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Healthcare providers billing for drug services must consider the drug and dosage form that was provided to the patient, the patient’s medical record, the coding requirements of each health insurer, and best coding practices. Billing and coding guidance provided on this website does not provide a guarantee of reimbursement and should be considered together with all applicable guidance and standards.

Yervoy™ (ipilimumab) Patient Assistance Program

Bristol-Myers Squibb is pleased to announce the availability of the Destination Access Yervoy Patient Assistance Program, a program developed to aid patients and healthcare providers with their reimbursement and patient assistance needs for Yervoy.

  1. How does the program work? Click For Answer
    • Eligible patients will have an annual household adjusted gross income of $150,000 or less.
    • There is an annual enrollment requirement. For the patient to remain enrolled, treatment must be ongoing and provided on an outpatient basis.
    • Patients treated with Yervoy who have received the denial of a Level 2 Medicare appeal (or commercial equivalent), or who have reached the maximum level of denied appeals from their health insurer, may elect to apply for patient assistance or continue with the appeals process.
    • If the patient is approved for the Destination Access Yervoy Patient Assistance Program, upon enrollment, the physician will be shipped Yervoy on the next business day, excluding weekend delivery unless specifically requested, for the patient’s next scheduled treatment date.
    • Refill forms may be obtained by clicking on the link below. In addition, the information can be typed directly into the form, saved to the desktop, printed, signed by the prescriber, and faxed to Destination Access for processing. Please note that the Destination Access Program does not provide product replacement or to practices when refill requests are not submitted prior to an enrolled patient’s treatment date.
  2. How does a patient apply to the Destination Access Yervoy Patient Assistance Program? Click For Answer
    • The patient and healthcare provider will need to complete the enrollment form provided in the link above and obtain any other documentation that is required. The information can be typed directly into the downloaded enrollment form, saved to the desktop, printed, and signed by the prescriber and the patient. Fully completed applications should be faxed to Destination Access for processing. Alternatively, the patient’s healthcare provider may call Destination Access to provide certain information requested on the enrollment form over the phone; the specialist will enter the information into the enrollment form prior to faxing it to the practice.
    • In addition, to help expedite the completion of the enrollment form, a Patient Enrollment Form Checklist is now available to assist patients in gathering the information that they will need to complete the patient portion of enrollment form. The Patient Enrollment Form Checklist may be obtained by clicking on the link below or by calling Destination Access to have one faxed or emailed to you. Download Patient Enrollment Checklist
    • A Destination Access program specialist will contact the patient’s healthcare provider within 48 hours to discuss any of the alternative sources of funding or coverage that may be available to the patient, including whether the patient qualifies to receive free Yervoy through the Destination Access Yervoy Patient Assistance Program.
    • If the patient would like to be considered for participation in the Destination Access Yervoy Patient Assistance Program, please include a photocopy of the patient’s proof of annual household income with the enrollment form. Examples of proof of income include the applicant’s most recent federal tax return, and Social Security or retirement income statements. Other documentation for proof of income may be considered. Please call Destination Access for more detailed information about what other forms of proof of income documentation are acceptable.
    • Please fax the completed and signed application, along with proof of income documentation and required signatures to Destination Access at: 1-888-776-2370.

    If the patient meets the eligibility criteria for the Yervoy Patient Assistance Program, the patient’s healthcare provider will be contacted within 48 hours by a Destination Access program specialist to initiate a product shipment.

