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Date Printed: June 25, 2017: 01:16 PM

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09-J0000-53

Original Effective Date: 01/01/06

Reviewed: 01/11/17

Revised: 02/15/17

Subject: Hepatitis C Drug Therapy

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Hepatitis C virus (HCV) is one of the leading causes of chronic liver disease in the United States. It is estimated that 3.9 million Americans have been infected with HCV with chronic liver disease developing in about 70% of the cases. About 1 – 5% of chronic liver disease cases due to HCV may die and HCV liver disease is the leading indication for liver transplants. The primary source for HCV infection is due to exposure to infected blood or blood products.

Currently the treatment of choice for chronic HCV infection in compensated liver disease is combination therapy. There are 6 major HCV genotypes, which predict treatment response. The majority of drug therapy data is dedicated to treating genotypes 1 – 4.

Production of hepatitis C protease inhibitors telaprevir (Incivek) and boceprevir (Victrelis) have been discontinued as of October 2014 and December 2015, respectively.

POSITION STATEMENT

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

NOTE:

Ledipasvir-Sofosbuvir (Harvoni®) and Sofosbuvir-Velpatasvir (Epclusa) are the preferred direct acting antiviral products.

• Approval duration is based on genotype, treatment regimen, ribavirin and/or interferon eligibility, prior treatment (including treatment failures), baseline HCV RNA, transplant status, and number of doses receieved of requested regimen

Initiation of hepatitis C drug therapy meets the definition of medical necessity when all of the following criteria are met:

1. Indication for use is treatment of chronic hepatitis C

2. Laboratory documentation of HCV genotype is provided

3. Laboratory documentation of baseline HCV viral RNA is provided

4. Treatment is prescribed or supervised by a gastroenterologist, hepatologist, or infectious disease or transplant physician with the following exceptions:

a. If coinfection with HIV, treatment must be prescribed or supervised by an infectious disease physician

b. If diagnosis of hepatocellular carcinoma, awaiting liver transplantation, or post-liver transplantation, treatment must be prescribed or supervised by a transplant physician

5. Member meets ONE of the following:

a. Documented fibrosis severity or cirrhosis indicated by one of the following:

i. Indirect serum biomarkers – laboratory documentation must be provided

ii. Direct serum biomarkers – laboratory documentation must be provided

iii. Fibroscan or similar elastographic devices – laboratory documentation must be provided

iv. Liver biopsy – laboratory documentation must be provided

b. Diagnosed with hepatocellular carcinoma awaiting liver transplantation – documentation from the medical record must be provided

c. Liver transplant recipient – documentation from the medical record must be provided

6. Both the member and prescriber agree to provide documentation of virological response (i.e., HCV viral RNA level) upon completion of therapy

7. Member meets product specific criteria outlined in Table 1

8. Continuation of hepatitis C drug therapy does not exceed the maximum treatment duration for the requested regimen (see Table 2)

Table 1

Initiation criteria for use of hepatitis C drug therapy

Product

Brand

Criteria

Daclatasvir

Daklinza

Use is a medical necessity when ALL criteria are met:

1. Member has a laboratory confirmed HCV genotype 1, 2, 3, or 4

2. Use is in combination with ONE of the following:

a. Sofosbuvir (Sovaldi)*

b. Sofosbuvir (Sovaldi)* AND ribavirin

3. Use of ledipasvir-sofosbuvir (Harvoni) is contraindicated – genotype 1 and 4 ONLY

4. Use of sofosbuvir-velpatasvir (Epclusa) is contraindicated – genotype 2 and 3 ONLY

5. Member meets one of the following:

a. Total daily dose does not exceed 60 mg

b. Total daily dose does not exceed 90 mg AND daclatasvir is coadministered with a moderate CYP3A inducer (e.g., bosentan, dexamethasone, efavirenz, etravirine, modafinil, nafcillin, rifapentine) or nevirapine

Approval duration: See Table 2

Elbasvir-Grazoprevir

Zepatier

Use is a medical necessity when ALL criteria are met:

1. Member has a laboratory confirmed HCV genotype 1 or 4

2. Member does not have decompensated liver disease (e.g. bleeding varices, ascites, encephalopathy, jaundice)

3. Use is alone (i.e., not in combination with any other hepatitis C therapy) OR in combination with ribavirin

4. Use of ledipasvir-sofosbuvir (Harvoni) is contraindicated or member has severe renal impairment (creatinine clearance less than 30 mL/min) or end-stage renal disease

