Discover Access and Reimbursement Solutions

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Solutions Plus®
Enrollment Form
Solutions Plus® Fact Sheet, Download PDF
Dispensing Pharmacy
Fact Sheet
Dispensing Pharmacy Fact Sheet, Download PDF
Solutions Plus® Enrollment Quick Reference
Comprehensive Solutions Plus® Booklet, Download PDF
Distribution Quick
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Distribution Quick Reference Card, Download PDF

Coverage & Reimbursement

Our knowledgeable Reimbursement Specialists will assist with the coverage and reimbursement process throughout your patient's GILOTRIF treatment journey.

Coverage and reimbursement assistance

  • Upon enrollment, designated Reimbursement Specialists investigate and verify coverage for your patients within 2 business days from initiation
  • Reimbursement Specialists anticipate and communicate prior authorization requirements for payers*

Co-pay Assistance Program

  • Ensures maximum out-of-pocket costs of $25 monthly for eligible commercially insured US-resident patients
  • No income eligibility, benefit cap, or additional paperwork

Alternative funding support

Our Reimbursement Specialists will direct patients to nonprofit independent foundations or the Patient Assistance Program


Eligible patients experiencing more than a 5-day payer approval delay can receive a 15-day supply of GILOTRIF for the FDA-approved indications


Patient and participating payers refunded for first month of therapy if eligible patients discontinue before first refill

* If prior authorization is needed and the patient receives GILOTRIF from our dedicated specialty pharmacy partner, Accredo®, Solutions Plus® then may assist with submission and tracking of prior authorization consistent with health plan requirements.

For commercially and publicly insured patients treated with GILOTRIF who may experience a payer delay ≥5 days for the FDA-approved indication, or when a patient changes insurance and a treatment gap is expected.

For commercially insured patients serviced through Accredo who are participating in the Nurse Support Program.

Financial Support Services & Tools

A range of services to help alleviate financial concerns around access

Insurance coverage should not be a barrier to cancer treatment—we will explore multiple options to help a variety of
patients afford their treatment.

  • Solutions Plus®, Patient 1

    Commercially insured patients* who are eligible, pay no more than a $25 co-pay per month through the Co-pay Assistance program

  • Solutions Plus®, Patient 2

    Publicly insured patients* are connected to alternative funding support, which may help offset co-pays, deductibles, or other treatment-related expenses

  • Solutions Plus®, Patient 3

    Uninsured and underinsured patients* who have been denied financial assistance from other foundations may be eligible for free medication through the BI Cares Foundation

Patient portrayals

BI = Boehringer Ingelheim

* US residents


What type of health insurance does the patient have?

Commercial Insurance

Public Insurance
(ie, Medicare, Medicaid)

No insurance or insufficient insurance



Read on to find a dispensing pharmacy convenient for your patient.

Solutions Plus® works closely with Accredo®, our single, dedicated, specialty pharmacy partner, to ensure:

  • Timely distribution
  • Seamless transition from enrollment to prescription fulfillment
  • Consistent support experience for patients

GILOTRIF is also available at select on-site pharmacies

  • Select, large group practices
  • Kaiser Permanente®
  • NCI-designated Cancer Centers
  • Select hospitals with outpatient clinics
  • Integrated delivery networks
  • Veterans Administration/Department of Defense
Solutions Plus®, Distribution Quick Reference Card

Distribution Quick
Reference Card


GILOTRIF Pledge Program

The GILOTRIF Pledge™ Program reduces the financial impact often caused by treatment discontinuations

  • Patient and participating payers are refunded for the first month of therapy if eligible
    • Patient discontinues before first refill
    • Lack of refill triggers GILOTRIF Pledge™ Program

The GILOTRIF Pledge™ Program is offered to patients who meet the following eligibility requirements:

  • Commercially insured by participating health plan
  • Serviced through our dedicated specialty pharmacy partner, Accredo®
  • Enrolled in Nurse Support Program*

How the GILOTRIF Pledge™ Program works

For patients serviced through Accredo®, Reimbursement Specialist confirms that patient’s insurer is participating in the GILOTRIF Pledge Program

When patient is called to schedule his or her first refill and indicates discontinuation, a call is placed to HCP’s office to confirm discontinuation

Solutions Plus® refunds patients and payers for the entire cost of first month of therapy

* Patients are automatically enrolled in the Nurse Support Program when they enroll in Solutions Plus®. Patients not serviced through Accredo® are able to opt in to the Nurse Support Program if interested.

