Pegasys Ribavirin

Size: px
Start display at page:

Download "Pegasys Ribavirin"

Transcription

1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subsection: Anti-infective Agents Original Policy Date: January 1, 2006 Subject: Pegasys Ribavirin Page: 1 of 6 Last Review Date: March 18, 2016 Pegasys Ribavirin Description Pegasys (peginterferon alfa-2a) with Ribavirin (Copegus, Moderiba, Rebetol, RibaPak, Ribasphere, RibaTab, ribavirin tablets/capsules - all strengths) Background Hepatitis C is a viral disease caused by the hepatitis C virus (HCV) that leads to inflammation of the liver. Most people who were recently infected with hepatitis C do not have symptoms, but most people infected with hepatitis C develop a chronic infection. Untreated, chronic infection can lead to liver cirrhosis and/or liver cancer. Six genotypes of the hepatitis C virus exist and genotyping is essential to effective treatment. Hepatitis C infection may be detected in the blood by the HCV RNA assay. Disease status may be monitored by assays of biochemical liver tests or liver biopsy (1). The goals of HCV treatment are to remove the virus from the blood and reduce the risk of cirrhosis and liver cancer that can result from long-term HCV infection. The most common treatment regimens are based on combinations of pegylated interferon alfa, ribavirin, and a protease inhibitor (1). Regulatory Status FDA-approved indications: Pegasys is an antiviral indicated for the treatment of chronic hepatitis C (CHC) in patients 5 years of age and older with compensated liver disease. Pegasys monotherapy is indicated for CHC only if patient has contraindication to or significant intolerance to other HCV antiviral drugs (2).

2 Subject: Pegasys Ribavirin Page: 2 of 6 Limitations of Use: Pegasys alone or in combination with ribavirin without additional HCV antiviral drugs is not recommended for treatment of patients with CHC who previously failed therapy with an interferon-alfa. Pegasys is not recommended for treatment of patients with CHC who have had solid organ transplantation (2). If Pegasys is administered with other antiviral agents, the contraindications to those agents also apply to the combination regimen (2). Ribavirin may cause birth defects and fetal death: avoid pregnancy in female patients and female partners of male patients (3,4). Related policies Intron A, PegIntron Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Pegasys with ribavirin may be considered medically necessary for the treatment of chronic hepatitis C in patients age 5 years and older with a detectable viral load in the serum; compensated liver disease; viral genotype must be provided and if genotype 1 must not be an appropriate candidate for treatment with a protease inhibitor; without renal failure if age 5 to 17; without pregnancy or a partner who is pregnant; and with instruction to practice effective contraception during therapy and for six months after stopping ribavirin therapy. A viral load will be required to be drawn at treatment week 24 if not coinfected with HIV to determine if continuation of treatment is medically necessary. Pegasys with ribavirin is considered investigational for patients below 5 years of age and for all other indications. Prior-Approval Requirements Age 5 years of age or older Diagnosis

3 Subject: Pegasys Ribavirin Page: 3 of 6 Patient must have the following: 1. Chronic hepatitis C AND ALL of the following: a. Detectable viral load in the serum b. Compensated liver disease c. Viral genotype must be provided and if genotype 1 must NOT be an appropriate candidate for treatment with a protease inhibitor d. NOT diagnosed with renal failure if age 5 to 17 e. Neither the patient nor the partner of the patient is pregnant f. Will be instructed to practice effective contraception during therapy and for 6 months after stopping ribavirin therapy if either the patient or their partner are of child bearing age g. Viral load will be drawn at treatment week 24 if not coinfected with HIV Prior Approval Renewal Requirements Diagnosis Patient must have ALL of the following: 1. UNDETECTABLE hepatitis C viral load after initial 24 weeks of therapy 2. Genotype 1, 4, 5 or 6 3. NOT already treated for 12 months (HIV co-infected) OR ONE of the following: 1. History of null or partial response to previous (non-protease inhibitor) treatment 2. Presence of cirrhosis Policy Guidelines Pre - PA Allowance None Prior - Approval Limits Duration 7 months if NOT co-infected with HIV (all genotypes) 12 months if co-infected with HIV (all genotypes)