  3. What are the eligibility criteria for the Yervoy Patient Assistance Program? Click For Answer
    • Patient must reside in the United States, Puerto Rico, or the U.S. Virgin Islands.
    • Patient must have an annual household adjusted gross income of $150,000 or less. Destination Access reviews all applications on a case-by-case basis and may consider additional factors when evaluating a patient’s level of financial hardship, such as out-of-pocket expenses related to the patient’s current disease state. Please contact Destination Access for more information.
    • Yervoy must be prescribed for an in-label or compendia-accepted diagnosis (refer to the Yervoy Package Insert, “Indications and Usage,” for labeled indications).
    • Patients cannot have any available prescription assistance for YERVOY through third-party insurers such as Medicaid, Medicare or commercial insurers.
    • Patients who have private prescription discount cards or who have prescription drug coverage and have met the annual or lifetime insurance spend are not considered as having coverage and may be eligible for the YERVOY Patient Assistance Program if they meet all other eligibility criteria.
    • The program will consider insured patients who have received a second-level appeal denial or who have reached the maximum level of appeal denials permitted by their insurer.
    • Patients who have exceeded either an annual or lifetime maximum benefit on their insurance coverage for Yervoy may be considered eligible for patient assistance.
    • Treatment must be ongoing in order to receive free product through the Patient Assistance Program. Please note that Destination Access does not provide product replacement as part of its Patient Assistance Program.
    • The patient must be treated with Yervoy on an outpatient basis in order to qualify for the Patient Assistance Program.
    • Incarcerated patients are not eligible to receive Yervoy through the Patient Assistance Program.
  4. How does refunding work? Click For Answer
    • Uninsured patients:
      • Healthcare providers may be eligible for a refund of the cost of Yervoy administered 60 days prior to the patient’s date of initial enrollment into the Yervoy Patient Assistance Program.
      • In order to be considered eligible for refunding, the patient’s treatment must be ongoing at the time the patient’s completed enrollment form and income documentation is submitted for patient assistance.
      • Upon the patient’s initial date of enrollment into the Yervoy Patient Assistance Program, a Destination Access program specialist will contact the patient’s healthcare provider if the practice may be eligible for a refund. The healthcare provider will be faxed a refund application form, including a detailed explanation of the Program’s eligibility criteria to receive a refund.
      • Once the patient’s healthcare provider submits the required information to Destination Access and the practice is eligible to receive a refund, the information will be forwarded to Bristol-Myers Squibb to be processed. On average, the provider should anticipate receiving a refund check within 90 days from the date that the refund is approved by Destination Access. The practice will receive a status notification for any refunding requests by the Destination Access Program.
      • Please note that these same eligibility criteria apply to patients who are not covered by their insurer for Yervoy because they have exceeded an annual or lifetime maximum benefit on their insurance coverage.
    • Insured patients:
      • Healthcare providers may be eligible to receive a refund for the cost of unreimbursed Yervoy used in treatments administered to eligible patients who have received a second-level appeal denial or who have reached the maximum level of appeal denials permitted by their health plan.
      • When the above criteria is met, the patient’s healthcare provider should contact Destination Access to let them know if the patient would like to apply for the Program. The healthcare provider will be faxed the enrollment materials which will include a detailed explanation of the information needed to qualify for a refund. The patient and healthcare provider will need to complete the forms and fax them to Destination Access, along with the required proof of income documentation.
      • Once the patient’s healthcare provider supplies the required information to Destination Access and the practice is eligible to receive a refund, the information will be forwarded to Bristol-Myers Squibb to be processed. On average, the provider should anticipate receiving a refund check within 90 days from the date that the refund is approved by Destination Access. The practice will receive a status notification from a Destination Access Program specialist for any outstanding refunding requests.
      • For patients who are still receiving Yervoy therapy at the time of application to the Program, a supply of Yervoy will be shipped directly to the patient’s healthcare provider to support the future treatment dates specified on the patient’s enrollment form.
      • If a patient is no longer receiving treatment with Yervoy but has received a second-level appeal denial or has reached the maximum level of appeal denials permitted by their health plan, the healthcare provider may still qualify to receive refunding for the cost of any unreimbursed Yervoy treatments that were administered from the start of the patient’s initial date of Yervoy treatment, as long as the patient’s treatment dates are continuous.
  5. Is it possible for patients who have exhausted their health plan’s lifetime or annual maximum benefit amount to be considered eligible to receive free product through the Yervoy Patient Assistance Program? Click For Answer
    • Yes, patients who have exceeded their health plan’s annual or lifetime maximum benefit amount are considered to be uninsured under the Program guidelines; therefore, if they meet all of the other program eligibility criteria, they may qualify to receive free Yervoy through the Yervoy Patient Assistance Program.
    • Patients who have exceeded their health plan’s annual maximum benefit amount but remain enrolled with their health plan for coverage of other services during the remainder of the benefit year are considered to be insured under the Program; however, if they meet all of the other Program eligibility criteria, insured patients without coverage for Yervoy may qualify to receive product at no charge through the Yervoy Patient Assistance Program.

Indication and Important Safety Information

Indication

YERVOY™ (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.

Important Safety Information

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

YERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs) and thyroid function tests at baseline and before each dose.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Recommended Dose Modifications

Withhold dose for any moderate immune-mediated adverse reactions or for symptomatic endocrinopathy until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving <7.5 mg prednisone or equivalent per day.