– For commercially insured patients serviced through Accredo® who are participating in the Nurse Support Program




  • GILOTRIF can cause diarrhea which may be severe and can result in dehydration with or without renal impairment. In clinical studies, some of these cases were fatal.
  • For patients who develop Grade 2 diarrhea lasting more than 48 hours or Grade 3 or greater diarrhea, withhold GILOTRIF until diarrhea resolves to Grade 1 or less, and then resume at a reduced dose.
  • Provide patients with an anti-diarrheal agent (e.g., loperamide) for self-administration at the onset of diarrhea and instruct patients to continue anti-diarrheal until loose stools cease for 12 hours.
Bullous and Exfoliative Skin Disorders
  • GILOTRIF can result in cutaneous reactions consisting of rash, erythema, and acneiform rash. In addition, palmar-plantar erythrodysesthesia syndrome was observed in clinical trials in patients taking GILOTRIF.
  • Discontinue GILOTRIF in patients who develop life-threatening bullous, blistering, or exfoliating lesions. For patients who develop Grade 2 cutaneous adverse reactions lasting more than 7 days, intolerable Grade 2, or Grade 3 cutaneous reactions, withhold GILOTRIF. When the adverse reaction resolves to Grade 1 or less, resume GILOTRIF with appropriate dose reduction.
  • Postmarketing cases of toxic epidermal necrolysis (TEN) and Stevens Johnson syndrome (SJS) have been reported in patients receiving GILOTRIF. Discontinue GILOTRIF if TEN or SJS is suspected.
Interstitial Lung Disease
  • Interstitial Lung Disease (ILD) or ILD-like adverse reactions (e.g., lung infiltration, pneumonitis, acute respiratory distress syndrome, or alveolitis allergic) occurred in patients receiving GILOTRIF in clinical trials. In some cases, ILD was fatal. The incidence of ILD appeared to be higher in Asian patients as compared to white patients.
  • Withhold GILOTRIF during evaluation of patients with suspected ILD, and discontinue GILOTRIF in patients with confirmed ILD.
Hepatic Toxicity
  • Hepatic toxicity as evidenced by liver function tests abnormalities has been observed in patients taking GILOTRIF. In 4257 patients who received GILOTRIF across clinical trials, 9.7% had liver test abnormalities, of which 0.2% were fatal.
  • Obtain periodic liver testing in patients during treatment with GILOTRIF. Withhold GILOTRIF in patients who develop worsening of liver function. Treatment should be discontinued in patients who develop severe hepatic impairment while taking GILOTRIF.
  • Keratitis has been reported in patients taking GILOTRIF.
  • Withhold GILOTRIF during evaluation of patients with suspected keratitis. If diagnosis of ulcerative keratitis is confirmed, treatment with GILOTRIF should be interrupted or discontinued. If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered. GILOTRIF should be used with caution in patients with a history of keratitis, ulcerative keratitis, or severe dry eye. Contact lens use is also a risk factor for keratitis and ulceration.
Embryo-Fetal Toxicity
  • GILOTRIF can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
  • Advise females of reproductive potential to use effective contraception during treatment, and for at least 2 weeks after the last dose of GILOTRIF. Advise female patients to contact their healthcare provider with a known or suspected pregnancy.


