IIVIIEkC>iE!

css:: ;;rn ilo u Budusky To: Nhau An otida Page 2

Independent Medical Expert Consulting Services, Inc. Berke-Weiss Law PLLC | www.berkeweisslaw.com

July 20, 20 IS

RE: IMR/
State ID#:
Case#:
Health Plan: Oxford Health Plan
Denied Health Service or Treatment: Harvoni
Denial Reason: Medical Necessity

Dear

Attached please find the expert reviewer report for your requested external a ppeal review
pursuant to the New York Public Health Law, Article 49.

IMEDECS attests that no prohibited materia] affiliation existed with respect to the clinical peer
reviewer(s).
\

The reviewer has decided to overturn the health plan's decision.

Summary of Expert's Qualifications

Reviewer #
Is a medical doctor (MD) board certified in internal medicine and gastroenterology. Completed
gastroenterology-hepatology fellowship. Maintains a private pra~tice and serves as attending
physician in internal medicine and gastro~nterology at a university affiliated medical center.

If you have any questions, please contact your health plan, Oxford Health Plan. A copy of this
information has also been sent to them.

Sincerely,

Theresa Strassner, RN, BSN,.MHA

Senior Case Review Manager

JES

Cc: Kimberly Day/Oxford Health Plan

Anotida Nhau/NYSDFS

100 West Main Street, Suite 310 Lansdale, PA 19446

Phone: 21 S .855.4633 Fax: 21 S.855.5318
www.lmedecs.com
SilentFax@ IMEDECS Jul 20. 15 13:35 From: Jimilou Budusky To: Nhau Anotida Page 3

Case Number:
Patient Name: Berke-Weiss Law PLLC | www.berkeweisslaw.com
Reviewer Number:
Page 1 of2

Summary:

The patient is a with chronic hepatitis C, genotype 4A, treatment nai"ve, requesting
Harvoni therapy. The previous request was denied due to a lack of advanced fibrosis, and a lack of
genotype one. There is no evidence of liver decompensation and no extrahepatic manifestation.
viral load is 3.9 million international units per ML on , fibrosis stage 0.52 consistent with fibrosis
stage F2, albumin normal, bilirubin normal, transaminases normal, platelets normal, no illicit drug use.
The progress note of describes no prior treatment, avoid alcohol, requesting Harvoni. A
liver biopsy documented stage 2 fibrosis.

Question(s):

1. Has the health plan, in its determination of medical necessity, acted reasonably, with sound medical
judgment and in the best interest of the patient?

The health plan, in its determination of medical necessity, has not acted reasonably, with sound
medical judgment and in the best interest of the patient.

2. Is the requested health service/treatment ofHarvoni medically necessary for this patient?

Yes. A prerequisite advanced fibrosis is not required to initiate therapy. Due to greater than 90%
eradication rates, Harvoni is recommended and appropriate despite a lack of advanced fibrosis. The
AASLD guidelines (American Association for the Study of Liver Diseases) do not require advanced
fibrosis to initiate therapy. In the guidelines section of "When and in Whom to initiate hepatitis C
therapy" treatment is recommended for patients with chronic hepatitis C infection. Although patients
with advanced fibrosis are assigned higher priority, this does not exclude patients with minimal or no
fibrosis from treatment. The AASLD recommends: "Successful hepatitis C treatment results in
sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected
to benefit nearly all chronically infected persons. Evidence clearly supports treatment in all HCV-
infected persons, except those with limited life expectancy (less than 12 months) due to non-liver-
related comorbid conditions. Because of the myriad benefits associated with successful HCV
treatment, clinicians should treat HCV-infected patients with antiviral therapy with the goal of
achieving an SVR, preferably early in the course of their chronic HCV infection before the
development of severe liver disease and other complications."

The AASLD recommends this approach as an effective treatment plan for genotype 4 hepatitis C:
"Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) for 12 weeks is
recommended for treatment-naive patients with HCV genotype 4 infection."

Abdel-Razek summarized the approach to genotype 4 with lcdipasvir (90 mg)/sofosbuvir (400 mg)
leading to high cure rates: "Optimal therapy for patients with hepatitis C virus (HCV) genotype 4
(HCV-4) infection is changing rapidly, and the possibility of a total cure is near. The standard of
care has been combination pegylated interferon (PEG-lFN)-ribavirin (RBV), with modest response
rates and considerable adverse events. Since the introduction of sofosbuvir (SOF), simeprevir (SJM),
Si lentFax @ IMEDECS Jul 20. 15 13:35 From : Jim ilou Bud usky To: Nhau An otida Page 4
Case Number:
Patient Name: Berke-Weiss Law PLLC | www.berkeweisslaw.com
Reviewer Number:
Page 2 of 2

and daclatasvir (DCV), the duration of treatment has been significantly shortened and response rates
have increased. The recommended treatment for IFN-eligible patients is PEG-IFN/RBV plus SOF,
SIM or DCV. In IFN ineligible patients, the optimal regimen is a 24-week course ofSOF/RBV, or a
12-week course of SOF-SIM or SOF-DCV with or without RBV. The pipeline for patients with
chronic HCV is highly active. IFN-free combinations with paritaprevir-ombitasvir, SOF-ledipasvir,
or DCV-asunaprevir (ASV)-beclabuvir (BMS-791325) for 12 weeks or less with close to 100% cure
rates will soon become the optimal therapy."

The SYNERGY trial was an open-label study evaluating 12 weeks ofledipasvir/sofosbuvir in 21

HCV genotype 4-infected patients, of whom 60% were treatment naive and 43% had advanced
fibrosis (Metavir stage F3 or F4). (Kapoor, 2014) In an interim analysis in which 20 patients had
completed a post-treatment week 12 follow-up, SVRl 2 rate was 95% in the intention-to-treat
analysis and I 00% in the per-protocol analysis. Abergel and colleagues reported data from an open-
label single-arm study including 22 HCV genotype 4--infected, treatment-naive patients (only I with
cirrhosis) with an SVR12 rate of95% (21/22).

3. Do you uphold or overturn, in whole or in part, the healrh plan's determination of medical
necessity?

Overturn in whole the health plan's determination of medical necessity.

Reference(s):

l. Optimal therapy in genotype 4 chronic hepatitis C: finally cured? Abdel-Razek W, Waked I.

Liver Int. 2015 Jan;35 Suppl I :27-34

2. AASLD clinical practice guidelines: American Association for the Study of Liver Diseases:
www .aasld.org

3. Kapoor R, Kohli A, Sidharthan Set al. All oral treatment for genotype 4 chronic hepatitis C
infection with sofosbuvir and ledipasvir: interim results from the NIAID SYNERGY trial. [Abstract
240.] 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
November 7-11, 2014; Boston, MA.

4. Abergel A, Loustaud-Ratti V, Metivier S et al. Ledipasvir/sofosbuvir for the treatment of patients

with chronic genotype 4 or 5 HCV infection. 50th Annual Meeting of the European Association for
the Study of the Liver (EASL). April 22-26, 2015; Vienna, Italy.