitioning treatment from Spinraza to Evrysdi, a waiting period of 90 days from the last injection is required before starting Evrysdi. The member's current approved PA request for Spinraza will be enddated upon approval of Evrysdi. If a member is transitioning treatment from Evrysdi to Spinraza, the member's current approved PA request for Evrysdi will be enddated upon approval of Spinraza. If a member has previously received treatment with Zolgensma, a PA request for another SMA drug treatment will be denied.

Claims Submission for Spinal Muscular Atrophy Drugs

SMA drugs, including Evrysdi, will be covered and reimbursed under the pharmacy benefit. Providers should submit claims for SMA drugs to ForwardHealth using a noncompound drug claim. For specific questions about the billing or coverage of high cost, orphan, and accelerated approval drugs Sprinraza or Zolgensma, providers may contact Provider Services or email dhsorphandrugs@dhs.wisconsin.gov.

Additional Requirements for Physician-Administered Spinal Muscular Atrophy Drugs

Physician-administered SMA drugs (for example, Spinraza and Zolgensma) are reimbursed separately from physician and clinical services associated with the administration of the SMA drugs. The pharmacy provider is required to establish a delivery process with the prescriber to ensure that the physician-administered SMA drugs are delivered directly to the prescriber or an agent of the prescriber. Pharmacy providers may only submit a claim to ForwardHealth for the SMA drugs that have been administered to a member. If an SMA drug has been dispensed for a member but the dose is not administered to the member, the prescriber is responsible for notifying the dispensing pharmacy. If ForwardHealth has paid the dispensing pharmacy for any portion of the dispensing of an SMA drug that is not administered to the member, the dispensing pharmacy is responsible for reversing any claims submitted to ForwardHealth.

Evrysdi

Clinical Criteria for Evrysdi

The following clinical criteria must be met and documented for approval of a PA request for Evrysdi:

• Evrysdi is prescribed by a neurologist, pulmonologist, or other physician with expertise in treating SMA and in a manner consistent with the FDA-approved product labeling.
• The member receives medication counseling prior to initiating Evrysdi treatment, and the provider must comply with administration requirements per FDA labeling. (Medication must be dosed after a meal, patients are instructed to drink water after the dose is administered, and medication must be given within five minutes after it has been drawn up into the oral syringe.)
• The member has SMA type 1, 2, or 3, which has been confirmed by genetic testing (5q SMN1: homozygous mutation, homozygous gene deletion, or compound heterozygote).
• The member has at least two copies of the SMN2 gene.
• The prescriber submits exam values from at least one of the following exams (based on member age and motor ability) to establish a baseline motor ability:
  • HINE (infant to early childhood)
  • HFMSE
  • RULM test (non-ambulatory members)
  • CHOP INTEND
  • 6MWT (ambulatory members)
  • MFM32
• The prescriber indicates the member's pulmonary status, including any requirement for ventilator support.

ForwardHealth will consider coverage for Evrysdi on a case-by-case basis if any of the following circumstances are present for the member:

• Complete paralysis of the limbs
• Ventilator dependent for 16 or more hours per day (including non-invasive respiratory support)

A copy of the member's medical records must be submitted and should sufficiently document:

• The information listed in the clinical criteria for PA approval.
• Details regarding previous medication use.
• The member's current treatment plan.

ForwardHealth will deny PA requests for Evrysdi if any of the following circumstances are present:

• The member is currently involved in a clinical trial for an SMA drug.
• The member has received treatment with Zolgensma.
• The member is currently receiving treatment with Spinraza.
• The member is diagnosed with a non-SMN1 variant of SMA.

Initial PA requests for Evrysdi to treat SMA may be approved for up to 183 days.