5. Total daily dose does not exceed one tablet (elbasvir 50 mg-grazoprevir 100 mg)

Approval duration: See Table 2

Ledipasvir-Sofosbuvir

Harvoni

Use is a medical necessity when ALL criteria are met:

1. Member has a laboratory confirmed HCV genotype 1, 4, 5, or 6

2. Member does not have severe renal impairment or end stage renal disease (estimated Glomerular Filtration Rate less than 30 mL/min/1.73m2) – laboratory documentation of recent (i.e., within 6 months) serum creatinine must be provided

3. Use is alone (i.e., not in combination with any other hepatitis C therapy) OR in combination with ribavirin

4. Total daily dose does not exceed one tablet (ledipasvir 90 mg-sofosbuvir 400 mg-)

Approval duration: See Table 2

Ombitasvir-paritaprevir-ritonavir

Technivie

Use is a medical necessity when ALL criteria are met:

1. Member has a laboratory confirmed HCV genotype 4

2. Member does not have decompensated liver disease (e.g. bleeding varices, ascites, encephalopathy, jaundice)

3. Use is in combination with ribavirin

4. Member has not previously been treated with telaprevir or boceprevir

5. Use of ledipasvir-sofosbuvir (Harvoni) is contraindicated

6. Total daily dose does not exceed two tablets (ombitasvir 12.5 mg-paritaprevir 75 mg-ritonavir 50 mg)

Approval duration: See Table 2

Ombitasvir-paritaprevir-ritonavir; dasabuvir

Viekira Pak

Use is a medical necessity when ALL criteria are met:

1. Member has a laboratory confirmed HCV genotype 1

2. Member does not have decompensated liver disease (e.g. bleeding varices, ascites, encephalopathy, jaundice)

3. Use is alone (i.e., not in combination with any other hepatitis C therapy) OR in combination with ribavirin

4. Member has not previously been treated with telaprevir or boceprevir

5. Use of ledipasvir-sofosbuvir (Harvoni) is contraindicated or member has severe renal impairment (creatinine clearance less than 30 mL/min) or end-stage renal disease

6. Total daily dose does not exceed:

a. Viekira Pak: two ombitasvir-paritaprevir-ritonavir (12.5 mg-75 mg-50 mg tablet) tablets and two dasabuvir (250 mg) tablets

b. Viekira XR: three dasabuvir-ombitasvir-paritaprevir-ritonavir (200 mg-8.33 mg-50 mg-33.33 mg) extended-release tablets

Approval duration: See Table 2

Dasabuvir-Ombitasvir-Paritaprevir-Ritonavir

Viekira XR

Simeprevir

Olysio

Use is a medical necessity when ALL criteria are met:

1. Member has a laboratory confirmed HCV genotype 1

2. Member does not have HCV genotype 1a with NS3 Q80K polymorphism

3. Member does not have decompensated liver disease (e.g. bleeding varices, ascites, encephalopathy, jaundice)

4. Use is in combination with sofosbuvir (Sovaldi)*

5. Member has not previously been treated with telaprevir or boceprevir

6. Use of ledipasvir-sofosbuvir (Harvoni) is contraindicated

7. Total daily dose does not exceed 150 mg

Approval duration: See Table 2

Sofosbuvir

Sovaldi

Use is a medical necessity when ALL criteria are met:

1. Member has a laboratory confirmed HCV genotype 1, 2, 3, 4, 5 or 6

2. Member does not have severe renal impairment or end stage renal disease (estimated Glomerular Filtration Rate less than 30 mL/min/1.73m2) – laboratory documentation of recent (i.e., within 6 months) serum creatinine must be provided

3. Use is in combination with ONE of the following:

a. Ribavirin

b. Daclatasvir (Daklinza)*

c. Daclatasvir (Daklinza)* AND ribavirin

d. Simeprevir (Olysio)*

4. Total daily dose does not exceed 400 mg

Approval duration: See Table 2

Sofosbuvir-velpatasvir

Epclusa

Use is a medical necessity when ALL criteria are met:

