MAVYRET: NOW APPROVED IN HCV

TREAT ALL GENOTYPES IN AS FEW AS 8 WEEKS

THE ONLY 8-WEEK PANGENOTYPIC (GT 1-6) REGIMEN FOR TREATMENT-NAÏVE, NON-CIRRHOTIC PATIENTS1

OVERALL98%CURE* RATE (SVR12)
per the USPI, in GT 1-6 patients who took the recommended regimen for 8, 12, or 16 weeks (n=1034/1060)

SVR12 varied by GT and prior treatment experience. Range: 92‑100% (ITT); 94‑100% (mITT)

  • NO ribavirin
  • NO baseline viral load restrictions
  • NO baseline resistance testing required
  • NO dose adjustment for renal impairment
0.1%
OVERALL DISCONTINUATION RATE DUE TO TREATMENT-RELATED ADVERSE REACTIONS

Most common adverse reactions (≥10% prevalence) were headache and fatigue

 

Most adverse reactions were mild in severity

 

1 subject experienced a serious adverse reaction
8WEEK
TREATMENT
FOR GT 1-6 TREATMENT-NAÏVE, NON-CIRRHOTIC PATIENTS

*Cure: sustained virologic response (SVR12); HCV RNA < LLOQ 12 weeks after the end of treatment.

GT=genotype, LLOQ = lower limit of quantification, mITT = ITT population modified to exclude subjects who did not achieve SVR12 for reasons other than virologic failure.

READY TO PRESCRIBE MAVYRET?

MAVYRET OFFERS A ONCE-DAILY REGIMEN, IN AS FEW AS 8 WEEKS.

8

WEEK
TREATMENT

GT 1-6

TREATMENT-NAÏVE

NON-CIRRHOTIC

12

WEEK
TREATMENT

GT 1-6

TREATMENT-NAÏVE

COMPENSATED CIRRHOTIC

16

WEEK
TREATMENT

GT 1

NS5A-EXPERIENCED
(NS3/4A PI-NAÏVE)

COMPENSATED CIRRHOTIC/
NON-CIRRHOTIC

In clinical trials, subjects were treated with prior regimens containing ledipasvir (LDV) and sofosbuvir (SOF) or daclatasvir (DCV) with pegylated interferon (pegIFN) and ribavirin (RBV).

Due to higher rates of virologic failure and treatment-emergent drug resistance, the data do not support labeling for treatment of HCV genotype 1 infected patients who are both NS3/4A PI and NS5A inhibitor-experienced.

Refer to the full Prescribing Information for further dosing information.

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No change in dosing required for renally impaired patients

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Once daily dosing

Each MAVYRET tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir.

SIMPLE, ONCE-DAILY DOSING

  • 3 tablets in a single-dose pack, taken once daily with food


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MAVYRET patient support program for people taking MAVYRET

DESIGNED TO PROVIDE PATIENTS WITH A TAILORED EXPERIENCE

MAVYRET Nurse Ambassadors provide a personal approach and are there for patients to help them feel knowledgeable and confident.

Nurse Ambassadors provide product support but do not provide medical advice and will direct patients to their healthcare professional for any medical advice or questions related to treatment decisions and plans.



MEDICAL EXCEPTION TEMPLATE

The guidance presented here is for informational purposes only and is not intended to provide reimbursement or legal advice. AbbVie does not guarantee that the use of any information provided will result in coverage or payment by any third-party payer. You are responsible for the submission based on your clinical judgment.

Typical elements of a Letter of Medical Necessity and frequently used supporting documents:

+  SEE MORE

For prescription approval, third-party payers may require physicians to submit documentation of medical necessity to support coverage of the prescribed treatment. A Letter of Medical Necessity documents a patient’s medical history and diagnosis and provides a medical justification for the prescribed treatment.

What is included in a Letter of Medical Necessity?

