Prior Authorization : Services Requiring Prior Authorization

Imcivree

Submitting Prior Authorization Requests for Imcivree

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

Clinical documentation supporting the use of Imcivree must be submitted with the PA request.

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 Imcivree may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system or calling the DAPO Center).

Conditions for Which PA Requests for Use of Imcivree Will Be Considered for Review

PA requests for Imcivree will only be approved for use to treat the following identified clinical conditions:

• Monogenic or syndromic obesity due to POMC, PCSK1, or LEPR deficiency
• Monogenic or syndromic obesity due to BBS

Clinical Criteria for Imcivree for Members With Monogenic or Syndromic Obesity Due to Proopiomelanocortin, Proprotein Convertase Subtilisin/Kexin Type 1, or Leptin Receptor Deficiency

Clinical criteria that must be documented for approval of a PA request for Imcivree for members with monogenic or syndromic obesity due to POMC, PCSK1, or LEPR deficiency are all of the following:

• The prescription is written by an endocrinologist or geneticist or through an endocrinology or genetics consultation.
• The member's current height, weight, and BMI are documented.
• One of the following is true:
  • The member is 6–17 years of age and has a current weight greater than or equal to the 95th percentile using growth chart assessments. (Note: An age-appropriate growth chart must be included with the PA request.)
  • The member is 18 years of age or older with a BMI of greater than or equal to 30.
• The member has monogenic or syndromic obesity due to POMC, PCSK1, or LEPR deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance. (Note: A copy of the genetic testing results must be submitted with the PA request.)
• The prescriber has evaluated the member and determined that the member does not have any medical or medication contraindications to treatment with Imcivree.

A copy of the member's current medical records must be submitted with all PA requests for Imcivree for members with monogenic or syndromic obesity due to POMC, PCSK1, or LEPR deficiency. The supporting clinical information and medical records must document the following:

• The member's medical condition being treated
• Details regarding previous medication use
• The member's current treatment plan

If clinical criteria for Imcivree for members with monogenic or syndromic obesity due to POMC, PCSK1, or LEPR deficiency are met, initial PA requests may be approved for up to 183 days. If members with monogenic or syndromic obesity due to POMC, PCSK1, or LEPR deficiency meet a weight loss goal of at least 5 percent of their weight from baseline or at least 5 percent of their BMI from baseline (for patients with continued growth potential) during the first 183 days of treatment, PA may be requested for an additional 365 days of treatment. If the member's weight or BMI (for patients with continued growth potential) remains at least 5 percent below the member's baseline weight or their BMI, subsequent PA renewal requests for Imcivree are a maximum of 365 days.

Clinical Criteria for Imcivree for Members With Monogenic or Syndromic Obesity Due to Bardet-Biedl Syndrome

Clinical criteria that must be documented for approval of a PA request for Imcivree for members with monogenic or syndromic obesity due to BBS are all of the following:

• The prescription is written by an endocrinologist or geneticist or through an endocrinology or genetics consultation.
• The member's current height, weight, and BMI are documented.
• One of the following is true:
  • The member is 6–17 years of age and has a current weight greater than or equal to the 97th percentile using growth chart assessments. (Note: An age-appropriate growth chart must be included with the PA request.)
  • The member is 18 years of age or older with a BMI of greater than or equal to 30.
• The member has monogenic or syndromic obesity due to BBS.
• The prescriber has evaluated the member and determined that the member does not have any medical or medication contraindications to treatment with Imcivree.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Imcivree for members with monogenic or syndromic obesity due to BBS. The supporting clinical information and medical records must document the following:

• The member's medical condition being treated
• Details regarding previous medication use
• The member's current treatment plan

If clinical criteria for Imcivree for members with monogenic or syndromic obesity due to BBS are met, initial PA requests may be approved for up to 365 days. If members with monogenic or syndromic obesity due to BBS meet a weight loss goal of at least 5 percent of their weight from baseline or at least 5 percent of their BMI from baseline (for patients aged less than 18 years) during the first 365 days of treatment, PA may be requested for an additional 365 days of treatment. If the member's weight or BMI (for patients aged less than 18 years) remains at least 5 percent below the member's baseline weight or their BMI, subsequent renewal PA requests for Imcivree are a maximum of 365 days.