1. Member has a laboratory confirmed HCV genotype 1, 2, 3, 4, 5, or 6

2. Member does not have severe renal impairment or end stage renal disease (estimated Glomerular Filtration Rate less than 30 mL/min/1.73m2) – laboratory documentation of recent (i.e., within 6 months) serum creatinine must be provided

3. Use is alone (i.e., not in combination with any other hepatitis C therapy) OR in combination with ribavirin

4. Use of ledipasvir-sofosbuvir (Harvoni) is contraindicated – genotype 1, 4, 5, or 6 ONLY

5. Total daily dose does not exceed one tablet (sofosbuvir 400 mg-velpatasvir 100 mg)

Approval duration: See Table 2

* Prior authorization required. Member must meet prior authorization criteria for ALL prescribed agents to be approved for combination therapy with the requested agent.

Continuation of hepatitis C drug therapy meets the definition of medical necessity when ALL of the following criteria are met:

1. Authorization/reauthorization has been previously approved by Florida Blue or another health plan, OR the member previously met all initiation criteria

2. Continuation of hepatitis C drug therapy does not exceed the maximum treatment duration for the requested regimen (see Table 2)

NOTE: Continuation of hepatitis C drug therapy will account for the number of doses the member has already received.

Approval duration: See Table 2

Table 2

NOTE:

• Ledipasvir-Sofosbuvir (Harvoni®) and Sofosbuvir-Velpatasvir (Epclusa) are the preferred direct acting antiviral products.

• Approval duration will account for any doses received since initiation of treatment.

Table 2: Maximum treatment/duration of approval for hepatitis C drug therapy

Genotype

Cirrhosis

Regimen

Required

(ALL must be met for desired regimen)

Maximum Approval Duration

1

Absent

Daklinza + Sovaldi

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

Epclusa

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

Harvoni

• Treatment naïve

• Pre-treatment HCV RNA less than 6 million IU/mL

8 weeks

• Treatment naïve

• Pre-treatment HCV RNA greater than 6 million IU/mL or HIV/HCV-coinfection

12 weeks

• Treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

Harvoni + RBV

• Treatment experienced with sofosbuvir (Sovaldi) + RBV based regimen

12 weeks

Olysio + Sovaldi

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Viekira Pak

or

Viekira XR

• Genotype 1b

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Viekira Pak + RBV or

Viekira XR + RBV

• Genotype 1a

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Zepatier

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Zepatier + RBV

• Treatment experienced with PEG-IFN + RBV + HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

• Genotype 1a with baseline NS5A RAVs present

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

16 weeks

Post-liver transplant

Daklinza + Sovaldi

• Treatment naïve

• RBV contraindicated

24 weeks

Daklinza + Sovaldi + RBV

• Treatment naïve or treatment experienced

12 weeks

Harvoni

• Treatment naïve

• RBV contraindicated

24 weeks

Harvoni + RBV

• Treatment naïve or treatment experienced

12 weeks

Compensated

Daklinza + Sovaldi +/- RBV

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

24 weeks

Epclusa

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

Harvoni

• Treatment naïve

12 weeks

• Treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

• RBV contraindicated

24 weeks

Harvoni + RBV

• Treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

• Treatment experienced with sofosbuvir (Sovaldi) + RBV based regimen

24 weeks

Viekira Pak

or

Viekira XR

• Genotype 1b

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Viekira Pak + RBV

or

Viekira XR + RBV

• Genotype 1a

• Treatment naïve or treatment experienced with PEG-IFN + RBV

24 weeks

Zepatier

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Zepatier + RBV

• Genotype 1a with baseline NS5A RAVs present

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

16 weeks

• Treatment experienced with PEG-IFN + RBV + HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

Decompensated

Daklinza + Sovaldi

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

• RBV contraindicated

24 weeks

Daklinza + Sovaldi + RBV

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

Epclusa

• Treatment naïve or treatment experienced

• RBV contraindicated

24 weeks

Epclusa + RBV

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

• Treatment experienced with a sofosbuvir (Sovaldi)- or NS5A (e.g.,daclatasvir, elbasvir, ledipasvir, ombitasvir)-based regimen