4 Subject: Pegasys Ribavirin Page: 4 of 6 Prior - Approval Renewal Limits Duration 5 months (if age 5 to 17) 12 months (if age 18 or older) Rationale Summary Hepatitis C is a viral disease caused by the hepatitis C virus (HCV) that leads to inflammation of the liver. Untreated, chronic infection can lead to liver cirrhosis and/or liver cancer. The most common treatment regimens are based on combinations of pegylated interferon alfa, ribavirin, and a protease inhibitor (1). Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Pegasys with ribavirin while maintaining optimal therapeutic outcomes. References 1. Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009; 49(4): Pegasys [package insert]. South San Francisco, CA: Genentech USA, Inc; March Copegus [package insert]. South San Francisco, CA. Genentech USA, Inc. August Ribasphere tablets [package insert]. Warrendale, PA: Three Rivers Pharmaceuticals, LLC; August Policy History Date January 2006 November 2007 July 2009 Action Criteria updated to reflect a process change to allow patients on Hepatitis C Combination Therapy to switch between ribavirin products during their authorization period without needing a new prior authorization record being set. Criteria updated to include criteria for renewal. Requirement that patients have not been previously unsuccessfully treated with pegylated interferon and ribavirin deleted. Criteria updated to remove Roferon A, which was discontinued by manufacturer.

5 Subject: Pegasys Ribavirin Page: 5 of 6 September 2011 September 2012 March 2014 December 2014 March 2015 March 2016 Criteria rewritten to follow current practice guidelines and package inserts, with genotype requirements, as follows: Patients with genotype 1, 4, 5 or 6 should be ideally treated for a full 48 weeks of therapy with peginterferon plus ribavirin. However, for genotypes 1, 4, 5 or 6 therapy should be discontinued if the patient has failed to achieve an undetectable viral load after 24 weeks of therapy. If the viral load remains detectable at 24 weeks of therapy it is unlikely the patient will respond to additional treatment and therapy should be stopped. Three important revisions have been to the Pegasys package insert as follows:first, FDA has approved the combination of Pegasys and Copegus for the treatment of chronic hepatitis C virus infection in pediatric patients 5 through 17 years of age. The criteria were changed to match the package insert: patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha (3). Second, guidelines for patients with renal impairment were revised. Adult patients ages 18 and older with renal impairment may now be treated with appropriate renal monitoring and dose reductions. No data is available for pediatric patients (ages 5-17) with renal impairment; therefore, renal impairment will remain in the criteria as a contraindication for members ages 5 through 17 (2). And the third change: studies identified a negative impact on growth in pediatric patients treated with Pegasys plus ribavirin. Retreatment of pediatric patients has not been studied beyond 48 weeks. For these two reasons, treatment of patients age 5 through 17 will not be covered beyond 12 months of therapy (2). Annual editorial and reference update Annual editorial and reference update Limitations of use added to Regulatory Status section Annual editorial and reference update. Addition of Moderiba Annual editorial review and reference update Annual editorial review and reference update Policy number changed from to Keywords

6 Subject: Pegasys Ribavirin Page: 6 of 6 This policy was approved by the FEP Pharmacy and Medical Policy Committee on March 18, 2016 and is effective April 1, Deborah M. Smith, MD, MPH

Infergen (interferon alfacon-1) with Ribavirin (Copegus, Rebetol, RibaPak, Ribasphere, RibaTab, ribavirin tablets/capsules - all strengths)

Infergen (interferon alfacon-1) with Ribavirin (Copegus, Rebetol, RibaPak, Ribasphere, RibaTab, ribavirin tablets/capsules - all strengths) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.03.04 Subject: Infergen with Ribavirin Page: 1 of 8 Last Review Date: March 13, 2014 Infergen with Ribavirin

More information

Pegasys Pegintron Ribavirin

Pegasys Pegintron Ribavirin Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.47 Subsection: Anti-infective nts Original Policy Date: January 1, 2019 Subject: Pegasys Pegintron