Renewal PA Requests

In addition to meeting the clinical criteria for initial PA request approval, renewal PA requests for Evrysdi require the submission of medical records (for example, chart notes, assessment of neurological and motor function) with the most recent results (less than two months prior to the submission of the renewal PA request) documenting a positive clinical response to Evrysdi therapy from pretreatment baseline status as demonstrated by one or more of the following exams:

• HINE that demonstrates the following:
  • Improvement or maintenance of previous improvement of at least a two-point (or maximal score) increase in the ability to kick or improvement or maintenance of previous improvement of at least a one-point increase in any other HINE milestone (for example, head control, rolling, sitting, crawling), excluding voluntary grasp
  • Net positive improvement in condition, defined as building on previous improvement from the pretreatment baseline in a majority of the HINE motor milestones or achievement or maintenance of any new motor milestone(s) from the pretreatment baseline when the member would otherwise be unexpected to do so (for example, sit unassisted, stand, walk)
• HFMSE that demonstrates one of the following:
  • Improvement or maintenance of previous improvement of at least a three-point increase in score from pretreatment baseline
  • Achievement and maintenance of any new motor milestone(s) from pretreatment baseline when the member would otherwise be unexpected to do so
• RULM test that demonstrates one of the following:
  • Improvement or maintenance of previous improvement of at least a two-point increase in score from pretreatment baseline
  • Achievement and maintenance of any new motor milestone(s) from pretreatment baseline when the member would otherwise be unexpected to do so
• CHOP INTEND that demonstrates one of the following:
  • Improvement or maintenance of previous improvement of at least a four-point increase in score from pretreatment baseline
  • Achievement and maintenance of any new motor milestone(s) from pretreatment baseline when the member would otherwise be unexpected to do so
• MFM32:
  • Improvement or maintenance of previous improvement of at least a two-point increase in score from pretreatment baseline
  • Achievement and maintenance of any new motor milestone(s) from pretreatment baseline when the member would otherwise be unexpected to do so

Renewal PA requests for Evrysdi used to treat SMA may be approved for up to 365 days.

Submitting PA Requests for Evrysdi

PA requests for Evrysdi must be submitted using the PA/DGA form.

PA requests for Evrysdi must be completed, signed, and dated by the prescriber. PA requests for Evrysdi should be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. Prescribers should not submit the PA form to ForwardHealth.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Evrysdi may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Spinraza

Clinical Criteria for Spinraza

The following clinical criteria must be met and documented for approval of a PA request for Spinraza:

• Spinraza is prescribed by a neurologist, pulmonologist, or other physician with expertise in treating SMA and in a manner consistent with the FDA-approved product labeling.
• The member has SMA type 1, 2, or 3, which has been confirmed by genetic testing (5q SMN1: homozygous mutation, homozygous gene deletion, or compound heterozygote).
• The member has at least two copies of the SMN2 gene.
• The prescriber submits exam values from at least one of the following exams (based on member age and motor ability) to establish a baseline motor ability:
  • HINE (infant to early childhood)
  • HFMSE
  • RULM test (non-ambulatory members)
  • CHOP INTEND
  • 6MWT (ambulatory members)
• The prescriber indicates the member's pulmonary status, including any requirement for ventilator support.

ForwardHealth will consider coverage for Spinraza on a case-by-case basis if any of the following circumstances are present for the member:

• Complete paralysis of the limbs
• Ventilator dependent for 16 or more hours per day (including non-invasive respiratory support)
• Pre-symptomatic infants who have not yet developed symptoms but have undergone genetic studies indicating a high likelihood of developing type 1, 2, or 3 SMA disease (that is, less than three copies of the SMN2 gene)

A copy of the member's medical records must be submitted and should sufficiently document:

• The information listed in the clinical criteria for PA approval.
• Details regarding previous medication use.
• The member's current treatment plan.

ForwardHealth will deny PA requests for Spinraza if any of the following circumstances are present:

• The member is currently involved in a clinical trial for an SMA drug.
• The member has received treatment with Zolgensma.
• The member is currently receiving treatment with Evrysdi.
• The member is diagnosed with a non-SMN1 variant of SMA.

Initial PA requests for Spinraza to treat SMA may be approved for up to 210 days to allow for up to five doses of Spinraza.

