Prior Authorization : Services Requiring Prior Authorization

Palynziq

Palynziq requires clinical PA.

Clinical Criteria for Palynziq

Clinical criteria that must be documented for approval of a PA request for Palynziq for the treatment of adult members 18 years of age or older with a documented diagnosis of PKU are all of the following:

• The member has blood Phe levels greater than 600 micromole/L on existing management (for example, restriction of dietary Phe and protein intake).
• At least one of the following is true:
  • The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction with sapropterin (Kuvan).
  • There is a clinically significant drug interaction between another drug(s) the member is taking and sapropterin (Kuvan).
  • The member has a medical condition(s) that prevents the use of sapropterin (Kuvan).
• Blood Phe levels will be obtained every four weeks until a maintenance dose is established. The drug dose should be titrated to the lowest effective dose. Once a maintenance dose is established, Phe levels will be monitored every six months.
• A copy of the member's medical records must be submitted and should document the following:
  • The medical record contains sufficient documentation to satisfy the clinical coverage criteria above.
  • The medical record contains details regarding previous medication use.
  • The medical record describes the member's current treatment plan.

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

In addition to meeting the clinical criteria for initial PA request approval, renewal PA requests for Palynziq require the submission of medical records (for example, chart notes, laboratory values) with the most recent results to demonstrate at least one of the following:

• The member has achieved at least a 20 percent reduction in blood Phe level from pretreatment baseline.
• The member has achieved a blood Phe level less than or equal to 600 micromole/L.

Submitting PA Requests for Palynziq

For PA requests for Palynziq, the prescriber is required to complete, sign, and date the PA/DGA form, using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the form. The prescriber is required to send the completed PA/DGA form to the pharmacy where the prescription will be filled. The pharmacy provider is required to complete a PA/RF and submit it, along with the PA/DGA form received from the prescriber, to ForwardHealth using the PA submission option most appropriate for the drug.

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