More information

Intron A (interferon alfa-2b) with ribavirin, (Copegus, Moderiba, Rebetol, Ribapak, Ribasphere, RibaTab, ribavirin tablets/capsules - all strengths)

Intron A (interferon alfa-2b) with ribavirin, (Copegus, Moderiba, Rebetol, Ribapak, Ribasphere, RibaTab, ribavirin tablets/capsules - all strengths) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Intron A Ribavirin Page: 1 of 5 Last Review Date: November 30, 2018 Intron A Ribavirin Description

More information

Olysio Pegasys Ribavirin

Olysio Pegasys Ribavirin Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.28 Subject: Olysio Pegasys Ribavirin Page: 1 of 7 Last Review Date: March 18, 2016 Olysio Pegasys

More information

Infergen Monotherapy. Infergen (interferon alfacon-1) Description

Infergen Monotherapy. Infergen (interferon alfacon-1) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.03.03 Subject: Infergen Monotherapy Page: 1 of 7 Last Review Date: March 13, 2014 Infergen Monotherapy

More information

Olysio PegIntron Ribavirin

Olysio PegIntron Ribavirin Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.27 Subject: Olysio PegIntron Ribavirin Page: 1 of 7 Last Review Date: March 18, 2016 Olysio PegIntron

More information

Olysio Pegasys Ribavirin

Olysio Pegasys Ribavirin Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.28 Subject: Olysio Pegasys Ribavirin Page: 1 of 8 Last Review Date: December 18, 2017 Olysio Pegasys

More information

Intron A (interferon alfa-2b) with ribavirin, (Moderiba, Rebetol, Ribasphere, RibaTab, ribavirin tablets/capsules - all strengths)

Intron A (interferon alfa-2b) with ribavirin, (Moderiba, Rebetol, Ribasphere, RibaTab, ribavirin tablets/capsules - all strengths) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.06 Subject: Intron A Ribavirin Page: 1 of 6 Last Review Date: March 18, 2016 Intron A Ribavirin Description

More information

Sovaldi (sofosbuvir) with Pegasys (peginterferon alfa-2a) and Ribavirin (Copegus, Moderiba, Rebetol, RibaPak, Ribasphere, RibaTab, ribavirin)

Sovaldi (sofosbuvir) with Pegasys (peginterferon alfa-2a) and Ribavirin (Copegus, Moderiba, Rebetol, RibaPak, Ribasphere, RibaTab, ribavirin) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.25 Subject: Sovaldi Pegasys Ribavirin Page: 1 of 6 Last Review Date: December 8, 2017 Sovaldi Pegasys

More information

Sovaldi (sofosbuvir) with PegIntron (peginterferon alfa-2b) and Ribavirin (Copegus, Moderiba, Rebetol, RibaPak, Ribasphere, RibaTab, ribavirin)

Sovaldi (sofosbuvir) with PegIntron (peginterferon alfa-2b) and Ribavirin (Copegus, Moderiba, Rebetol, RibaPak, Ribasphere, RibaTab, ribavirin) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.24 Subject: Sovaldi PegIntron Ribavirin Page: 1 of 6 Last Review Date: November 30, 2018 Sovaldi PegIntron

More information

Sovaldi Ribavirin. Sovaldi (sofosbuvir) with Ribavirin (Copegus, Moderiba, Rebetol, RibaPak, Ribasphere, RibaTab, ribavirin) Description

Sovaldi Ribavirin. Sovaldi (sofosbuvir) with Ribavirin (Copegus, Moderiba, Rebetol, RibaPak, Ribasphere, RibaTab, ribavirin) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Sovaldi Ribavirin Page: 1 of 7 Last Review Date: December 3, 2015 Sovaldi Ribavirin Description

More information

Intron A Hepatitis C. Intron A (interferon alfa-2b) Description

Intron A Hepatitis C. Intron A (interferon alfa-2b) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.05 Subject: Intron A Hepatitis C Page: 1 of 5 Last Review Date: November 30, 2018 Intron A Hepatitis