Renewal PA Requests

In addition to meeting the clinical criteria for initial PA request approval, renewal PA requests for Spinraza require the submission of medical records (for example, chart notes, assessment of neurological and motor function) with the most recent results (less than one month prior to the submission of the renewal PA request) documenting a positive clinical response to Spinraza therapy from pretreatment baseline status as demonstrated by one or more of the following exams:

• HINE that demonstrates the following:
  • Improvement or maintenance of previous improvement of at least a two-point (or maximal score) increase in the ability to kick or improvement or maintenance of previous improvement of at least a one-point increase in any other HINE milestone (for example, head control, rolling, sitting, crawling), excluding voluntary grasp
  • Net positive improvement in condition, defined as building on of previous improvement from the pretreatment baseline in a majority of the HINE motor milestones or achievement or maintenance of any new motor milestone(s) from the pretreatment baseline when the member would otherwise be unexpected to do so (for example, sit unassisted, stand, walk)
• HFMSE that demonstrates one of the following:
  • Improvement or maintenance of previous improvement of at least a three-point increase in score from pretreatment baseline
  • Achievement and maintenance of any new motor milestone(s) from pretreatment baseline when the member would otherwise be unexpected to do so
• RULM test that demonstrates one of the following:
  • Improvement or maintenance of previous improvement of at least a two-point increase in score from pretreatment baseline
  • Achievement and maintenance of any new motor milestone(s) from pretreatment baseline when the member would otherwise be unexpected to do so
• CHOP INTEND that demonstrates one of the following:
  • Improvement or maintenance of previous improvement of at least a four-point increase in score from pretreatment baseline
  • Achievement and maintenance of any new motor milestone(s) from pretreatment baseline when the member would otherwise be unexpected to do so

Renewal PA requests for Spinraza used to treat SMA may be approved for up to 365 days.

Submitting PA Requests for Spinraza

PA requests for Spinraza must be submitted using the PA/DGA form.

PA requests for Spinraza must be completed, signed, and dated by the prescriber. PA requests for Spinraza should be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. Prescribers should not submit the PA form to ForwardHealth.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Spinraza may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Zolgensma

Clinical Criteria for Zolgensma

The following clinical criteria must be met and documented for approval of a PA request for Zolgensma:

• Zolgensma is prescribed by a neurologist, pulmonologist, or other physician with expertise in treating SMA and in a manner consistent with the FDA-approved product labeling.
• The member is less than 2 years old.
• The member has SMA, type 1, 2, or 3, which has been confirmed, by genetic testing (5q SMN1: homozygous mutation, homozygous gene deletion, or compound heterozygote).
• The member has at least two copies of the SMN2 gene.
• The member does not have advanced SMA including, but not limited to, any of the following:
  • Complete paralysis of the limbs
  • Ventilator dependent for 16 or more hours per day (including non-invasive respiratory support)
• The prescriber submits the most recent pre-treatment anti-AAV9 antibody testing, demonstrating a titer ratio of less than 50 to 1.

A copy of the member's medical records must be submitted and should sufficiently document:

• The information listed in the clinical criteria for PA approval.
• Details regarding previous medication use.
• The member's current treatment plan.

Note: ForwardHealth covers one treatment per lifetime with Zolgensma for pediatric members less than 2 years of age.

ForwardHealth will deny PA requests for Zolgensma if any of the following circumstances are present:

• The member is currently involved in a clinical trial for an SMA drug.
• The member has received prior treatment with Zolgensma.
• The member is currently receiving treatment with Spinraza or Evrysdi.
  Note: If a member already has a current approved PA request for Spinraza or Evrysdi, ForwardHealth will enddate the Spinraza or Evrysdi PA request upon approval of Zolgensma.
• The member is diagnosed with a non-SMN1 variant of SMA.
• The member is over 2 years of age.

Submitting PA Requests for Zolgensma

PA requests for Zolgensma must be submitted using the PA/DGA form.

PA requests for Zolgensma must be completed, signed, and dated by the prescriber. PA requests for Zolgensma should be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. Prescribers should not submit the PA form to ForwardHealth.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

PA requests for Zolgensma may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).