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How to Get TRUSELTIQ

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Our philosophy puts patients first—helping you, your staff, and your patients identify potential access barriers right away

ForgingBridges | TRUSELTIQ Access and Support program is designed to expedite and simplify patient access to TRUSELTIQ

Our support team collaborates with insurance companies to conduct the TRUSELTIQ benefits verification process, and provide you with a full coverage summary report. We offer guidance when a TRUSELTIQ claim is rejected, and can help you navigate the prior authorization and appeals process.

For questions or additional
info, give us a call. Our support team is ready to help

1-888-55BRIDGE
(1-888-552-7434)

Monday-Friday
8 AM-8 PM ET

The support starts here.

Disease state TRUSELTIQ ICD-10 code
Intrahepatic Bile Duct Carcinoma C22.1
Malignant Neoplasm of Extrahepatic Bile Duct C24.0

QED Therapeutics has provided these codes for your background information only. These codes are not inclusive of all the available ICD-10-CM codes for these disease states. Use of the above codes does not guarantee or support payment, coverage, or reimbursement decisions. For more information about ICD-10 codes, visit CMS.gov.

NDC codes for TRUSELTIQ dose cartons:

125 mg NDC-72730-101-01 |
100 mg NDC-72730-111-01 |
75 mg NDC-72730-202-01 |
50 mg NDC-72730-506-01

To inquire about ordering TRUSELTIQ, please contact your distributor or wholesaler.

To prescribe TRUSELTIQ through a specialty pharmacy, please contact Biologics or US Bioservices.

Biologics by McKesson:
(800) 850-4306
biologics.mckesson.com
US Bioservices:
(877) 757-0667
usbioservices.com

  • ForgingBridges conducts the benefits verification process and will notify your office once the process is complete.

During the benefits verification process, we:

  • Work with insurance companies to determine if:
    • TRUSELTIQ is covered
    • The patient will be responsible for any costs
  • Provide updates on the verification status and the outcome, when it is determined
  • Work with you and your staff to obtain and submit additional information if required by the insurance company to determine TRUSELTIQ coverage
  • Notify your office of any prior authorization (PA) requirements from the insurance company and ensure you have the information needed to complete the PA request
  • Monitor the PA request status and alert you and your staff once a decision is made
  • Provide you with a full summary of the investigation, including the coverage and costs for TRUSELTIQ. If a TRUSELTIQ claim is rejected, a sample letter of appeal will be provided to help complete and submit an appeal
Enrollment Form
Appeal Summary Letter
Medical Necessity Letter

  • Eligible physicians who are new to prescribing TRUSELTIQ may qualify for the Free Trial Program. Through this program, you may be able to help your TRUSELTIQ-naive patients begin therapy within ~48 hours of being prescribed TRUSELTIQ.
Enrollment Form

  • During the benefits verification and prescription fulfillment process, your patients may be eligible for the QuickStart Program. This program is designed to help patients whose insurance benefits coverage for TRUSELTIQ is delayed by more than 5 days. This program provides up to 2 months of TRUSELTIQ at no cost to help ensure your patients can receive the treatment they need. There are no income requirements; government-insured as well as commercially insured patients may qualify.
  • If insurance coverage is delayed, a 1-month supply of TRUSELTIQ will be sent to your patient's home. If after 25 days there is still no coverage determination, your patient may be eligible for a second month's supply of TRUSELTIQ. To be eligible for the second month's supply, the patient must be enrolled in the QuickStart Program
  • If a “No Coverage Determination” is returned, patients will be evaluated for Patient Assistance Program (PAP) eligibility

Don’t let insurance delays keep your patients
from prescribed treatment

INDICATION AND IMPORTANT
SAFETY INFORMATION

INDICATION

TRUSELTIQ is indicated for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

Accelerated approval was granted based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Warnings and precautions