More information

Technivie. Technivie (ombitasvir, paritaprevir, ritonavir) and Ribavirin. Description

Technivie. Technivie (ombitasvir, paritaprevir, ritonavir) and Ribavirin. Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Technivie Page: 1 of 6 Last Review Date: March 18, 2016 Technivie Description Technivie (ombitasvir,

More information

SECTION 1: OLYSIO with (PEGASYS) AND RIBAVIRIN SECTION 2: OLYSIO with (PEGINTRON) AND RIBAVIRIN RATIONALE FOR INCLUSION IN PA PROGRAM

SECTION 1: OLYSIO with (PEGASYS) AND RIBAVIRIN SECTION 2: OLYSIO with (PEGINTRON) AND RIBAVIRIN RATIONALE FOR INCLUSION IN PA PROGRAM SECTION 1: OLYSIO with (PEGASYS) AND RIBAVIRIN SECTION 2: OLYSIO with (PEGINTRON) AND RIBAVIRIN RATIONALE FOR INCLUSION IN PA PROGRAM SECTION 1: OLYSIO with (PEGASYS) AND RIBAVIRIN Background Hepatitis

More information

Zepatier. Zepatier (elbasvir, grazoprevir) and Ribavirin. Description

Zepatier. Zepatier (elbasvir, grazoprevir) and Ribavirin. Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Zepatier Page: 1 of 6 Last Review Date: March 18, 2016 Zepatier Description Zepatier (elbasvir,

More information

Daklinza Sovaldi. Daklinza (daclatasvir) and Sovaldi (sofosbuvir) Description

Daklinza Sovaldi. Daklinza (daclatasvir) and Sovaldi (sofosbuvir) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Daklinza Sovaldi Page: 1 of 7 Last Review Date: June 24, 2016 Daklinza Sovaldi Description Daklinza

More information

Technivie. Technivie (ombitasvir, paritaprevir, ritonavir) and Ribavirin. Description

Technivie. Technivie (ombitasvir, paritaprevir, ritonavir) and Ribavirin. Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.37 Subject: Technivie Page: 1 of 6 Last Review Date: December 8, 2017 Technivie Description Technivie

More information

Zepatier is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to potential toxicity (1).

Zepatier is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to potential toxicity (1). Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Zepatier Page: 1 of 6 Last Review Date: June 24, 2016 Zepatier Description Zepatier (elbasvir,

More information

Intron A Hepatitis B. Intron A (interferon alfa-2b) Description

Intron A Hepatitis B. Intron A (interferon alfa-2b) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.01 Subject: Intron A Hepatitis B Page: 1 of 7 Last Review Date: November 30, 2018 Intron A Hepatitis

More information

Daklinza Sovaldi. Daklinza (daclatasvir) and Sovaldi (sofosbuvir) Description

Daklinza Sovaldi. Daklinza (daclatasvir) and Sovaldi (sofosbuvir) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.36 Subject: Daklinza Page: 1 of 8 Last Review Date: March 18, 2016 Daklinza Description Daklinza (daclatasvir)

More information

PEGINTRON (peginterferon alfa-2b) SECTION 1: Pegintron - Hepatitis C Monotherapy

PEGINTRON (peginterferon alfa-2b) SECTION 1: Pegintron - Hepatitis C Monotherapy SECTION 1: Hepatitis C Pegintron SECTION 2: Hepatitis C Pegintron & Ribavirin SECTION 3: Hepatitis C Pegintron, Ribavirin, & Sovaldi SECTION 4: Hepatitis C Pegintron, Ribavirin, & Olysio SECTION 1: Pegintron

More information

Harvoni. Harvoni (ledipasvir & sofosbuvir) Description

Harvoni. Harvoni (ledipasvir & sofosbuvir) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Harvoni Page: 1 of 7 Last Review Date: June 19, 2015 Harvoni Description Harvoni (ledipasvir &

