INDICATION: LONSURF is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan‑based chemotherapy, an anti‑VEGF biological therapy, and if RAS wild type, an anti‑EGFR therapy.
INDICATION: LONSURF is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan‑based chemotherapy, an anti‑VEGF biological therapy, and if RAS wild type, an anti‑EGFR therapy.

Support Services

Access & Reimbursement

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Dosage

Taiho Oncology Patient Support

Designed to simplify patient access to LONSURF

We know getting patients access to LONSURF® (trifluridine and tipiracil) tablets is a critical step in their treatment. We strive to make this process as simple as possible with:

Access and reimbursement support
  • Benefit Verifications (BVs) to determine and report patients' insurance coverage for LONSURF
  • Prior authorization assistance to meet payer requirements
  • Claims appeals assistance if coverage is denied
Specialty pharmacy prescription coordination
  • Prescription triage
  • Coordination with the in‑network specialty pharmacy, self‑dispensing practice, or hospital outpatient pharmacy
  • Communicating regularly with patients about their prescription status
Co‑pay support
  • Eligible, privately insured patients can enroll in the Taiho Oncology Patient Support Co‑pay Assistance Program to reduce out‑of‑pocket expenses for LONSURF to $0*
  • Learn more about the Taiho Oncology Patient Support Co-pay Assistance Program here.

*Restrictions and eligibility: Offer valid in the US, Puerto Rico, and US territories only. Only valid for patients with private insurance. Offer not valid for prescriptions reimbursed under Medicaid, a Medicare drug benefit plan, Tricare, or other federal or state programs (such as medical assistance programs). If the patient is eligible for drug benefits under any such program, this offer is not valid and the patient cannot use this offer. By presenting or accepting this benefit, patient and pharmacist agree not to submit claim for reimbursement under the above programs. Patient further agrees to comply with any and all terms of his or her health insurance contract requiring notification to his or her payer of the existence and/or value of this offer. It is illegal to or offer to sell, purchase, or trade this benefit. Maximum reimbursement limits apply; patient out-of-pocket expense may vary. Taiho Oncology, Inc., reserves the right to rescind, revoke, or amend this offer at any time without notice.

Patient Assistance Program
  • We research financial assistance for patients with no or insufficient prescription insurance coverage or insufficient resources to pay for LONSURF. Eligible patients may receive LONSURF at no cost based on assistance, financial, and medical criteria
Alternate funding support
  • We refer eligible, publicly insured patients (eg, Medicare, Medicaid) to nonprofit foundations for co‑pay assistance
Personalized nurse support upon request
  • Our nurse support services are available as needed to support patient care, including education about the importance of taking the medicine as prescribed and refill reminders. We will quickly verify each patient's LONSURF coverage, and help them get access to the LONSURF treatment they have been prescribed.

If selected on the Patient Enrollment Form, a Nurse Navigator will be assigned to provide telephone support to the patient and will address general inquiries about the patient's LONSURF treatment 24 hours a day, 7 days a week.

To enroll your patients, complete the Patient Enrollment form on TaihoPatientSupport.com.

Or, call our Toll‑free Resource Center at

1‑8‍4‍4‑T‍A‍I‍H‍O‑4‍U (1‑8‍4‍4‑8‍2‍4‑4‍6‍4‍8)

Monday through Friday, 8:00 AM to 8:00 PM ET
On‑call Nurse Phone Support—24 hours a day, 7 days a week

Fax:
1‑8‍4‍4‑2‍8‍7‑2‍5‍5‍9


Patient Starter Kit: Request a Kit for your patients

Along with our Patient Support program, Taiho Oncology is pleased to offer a Patient Starter Kit containing useful resources to help inform patients and caregivers about all aspects of LONSURF – including how it works, how it may help, potential side effects, and dosage information.

To request a Patient Starter Kit, please call 1‑8‍4‍4‑T‍A‍I‍H‍O‑4‍U (1‑8‍4‍4‑8‍2‍4‑4‍6‍4‍8). To request a Patient Starter Kit, please call 1‑8‍4‍4‑T‍A‍I‍H‍O‑4‍U (1‑8‍4‍4‑8‍2‍4‑4‍6‍4‍8).

LONSURF Patient Starter Kit

LONSURF Coding Information

The following 2018 ICD-10 codes are effective from October 1, 2017 through September 30, 2018. The diagnostic codes contained in this section are designed to provide important reimbursement information that will be helpful for your practice. ICD codes continually change, so it is recommended that you consult your ICD-10 code book or contact the payer for coding and billing guidance.