24 weeks

Harvoni

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

• RBV contraindicated

24 weeks

Harvoni + RBV

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

• Treatment experienced with sofosbuvir-based regimen

24 weeks

2

Absent

Daklinza + Sovaldi

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Daklinza + Sovaldi +/- RBV

• Treatment experienced with sofosbuvir (Sovaldi) + RBV

24 weeks

Epclusa

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

Epclusa + RBV

• Treatment experienced with sofosbuvir (Sovaldi) + RBV

12 weeks

Post-liver transplant

Daklinza + Sovaldi

• Treatment naïve or treatment experienced

• RBV contraindicated

24 weeks

Daklinza + Sovaldi + RBV

• Treatment naïve or treatment experienced

12 weeks

Sovaldi + RBV

• Treatment naïve or treatment experienced

24 weeks

Compensated

Daklinza + Sovaldi

• Treatment naïve or treatment experienced with PEG-IFN + RBV

24 weeks

Daklinza + Sovaldi +/- RBV

• Treatment experienced with sofosbuvir (Sovaldi) + RBV

24 weeks

Epclusa

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

Epclusa + RBV

• Treatment experienced with sofosbuvir (Sovaldi) + RBV

12 weeks

Decompensated

Daklinza + Sovaldi + RBV

• Treatment naïve or treatment experienced

12 weeks

Epclusa + RBV

• Treatment naïve or treatment experienced

12 weeks

3

Absent

Daklinza + Sovaldi

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Daklinza + Sovaldi + RBV

• Treatment experienced with sofosbuvir (Sovaldi) + RBV

24 weeks

Epclusa

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

Epclusa + RBV

• Treatment experienced with sofosbuvir (Sovaldi) + RBV

12 weeks

Post-liver transplant

Daklinza + Sovaldi

• Treatment naïve or treatment experienced

• RBV contraindicated

24 weeks

Daklinza + Sovaldi + RBV

• Treatment naïve or treatment experienced

12 weeks

Sovaldi + RBV

• Treatment naïve or treatment experienced

24 weeks

Compensated

Daklinza + Sovaldi + RBV

• Treatment naïve or treatment experienced with PEG-IFN + RBV or sofosbuvir (Sovaldi) + RBV

24 weeks

Daklinza + Sovaldi

• Treatment naïve

• RBV contraindicated

24 weeks

Epclusa

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

Epclusa + RBV

• Treatment experienced with sofosbuvir (Sovaldi) + RBV

12 weeks

Decompensated

Daklinza + Sovaldi + RBV

• Treatment naïve or treatment experienced

12 weeks

Epclusa + RBV

• Treatment naïve or treatment experienced

12 weeks

4

Absent

Epclusa

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

Harvoni

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Technivie + RBV

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Zepatier

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Zepatier + RBV

• On-treatment virologic failure with PEG-IFN + RBV

16 weeks

Post-liver transplant

Daklinza + Sovaldi

• Treatment naïve or treatment experienced

• RBV contraindicated

24 weeks

Daklinza + Sovaldi + RBV

• Treatment naïve or treatment experienced

12 weeks

Harvoni

• Treatment naïve or treatment experienced

• RBV contraindicated

24 weeks

Harvoni + RBV

• Treatment naïve or treatment experienced

12 weeks

Compensated

Epclusa

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

Harvoni

• Treatment naïve

12 weeks

• Treatment experienced with PEG-IFN + RBV

• RBV contraindicated

24 weeks

Harvoni + RBV

• Treatment experienced with PEG-IFN + RBV

12 weeks

Technivie + RBV

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Zepatier

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Zepatier + RBV

• On-treatment virologic failure with PEG-IFN + RBV

16 weeks

Decompensated

Daklinza + Sovaldi

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

• RBV contraindicated

24 weeks

Daklinza + Sovaldi + RBV

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

Epclusa

• Treatment naïve or treatment experienced

• RBV contraindicated

24 weeks

Epclusa + RBV

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

• Treatment experienced with a sofosbuvir (Sovaldi)- or NS5A (e.g.,daclatasvir, elbasvir, ledipasvir, ombitasvir)-based regimen

24 weeks

Harvoni

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

• RBV contraindicated

24 weeks

Harvoni + RBV

• Treatment naïve or treatment experienced with PEG-IFN + RBV +/- HCV protease inhibitor (telaprevir, boceprevir, simeprevir)