  • Ocular toxicity: Retinal pigment epithelial detachment (RPED), which may cause blurred vision, occurred in 11% of 351 patients treated with TRUSELTIQ, including patients with asymptomatic RPED, with a median onset of 26 days. Perform comprehensive ophthalmological exam including optical coherence tomography prior to initiating, at 1 month, at 3 months, and then every 3 months during treatment with TRUSELTIQ. Urgently evaluate patients for onset of visual symptoms and follow up every 3 weeks until resolved or TRUSELTIQ is discontinued. Withhold TRUSELTIQ as recommended. Dry eye occurred in 29% of 351 patients; treat with ocular demulcents as needed
  • Hyperphosphatemia and soft tissue mineralization: Hyperphosphatemia, which can lead to soft tissue mineralization, cutaneous calcinosis, non-uremic calciphylaxis, vascular calcification, and myocardial calcification, occurred in 82% of 351 patients treated with TRUSELTIQ, with a median time to onset of 8 days (range 1-349); 83% of 351 patients treated with TRUSELTIQ received phosphate binders. Monitor for hyperphosphatemia throughout treatment. Initiate phosphate-lowering therapy for serum phosphate >5.5 mg/dL; withhold TRUSELTIQ and initiate phosphate-lowering therapy for serum phosphate >7.5 mg/dL; withhold, reduce the dose, or permanently discontinue TRUSELTIQ based on duration and severity of hyperphosphatemia
  • Embryo-fetal toxicity: TRUSELTIQ can cause fetal harm. Advise pregnant women of the potential risk to the fetus; advise females of reproductive potential and men who are partnered with women of reproductive potential to use effective contraception during treatment with TRUSELTIQ and for 1 month after the final dose

Adverse reactions

  • Most common adverse reactions (incidence ≥20%, all grades): nail toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal pain, dry mouth, eyelash changes, diarrhea, dry skin, decreased appetite, blurred vision, and vomiting
  • Most common laboratory abnormalities (incidence ≥20%, all grades): increased creatinine, increased phosphate, decreased phosphate, increased alkaline phosphatase, decreased hemoglobin, increased alanine aminotransferase, increased lipase, increased calcium, decreased lymphocytes, decreased sodium, increased triglycerides, increased aspartate aminotransferase (AST), increased urate, decreased platelets, decreased leukocytes, decreased albumin, increased bilirubin, and decreased potassium

Drug interactions

  • CYP3A inhibitors: Avoid use with strong and moderate CYP3A inhibitors
  • CYP3A inducers: Avoid use with strong and moderate CYP3A inducers
  • Gastric acid–reducing agents: Avoid coadministration with proton pump inhibitors, histamine-2 receptor antagonists (H2RA), and locally acting antacids. If coadministration of H2RA or locally acting antacids cannot be avoided, separate TRUSELTIQ administration
    • H2RA: Take TRUSELTIQ 2 hours before or 10 hours after
    • Locally-acting antacid: Take TRUSELTIQ 2 hours before or 2 hours after

Dosage and administration

  • Prior to initiating TRUSELTIQ: Confirm FGFR2 fusion or rearrangement; perform comprehensive ophthalmic exam including OCT; confirm negative pregnancy test in females of reproductive potential
  • Starting dose: Take TRUSELTIQ orally once daily on Days 1-21 of 28-day cycles; continue treatment until disease progression or unacceptable toxicity. Take TRUSELTIQ on an empty stomach with a glass of water at least 1 hour before or 2 hours after food
    • No renal or hepatic impairment
      • 125 mg (one 100 mg capsule and one 25 mg capsule)
    • Mild and moderate renal impairment (creatinine clearance 30-89 mL/min)
      • 100 mg (one 100 mg capsule)
    • Mild hepatic impairment (total bilirubin >upper limit of normal [ULN] to 1.5 x ULN or AST > ULN)
      • 100 mg (one 100 mg capsule)
    • Moderate hepatic impairment (total bilirubin >1.5 to 3 x ULN with any AST)
      • 75 mg (three 25 mg capsules)
  • Dose modification: Consult the TRUSELTIQ full Prescribing Information for dose modifications and monitoring recommendations for RPED, hyperphosphatemia, and other Grades 3-4 adverse reactions

Please click here for full Prescribing Information.