More information

Daklinza Sovaldi. Daklinza (daclatasvir) and Sovaldi (sofosbuvir) Description

Daklinza Sovaldi. Daklinza (daclatasvir) and Sovaldi (sofosbuvir) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Daklinza Sovaldi Page: 1 of 4 Last Review Date: September 18, 2015 Daklinza Sovaldi Description

More information

Harvoni. Harvoni (ledipasvir & sofosbuvir) Description

Harvoni. Harvoni (ledipasvir & sofosbuvir) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.03.32 Subject: Harvoni Page: 1 of 7 Last Review Date: December 3, 2015 Harvoni Description Harvoni (ledipasvir

More information

Harvoni. Harvoni (ledipasvir & sofosbuvir) Description

Harvoni. Harvoni (ledipasvir & sofosbuvir) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.32 Subject: Harvoni Page: 1 of 9 Last Review Date: March 18, 2016 Harvoni Description Harvoni (ledipasvir

More information

Harvoni. Harvoni (ledipasvir & sofosbuvir) Description

Harvoni. Harvoni (ledipasvir & sofosbuvir) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.32 Subject: Harvoni Page: 1 of 9 Last Review Date: December 2, 2016 Harvoni Description Harvoni (ledipasvir

More information

Pegasys Hepatitis B. Pegasys (peginterferon alfa-2a) Description

Pegasys Hepatitis B. Pegasys (peginterferon alfa-2a) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.03.02 Subject: Pegasys Hepatitis B Page: 1 of 5 Last Review Date: September 18, 2015 Pegasys Hepatitis

More information

Odomzo. Odomzo (sonidegib) Description

Odomzo. Odomzo (sonidegib) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.61 Subject: Odomzo Page: 1 of 5 Last Review Date: June 22, 2017 Odomzo Description Odomzo (sonidegib)

More information

Ribavirin (Medicare Prior Authorization)

Ribavirin (Medicare Prior Authorization) Prior Authorization Form ARKANSAS BLUE CROSS AND BLUE SHIELD Medi-Pak Rx (PDP), Medi-Pak Advantage (PFFS), and Medi-Pak Advantage PPO Ribavirin (Medicare Prior Authorization) This fax machine is located

More information

Express Scripts, Inc. monograph dated 5/25/2011; selected revision 6/1/2011

Express Scripts, Inc. monograph dated 5/25/2011; selected revision 6/1/2011 BENEFIT DESCRIPTION AND LIMITATIONS OF COVERAGE ITEM: PRODUCT LINES: COVERED UNDER: DESCRIPTION: CPT/HCPCS Code: Company Supplying: Setting: Coverage Criteria: Approval Period: Victrelis (boceprevir capsules)

More information

SUMMACARE COMMERCIAL MEDICATION REQUEST GUIDELINES

SUMMACARE COMMERCIAL MEDICATION REQUEST GUIDELINES Generic Brand HICL GCN Exception/Other TELAPREVIR INCIVEK 37629 This drug requires a written request for prior authorization. All requests for hepatitis C medications require review by a pharmacist prior

More information

Siklos. Siklos (hydroxyurea) Description

Siklos. Siklos (hydroxyurea) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.85.27 Subject: Siklos Page: 1 of 5 Last Review Date: November 30, 2018 Siklos Description Siklos (hydroxyurea)

More information

Targretin. Targretin (bexarotene) Description

Targretin. Targretin (bexarotene) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.81 Subject: Targretin Page: 1 of 5 Last Review Date: June 22, 2017 Targretin Description Targretin

More information

Intron A. Intron A (interferon alfa-2b) Description

Intron A. Intron A (interferon alfa-2b) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.07 Subject: Intron A Page: 1 of 6 Last Review Date: June 24, 2016 Intron A Description Intron A (interferon

More information

Actimmune. Actimmune (interferon gamma-1b) Description

Actimmune. Actimmune (interferon gamma-1b) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.01 Subject: Actimmune Page: 1 of 5 Last Review Date: March 18, 2016 Actimmune Description Actimmune

