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Harvoni Criteria Anthem/Express Scripts
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Download the PDF here
10/15/2014
Here is Anthem/Express Scripts Criteria (Prior Authorization) for Harvoni:
http://www.anthem.com/provider/noapplication/f0/s0/t0/pw_e225443.pdf?na
Prior Authorization of Benefits
Individual is considered at highest risk for severe hepatitis C-related complications
(AASLD/IDSA 2014):
a. Advanced fibrosis as documented by one of the following:
1. Liver biopsy-proven fibrosis staging score of F3 or F4 on the IASL,
Batts-Ludwig,
or Metavir fibrosis staging scales2,3;
OR
b. Liver transplant recipient; OR
c. Type 2 or 3 essential cryoglobulinemia with end-organ manifestations (for example,
vasculitis); OR
d. Glomerular disease [proteinuria (greater than 300 mg/day), nephrotic syndrome, or
membranoproliferative glomerulonephritis];
AND
VII. Individual meets one of the following:
a. Individual is not actively abusing illicit drugs and/or alcohol; OR
b. Individual is receiving concurrent treatment to facilitate cessation of drug and/or
alcohol abuse (AASLD/IDSA 2014).
Harvoni (sofosbuvir/ledipasvir) may not be approved for the following:
I. Individual has severe renal impairment (CrCl less than 30 mL/min), end stage renal
disease, or requires dialysis (AASLD/IDSA 2014); OR
II. Individual is using in combination with another nucleotide NS5B polymerase inhibitor
[such as Sovaldi (sofosbuvir)]; OR
III. Individual is using in combination with another NS5A inhibitor; OR
IV. Individual is requesting the regimen for re-treatment and either failed to achieve a SVR
(defined as a lower limit HCV RNA of 25 IU/mL) or relapsed after achieving a SVR during
a prior successfully completed treatment regimen consisting of sofosbuvir; OR
V. Individual is requesting the regimen for re-treatment and either failed to achieve a SVR
(defined as a lower limit HCV RNA of 25 IU/mL) or relapsed after achieving a SVR during
a prior successfully completed treatment regimen consisting of ledipasvir.
According to the American Association for the Study of Liver Diseases/Infectious Diseases Society of America (AASLD/IDSA 2014), it may be advisable, in many instances, to delay treatment for some individuals with documented early fibrosis stage (F 0-2). In these instances, waiting for future highly effective, pangenotypic, direct-acting antiviral agent combinations in interferon-free regimens may be prudent.
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