Medical Policy

Effective Date:06/01/2015 Title:Hepatitis C Treatment with Direct Acting Antivirals (DAA)
Revision Date:11/01/2019 Document:BI482:00
CPT Code(s):None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1.    All covered direct acting antiviral agents (DAA) for the treatment of Hepatitis C require prior authorization.

2.    The natural course of illness in patients with hepatitis C virus (HCV) infections is highly variable.  Some patients may be entirely asymptomatic and recover spontaneously—usually within the first three years of becoming infected. Most patients will go on to have chronic HCV with no symptoms for many years until after liver structure and function have been significantly impacted.  If this is allowed to progress to scarring and cirrhosis, quality of life is compromised and serious complications can develop, including liver cancer and death.  However, some patients with chronic HCV may go for decades without ever having signs of progression, symptoms, or complications. The combination of individual genetics, immune response, subtype of virus, lifestyle choices and other associated illness may all play a role in this highly variable response.

Guidelines developed for treatment of patients with chronic HCV have debated when/if and how patients should be prioritized for treatment.  This is an ongoing area of debate with guidelines developed by the WHO (World Health Organization) and the EASL (European Association for the Study of the Liver) both making a clear prioritization distinction between patients with and without evidence of early liver fibrosis.  The AASLD (American Association for the Study of Liver Diseases) has developed guidelines strongly influenced by the pharmaceutical industry.  Not surprisingly, AASLD recommends treating all patients with chronic HCV, regardless of any evidence of early fibrosis.  QualChoice believes the WHO and EASL guidelines are more credible and our policy for treatment of chronic HCV is based on these guidelines.  



Active surveillance and proven preventive measures are medically necessary to identify early, reversible changes in liver structure or function that, if left untreated, could progress to symptomatic disease.  Treatment with direct-acting antivirals (DAAs) is only considered medically necessary for patients with early, reversible changes in liver structure or function since there is no evidence they will progress to symptomatic disease without these changes.  By definition, interventions that will not make a difference in outcomes are not medically necessary (see BI024 Medical Necessity Determinations).

Covered DAAs used to treat Hepatitis C require prior authorization to ensure active surveillance is no longer indicated and treatment with DAAs is medically necessary to prevent progression to symptomatic disease (or to prevent further progression and complications for patients whose diagnosis was delayed until after already having symptomatic disease).

3.    Covered drugs include Mavyret, Vosevi, and Sofosbuvir/velpatasvir.

4.    Viekira Pak, Epclusa, Harvoni, ledipasvir/sofosbuvir, Sovaldi, Daklinza, Zepatier, and Technivie are not covered.

Medical Statement

Guidelines developed for treatment of patients with chronic HCV have debated when/if and how patients should be prioritized for treatment.  This is an ongoing area of debate with guidelines developed by the WHO (World Health Organization) and the EASL (European Association for the Study of the Liver) both making a clear prioritization distinction between patients with and without evidence of early liver fibrosis.  The AASLD (American Association for the Study of Liver Diseases) has developed guidelines strongly influenced by the pharmaceutical industry.  Not surprisingly, AASLD recommends treating all patients with chronic HCV, regardless of any evidence of early fibrosis.  QualChoice believes the WHO and EASL guidelines are more credible and our policy for treatment of chronic HCV is based on these guidelines.  

Active surveillance with preventive measures are the first choice for treating asymptomatic patients with chronic HCV due to the highly variable natural course of this condition.

 

Active surveillance and important preventive measures include the following:

·         Periodic physical examination

·         Periodic blood tests (CBC and LFTs) with calculation of APRI score

·         Evaluation of liver fibrosis by Fibroscan or biopsy

·         Liver ultrasound if evidence of abnormalities on exam or testing

·         Preventive vaccination (HBV if HBV negative)

·         Testing for HIV

·         Avoidance of alcohol or other substance abuse

 

Direct-acting antiviral drug therapy is considered medically necessary in patients meeting the following criteria:

1)    Patient is 18 years of age or older  AND

2)    Absence of metastatic cancer or other significant comorbidities resulting in a life expectancy of less than 2 years AND

3)    Diagnosis of chronic Hepatitis C with evidence of HCV viral load within 6 months of request  AND

4)    No history of illicit drug use in the past 6 months with a negative drug screen prior to start of therapy (within one month of request)  AND

5)    If history of alcoholism, provider must document patient has not abused alcohol  for the past 6 months  AND

6)    One of the following:

a.    Evidence of stage 2 or greater liver fibrosis confirmed by METAVIR score (or comparable measure such as Fibroscan or Fibrosure)  OR

b.    Documented HCV re-infection following liver transplantation. In this situation, evidence of stage 2 fibrosis is not required.  OR

c.    Documented evidence of serious extra hepatic manifestations of HCV (i.e. symptomatic cryoglobulinemia with membranoproliferative glomerulonephritis, leukocytoclastic vasculitis).  In these situations, evidence of stage 2 fibrosis is not required. OR

d.    Patients with type 2 diabetes or a BMI >35.  In these situations, evidence of stage 2 fibrosis is not required. OR

e.    Patients with nonalcoholic steatohepatitis (NASH) confirmed by a NAFLD score of 5 – 8.  In this situation, evidence of stage 2 fibrosis is not required. OR

f.     Co-infection with HIV or HBV.  In these situations, evidence of stage 2 fibrosis is not required.

7)    Patient is not taking amiodarone concurrently with Sofosbuvir/velpatasvir.