More information

Intron A. Intron A (interferon alfa-2b) Description

Intron A. Intron A (interferon alfa-2b) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Intron A Page: 1 of 6 Last Review Date: June 19, 2015 Intron A Description Intron A (interferon

More information

Gilotrif. Gilotrif (afatinib) Description

Gilotrif. Gilotrif (afatinib) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.04.39 Subject: Gilotrif Page: 1 of 5 Last Review Date: September 12, 2014 Gilotrif Description Gilotrif

More information

Tarceva. Tarceva (erlotinib) Description

Tarceva. Tarceva (erlotinib) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.82 Subject: Tarceva Page: 1 of 5 Last Review Date: June 22, 2018 Tarceva Description Tarceva (erlotinib)

More information

Regulatory Status FDA-approved indication: Otrexup and Rasuvo are folate analog metabolic inhibitors indicated for: (1-2)

Regulatory Status FDA-approved indication: Otrexup and Rasuvo are folate analog metabolic inhibitors indicated for: (1-2) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.37 Subject: Methotrexate Injections Page: 1 of 5 Last Review Date: March 16, 2018 Methotrexate Injections

More information

Limitations of Use: Glumetza is not used for the treatment of type 1 diabetes or ketoacidosis (1).

Limitations of Use: Glumetza is not used for the treatment of type 1 diabetes or ketoacidosis (1). Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.30.20 Subject: Glumetza Page: 1 of 5 Last Review Date: March 18, 2016 Glumetza Description Glumetza (extended-release

More information

Movantik (naloxegol), Relistor (methylnaltrexone bromide)

Movantik (naloxegol), Relistor (methylnaltrexone bromide) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.50.06 Subject: Opioid Antagonist Drug Class Page: 1 of 5 Last Review Date: December 2, 2016 Opioid Antagonist

More information

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

UnitedHealthcare Pharmacy Clinical Pharmacy Programs UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 1231-1 Program Prior Authorization/Notification Medication Mavyret (glecaprevir/pibrentasvir) P&T Approval Date 9/2017 Effective

More information

Regulatory Status FDA approved indication: Kineret is an interleukin-1 receptor antagonist indicated for: (1)

Regulatory Status FDA approved indication: Kineret is an interleukin-1 receptor antagonist indicated for: (1) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.50 Subject: Kineret Page: 1 of 5 Last Review Date: March 17, 2017 Kineret Description Kineret (anakinra)

More information

Kadcyla. Kadcyla (ado-trastuzumab) Description

Kadcyla. Kadcyla (ado-trastuzumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.32 Subject: Kadcyla Page: 1 of 5 Last Review Date: June 24, 2016 Kadcyla Description Kadcyla (ado-trastuzumab)

More information

2. Treatment of patients with metastatic, squamous NSCLC progressing after platinumbased

2. Treatment of patients with metastatic, squamous NSCLC progressing after platinumbased Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.39 Subject: Gilotrif Page: 1 of 5 Last Review Date: June 24, 2016 Gilotrif Description Gilotrif (afatinib)

More information

2017 UnitedHealthcare Services, Inc.

2017 UnitedHealthcare Services, Inc. UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 1146-7 Program Prior Authorization/Notification Medication Harvoni (ledipasvir/sofosbuvir) P&T Approval Date 10/2014, 2/2015,

More information

Keveyis. Keveyis (dichlorphenamide) Description

Keveyis. Keveyis (dichlorphenamide) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.40.09 Subject: Keveyis Page: 1 of 5 Last Review Date: September 20, 2018 Keveyis Description Keveyis

More information

Durlaza. Durlaza (aspirin) Description

Durlaza. Durlaza (aspirin) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.85.13 Subject: Durlaza Page: 1 of 4 Last Review Date: September 15, 2016 Durlaza Description Durlaza

More information

Zytiga. Zytiga (abiraterone acetate) Description

Zytiga. Zytiga (abiraterone acetate) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.04.28 Subject: Zytiga Page: 1of 5 Last Review Date: March 13, 2014 Zytiga Description Zytiga (abiraterone