Diagnosis Codes for LONSURF1

ICD-10-CM
Description
C18.0
Malignant neoplasm of cecum
C18.1
Malignant neoplasm of appendix
C18.2
Malignant neoplasm of ascending colon
C18.3
Malignant neoplasm of hepatic flexure
C18.4
Malignant neoplasm of transverse colon
C18.5
Malignant neoplasm of splenic flexure
C18.6
Malignant neoplasm of descending colon
C18.7
Malignant neoplasm of sigmoid colon
C18.8
Malignant neoplasm of overlapping sites of colon
C18.9
Malignant neoplasm of colon, unspecified
C19
Malignant neoplasm of rectosigmoid junction
C20
Malignant neoplasm of rectum
C21.8
Malignant neoplasm of overlapping sites of rectum, anus and anal canal
C78.4
Secondary malignant neoplasm of small intestine
C78.5
Secondary malignant neoplasm of large intestine and rectum
C78.6
Secondary malignant neoplasm of retroperitoneum and peritoneum
D37.2
Neoplasm of uncertain behavior of small intestine
D37.3
Neoplasm of uncertain behavior of appendix
D37.4
Neoplasm of uncertain behavior of colon
D37.5
Neoplasm of uncertain behavior of rectum
ICD-10-CM=International Classification of Diseases, 10th Revision, Clinical Modification.

This information is not intended as coverage or coding advice and does not guarantee reimbursement. You should verify the appropriate reimbursement information for services or items you provide. Each health care professional is responsible for ensuring all coding is accurate and appropriate.

Reference: 1. Centers for Medicare & Medicaid Services. 2018 ICD-10 CM and GEMs. https://www.cms.gov/Medicare/Coding/ICD10/2018-ICD-10-CM-and-GEMs.html. Accessed November 1, 2017.

Important Safety Information +

WARNINGS AND PRECAUTIONS

Severe Myelosuppression: In Study 1, LONSURF caused severe and life‑threatening myelosuppression (Grade 3‑4) consisting of anemia (18%), neutropenia (38%), thrombocytopenia (5%), and febrile neutropenia (3.8%). One patient (0.2%) died due to neutropenic infection. In Study 1, 9.4% of LONSURF‑treated patients received granulocyte‑colony stimulating factors.

Obtain complete blood counts prior to and on day 15 of each cycle of LONSURF and more frequently as clinically indicated. Withhold LONSURF for febrile neutropenia, Grade 4 neutropenia, or platelets less than 50,000/mm3. Upon recovery, resume LONSURF at a reduced dose as clinically indicated.

Embryo‑Fetal Toxicity: LONSURF can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LONSURF.

USE IN SPECIFIC POPULATIONS

Lactation: It is not known whether LONSURF or its metabolites are present in human milk. There are no data to assess the effects of LONSURF or its metabolites on the breast‑fed infant or the effects on milk production. Because of the potential for serious adverse reactions in breast‑fed infants, advise women not to breastfeed during treatment with LONSURF and for 1 day following the final dose.

Male Contraception: Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with LONSURF and for at least 3 months after the final dose.

Geriatric Use: Patients 65 years of age or over who received LONSURF had a higher incidence of the following compared to patients younger than 65 years: Grade 3 or 4 neutropenia (48% vs 30%), Grade 3 anemia (26% vs 12%), and Grade 3 or 4 thrombocytopenia (9% vs 2%).

Hepatic Impairment: Patients with severe hepatic impairment (total bilirubin greater than 3 times ULN and any AST) were not studied. No adjustment to the starting dose of LONSURF is recommended for patients with mild hepatic impairment. Do not initiate LONSURF in patients with baseline moderate or severe (total bilirubin greater than 1.5 times ULN and any AST) hepatic impairment.

Renal Impairment: In Study 1, patients with moderate renal impairment (CLcr=30 to 59 mL/min, n=47) had a higher incidence (difference of at least 5%) of ≥Grade 3 adverse events, serious adverse events, and dose delays and reductions compared to patients with normal renal function (CLcr ≥90 mL/min, n=306) or patients with mild renal impairment (CLcr=60 to 89 mL/min, n=178).

Patients with moderate renal impairment may require dose modifications for increased toxicity. Patients with severe renal impairment were not studied.

ADVERSE REACTIONS

Most Common Adverse Drug Reactions in Patients Treated With LONSURF (≥5%): The most common adverse drug reactions in LONSURF‑treated patients vs placebo‑treated patients with refractory mCRC, respectively, were asthenia/fatigue (52% vs 35%), nausea (48% vs 24%), decreased appetite (39% vs 29%), diarrhea (32% vs 12%), vomiting (28% vs 14%), abdominal pain (21% vs 18%), pyrexia (19% vs 14%), stomatitis (8% vs 6%), dysgeusia (7% vs 2%), and alopecia (7% vs 1%).

Additional Important Adverse Drug Reactions: The following occurred more frequently in LONSURF‑treated patients compared to placebo: infections (27% vs 15%) and pulmonary emboli (2% vs 0%).

The most commonly reported infections which occurred more frequently in LONSURF‑treated patients were nasopharyngitis (4% vs 2%) and urinary tract infections (4% vs 2%).

Interstitial lung disease (0.2%), including fatalities, has been reported in clinical studies and clinical practice settings in Asia.

Laboratory Test Abnormalities in Patients Treated With LONSURF: Laboratory test abnormalities in LONSURF‑treated patients vs placebo-treated patients with refractory mCRC, respectively, were anemia (77% vs 33%), neutropenia (67% vs 1%), and thrombocytopenia (42% vs 8%).

Please see full Prescribing Information.