Criteria for Indiana Medicaid Hepatitis C Agents

Transcription

1 Prepared for State of Indiana by OptumRx EXECUTIVE SUMMARY Purpose: Promote prudent prescribing of Setting & Population: All members Type of Criteria: Increased Risk of ADE Non-Preferred Agent Appropriate Indications Other: Data Sources: Only administrative databases Databases + Prescriber-supplied TARGETED PRODUCTS Drug Name DAKLINZA (DACLATASVIR) EPCLUSA (SOFOSBUVIR/VELPATASVIR) HARVONI (LEDIPASVIR/SOFOSBUVIR) MAVYRET (GLECAPREVIR/PIBRENTASVIR) OLYSIO (SIMEPREVIR) SOVALDI (SOFOSBUVIR) TECHNIVIE (OMBITASVIR/PARITAPREVIR/RITONAVIR) VIEKIRA PAK; VIEKIRA XR (OMBITASVIR/PARITAPREVIR/RITONAVIR/DASABUVIR) VOSEVI (SOFOSBUVIR/VELPATASVIR/VOXILAPREVIR) ZEPATIER (ELBASVIR/GRAZOPREVIR) APPROVAL DURATION Approvals will be granted for up to 12 weeks APPROVAL CRITERIA Prior authorization for the prescribed drug will be granted when the following approval criteria has been met: PA Requirements for initial treatment: Must be 18 years of age ( 12 years of age for Harvoni and Sovaldi) For women of childbearing age, must confirm negative pregnancy test prior to therapy Prescription must be written by or in consultation with an Infectious Disease or GI specialist If request is for DAKLINZA: Page 1

2 Must have a diagnosis of chronic hepatitis C genotype 1 or 3 with >stage 1 fibrosis, co-infection Must confirm concurrent sofosbuvir therapy Must have tried and failed preferred agent(s) or have medical justification for use May receive one 12-week approval only Dosage approved will be 60mg daily (30mg dose and 90mg dose will be considered in instance of drug-drug interaction) If request is for EPCLUSA: Must have a diagnosis of chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6 with >stage 1 fibrosis, coinfection Must have tried and failed preferred agent(s) or have medical justification for use May receive one 12-week approval only Dosage approved will be 400mg-100mg daily If request is for HARVONI: Must have a diagnosis of chronic hepatitis C genotype 1, 4, 5, or 6 with >stage 1 fibrosis, coinfection May receive one 12-week approval only for treatment naïve members or up to 24 weeks (genotype 1 only) for treatment experienced members Must have tried and failed preferred agent(s) or have medical justification for use For re-approvals, must confirm compliance on Harvoni therapy Dosage approved will be mg daily If request is for MAVYRET: Must have a diagnosis of chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6 with >stage 1 fibrosis, coinfection Dosage approved will be 300mg-120mg (3 tablets) daily May receive one of the following approval durations: o May receive one 8-week approval only in the following: Treatment naïve, any genotype, without cirrhosis Genotypes 1, 2, 4, 5, or 6; without cirrhosis; treatment experience with interferon, ribavirin, and/or sofosbuvir; without NS3/4A PI or NS5A inhibitor experience o May receive one 12-week approval only in the following: Treatment naïve patients, any genotype, with compensated cirrhosis (Child-Pugh A) Genotype 1, without cirrhosis or with compensated cirrhosis, treatment experience with an NS3/4A PI, without NS5A inhibitor experience Genotypes 1, 2, 4, 5, or 6; with compensated cirrhosis; treatment experience with interferon, ribavirin, and/or sofosbuvir; without NS3/4A PI or NS5A inhibitor experience o May receive one 16-week approval only in the following: Genotype 1, without cirrhosis or with compensated cirrhosis, treatment experience with NS5A inhibitor, without NS3/4A PI experience Page 2

