myAgios Patient Support Managers (PSMs): Patient Support for Patients With Pyruvate Kinase (PK) Deficiency
Who are the PSMs and what is their role? PSMs:
– Regular phone calls (cadence is approximately monthly)
– Email communications
– Social support via patient webinars with other patients with PK deficiency
How do the PSMs work together with physicians and eligible patients?
Prescription Submission, Benefits, and Coverage
Completes the PYRUKYND Commercial Enrollment Form and faxes it to myAgios Patient Support Services at 1-800-951-7814
Becomes enrolled in myAgios when Enrollment Form is received and patient's HIPAA release authorization is obtained
Connects with physician's office to confirm prescription has been received
Conducts a welcome call with patient to provide information about PK deficiency, PYRUKYND, and insurance coverage
Calls specialty pharmacy to help coordinate initial dispense and subsequent refills
Connects with physician to discuss patient’s plan, prior authorization requirements, or questions insurance company might have while determining patient’s coverage
– Can screen for Patient Assistance Program (PAP) eligibility if patients are uninsured or underinsured, or if the PYRUKYND prescription is rejected due to multiple properly completed authorization denials. On-label prescriptions only
Office completes paperwork needed for myAgios support program
Discusses copay/coinsurance options with PSM as needed, to determine what financial assistance might be available
– Assists with the coordination of the initial dispense and subsequent refills with the specialty pharmacy
– Provides treatment and product education to support patient adherence to the medication
PYRUKYND is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.
IMPORTANT SAFETY INFORMATION
Acute Hemolysis: Acute hemolysis with subsequent anemia has been observed following abrupt interruption or discontinuation of PYRUKYND in a dose-ranging study. Avoid abruptly discontinuing PYRUKYND. Gradually taper the dose of PYRUKYND to discontinue treatment if possible. When discontinuing treatment, monitor patients for signs of acute hemolysis and anemia including jaundice, scleral icterus, dark urine, dizziness, confusion, fatigue, or shortness of breath.
Adverse Reactions: Serious adverse reactions occurred in 10% of patients receiving PYRUKYND in the ACTIVATE trial, including atrial fibrillation, gastroenteritis, rib fracture, and musculoskeletal pain, each of which occurred in 1 patient. In the ACTIVATE trial, the most common adverse reactions including laboratory abnormalities (≥10%) in patients with PK deficiency were estrone decreased (males), increased urate, back pain, estradiol decreased (males), and arthralgia.
- Strong CYP3A Inhibitors and Inducers: Avoid concomitant use.
- Moderate CYP3A Inhibitors: Do not titrate PYRUKYND beyond 20 mg twice daily.
- Moderate CYP3A Inducers: Consider alternatives that are not moderate inducers. If there are no alternatives, adjust PYRUKYND dosage.
- Sensitive CYP3A, CYP2B6, CYP2C Substrates Including Hormonal Contraceptives: Avoid concomitant use with substrates that have narrow therapeutic index.
- UGT1A1 Substrates: Avoid concomitant use with substrates that have narrow therapeutic index.
- P-gp Substrates: Avoid concomitant use with substrates that have narrow therapeutic index.
Hepatic Impairment: Avoid use of PYRUKYND in patients with moderate and severe hepatic impairment.
Please see full Prescribing Information for PYRUKYND.