X Linked Hypophosphatemia Treatment

Common PA requirements for CRYSVITA

For informational purposes only.

ICD-10 Codes¹	E83.31	Familial hypophosphatemia
ICD-10 Codes¹	E83.39	Other disorders of phosphorus metabolism
CPT Codes¹	96401	Chemotherapy administration, subcutaneous or intramuscular, nonhormonal antineoplastic
CPT Codes¹	96372	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular
Home Health Care Nursing Codes²	99601	Home Infusion Procedures and Services—use this code for up to the first two hours of a visit
Home Health Care Nursing Codes²	99602	Home Infusion Procedures and Services—use this code for each additional hour of the visit after the first two hours

ICD-10 Codes
E83.31	Familial hypophosphatemia
E83.39	Other disorders of phosphorus metabolism

Previous dose (mg)
96401	Chemotherapy administration, subcutaneous or intramuscular, nonhormonal antineoplastic
96372	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular

Home Health Care Nursing Codes
99601	Home Infusion Procedures and Services—use this code for up to the first two hours of a visit
99602	Home Infusion Procedures and Services—use this code for each additional hour of the visit after the first two hours

Use of the above ICD-10 or CPT codes does not guarantee that claims related to the treatment of patients with XLH will be reimbursed by a health plan. Please refer to the specific health plan when deciding how to submit a claim for care.

This checklist should be used for educational purposes only. Many health insurers have developed specific policies and criteria for their prior authorization process when it comes to approving the use of CRYSVITA to treat patients with XLH. Please refer to the patient’s health plan for specific criteria and documentation requirements. This prior authorization checklist is not intended as a diagnostic tool for XLH and should not be a substitute for a healthcare provider’s clinical expertise.

Common documentation for diagnosis of XLH

The following diagnosis criteria are a representation of common signs and symptoms that may help diagnose XLH and meet some common payer requirements. This is not to suggest that use of CRYSVITA will improve these clinical symptoms. Additional documentation may be required.

STEP 1: Biochemical Markers*	STEP 2: Clinical Presentation	STEP 3: Genetic Testing	STEP 4: Additional Requirements
Low fasting serum phosphate Elevated alkaline phosphatase (ALP) (patients aged <18 years) Elevated bone-specific alkaline phosphatase (BAP) (patients aged ≥18 years) Decreased TmP/GFR Elevated or inappropriately normal FGF23 levels^† Low or inappropriately normal 1,25(OH)₂D	Rickets in pediatrics Osteomalacia in adults Skeletal deformities Fractures/ pseudofractures Past orthopedic surgeries Enthesopathy Frequent dental abscesses that may lead to tooth loss Growth impairment	Confirmed PHEX mutation* Confirmed PHEX mutation in directly related family member	Prescribed by, or in consultation with, an endocrinologist, nephrologist, geneticist, or other specialist experienced in the treatment of metabolic bone disorders Individual does not have severe renal impairment or end-stage renal disease Office visit notes

STEP 1:
Biochemical Markers*

Low fasting serum phosphate
Elevated alkaline phosphatase (ALP) (patients aged <18 years)
Elevated bone-specific alkaline phosphatase (BAP) (patients aged ≥18 years)
Decreased TmP/GFR
Elevated or inappropriately normal FGF23 levels^†
Low or inappropriately normal 1,25(OH)₂D

STEP 2:
Clinical Presentation

Rickets in pediatrics
Osteomalacia in adults
Skeletal deformities
Fractures/ pseudofractures
Past orthopedic surgeries
Enthesopathy
Frequent dental abscesses that may lead to tooth loss
Growth impairment

STEP 3:
Genetic Testing

Confirmed PHEX mutation*
Confirmed PHEX mutation in directly related family member

STEP 4:
Additional Requirements

Prescribed by, or in consultation with, an endocrinologist, nephrologist, geneticist, or other specialist experienced in the treatment of metabolic bone disorders
Individual does not have severe renal impairment or end-stage renal disease
Office visit notes

Prior/current disease management interventions

Use of oral phosphate agent
Use of active vitamin D therapy

Documentation that may be used for reauthorization/ continuation of therapy

Biochemical Markers	Clinical Presentation
Increased/normalized fasting serum phosphate^‡ Reduction in serum alkaline phosphatase in pediatrics Increased TmP/GFR from baseline	Notes on patient’s clinical presentation and additional documentation as required by payer

*Appropriate for age and gender.