  • Reason for request
  • Reason for denial
  • Rationale to address each reason for denial, including relevant medical exception where applicable
  • Relevant overall patient medical history and current condition
  • Relevant cost information (if known)
  • Summary of your professional opinion of likely outcome with the treatment
  • Restatement of request for approval

A Letter of Medical Necessity is usually submitted as part of a more comprehensive medical exception request package. Many physicians submit additional supporting documents to the payer, along with the Letter of Medical Necessity for clinical justification. Keep in mind the specific coverage policies and processes vary by payer.

Frequently used supporting documents:

  • Any required appeal form from the insurer (if applicable)
  • Copy of the denial letter from the insurance company
  • Copy of the prescription
  • Patient’s signature on consent form for treatment
  • Patient’s complete medication profile including patient’s current, previous, and discontinued medications
  • Patient’s medical profile
-  SEE LESS

YOUR DETAILS


PAYER DETAILS

State:


Denial Reason


PATIENT DETAILS


Gender:


Description of Patient's Medical History


Medical Exception



IMPORTANT SAFETY INFORMATION

INDICATION

MAVYRET™ (glecaprevir and pibrentasvir) tablets are indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with MAVYRET. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated

CONTRAINDICATIONS

MAVYRET is contraindicated:

  • In patients with severe hepatic impairment (Child-Pugh C)
  • With the following drugs: atazanavir or rifampin

WARNINGS AND PRECAUTIONS

Risk of Reduced Therapeutic Effect Due to Concomitant Use of MAVYRET with Carbamazepine, Efavirenz-containing Regimens, or St. John’s Wort

Carbamazepine, efavirenz, and St. John’s Wort may significantly decrease plasma concentrations of glecaprevir and pibrentasvir, leading to reduced therapeutic effect of MAVYRET. The use of these agents with MAVYRET is not recommended.

ADVERSE REACTIONS

Most common adverse reactions observed with MAVYRET:

  • >10% of subjects: headache and fatigue
  • ≥5% of subjects: headache, fatigue, and nausea
Please click here for full Prescribing Information or visit www.mavyret.com


 


 

Date: {{vm.todaysDate | date:'yyyy-MM-dd'}}
Payer Name: {{vm.payerFullName}}
Payer Address: {{vm.payerAddress}}
{{vm.payerCity}}, {{vm.payerState}} {{vm.payerZipCode}}
Payer Fax Number: {{vm.payerFaxNumber}}

Attn: {{vm.payerDepartment}}

Re: Coverage of {{vm.drugName}}
Patient Name: {{vm.patientFullName}}
Patient Date of Birth: {{vm.patientDOB}}
Patient Member ID: {{vm.patientMemberID}}

To whom it may concern,

I am writing to request approval of {{vm.drugName}} to treat my patient {{vm.patientFullName}}. This product was denied on {{vm.payerDenialDate}} for the following reason(s) {{vm.payerDenialReason}}.

{{vm.patientFullName}} is a {{vm.patientAge}}-year-old {{vm.patientGender}} who has been diagnosed with chronic HCV infection.

{{vm.patientFullName}} was diagnosed with chronic HCV infection on {{vm.patientDiagnosedDate}}. {{vm.patientFullName}}'s medical history includes {{vm.patientMedicalHistory}}.

Approval is being requested for {{vm.drugName}} based on my clinical opinion of the following clinical evidence and rationale:

{{vm.patientClinicalRationale}}

If I can provide any additional information, please contact me at {{vm.phoneNumber}} to ensure the prompt approval of this course of treatment.

Regards,

{{vm.firstName}} {{vm.lastName}}



Please click here for Important Safety Information, including BOXED WARNING on Hepatitis B Virus Reactivation.
Please click here for full Prescribing Information.