12 weeks

• Treatment experienced with sofosbuvir-based regimen

24 weeks

5

Absent or Compensated or Decompensated

Epclusa

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Harvoni

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

6

Absent or Compensated or Decompensated

Epclusa

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Harvoni

• Treatment naïve or treatment experienced with PEG-IFN + RBV

12 weeks

Preferred direct-acting antiviral product

RBV: ribavirin; PEG-IFN: peginterferon

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

Dosage and administration varies considerably between specific indications for use and treatment history. A brief overview of selected products is provided in Table 3, however it is strongly recommended that the prescriber refer to current guidelines and product-specific labeling for complete dosing and administration instructions.

Table 3

Dosage/Administration of hepatitis C drug therapy

Product
Brand

Dosage/Administration

Daclatasvir

Daklinza

60 mg once daily (reduce to 30 mg once daily when coadminstered with strong CYP3A inhibitors; increase to 90 mg once daily when coadministered with moderate CYP3A inducers)Available as a 30 mg and 60 mg tablet

Elbasvir-Grazoprevir

Zepatier

One tablet daily

Available as 50 mg elbasvir-100 mg grazoprevir tablet

Ledipasvir-Sofosbuvir

Harvoni

One tablet daily

Available as a 90 mg ledipasivir-400 mg sofosbuvir tablet

Ombitasvir-paritaprevir-ritonavir

Technivie

Two tablets once daily (in the morning) and one dasabuvir tablet twice daily (morning and evening) with a meal without regard to fat or calorie content

Available as a 12.5 mg ombitasvir-75 mg paritaprevir-50 mg ritonavir tablet

Ombitasvir-paritaprevir-ritonavir; dasabuvir

Viekira Pak

Two ombitasvir-paritaprevir-ritonavir tablets once daily (in the morning) and one dasabuvir tablet twice daily (morning and evening) with a meal without regard to fat or calorie content

Available as a 12.5 mg ombitasvir-75 mg paritaprevir-50 mg ritonavir tablet and a 250 mg dasabuvir tablet

Dasabuvir-Ombitasvir-Paritaprevir-Ritonavir

Viekira XR

Three tablets taken once daily

Available as a 200 mg dasabuvir-8.33 mg ombitasvir-50 mg

paritaprevir-33.33 mg ritonavir extended-release tablet

Simeprevir

Olysio

150 mg once daily with food

Available as a 150 mg capsule

Sofosbuvir

Sovaldi

400 mg once daily with food

Available as a 400 mg capsule

Sofosbuvir-velpatasvir

Epclusa

One tablet daily

Available as a 400 mg sofosbuvir-100 mg velpatasvir tablet

PRECAUTIONS:

Specific precautions and warnings are highlighted in Table 4.

Table 4

Precautions and warnings of hepatitis C drug therapy

Product
Brand

Precautions/Warnings

Daclatasvir

Daklinza

Contraindicated for co-administration with strong inducers of CYP3A

Elbasvir-Grazoprevir

Zepatier

Contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C). Contraindicated for co-administration with OATP1B1/3 inhibitors, strong CYP3A inducers, and efavirenz.

Ledipasvir-Sofosbuvir

Harvoni

Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended.

Use with P-gp inducers (e.g., rifampin, St. John's wort) may alter concentrations of ledipasvir and sofosbuvir

Ombitasvir-paritaprevir-ritonavir

Technivie

Contraindicated in those with severe hepatic impairment and for co-administration with drugs that are highly dependent on CYP3A for clearance, moderate and strong inducers of CYP3A

Ombitasvir-paritaprevir-ritonavir; dasabuvir

Viekira Pak

Contraindicated for co-administration with drugs that are: highly dependent on CYP3A for clearance; strong inducers of CYP3A and CYP2C8; and strong inhibitors of CYP2C8

Dasabuvir-Ombitasvir-Paritaprevir-Ritonavir

Viekira XR

Simeprevir

Olysio

Use has been associated with photosensitivity.

Sofosbuvir

Sovaldi

Bradycardia with amiodarone coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone is not recommended. In patients without alternative, viable treatment options, cardiac monitoring is recommended.