Adverse Reactions observed in clinical trials were as follows:
First-line treatment of EGFR mutation-positive, metastatic non-small cell lung cancer (NSCLC)
  • In GILOTRIF-treated patients (n=229) the most common adverse reactions (≥20% all grades & vs pemetrexed/cisplatin-treated patients (n=111)) were diarrhea (96% vs 23%), rash/acneiform dermatitis (90% vs 11%), stomatitis (71% vs 15%), paronychia (58% vs 0%), dry skin (31% vs 2%), and pruritus (21% vs 1%). Other clinically important adverse reactions observed in patients treated with GILOTRIF include: decreased appetite (29%), nausea (25%), and vomiting (23%).
  • Serious adverse reactions were reported in 29% of patients treated with GILOTRIF. The most frequent serious adverse reactions reported in patients treated with GILOTRIF were diarrhea (6.6%); vomiting (4.8%); and dyspnea, fatigue, and hypokalemia (1.7% each). Fatal adverse reactions in GILOTRIF-treated patients included pulmonary toxicity/ILD-like adverse reactions (1.3%), sepsis (0.43%), and pneumonia (0.43%).
  • More GILOTRIF-treated patients (2.2%) experienced ventricular dysfunction (defined as diastolic dysfunction, left ventricular dysfunction, or ventricular dilation; all < Grade 3) compared to chemotherapy-treated patients (0.9%).
Previously Treated Metastatic Squamous NSCLC
  • In GILOTRIF-treated patients (n=392) the most common adverse reactions (≥20% all grades & vs erlotinib-treated patients (n=395)) were diarrhea (75% vs 41%), rash/acneiform dermatitis (70% vs 70%), stomatitis (30% vs 11%), decreased appetite (25% vs 26%), and nausea (21% vs 16%).
  • Serious adverse reactions were reported in 44% of patients treated with GILOTRIF. The most frequent serious adverse reactions reported in patients treated with GILOTRIF were pneumonia (6.6%), diarrhea (4.6%); and dehydration and dyspnea (3.1% each). Fatal adverse reactions in GILOTRIF-treated patients included ILD (0.5%), pneumonia (0.3%), respiratory failure (0.3%), acute renal failure (0.3%), and general physical health deterioration (0.3%).
Postmarketing Experience

Pancreatitis has been reported during post-marketing use of GILOTRIF. The frequency and causal relationship of pancreatitis to GILOTRIF has not been established.


Effect of P-glycoprotein (P-gp) Inhibitors and Inducers
  • Concomitant use of P-gp inhibitors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) with GILOTRIF can increase exposure to afatinib.
  • Concomitant use of P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John’s wort) with GILOTRIF can decrease exposure to afatinib.


  • Because of the potential for serious adverse reactions in nursing infants from GILOTRIF, lactating women should not breastfeed during treatment with GILOTRIF and for 2 weeks after the final dose.
Females and Males of Reproductive Potential
  • GILOTRIF may reduce fertility in females and males of reproductive potential. It is not known if the effects on fertility are reversible.
Renal Impairment
  • Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 mL/min /1.73 m2) have a higher exposure to afatinib than patients with normal renal function. Administer GILOTRIF at a starting dose of 30 mg once daily in patients with severe renal impairment. GILOTRIF has not been studied in patients with eGFR <15 mL/min/1.73 m2 or who are on dialysis.
Hepatic Impairment
  • GILOTRIF has not been studied in patients with severe (Child Pugh C) hepatic impairment. Closely monitor patients with severe hepatic impairment and adjust GILOTRIF dose if not tolerated.


  • GILOTRIF (afatinib) is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

    Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations.
  • GILOTRIF is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.

GF PROF ISI July 2016

References: 1. Gilotrif® (afatinib) tablets Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2. Yang JC-H, Wu Y-L, Schuler M, et al. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015;16(2):141-151. 3. Sequist LV, Yang JC, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013;31(27):3327-3334. 4. Data on file. Boehringer Ingelheim. CTR. 5. Lee CK, Wu YL, Ding PN, et al. Impact of specific epidermal growth factor receptor (EGFR) mutations and clinical characteristics on outcomes after treatment with EGFR tyrosine kinase inhibitors versus chemotherapy in EGFR-mutant lung cancer: a meta-analysis. J Clin Oncol. 2015;33(17):1958-1965. 6. Soria J-C, Felip E, Cobo M, et al. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2015;16:897-907. 7. Yang JC, Sequist LV, Zhou C, et al. Effect of dose adjustment on the safety and efficacy of afatinib for EGFR mutation-positive lung adenocarcinoma: post hoc analyses of the randomized LUX-Lung 3 and 6 trials [published online September 6, 2016]. Ann Oncol. 2016. doi: 10.1093/annonc/mdw322. 8. Peters S, Zimmermann S, Adjei AA. Oral epidermal growth factor receptor tyrosine kinase inhibitors for the treatment of non-small cell lung cancer: comparative pharmacokinetics and drug-drug interactions. Cancer Treat Rev. 2014;40(8):917-926. 9. Sharma SV, Bell DW, Settleman J, Haber DA. Epidermal growth factor receptor mutations in lung cancer. Nat Rev Cancer. 2007;7(3):169-181. 10. Data on file. Boehringer Ingelheim. Other mutations PFS table. 11. Wu YL, Zhou C, Hu CP, et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014;15(2):213-222.

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