Permanently discontinue YERVOY for any of the following:

  • Persistent moderate adverse reactions or inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day
  • Failure to complete full treatment course within 16 weeks from administration of first dose
  • Severe or life-threatening adverse reactions, including any of the following
    • Colitis with abdominal pain, fever, ileus, or peritoneal signs; increase in stool frequency (≥7 over baseline), stool incontinence, need for intravenous hydration for >24 hours, gastrointestinal hemorrhage, and gastrointestinal perforation
    • AST or ALT >5 × the upper limit of normal (ULN) or total bilirubin >3 × the ULN
    • Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full-thickness dermal ulceration or necrotic, bullous, or hemorrhagic manifestations
    • Severe motor or sensory neuropathy, Guillain-Barré syndrome, or myasthenia gravis
    • Severe immune-mediated reactions involving any organ system
    • Immune-mediated ocular disease which is unresponsive to topical immunosuppressive therapy

Immune-mediated Enterocolitis:

  • In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 (5%) patients
  • Across all YERVOY-treated patients (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis
  • Infliximab was administered to 5 of 62 (8%) patients with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids
  • Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms
  • Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue over at least 1 month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients
  • Withhold YERVOY for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for >1 week, initiate systemic corticosteroids (0.5 mg/kg/day prednisone or equivalent)

Immune-mediated Hepatitis:

  • In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3–5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%
  • 13 (2.5%) additional YERVOY-treated patients experienced moderate hepatotoxicity manifested by LFT abnormalities (AST or ALT elevations >2.5x but ≤5x the ULN or total bilirubin elevation >1.5x but ≤3x the ULN; Grade 2)
  • Monitor LFTs (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of LFT monitoring until resolution
  • Permanently discontinue YERVOY in patients with Grade 3-5 hepatotoxicity and administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When LFTs show sustained improvement or return to baseline, initiate corticosteroid tapering and continue over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients with persistent severe hepatitis despite high-dose corticosteroids
  • Withhold YERVOY in patients with Grade 2 hepatotoxicity

Immune-mediated Dermatitis:

  • In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening or fatal immune-mediated dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3–5) occurred in 13 (2.5%) patients
    • 1 (0.2%) patient died as a result of toxic epidermal necrolysis
    • 1 additional patient required hospitalization for severe dermatitis
  • There were 63 (12%) YERVOY-treated patients with moderate (Grade 2) dermatitis
  • Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated
  • Permanently discontinue YERVOY in patients with severe, life-threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids
    (1-2 mg/kg/day of prednisone or equivalent). When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. Withhold YERVOY in patients with moderate to severe signs and symptoms
  • Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically. Administer topical or systemic corticosteroids if there is no improvement within 1 week

Immune-mediated Neuropathies:

  • In the pivotal Phase 3 study in YERVOY-treated patients, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported
  • Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-Barré syndrome have been reported
  • Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities) such as Guillain-Barré–like syndromes
  • Institute medical intervention as appropriate for management of severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies. Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities)

Immune-mediated Endocrinopathies:

  • In the pivotal Phase 3 study in YERVOY- treated patients, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients
    • All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism
    • 6 of the 9 patients were hospitalized for severe endocrinopathies
  • Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 (2.3%) YERVOY-treated patients and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and 1 case each of hyperthyroidism and Cushing’s syndrome
  • Median time to onset of moderate to severe immune-mediated endocrinopathy was 11 weeks and ranged up to 19.3 weeks after the initiation of YERVOY
  • Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism
    • Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms should be considered immune-mediated
    • Monitor thyroid function tests and clinical chemistries at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland
  • Withhold YERVOY in symptomatic patients. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. Long-term hormone replacement therapy may be necessary

Other Immune-mediated Adverse Reactions, Including Ocular Manifestations:

  • In the pivotal Phase 3 study in YERVOY-treated patients, clinically significant immune-mediated adverse reactions seen in <1% were: nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia
  • Across the clinical development program for YERVOY, immune-mediated adverse reactions also reported with <1% incidence were: myocarditis, angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, pancreatitis, arthritis, and autoimmune thyroiditis
  • Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe immune-mediated adverse reactions
  • Administer corticosteroid eye drops for uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease unresponsive to local immunosuppressive therapy

Pregnancy & Nursing:

  • YERVOY is classified as pregnancy category C. There are no adequate and well-controlled studies of YERVOY in pregnant women. Use YERVOY during pregnancy only if the potential benefit justifies the potential risk to the fetus
  • Human IgG1 is known to cross the placental barrier and YERVOY is an IgG1; therefore, YERVOY has the potential to be transmitted from the mother to the developing fetus
  • It is not known whether YERVOY is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from YERVOY, a decision should be made whether to discontinue
    nursing or to discontinue YERVOY

Common Adverse Reactions:

  • The most common adverse reactions (≥5%) in patients who received YERVOY at
    3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and
    colitis (8%)

Please see YERVOY US Full Prescribing Information including Boxed WARNING regarding immune-mediated adverse reactions.

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