Prior Authorization : Preferred Drug List

Antibiotics, Inhaled

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

Non-preferred drugs in the antibiotics, inhaled drug class require PA.

Tobi Podhaler and Cayston require clinical PA.

PA requests for non-preferred drugs in the antibiotics, inhaled drug class must be completed, signed, and dated by the prescriber. PA requests for non-preferred drugs in the antibiotics, inhaled drug class 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 non-preferred drugs in the antibiotics, inhaled drug class 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 non-preferred drugs in the antibiotics, inhaled drug class 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.

The following indicate how PA requests for non-preferred drugs in the antibiotics, inhaled drug class will be approved when clinical criteria have been met:

• PA requests will be approved for up to a maximum 28-day supply per dispensing.
• PA requests will be approved with an alternating 28-day treatment schedule of 28 days of a non-preferred drug in the antibiotics, inhaled drug class with 28 days of no inhaled antibiotics/anti-infective agents.

Note: The alternating 28-day treatment schedule with 28 days of no inhaled antibiotics/anti-infective agents above does not apply to approved PA requests for Cayston for CAT treatment. When PA is approved for Cayston for CAT, members may alternate between two inhaled antibiotics/anti-infective agents.

Clinical Criteria for Tobi Podhaler

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

• The member has cystic fibrosis.
• The prescriber has confirmed that the member has a positive sputum culture for Pseudomonas aeruginosa. Prescribers are required to include a copy of the sputum culture report with all PA requests.
• The prescriber has confirmed that the member is not colonized with Burkholderia cepacia.
• The member is not receiving treatment with other inhaled antibiotics/anti-infective agents, including alternating treatment schedules. Prescribers are required to provide a history of all inhaled antibiotics/anti-infective agents within the most recent 90-day period.
• The prescriber has submitted detailed clinical justification for prescribing Tobi Podhaler instead of Bethkis, Kitabis Pak, or tobramycin solution (generic Tobi), including clinical information describing why the member cannot use Bethkis, Kitabis Pak, or tobramycin solution (generic Tobi), and why it is medically necessary that the member receive Tobi Podhaler instead of Bethkis, Kitabis Pak, or tobramycin solution (generic Tobi).
• The member has been adherent with their prescribed treatment regimen for inhaled medications.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Tobi Podhaler. 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

Initial and renewal PA requests for Tobi Podhaler may be approved for up to 168 days.

Renewal PA requests for Tobi Podhaler require that the member be adherent with their inhaled antibiotic treatment.

Clinical Criteria for Cayston

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

• The member has cystic fibrosis.
• The prescriber has confirmed that the member has a positive sputum culture for Pseudomonas aeruginosa. Prescribers are required to include a copy of the sputum culture report with all PA requests.
• The prescriber has confirmed that the member is not colonized with Burkholderia cepacia.
• The member is not receiving treatment with other inhaled antibiotics/anti-infective agents, including alternating treatment schedules. Prescribers are required to provide a history of all inhaled antibiotics/anti-infective agents within the most recent 90-day period.
• At least one of the following is true:
  • The member has previously used inhaled tobramycin and experienced a clinically significant adverse drug reaction or an unsatisfactory therapeutic response.
  • The member has a medical condition(s) that prevents the use of inhaled tobramycin.
• The member has been adherent with their prescribed treatment regimen for inhaled medications.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Cayston. 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

Initial and renewal PA requests for Cayston may be approved for up to 168 days.

Renewal PA requests for Cayston require that the member be adherent with their prescribed Cayston treatment regimen.

Clinical Criteria for Cayston for Continuous Alternating Therapy

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

• The member has cystic fibrosis.
• The prescriber has confirmed that the member has a positive sputum culture for Pseudomonas aeruginosa. Prescribers are required to include a copy of the sputum culture report with all PA requests.
• The prescriber has confirmed that the member is not colonized with Burkholderia cepacia.
• The member is experiencing persistent exacerbations or FEV1 decline with no significant improvement while using a single inhaled antibiotic drug or significant worsening of other markers that are being regularly tracked to monitor pulmonary disease progression.
• The prescriber has provided specific treatment goals for the member's CAT.
• The prescriber has provided a history of all inhaled antibiotics/anti-infective agents within the most recent 90-day period.
• The member has been adherent with their prescribed treatment regimen for inhaled medications.

Note: ForwardHealth will not consider CAT as an initial choice for inhaled antibiotic therapy.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Cayston for CAT. 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

Initial and renewal PA requests for Cayston for CAT may be approved for up to 168 days.

Renewal PA requests for Cayston for CAT require that the member has been adherent with their CAT treatment. Prescribers are required to include documentation with renewal PA requests that clearly demonstrates the member has made progress toward their CAT treatment goals.