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Berke-Weiss Law PLLC | www.berkeweisslaw.com

Corporate Programs Department ISO

1979 Marcus Avenue

Lake Success, NY 11042-1002 9001 :2008
www.ipro.org CERTIFIED

Phone: (516) 326-7767, ext. 411

Improving He.lithe"' Fax: (516) 326-1034
f or the Common Good

September 2, 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 Viekira Pak 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 8/4/15. The review was conducted on 9/1/15. A decision was
rendered 9/2/15.

Documentation submitted for review included:

Letter from Charin Baum-Martinez, New York State Department of Financial Services to T . Giorgio,
IPRO dated 8/4/15
Letter from Charin Baum-Martinez, New York State Department of Financial Services to Kimberly
Day, Oxford Health Plans of New York dated 8/4/15
New York State External Appeal Application filed by undated
Patient Consent for the Release of Records for NYS External Appeal Application signed by

Letter from Robert F, Resolving Analyst, United Healthcare Oxford to dated 6/24/15
Letter from Optum Rx, United Healthcare Oxford to dated 5/31/15
Letter from Optum Rx, United Healthcare Oxford to dated 5/31/15
Letter from Leonard Serebro, MD, United Healthcare Oxford to dated 7n/15
Letter from Re: dated 6/17/15
Letter from Margaret Williams, Regulatory Affairs Analyst/External Agent, United Healthcare Oxford
to T. Giorgio, IPRO dated 8/9/15
Email from to Barbara Prescott dated 8/3/15
Email from Barbara Prescott to dated 8/3/15
Letter from Sherri Cohmer. United Healthcare Oxford to dated 1/10/15
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Berke-Weiss Law PLLC | www.berkeweisslaw.com

-
September 2, 2015

I Page 2

"Initial Treatment of HCV Infection." American Association for the Study of Liver Diseases and
Infectious Diseases Society of America
"Recommendations for Testing, Managing, and Treating Hepatitis C." American Association for the
Study of Liver Diseases and Infectious Diseases Society of America
"Retreatment of Persons in Whom Prior Therapy has Failed." American Association for the Study of
Liver Diseases and Infectious Diseases Society of America
Optum Prior Authorization Request Form
Liberty .H MO Schedule of Benefits Gold Plan
United Healthcare Oxford Clinical Policy, Drug Coverage Guidelines
United Healthcare Pharmacy, Clinical Appeals Response Form
Medical Records from for

The basis for this determination is as follows:

Issue:

According to the a letter of medical necessity dated 06/17/2015 from

Hepatology this is a patient with hepatitis C genotype 1b. The patient
Is noted to have failed treatment with Pegasys 180 mcq. and Rlbavirin 1200mg/day. Lab results
dated reveal a Fibrosis stage of F3 and a hepatitis C quantification of 1,562,270
IU/ml. Drug profile results from were noted to be negative for all substances tested
including Amphetamines, Barbiturates, Benzodiazepines, Cannabinoid, Cocaine, Opiates,
Phencyclidine, Methadone and Propoxyphene.

The insurer has denied coverage for the medication Viekira Pak. In their Letter of Final Adverse
Determination dated 06/24/2015, they note the patient is using this drug for chronic hepatitis C
genotype 1 b. They state they require evidence the patient has tried and failed, or could not
tolerate the preferred alternative drugs that treat the condition, Harvoni. They state evidence of
trial and failure of the alternative drug was not provided.

are appealing on behalf of the patient. In a letter

of medical necessity dated 06/17/2015, , states the use
of Viekira Pak and Rlbavirin is applicable to the patient as has failed treatment with
Pegasys 180 mcq and Rlbivirin 1200 mg/day and relapsed one month after stopping treatment.
states treatment with Viekira Pak and Ribavirin for 12 weeks is nec~ssary therapy for the
patient's medical condition, as it prevents disease progression to cirrhosis, hepatocellular
carcinoma or even liver failure. states the regimen is not only Food and Drug
Administration (FDA) approved, it is consistent with the joint recommendations of the American
Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of
America (IDSA), which have become the gold standard of treatment for persons with hepatitis C
virus.

Reviewer Findings:

The patient has Hepatitis C genotype 1 B. failed treatment with interferon and ribavirin. The
viral load is elevated and the fibrosis stage is F3.
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Berke-Weiss Law PLLC | www.berkeweisslaw.com

. September 2, 2015

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
Page3

position that evidence clearly supports treatment in all HCV infected persons except those with
a limited life expectancy. The papers that were submitted for this patient list the
recommendations for genotype 1 in patients who previously received interferon and ribavirin.
The first recommendation is for Harvoni. However, other recommendations include Viekira Pak
or the regimen of sofosbuvir and simeprevir.

A letter was submitted from stating that Vlekira Pak Is FDA approved and is
consistent with AASLD and IDSA guidelines. Both of these statements are true and this patient
does require treatment. The proposed treatment Is recommended by AASLD and IDSA and this
treatment would meet the AASLD and IDSA guidelines. Therefore, the denial is reversed. This
treatment is medically necessary.

Based on the above, the medical necessity for Viekira Pak is substantiated. The insurer's denial
is reversed.

Reference:

1- The American Association for the Study of Liver Diseases and Infectious Diseases
Society of America Guidelines for the Treatment of Hepatitis C.

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,

Monty M. Bodenheimer, MD
Medical Director, Health Care Assessment
MMB: jt

cc: Charin Baum-Martinez, New York State Department of Financial Services

Kimberly Day, Oxford Health Plans- NY