3 Genotype 3; without cirrhosis or with compensated cirrhosis; treatment experience with interferon, ribavirin, and/or sofosbuvir; without NS3/4A PI or NS5A inhibitor experience If request is for OLYSIO: Must have a diagnosis of chronic hepatic C genotype 1 with >stage 1 fibrosis, co-infection with Must confirm peginterferon alfa and ribavirin or Sovaldi will be used concurrently with Olysio Dosage approved will be 150 mg daily May receive one 12-week approval only Patients with a history of Victrelis or Incivek therapy will be denied If request is for SOVALDI: Must have a diagnosis of chronic hepatitis C genotypes 1, 2, 3, or 4 with >stage 1 fibrosis, coinfection with HIV or AIDS, post liver transplant, other comorbidity associated with rapid, or hepatocellular carcinoma that meets criteria for liver transplant Must confirm concurrent peginterferon alfa and ribavirin, ribavirin therapy, Daklinza, or Olysio therapy For re-approvals, must confirm compliance on Sovaldi and ribavirin combination therapy Must have tried and failed preferred agent(s) or have medical justification for use Dosage approved will be 400mg daily May receive up to 12 weeks of therapy for triple therapy with Sovaldi, ribavirin, and peginterferon alfa, dual therapy with Sovaldi and Olysio or Sovaldi and Daklinza; up to 24 weeks for dual therapy with Sovaldi and ribavirin, or up to 48 weeks with Sovaldi and ribavirin for members with hepatocellular carcinoma that meet criteria for liver transplant If request is for TECHNIVIE: Must have a diagnosis of chronic hepatitis C genotype 4 with >stage 1 fibrosis, co-infection with Must not have moderate to severe hepatic disease (Child-Pugh Class B and C) Must confirm concurrent ribavirin therapy (contraindications or intolerance to ribavirin therapy will be assessed at the call center) Must have tried and failed preferred agent(s) or have medical justification for use May receive one 12-week approval only Dosage approved will be two mg tablets daily If request is for VIEKIRA/VIEKIRA XR: Must have a diagnosis of chronic hepatitis C genotype 1 with >stage 1 fibrosis, co-infection with Must not have moderate to severe hepatic disease (Child-Pugh Class B and C) Must have tried and failed preferred agent(s) or have medical justification for use May receive one 12-week approval only for treatment naïve members or up to 24 weeks for treatment experienced members, genotype 1a with compensated cirrhosis, or liver transplant recipients For re-approvals, must confirm compliance of Viekira with ribavirin therapy Dosage approved will be 1 PAK every 28 days Page 3

4 If request is for VOSEVI: Must have a diagnosis of chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6 with >stage 1 fibrosis, coinfection WITH prior treatment failure with an HCV regimen containing an NS5A inhibitor, OR genotypes 1a or 3 WITH prior treatment failure with an HCV regimen containing sofosbuvir without an NS5A inhibitor. Dosage approved will be one mg tablet daily Must meet relapse/re-infection criteria If request is for ZEPATIER: Must have a diagnosis of chronic hepatitis C genotype 1 or 4 with >stage 1 fibrosis, co-infection Must not have moderate to severe hepatic disease (Child-Pugh Class B and C) May receive one 12-week approval only or up to 16 weeks for members with baseline NS5A polymorphisms in genotype 1a or treatment experienced individuals in genotype 4 For re-approvals, must confirm compliance of Zepatier with/without ribavirin therapy Dosage approved will be one 50/100mg tablet daily PA Requirements for Relapse and Re-infection: Must be 18 years of age For women of childbearing age, must confirm negative pregnancy test prior to therapy Prescription must be written by or in consultation with an Infectious Disease or GI specialist Duration of approval will be up to 24 weeks Must confirm member was compliant with therapy o Non-compliance due to intolerance of drug therapy will be approved if new regimen does not contain therapy that produced intolerance o Non-compliance will be further reviewed through medical review Must have a diagnosis of chronic hepatitis C with >stage 3 fibrosis (regimen approved will be dependent on genotype per initial treatment criteria) Must be first request for re-treatment Prescriber and member must provide documentation regarding rationale and methodology to ensure compliance with therapy If request for retreatment is due to relapse (member was not previously cured/did not re-introduce virus): Must confirm that therapy requested is different than initial therapy Must submit completed MedWatch form to FDA documenting treatment failure (and provide copy of form with PA submission) If request for retreatment is due to re-infection (member was previously cured and virus was reintroduced): Must have a diagnosis of chronic hepatitis C with >stage 3 fibrosis (regimen approved will be dependent on genotype per initial treatment criteria) Re-infection due to illicit drug use will be subject to medical review o Prescriber documentation required that member has been sober for at least 1 year and provide continued treatment plan Re-infection through sexual intercourse will be subject to medical review Page 4

5 o Prescriber must provide documentation regarding the member s sexual habits and prevention mechanisms to prevent further re-infection Re-infection through organ transplant or blood transfusion o Prescriber must provide documentation of transplant/transfusion Re-infection due to other circumstances will be subject to medical review o Prescriber must provide detailed documentation regarding other method of re-infection and future prevention Existing Criteria Revision of Existing Criteria New Criteria Page 5