Helping People Get VICTRELIS™ (boceprevir)

Helping People Get VICTRELIS™ (boceprevir)

Merck is offering a discount co-pay card that will allow eligible individuals to save up to $200 each on up to 12 boceprevir prescriptions .

If eligible, follow these steps to save up to $200 off on each of up to 12 qualifying prescriptions for VICTRELIS.

• Activate and print the card here .
• Take the card to your doctor as a reminder to ask if VICTRELIS is right for you. If the doctor thinks that VICTRELIS is right for you, he or she will write a prescription for VICTRELIS.
• The card can be used up to 12 times before the expiration date and provides a maximum benefit of up to $200 or the amount of your copay, whichever is less, off on each of up to 12 qualifying prescriptions.
• Present the card and your insurance card (if any) with a valid signed prescription at any participating eligible retail or mail-order pharmacy (certain restrictions apply).

Please Note:

• The same coupon offer is available in different forms. For example, you may receive a coupon in card form from your doctor (which also includes a fax form), or you may print the coupon yourself from victrelis.com. Regardless of how many coupons you receive or print, you may only use the coupons, and receive up to $200 off an eligible prescription, up to 12 times prior to the expiration date printed on the coupons.
• The card is valid for patients with private insurance or cash-paying patients. Not valid for patients covered under Medicaid, Medicare, a Medicare Part D or Medicare Advantage plan (regardless of whether a specific prescription is covered), TRICARE, CHAMPUS, Puerto Rico Government Health Insurance Plan (“Healthcare Reform”), or any other state or federal medical or pharmaceutical benefit program or pharmaceutical assistance program.
• The card is void for Massachusetts residents if a third-party payer reimburses or pays any amount of the prescription price or otherwise provides coverage for VICTRELIS.
• The card can be used only by eligible US or Commonwealth of Puerto Rico residents at participating eligible retail or mail-order pharmacies in the United States or the Commonwealth of Puerto Rico. Product must originate in the United States or the Commonwealth of Puerto Rico.
  

Activate, print or replace your cards online here

For further information contact Merck at 866-363-6379.

• Expiration Date: 04/30/2013.

Merck Helps

Program Patient Assistance

Merck Patient Assistance Program --this is for low-income people who do not have private insurance and are not covered by any other benefits programs.

Please call The ACT Program at 1-866-363-6379 for the full list of covered products.

What Medicines Are Covered

• PEGINTRON^® (peginterferon alfa-2b) Powder for Injection
  Before prescribing PEGINTRON, please read the Prescribing Information, including Medication Guide and Boxed Warnings about fatal or life-threatening neuropsychiatric, autoimmune, ischemic and infectious disorders and ribavirin-associated birth defects and fetal death.
• VICTRELIS^™ (boceprevir)

Who may qualify for patient assistance?

You may qualify for patient assistance if you meet all 3 of the following conditions:

1. You are a US resident and have a prescription for a Merck medicine from a doctor licensed in the United States.**

   AND

2. You do not have insurance or other coverage for your prescription medicine.

   AND

3. You cannot afford to pay for your medicine.You may qualify for the patient assistance program if you have a household income of $54,450 or less for individuals, $73,550 or less for couples, or $111,750 or less for a family of 4.

At Merck we realize that sometimes exceptions need to be made based on the patient's individual circumstances. If you do not meet the prescription drug coverage criteria, your income meets the program criteria, and there are special circumstances of financial and medical hardship that apply to your situation, you can request that an exception be made for you.

The ACT Program Specialists can help you and your Health Care Provider answer questions related to insurance coverage and reimbursement. They can also explain program requirements and available options. You and Your Health Care Provider must complete an enrollment form.

Call 1-866-363-6379, Monday through Friday, 8AM to 8PM ET

Indications and Usage

VICTRELIS is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 (G1) infection, in combination with peginterferon alfa
and ribavirin (PR), in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy. The following points should be considered when initiating VICTRELIS for treatment of CHC infection:

• VICTRELIS must not be used as monotherapy and should only be used in combination with PR.
• VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other hepatitis C virus (HCV) NS3/4A protease inhibitors.
• VICTRELIS in combination with PR has not been studied in patients documented to be historical null responders (<2-log10 HCV-RNA decline by Treatment Week [TW] 12) during prior therapy with PR. The clinical studies included subjects who were poorly interferon responsive. Subjects with <0.5-log10 HCV-RNA decline in viral load at TW 4 with PR alone are predicted to have a null response (<2-log10 viral load decline at TW 12) to PR therapy.
• Poorly interferon responsive patients who were treated with VICTRELIS in combination with PR have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to PR.

Selected Safety Information

• All contraindications to PR also apply since VICTRELIS must be administered
  with PR.
• Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with PR is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use 2 or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least 6 months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS and concomitant ribavirin.
• VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS is also contraindicated in coadministration with potent CYP3A4/5 inducers, where significantly reduced VICTRELIS plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio^® (sildenafil) or Adcirca^® (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and orally administered midazolam.
• Anemia and/or Neutropenia - The addition of VICTRELIS to PR is associated with an additional decrease in hemoglobin concentrations compared with PR alone and/or may result in worsening of neutropenia associated with PR therapy alone. Dose reduction or discontinuation of peginterferon alfa and/or ribavirin may be required. Complete blood count (with white blood cell differential counts) must be conducted in all patients prior to initiating VICTRELIS combination therapy. Complete blood counts should be obtained at TWs 4, 8, and 12, and should be monitored closely at other time points, as clinically appropriate.
• The most commonly reported adverse reactions (>35%) in clinical trials in adult patients receiving the combination of VICTRELIS with PR were fatigue, anemia, nausea, headache, and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates ≥5% above the rates for PR alone in either clinical study. The incidence of these adverse reactions in previously untreated patients that were treated with VICTRELIS combination therapy compared with PR alone were: fatigue (58% vs 59%), anemia (50% vs 30%), nausea (46% vs 42%), dysgeusia (35% vs 16%), respectively. The incidence of these adverse reactions in previously treated patients that were treated with VICTRELIS combination therapy compared with PR alone were: fatigue (55% vs 50%), anemia (45% vs 20%), nausea (43% vs 38%), dysgeusia (44% vs 11%), respectively.
• VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.

• Prescribing Information
• Medication Guide