Use with caution in combination with drugs that are potent P-gp inducers in the intestine (e.g., rifampin, St. John’s wort)

Sofosbuvir-velpatasvir

Epclusa

Bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone is not recommended. In patients without alternative viable treatment options, cardiac monitoring is recommended.

BILLING/CODING INFORMATION:

HCPCS Coding:

J8499

Prescription drug, oral, non-chemotherapeutic, not otherwise specified

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

B18.2

Chronic viral hepatitis C

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

Compensated liver disease: condition is stable and no clinical signs of physical or metabolic changes such as, but not limited to hepatic encephalopathy, variceal bleeding, ascites, acute changes in bilirubin, albumin, platelet count or bleeding time that cannot be not attributed to other organic cause(s).

Decompensated cirrhosis: moderate or severe hepatic impairment (Child Pugh class B or C)

Early Virological Response (EVR): a ≥ 2 log 10 reduction in HCV RNA level compared to baseline HCV RNA level (partial EVR) or HCV RNA negative at treatment week 12 (complete EVR).

Genotype: the genetic constitution of an organism or cell, as distinct from its expressed features or phenotype.

Hepatitis C virus: a viral infection caused by a single-stranded RNA virus of the family Flaviviridae (species Hepatitis C virus of the genus Hepacivirus) that tends to persist in the blood serum and is usually transmitted by infected blood (as by injection of an illicit drug, blood transfusion, or exposure to blood or blood products) and that accounts for most cases of chronic liver disease.

Null responder: those that fail to achieve a 2log10 HCV RNA decrease at week 24 of treatment.

Phenotype: the observable properties of an organism that are produced by the interaction of the genotype and the environment.

Rapid Virological Response (RVR): those that are HCV RNA negative at treatment week 4.

Responder: those that achieve an HCV RNA decrease greater than or equal to 2log10 by treatment week 12 followed by a sustained virological response (SVR) at the end of treatment.

Partial responder: those that achieve an HCV RNA decrease greater than or equal to 2log10 by treatment week 12, but fail to have a sustained virological response (SVR) at the end of treatment.

Poor interferon responder: those with less than 1 log 10 decline in viral load at treatment week 4.

Relapse: HCV RNA levels undetectable at end of treatment, but are detectable again at post treatment follow-up.

Sustained Virological Response (SVR): a negative HCV RNA level 24 weeks after cessation of treatment.

RELATED GUIDELINES:

None applicable.

OTHER:

Table 5: Metavir Fibrosis Scores

F0

No fibrosis

F1

Portal fibrosis without septa

F2

Portal fibrosis with few septa

F3

Numerous septa without cirrhosis

F4

Cirrhosis

Table 6: Child Turcotte Pugh (CTP) classification of the severity of cirrhosis

 

Class A

Class B

Class C

Total points

5–6

7–9

10–15

Factor

1 Point

2 Points

3 Points

Total bilirubin (µmol/L)

<34

34–50

>50

Serum albumin (g/L)

>35

28–35

<28

Prothrombin time/international normalized ratio

<1.7

1.71–2.30

>2.30

Ascites

None

Mild

Moderate to Severe

Hepatic encephalopathy

None

Grade I–II

(or suppressed with medication)

Grade III–IV

(or refractory)

Table 7: Interferon ineligible

IFN ineligible is defined as one or more of the below:

• Intolerance to IFN

• Autoimmune hepatitis and other autoimmune disorders

• Hypersensitivity to PEG or any of its components

• Decompensated hepatic disease

• Major uncontrolled depressive illness

• A baseline neutrophil count below 1500/µL, a baseline platelet count below 90,000/µL or baseline hemoglobin below 10 g/dL

• A history of preexisting cardiac disease

REFERENCES:

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  2. AbbVie, Inc. Viekira Pak (dasabuvir and ombitasvir and paritaprevir and ritonavir) tablets; Viekira XR (dasabuvir and ombitasvir and paritaprevir and ritonavir) extended-release tablets . 2016 [cited 2016 Aug 7]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab74e474-9fd6-902c-9bd9-16dc9541edd0/.
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COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 01/11/17.

GUIDELINE UPDATE INFORMATION:

01/01/06

New Medical Coverage Guideline.

12/15/06

Reviewed: reformatted, added note regarding MCG for hepatitis C only and combo therapy is therapy of choice, and added HCPCS codes and updated CPT coding. MCG revised to include Medicare Part D as a program exception.

