Prior Authorization : Preferred Drug List

Immunomodulators, Asthma

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

Clinical PA is required for non-preferred immunomodulator, asthma drugs.

Nucala and Tezspire

Nucala and Tezspire require clinical PA.

PA requests for Nucala or Tezspire must be completed, signed, and dated by the prescriber. PA requests for Nucala or Tezspire 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 Nucala or Tezspire 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 Nucala or Tezspire may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

For information about general ForwardHealth PA policy for drugs that require PA approval, prescribers and pharmacy providers may refer to the Standard Pharmacy Policy for Covered and Noncovered Drugs topic. Providers may also refer to this topic for information about what may not be considered criteria to support the need for a drug.

Note: Fasenra, Nucala, Tezspire, and Xolair in the immunomodulators, asthma drug class are available as physician-administered drugs, as well as through the pharmacy benefit. The PDL and clinical PA criteria apply only to drugs billed through the pharmacy benefit.

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

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

• Asthma with an eosinophilic phenotype
• CRSwNP
• EGPA
• HES

Clinical Criteria for Nucala for Members With Asthma With an Eosinophilic Phenotype

Clinical criteria that must be documented for approval of a PA request for Nucala for members with asthma with an eosinophilic phenotype are all of the following:

• The member has severe asthma with an eosinophilic phenotype. A baseline blood eosinophil count of greater than 150 cells/mcL within the previous three months must be documented.
• The prescription is written by or through consultation with an asthma specialist (for example, an allergist, an immunologist, or a pulmonologist).
• The member has been adherent to and maintained on a maximized asthma treatment regimen, including a high-dose ICS in combination with a LABA for at least three months prior to requesting Nucala. Documentation should include the ICS and LABA names, doses, and start dates.
• One of the following is true:
  • The member is 6–11 years old.
  • The member is 12 years of age or older and has taken Fasenra for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
• The member will not use Nucala in combination with any biologic immunomodulator.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Nucala for members with asthma with an eosinophilic phenotype. 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 Nucala are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Nucala may be approved for up to 365 days. Renewal PA requests for members who have asthma with an eosinophilic phenotype must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant reduction in asthma symptoms compared to the member's baseline prior to the initiation of Nucala. Members must also continue to take their maximized asthma treatment regimen, including an ICS and a LABA, during treatment with Nucala.

Note: All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Clinical Criteria for Nucala for Members With Chronic Rhinosinusitis With Nasal Polyposis

Clinical criteria that must be documented for approval of a PA request for Nucala for members with CRSwNP are all of the following:

• The member's age must be consistent with FDA-approved product labeling for Nucala.
• The member has CRSwNP.
• The prescription is written by or through consultation with an allergist or an ear, nose, and throat specialist.
• The member has been adherent to and maintained on a maximized CRSwNP treatment regimen, including an INCS for at least three months prior to requesting Nucala. Documentation should include the CRSwNP drug treatment names, doses, and start dates.
• The member has taken Xolair for at least three consecutive months and experienced an unsatisfactory therapeutic response or experienced a clinically significant adverse drug reaction.
• The member will not use Nucala in combination with any biologic immunomodulator.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Nucala for members with CRSwNP. 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 Nucala are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Nucala may be approved for up to 365 days. Renewal PA requests for members who have CRSwNP must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant reduction in CRSwNP symptoms compared to the member's baseline prior to the initiation of Nucala. Members must also continue to take their maximized CRSwNP treatment regimen, including the INCS, during treatment with Nucala.

Note: All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Clinical Criteria for Nucala for Members With Eosinophilic Granulomatosis With Polyangiitis

Clinical criteria that must be documented for approval of a PA request for Nucala for members with EGPA are all of the following:

• The member's age must be consistent with FDA-approved product labeling for Nucala.
• The member has EGPA.
• The prescription is written by or through consultation with an EGPA specialist.
• The member will not use Nucala in combination with any biologic immunomodulator.

Supporting clinical information and a copy of the member's current medical records must be submitted with the PA request to support the member's condition of EGPA and outline the member's current treatment plan for EGPA.

If clinical criteria for Nucala are met, initial PA requests may be approved for up to 183 days. Renewal PA requests for Nucala may be approved for up to 365 days.

Note: All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Clinical Criteria for Nucala for Members With Hypereosinophilic Syndrome

Clinical criteria that must be documented for approval of a PA request for Nucala for members with HES are all of the following:

• The member's age must be consistent with FDA-approved product labeling for Nucala.
• The member has had HES for six or more months without an identifiable non-hematologic secondary cause.
• The prescription is written by or through consultation with an HES specialist.
• The member will not use Nucala in combination with any biologic immunomodulator.

Supporting clinical information and a copy of the member's current medical records must be submitted with the PA request to support the member's condition of HES and outline the member's current treatment plan for HES.

If clinical criteria for Nucala are met, initial PA requests may be approved for up to 183 days. Renewal PA requests for Nucala may be approved for up to 365 days.

Note: All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Clinical Criteria for Tezspire

Clinical criteria that must be documented for approval of a PA request for Tezspire are all of the following:

• The member has severe asthma.
• The prescription is written by or through consultation with an asthma specialist (for example, an allergist, an immunologist, or a pulmonologist).
• The member has a history of two or more asthma exacerbations that required treatment with systemic corticosteroids or an emergency department visit or hospitalization for the treatment of asthma in the past year. Documentation should include the approximate dates and what interventions took place for each exacerbation.
• The member has been adherent to and maintained on a maximized asthma treatment regimen, including a high-dose ICS in combination with a LABA for at least three months prior to requesting Tezspire. Documentation should include the ICS and LABA names, doses, and start dates.
• Exacerbating factors that may contribute to the member's asthma, such as member non-compliance with therapy, environmental factors, dietary factors, and other similar respiratory conditions, have been ruled out.
• The member will not use Tezspire in combination with any biologic immunomodulator.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Tezspire. 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 Tezspire are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Tezspire may be approved for up to 365 days. Renewal PA requests for members who have severe asthma must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a decrease in the number of asthma exacerbations compared to the member's baseline prior to the initiation of Tezspire. Members must also continue to take their maximized asthma treatment regimen, including an ICS and a LABA, during treatment with Tezspire.

Note: All renewal PA requests require the member to be adherent with the prescribed treatment regimen.