©2017 AbbVie Inc. North Chicago, IL 60064 46A-1923409 August 2017

Step 4: GENERATE LETTER PDF

YOU MAY BE ELIGIBLE TO GET MAVYRET FOR AS LITTLE AS $5 WITH THE MAVYRET CO-PAY CARD*

Abbvie co-pay card for hep C treatment

*Eligibility: Available to patients with commercial prescription insurance coverage for an FDA-approved AbbVie product prescription for treatment of hepatitis C virus (“AbbVie HCV product prescription”). Co-pay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, the patient will no longer be able to use the AbbVie HCV Co-pay Card and the patient must call PSKW at 1-844-865-8725 to stop participation. Patients may not seek reimbursement for value received from the AbbVie HCV Co-pay Program from any third-party payers. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. This is not health insurance.

NOW COULD BE YOUR TURN TO BE CURED* OF HEP C.
MAVYRET IS A NEW TREATMENT OPTION.

MAVYRET is the only 8-week treatment for patients with hep C virus GT 1-6 without cirrhosis and who have not been treated for hep C before

  • You may take MAVYRET for 8, 12, or 16 weeks depending on your hep C genotype, previous hep C treatment experience and if you have compensated cirrhosis. Your doctor will tell you how long you need to take MAVYRET
  • In clinical trials, 98% of patients were cured
    - Cure rates varied from 92‑100% based on the subtype of hep C and previous treatment experience
  • 3 tablets once a day with food
  • The most common side effects of MAVYRET are headache and tiredness

*Cure means the hep C virus is not detectable in the blood 3 months after treatment ends. Individual results may vary.

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logo_mavyret-patient-support_700x77

YOUR CONNECTION TO PERSONALIZED SUPPORT

Icon of two people representing nurse support

Once you get a MAVYRET prescription, you can enroll in MAVYRET Patient Support and work one-on-one with the MAVYRET Patient Support Nurse Ambassadors. They are available to give you any assistance or advice you need to get you started and while you are treating your hep C. MAVYRET Nurse Ambassadors provide product support but do not provide medical advice and will direct patients to their healthcare professional for any medical advice or questions related to treatment decisions and plans.

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READY TO TALK TO YOUR DOCTOR ABOUT MAVYRET?

Use these questions to help guide your conversation.



ENDURANCE 12
A randomized, open-label, multicenter, phase 3 study to evaluate the efficacy and safety of MAVYRET for 8 or 12 weeks in 703 treatment-naïve or prior treatment-experienced (ie, IFN or pegIFN ± RBV, or SOF + RBV ± pegIFN) GT 1-infected adults without cirrhosis and with or without HIV-1 coinfection. Primary endpoints: SVR12 in the 12-week ITT-PS population (ITT population excluding patients with HIV coinfection and patients with SOF experience); SVR12 in the 8-week arm compared with the 12-week arm in the ITT-PS and per-protocol ITT-PS populations (“per-protocol” excludes patients with premature discontinuation or virologic failure prior to week 8 and missing data in the SVR12 window).

ENDURANCE 33
A partially randomized, open-label, active-controlled, multicenter, phase 3 study to evaluate the efficacy and safety of MAVYRET for 8 or 12 weeks vs SOF + DCV for 12 weeks in 505 treatment-naïve GT 3-infected adults without cirrhosis. Primary endpoints: demonstrate noninferiority in the percentage of subjects achieving SVR12 with 12 weeks of MAVYRET treatment to 12 weeks of treatment with SOF + DCV, and demonstrate noninferiority of 8 weeks of MAVYRET treatment to 12 weeks of MAVYRET treatment.

EXPEDITION 11
A single-arm, open-label, phase 3 study to evaluate the efficacy and safety of MAVYRET for 12 weeks in 146 treatment-naïve or prior treatment-experienced (ie, IFN or pegIFN ± RBV, or SOF + RBV ± pegIFN) GT 1, 2, 4–6-infected adults with compensated cirrhosis. Primary endpoint: SVR12.

