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To: FaxServer Frot1: IPRO Fax : 516-328-2310 OCT-08-2015-13: 15 Page: 003 of 005

Berke-Weiss Law PLLC | www.berkeweisslaw.com

.
Corporate Programs Department ISO
1979 Marcus Avenue


Lake Success, NY 11042-1002 9001:2008

I www.ipro.org CERTIFIED

Phone : (516) 326-7767, ext. 41 1


lmproYing Healthcare Fax: (516) 326-1034
fOf the Common Good

October 8, 2015

Re: External Appeal Application-


Reference:

Dear :

IPRO has completed review of all documentation submitted relative to your request for external appeal
on behalf of and has determined that the decision of Oxford Health Plans- NY to
deny coverage for Harvoni should be reversed.

Review of this appeal was conducted by a physician reviewer, who is Board Certified in Internal
Medicine and Gastroenterology. This reviewer is licensed in New York, and is on staff at two medical
centers. This reviewer also has a faculty appointment at a college of medicine. Professional
organization affiliations include the American Society of Gastroenterologic Endoscopy and American
College of Gastroenterology. IPRO has screened this clinical reviewer for any prohibited material
affiliation and has determined that none exists. IPRO has no organizational conflict of interest in the
review of this appeal.

The case was received by IPRO on 9/10/15. The review was conducted on 10/7/ 15. A decision was
rendered 10/8/15.

Documentation submitted for review included:

Letter from Nina Doss. New York State Department of Financial Serv ices to T . Giorgio, IPRO dated
9/ 10/15
Letter from Nina Doss, New York State Department of Financial Services to dated
9/10/15
Letter from Nina Doss, New York State Department of Financial Services to Abby Seay, Appeals
and Grievances, Oxford Health Plans of New York dated 9/10/15
New York State External Appeal Application filed by for
undated
Patient Consent for the Release of Records for NYS External Appeal Application signed by
dated 8/28/15
Letter from Robert F, Resolving Analyst, United Healthcare Oxford to dated
8/ 14/15
Letter from Optum Rx, United Healthcare Oxford to dated 7/28/15
Letter from to Whom It May
Concern dated 8/4/15
Letter from Andrea Terdik, Regulatory Affairs Analyst/External Agent, United Healthcare Oxford to
T. Giorgio, IPRO dated 9/15/15
Letter from to dated 12/17/14
To: FaxServer Fro.: IPRO Fax : 516-328-2310 OCT- 08-2015-13: 15 Page:004 of 005

Berke-Weiss Law PLLC | www.berkeweisslaw.com

October 8, 2015


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Page 2

Letter from Sherri Cohmer, United Healthcare Oxford to dated 11/2/14


Consultation Notes from Re:
undated
United Healthcare Oxford Clinical Policy. Drug Coverage Guidelines
United Healthcare Oxford Clinical Policy. Drug Coverage Criteria - New and Therapeutic Equivalent
Medications
United Healthcare Clinical Pharmacy Programs
United Healthcare Clinical Appeals Response Form
Afdhal et al., "Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection." New
England Journal of Medicine. April 17, 2014
Medical Records for

The basis for this determination is as follows:

Issue:

According to a letter dated 8/4/15 from , this is a who


was being followed by in the Division of Hepatology. The provider indicated
that the patient had Hepatitis C, genotype 1a, and was status post incomplete treatment to triple
therapy due to neutropenic side effects prior to boceprevir lead treatment that was discontinued
at week 4 due to severe side effects as well. The patient had elevated liver function enzymes
where elastography of the liver was performed that showed F1-F2 disease. The provider
indicated that wanted the patient to be treated because did not want the fibrosis to
progress to stage 3 or 4.

Lab tests included for review revealed a Hepatitis C RNA Detection by PCR level of 939910.

The insurer has denied coverage for Harvoni. They stated in a final adverse determination letter
dated 8/14/15 that the plan would approve coverage for this medicine in the patient had stage 3
or 4 liver fibrosis. The insurer added that this must be documented by testing. They explained
that the patient might also be covered if there were serious complications of Hepatitis C virus
outside of the patient's liver, or have Human Immunodeficiency Virus infection. The insurer
maintained that since the patient did not have this, Harvoni was not considered to be medically
necessary in the patient's case.

is appealing.

stated in her appeal letter of 8/4/15 that questioned the insurer's


denial for the requested medication because the patient did not have advanced fibrosis. The
provider maintained that this should not be the reason for not treating the patient who had
stage 2 fibrosis. explained that the patient could be cured of Hepatitis C so could
avoid future complications of advanced diseases.
To: FaxServer FrOII: IPRO Fax : 516-328-2310 OCT- 08-2015-13: 15 Page:005 of 005

Berke-Weiss Law PLLC | www.berkeweisslaw.com

October 8, 2015


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Page 3

Reviewer Findings:

The patient has chronic Hepatitis C genotype 1a. had previous treatment with boceprevir but
needed to stop it due to neutropenia. has elevated liver enzymes and has a fibrosis stage of
F1-F2. The viral load is elevated.

The American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases
Society of America (IDSA) have issued guidelines for the treatment of Hepatitis C. It is their
position that evidence clearly supports treatment in all HCV-infected persons except those with
a limited life expectancy due to non-liver related co-morbid conditions. For those patients who
previously failed a protease inhibitor, there are two recommendations for genotype 1 without
cirrhosis. One option is Daclatasvir and sofosbuvir. Another recommended regimen is Harvoni
with or without ribavirin.

This patient has chronic Hepatitis C. The AASLD and IDSA guidelines do not require that a
patient have cirrhosis in order to be treated. In the ION-2 trial 440 treatments experienced
patients received Harvoni with a 94-96% Sustained Virologic Response (SVR) rate. There is no
reason to wait for the patient to develop either cirrhosis or hepatocellular carcinoma. Harvoni is
recommended by the AASLD and IDSA for genotype 1 and is appropriate therapy.

The denial is reversed.


oc:1::.,1::u u11 "'11: auuv"', unr 111'l:lu1\ia1 1111:\i11:::.,::.,11y 1u1 na1vu111 1::., ::.,uu::.,1.e111"0,1::u . 1111;: 111::.,u1t=1::., ut=111c:u 1::.
reversed.

Reference:

1- American Association for the Study of Liver Diseases and Infectious Diseases Society of
America, HCV Guidance, Recommendations for Testing, Managing and Treating Hepatitis
c, 2015.
Should you have any questions in regard to this review determination, please do not hesitate to contact
me or Terese Giorgio at (516) 209-5411, fax number 516 326-1034.

Sincerely,

L~.4~M7'.
Frank E. laquinta, MD
Medical Consultant
FEI: jt

cc: Nina Doss, New York State Department of Financia l Services


Abby Seay, Oxford Health Plans- NY

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