08/15/07

Review and revision to guideline; consisting of reformatting guideline, adding criteria for treating genotypes 1 and 4 hepatitis C beyond 12 weeks, updated internet links and updated references.

11/15/07

Revision of guideline; consisting of changing all references to length of therapy to weeks to be consistent with Position Statement.

07/15/08

Review and revision to guideline; consisting of adding Alferon® N to MCG, adding note stating that Roferon® brand of interferon alfa-2a has been discontinued by the manufacturer, adding genotypes 5 & 6 to the guideline, adding boxed warning under precautions section and updating references and links.

01/01/09

Annual HCPCS coding update: revised descriptor codes J9212, J9213, J9214 and J9215; deleted 90772; added 96372.

08/15/09

Review and revision to guideline; consisting of adding consideration for up to 72 weeks for genotype 1 infection, highlight “notes” in position statement, updating precautions section and references.

09/15/10

Review and revision to guideline; consisting of updating references.

01/15/11

Revision to guideline; consisting of adding ICD-10 codes.

07/13/11

Review and revision to guideline; consisting of addition of treatment post liver transplant and triple combination therapy to the position statement, added definition of responder, partial responder, null responder, HCPCS code update, deleted Roferon A, added drug information for IncivekTM (telaprevir) and Victrelis® (boceprevir).

10/15/11

Updated guideline to add note preferred pegylated interferon product Pegasys, removed Alferon N from the description and coding section, updated coverage to cirrhosis to include compensated only, updated to include justification for need of monotherapy, added pediatric use dual therapy, updated the definitions.

08/15/12

Review and revision to guideline; consisting of updated position statement and drug-drug interaction lists to include new data and recommendations regarding the drug-drug interactions with boceprevir and ritonavir boosted HIV therapies, updated the formatting to include all criteria in a table format, added consideration for extended dosing in genotype 2, 3, added definition of compensated liver disease.

02/15/13

Revision to guideline; consisting of updating format in the note for dual therapy. Removed viral titer quantification < 100 IU/ml from boceprevir TW 8.

08/15/13

Review and revision to guideline; consisting of updating the coverage to include HCV recurrence in liver transplant. Updated response guided therapy chart to provide 24 week of therapy results for telaprevir (IncivekTM). Minor formatting changes. Updated ICD-9, ICD-10, and Program Exceptions section. Updated sources.

02/01/14

Revision to guideline; consisting of updating the position statement to include HCV therapy with simeprevir and sofosbuvir and updated the Response Guided Therapy for Table 1 and Therapy by Genotype Table 2. Updated introduction, product information and references.

02/15/14

Revision to guideline; consisting of updating position statement due to updated ASSLD guidelines in the treatment of Hepatitis C infection.

08/15/14

Review and revision to guideline; consisting of description, position statement, dosage/administration, precautions/warning, references.

10/15/14

Revision to guideline; consisting of position statement, dosage/administration, precautions/warnings, references, description.

11/15/14

Revision to guideline; consisting of position statement.

12/15/14

Revision to guideline; consisting of position statement, dosage/administration, coding, other.

02/15/15

Revision to guideline; consisting of position statement, dosage/administration, precautions/warnings, references.

04/01/15

Revisin to guideline; consisting of position statement, dosage/administration, precautions/warnings

06/15/15

Revision to guideline; consisting of position statement

08/15/15

Review and revision to guidelines; consisting of precautions, program exceptions, references

09/15/15

Revision to guideline; consisting of updating position statement, dosage/administration, precautions, coding, and references.

11/01/15

Revision: ICD-9 Codes deleted.

12/18/15

Revision to guideline; consisting of updating position statement and dosage/administration.

03/15/16

Revision to guideline; consisting of updating position statement and dosage/administration, precautions/warnings, references.

08/15/16

Review and revision to guideline; consisting of updating position statement and dosage/administration, precautions/warnings, references.

09/16/16

Revision of guideline to update position statement, dosage/administration, precautions/warnings, references.

11/15/16

Revision to guideline; consisting of updating Tabe 2 with “PEG-IFN + RBV”.

02/15/17

Revision to guideline; consisting of updating position statement, precautions, coding.

Date Printed: June 25, 2017: 01:16 PM