MAGELLAN 11
A randomized, open-label, 2-part, phase 2 study to evaluate the efficacy, safety, and pharmacokinetics of MAVYRET with or without RBV for 12 or 16 weeks in 141 direct-acting antiviral-experienced GT 1, 4-infected adults without cirrhosis or with compensated cirrhosis. Part 1: GT 1 non-cirrhotic patients were administered MAVYRET with or without RBV for 12 weeks. Part 2: GT 1, 4 patients without cirrhosis or with compensated cirrhosis were administered MAVYRET for 12 or 16 weeks. Primary endpoint: SVR12.

SURVEYOR 2, Part 2-44-7
A randomized, open-label, multicenter, 4-part, phase 2 study to evaluate the efficacy, safety, and pharmacokinetics of MAVYRET with or without RBV in 691 treatment-naïve or treatment-experienced (ie, IFN or pegIFN ± RBV, or SOF + RBV ± pegIFN) GT 2–6-infected adults, without cirrhosis or with compensated cirrhosis. Part 2: GT 2, 3 non-cirrhotic patients were administered MAVYRET for 8 weeks and GT 3 patients without cirrhosis or with compensated cirrhosis were administered MAVYRET with or without RBV for 12 weeks. Part 3: GT 3 patients without cirrhosis or with compensated cirrhosis were administered MAVYRET for 12 or 16 weeks. Part 4: GT 2, 4-6 non-cirrhotic patients were administered MAVYRET for 8 weeks. Primary endpoints: SVR12 in each treatment arm and noninferiority of SVR12 for GT 2 (Part 4) to historical control with 12 weeks of SOF + RBV.

DCV=daclatasvir, GT=genotype, IFN=interferon, ITT=intent-to-treat, pegIFN=peginterferon, RBV=ribavirin, SOF=sofosbuvir
REFERENCES
  1. MAVYRET [package insert]. North Chicago, IL: AbbVie Inc.; 2017.
  2. Zeuzem S, Feld J, Wang S, et al. ENDURANCE-1: A phase 3 evaluation of the efficacy and safety of 8- versus 12-week treatment with glecaprevir/pibrentasvir (formerly ABT-493/ABT-530) in HCV genotype 1 infected patients with or without HIV-1 co-infection and without cirrhosis. Poster presented at: The Liver Meeting® 2016. American Association for the Study of Liver Disease; November 11-15, 2016; Boston, MA.
  3. Foster GR, Gane E, Asatryan A, et al. ENDURANCE-3: safety and efficacy of glecaprevir/pibrentasvir compared to sofosbuvir plus daclatasvir in treatment-naïve HCV genotype 3-infected patients without cirrhosis. Abstract presented at: 52nd Annual Meeting of the European Association for the Study of the Liver; April 19-23, 2017; Amsterdam, the Netherlands.
  4. Data on file. ABVRRTI64729. AbbVie Inc.; 2017.
  5. Kwo PY, Wyles DL, Wang S, et al. 100% SVR12 with ABT-493 + ABT-530 with or without ribavirin in treatment-naïve HCV genotype 3-infected patients with cirrhosis. Poster presented at: 51st Annual Meeting of the European Association for the Study of the Liver; April 16, 2016; Barcelona, Spain.
  6. Wyles D, Poordad F, Wang S, et al. SURVEYOR-II, Part 3: efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in patients with hepatitis C virus genotype 3 infection with prior treatment experience and/or cirrhosis. Poster presented at: The Liver Meeting® 2016. American Association for the Study of Liver Disease; November 11-15, 2016; Boston, MA.
  7. Hassanein T, Wyles D, Wang S, et al. SURVEYOR-II, Part 4: glecaprevir/pibrentasvir demonstrates high SVR rates in patients with HCV genotype 2, 4, 5, or 6 infection without cirrhosis following an 8-week treatment duration. Poster presented at: 52nd Annual Meeting of the European Association for the Study of the Liver; April 19-23, 2017; Amsterdam, the Netherlands.