Harvoni Case Studies

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A review of the records reveals the member to be an adult female with a birth date of 02/13/1959. The member has a diagnosis of Chronic Hepatitis C, genotype 1 B compensated Liver Disease. The member’s treating provider, Brett Neustater, MD recommended the member be treated with Harvoni 90/400 mg tablets one po qd X 12 weeks.

The carrier has denied coverage of Harvoni 90/400 mg tablets one po qd X 12 weeks as not medically necessary. There is a letter from the carrier to the member dated 01/18/2016, which states in part:

“The specific reason for this denial of your appeal for Harvoni is that coverage guidelines have not been met based on AvMed’s Medical Department Procedure 07.171, ‘sofosbuvir /Ledipasvir (Harvoni®)’ and the manufacturer's …show more content…

In a long-term follow-up study, 820 patients with Metavir stage F0 or F1 fibrosis confirmed by biopsy were followed for up to 20 years. The 15-year survival rate was statistically significantly better for those who experienced an SVR than for those whose treatment had failed or for those who remained untreated (93%, 82%, and 88%, respectively; P =.003). The study argues for consideration of earlier initiation of treatment (Jezequel, 2015). Several other modeling studies suggest a greater mortality benefit if treatment is initiated at stages prior to F3. (Øvrehus, 2015); (Zahnd, 2015); (McCombs, …show more content…

(Foster, 1998) The presence and severity of fatigue appears to correlate poorly with disease activity, although it may be more common and severe in HCV-infected individuals with cirrhosis. (Poynard, 2002a) Despite difficulties in separating fatigue symptoms associated with hepatitis C from those associated with other concurrent conditions (eg, anemia, depression), numerous studies have reported a reduction in fatigue after cure of HCV. (Bonkovsky, 2007) In the Virahep-C study, 401 HCV patients were evaluated for fatigue prior to treatment and after therapy using validated scales assessing presence and severity of fatigue. (Sarkar, 2012) At baseline, 52% of patients reported having fatigue, which was more frequent and severe in patients with cirrhosis than in those without cirrhosis. Achieving an SVR was associated with a substantial decrease in frequency and severity of fatigue. A recent analysis of 413 patients who achieved an SVR12 from the NEUTRINO and FUSION trials treated with a sofosbuvir-containing regimen demonstrated improvement in patient fatigue (present in 12%) from the pretreatment level. (Younossi, 2014) After achieving an SVR12, participants had marked improvement in fatigue over their pretreatment scores using 3 separate validated

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