Prior Authorization : Services Requiring Prior Authorization

Strensiq

Strensiq requires clinical PA. PA requests for Strensiq must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form and the PA/RF.

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.

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

Clinical Criteria for Strensiq

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

• Perinatal/infantile-onset HPP
• Juvenile-onset HPP

Clinical criteria that must be documented for approval of an initial PA request for Strensiq are all of the following:

• The member has perinatal/infantile-onset HPP or juvenile-onset HPP.
• The member was 18 years of age or younger at the onset of signs and/or symptoms of HPP.
• The member's current weight is provided.
• The member has clinical manifestations consistent with HPP (for example, skeletal abnormalities, respiratory problems, hypercalcemia, seizures).
• Findings on radiographic imaging support the diagnosis of HPP (for example, infantile rickets, alveolar bone loss, osteoporosis, low bone mineral content for age).
• The prescription is written by an endocrinologist or a provider who specializes in HPP.
• The member has a documented history of HPP-related skeletal abnormalities.
• The member has a serum alkaline phosphatase below the age-adjusted normal range.
• The member has a plasma pyridoxal-5'-phosphate level above the upper limit of normal.
• The member has a documented tissue-nonspecific alkaline phosphatase gene mutation.

Medical records must be provided to demonstrate the member meets the clinical criteria previously listed.

Note: A copy of the gene mutation testing must be included with an initial PA request.

If clinical criteria for Strensiq are met, initial PA requests may be approved for up to a maximum of 183 days.

Clinical criteria that must be documented for approval of an initial renewal PA request for Strensiq are all of the following:

• The member meets the clinical criteria for an initial PA request approval for Strensiq.
• The member has responded to treatment with Strensiq as evidenced by improvement in respiratory status, growth, or radiographic findings compared to their baseline prior to initiation of treatment with Strensiq.

Medical records must be provided to demonstrate that the member meets the clinical criteria previously listed.

Initial renewal PA requests for Strensiq may be approved for up to a maximum of 365 days.

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

• The member meets the clinical criteria for an initial PA request approval for Strensiq.
• The member has responded to treatment with Strensiq as evidenced by a sustained improvement in respiratory status, growth, or radiographic findings compared to their baseline prior to initiation of treatment with Strensiq.

Medical records must be provided to demonstrate that the member meets the clinical criteria previously listed.

Subsequent renewal PA requests for Strensiq may be approved for up to a maximum of 365 days.