Child Pugh score (A, B, or C) should be provided for all patients.

If a patient completed a previous course of HCV eradication therapy but relapsed, they may be eligible for subsequent re-treatment depending on what is requested and the clinical evidence.  Provider must provide information related to the treatment regimen and duration of therapy before re-treatment may be considered.

If a patient discontinues therapy with a DAA prior to completion of the prescribed therapy duration, they may not be eligible for a second course of treatment.

For patients meeting the above criteria for treatment, Mavyret, Vosevi, and Sofosbuvir/velpatasvir are the exclusive DAA’s approved for therapy subject to the dosing regimens listed below for the different scenarios.

Genotype

CPS

 Cirrhosis

Prev Treatment

Drug/Dosing Regimen

1,2,3,4,5, or 6

A

No

TN

Mavyret x 8 weeks

1,2,3,4,5, or 6

A

Compensated or post transplant

TN

Mavyret x 12 weeks

1

A

No or Compensated

TE-5

Mavyret x 16 weeks

1

A

No or Compensated

TE-3/4

Mavyret x 12 weeks

1,2,4,5, or 6

A

No

TE-PR or TE-SR

Mavyret x 8 weeks

1,2,4,5, or 6

A

Compensated

TE-PR or TE-SR

Mavyret x 12 weeks

3

A

No or Compensated

TE-PR or TE-SR

Mavyret x 16 weeks

1a, 3

A

No or Compensated

TE-S

Vosevi x 12 weeks

1

BorC

N/A

TN or TE

Sofosbuvir/velpatasvir + RBV x 12 weeks

2

BorC

N/A

TN or TE

Sofosbuvir/velpatasvir + RBV x 12 weeks

3

BorC

N/A

TN or TE

Sofosbuvir/velpatasvir + RBV x 12 weeks

4

BorC

N/A

TN or TE

Sofosbuvir/velpatasvir + RBV x 12 weeks

5 or 6

BorC

N/A

TN or TE

Sofosbuvir/velpatasvir + RBV x 12 weeks

CPS = Child Pugh Score (A, B, or C)      

TN = Treatment Naïve   TE-PR = Treatment Experienced w/ PegINF/Ribavirin (RBV)

TE-PI = Treatment Experienced w/ Protease Inhibitor 

TE-5 = previously treated with NS5A inhibitor but not NS3/4A inhibitor

TE-SR = Treatment Experienced w/ Sovaldi/Ribavirin  

TE-3/4 = previously treated with NS3/4 protease inhibitor without prior treatment with an NS5A inhibitor

TE-S = previously treated with Sovaldi without a NS5A inhibitor

Limits

All specialty drugs are limited to a maximum of 30 day supply per fill.

Reference

1.    Epclusa Prescribing Information. Gilead Sciences, Inc. Foster City, CA.  June 2016.

2.    Clinical Pharmacology.  Accessed online November 13, 2017.

3.    AASLD/IDSA/IAS-USA. Recommendations for Testing, Managing, and Treating Hepatitis C. Accessed November 13, 2017 at www.hcvguidelines.org.

4.    American Medical Association. Ethical considerations in the development of clinical practice guidelines H-410.953 https://searchpf.ama-assn.org/SearchML/searchDetails.action?uri=%2FAMADoc%2FHOD.xml-0-3636.xml

5.    Institute of Medicine. Clinical Practice Guidelines We Can Trust. The National Academies Press, Washington, DC 2011  http://nap.edu/13058

6.    Choudry NK, Stelfox HT and Detsky AS. Relationships between Authors of Clinical Practice Guidelines and the Pharmaceutical Industry. JAMA. 2002; 207(5):612-617

7.     Jefferson AA and Pearson SD. Conflict of Interest in Seminal Hepatitis C Virus and Cholesterol Management Guidelines. JAMA Intern Med. 2017; 177(3):352-357.

8.     Lin. Z.-H., Xin, Y.-N., Dong, Q.-J., Wang, Q., Jiang, X.-J., Zhan, S.-H., Sun, Y. and Xuan, S.-Y. Performance of the aspartate aminotransferase-to-platelet ratio index for the staging of hepatitis C-related fibrosis: An updated meta-analysis. Hepatology. 2011; 53: 726–736.

9.    Sox, Harold C. Conflict of interest in Practice Guideline Panels. JAMA. 2017; 317(17):1739-1740.

10.  Tringale KR et al. Types and Distribution of Payments from Industry to Physicians in 2015. JAMA. 2017; 317(17):1774-1784.

11.  Mavyret Prescribing Information. AbbVie, Inc. August 2017.

12.  Vosevi Prescribing Information. Gilead Sciences. July 2017

13. Natural history and management of nonalcoholic fatty liver disease in adults. UpToDate (accessed 04/18/2018).  https://www.uptodate.com/contents/natural-history-and-management-of-nonalcoholic-fatty-liver-disease-in-adults

14. EASL Recommendations on Treatment of Hepatitis C 2016. (accessed 04/08/2018)
http://www.easl.eu/research/our-contributions/clinical-practice-guidelines/detail/easl-recommendations-on-treatment-of-hepatitis-c-2016

15. Guidelines for the screening, care and treatment of persons with chronic hepatitis C infection, Updated version, April 2016.  (accessed 04/18/2018)  http://www.who.int/hepatitis/publications/hepatitis-c-guidelines-2016/en/
Application to Products

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.


Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.