Prior Authorization : Services Requiring Prior Authorization

Jynarque

Jynarque requires clinical PA.

Clinical Criteria for Jynarque

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

• The member has ADPKD.
• The member is 18 years of age or older.
• The prescription is written by, or in consultation with, a nephrologist or kidney transplant specialist.
• The member has an eGFR equal to or greater than 25 mL/min per 1.73 m2.
• The member has a high risk for progression to ESRD due to one or more of the following:
  • A confirmed annual eGFR decline of at least 5 mL/min/1.73 m2 in one year
  • A confirmed annual eGFR decline of at least 2.5 mL/min/1.73 m2 per year over a period of five years
  • A greater than 5 percent increase in total kidney volume per year on at least three repeated measurements (via MRI or CT, each at least six months apart)
  • A truncated PDK1 mutation and early clinical signs (that is, hypertension, macroscopic hematuria, cyst infection, or flank pain before the age of 35)
  • A Mayo classification (height adjusted total kidney volume by CT or MRI and age) of class 1C, 1D, and 1E
  • Documentation of average kidney length greater than 16.5 cm per ultrasonography, CT, or MRI

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

Note: The safety and efficacy of Jynarque in adults over the age of 55 is not yet known.

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

Renewal PA Requests

Requests for renewal must meet the clinical criteria for initial PA approval and have documentation to support that there has been a decrease in the member's kidney disease progression. In order to confirm the necessary adherence, the claims history and medical records will be reviewed for all renewal requests. A copy of the pertinent medical records must be included with the PA request.

Submitting PA Requests for Jynarque

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

PA requests for Jynarque must be completed, signed, and dated by the prescriber. PA requests for Jynarque should be submitted using using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA 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 Jynarque may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).