†Many current health plan policies require the testing of either PHEX mutations or FGF23 levels for approval.

‡For adults: check monthly, 2 weeks post-dose for the first 3 months of treatment, and thereafter as appropriate. For pediatric patients: check every 4 weeks for the first 3 months of treatment, and thereafter as appropriate.

ACCESS STEPS FOR CRYSVITA

The decision to prescribe CRYSVITA has been made. Now what?

Enroll your patient today! Kyowa Kirin Cares can help get your patient from prescription to treatment with an overview of insurance coverage, financial assistance options, and shipment coordination.

Step 1: Enrollment

Download the enrollment form, fill it out with your patient’s information, sign it, and fax it to 833-552-3299.

Provide complete and accurate information to reduce additional follow-up and potential treatment delay

Completing confirmatory testing prior to submitting a completed enrollment form may prevent delays (and testing may be required by patient’s health plan).

ENROLLMENT FORM

Set expectations with your patient

Patient consent is needed to facilitate Kyowa Kirin Cares access services and financial assistance options for those who qualify. If the patient or care partner wishes to consent, be sure to have them sign the Patient Authorization on the enrollment form
Alternatively, a Case Manager can send the patient an enrollment form and assist them with the process over the phone
Use the Patient Next Steps guide to help your patient understand the process and the role they play

Step 2: Authorization

Upon receiving the completed enrollment form, Kyowa Kirin Cares will begin the benefits investigation (BI) process for the patient, then inform you of results within two business days.

Show description

A flow diagram that shows 2 pathways for the benefits investigation results for the patient. In the first pathway, CRYSVITA is covered without prior authorization and you receive an overview of the benefits investigation. In the second pathway, prior authorization or exception is required for CRYSVITA and a Patient Services Representative calls to inform you of next steps.

A dedicated Case Manager will call the patient to review insurance coverage. They will inform the patient of the co-pay program and other assistance options.

Step 3: Procurement

A dedicated Patient Access Liaison (PAL) will work with you to coordinate a procurement option based on your patient’s BI results. CRYSVITA can be procured by an authorized Specialty Distributor or from a select group of Specialty Pharmacies, and ordering requirements may differ based on the patient’s coverage.

Questions? Ask a representative or call Kyowa Kirin Cares at 833-KK-CARES (833-552-2737) Monday through Friday, 8 am to 8 pm (ET).

Prior authorization and medical documentation for CRYSVITA

Understanding prior authorization

Documents and other criteria are commonly required by health plans to cover CRYSVITA. A dedicated Patient Access Liaison (PAL) will contact you with your patient’s plan-specific drug requirements.

Provide all documentation required by the patient’s health plan to prevent delays and denials

Health plans may require documentation of past and current disease management interventions, such as use of supplement therapy or growth hormone, or orthopedic/dental surgery

Schedule testing

Your patient’s health plan may have specific testing requirements
A dedicated PAL can help you determine plan-specific criteria
Timely submission of test results will facilitate the prior authorization (PA) process

Monitor communications with the patient’s health plan and answer any additional requests or questions promptly

Your patient’s plan may require genetic testing. A PAL can help you navigate diagnostic documentation and other plan requirements for your patient. Contact Kyowa Kirin Cares by calling 833-KK-CARES (833-552-2737).

A doctor measuring the height of a young girl

Actor portrayal

Ready to start your patients on CRYSVITA?

Take the first step by filling out the enrollment form

Enrollment form

Starting patients on CRYSVITA

The decision to prescribe CRYSVITA has been made. Now what?

Ready to start your patients on CRYSVITA?