More information

Krystexxa. Krystexxa (pegloticase) Description

Krystexxa. Krystexxa (pegloticase) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.14 Subject: Krystexxa Page: 1 of 5 Last Review Date: March 16, 2018 Krystexxa Description Krystexxa

More information

Xeljanz. Xeljanz, Xeljanz XR (tofacitinib) Description

Xeljanz. Xeljanz, Xeljanz XR (tofacitinib) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.24 Subject: Xeljanz Page: 1 of 5 Last Review Date: March 18, 2016 Xeljanz Description Xeljanz, Xeljanz

More information

Gazyva. Gazyva (obinutuzumab) Description

Gazyva. Gazyva (obinutuzumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.29 Subject: Gazyva Page: 1 of 7 Last Review Date: September 15, 2016 Gazyva Description Gazyva (obinutuzumab)

More information

Intron A HEPATITIS B. Intron A (interferon alfa-2b) Description

Intron A HEPATITIS B. Intron A (interferon alfa-2b) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.03.01 Subject: Intron A Hepatitis B Page: 1 of 8 Last Review Date: September 18, 2015 Intron A HEPATITIS

More information

Promacta. Promacta (eltrombopag) Description

Promacta. Promacta (eltrombopag) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.85.15 Subject: Promacta Page: 1 of 6 Last Review Date: September 15, 2017 Promacta Description Promacta

More information

Limitation of use: Onivyde is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas (1).

Limitation of use: Onivyde is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas (1). Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Onivyde Page: 1 of 5 Last Review Date: June 24, 2016 Onivyde Description Onivyde (irinotecan liposome

More information

Pegylated Interferon Agents for Hepatitis C

Pegylated Interferon Agents for Hepatitis C Applicable X X X X X X X Pegylated Interferon Agents for Hepatitis C Override(s) Prior Authorization Quantity Limit Initial for Monotherapy or Combination with Ribavirin based on Genotype, Status, or Co-Infection

More information

Cimzia. Cimzia (certolizumab pegol) Description

Cimzia. Cimzia (certolizumab pegol) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Cimzia Page: 1 of 5 Last Review Date: March 17, 2017 Cimzia Description Cimzia (certolizumab pegol)

More information

Myalept. Myalept (metreleptin) Description

Myalept. Myalept (metreleptin) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.30.45 Subject: Myalept Page: 1 of 5 Last Review Date: September 15, 2016 Myalept Description Myalept

More information

WARNING LETTER TRANSMITTED BY FACSIMILE

WARNING LETTER TRANSMITTED BY FACSIMILE DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Samuel D. Waksal, Ph.D. Chairman and Chief Executive Officer 119

More information

Xeljanz. Xeljanz, Xeljanz XR (tofacitinib) Description

Xeljanz. Xeljanz, Xeljanz XR (tofacitinib) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.24 Subject: Xeljanz Page: 1 of 5 Last Review Date: March 17, 2017 Xeljanz Description Xeljanz, Xeljanz

More information

Gilotrif. Gilotrif (afatinib) Description

Gilotrif. Gilotrif (afatinib) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.39 Subject: Gilotrif Page: 1 of 6 Last Review Date: March 16, 2018 Gilotrif Description Gilotrif (afatinib)

More information

Regulatory Status FDA-approved indication: Tysabri is an integrin receptor antagonist indicated for treatment of:

Regulatory Status FDA-approved indication: Tysabri is an integrin receptor antagonist indicated for treatment of: Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.08.27 1 of 6 Last Review Date: December 5, 2014 Tysabri Description Tysabri (natalizumab) Background

More information

Regulatory Status FDA-approved indication: Ofev is a kinase inhibitor indicated for the treatment of idiopathic pulmonary fibrosis (IPF) (1).

Regulatory Status FDA-approved indication: Ofev is a kinase inhibitor indicated for the treatment of idiopathic pulmonary fibrosis (IPF) (1). Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.45.05 Subject: Ofev Page: 1 of 5 Last Review Date: March 17, 2017 Ofev Description Ofev (nintedanib)

More information

RATIONALE FOR INCLUSION IN PA PROGRAM

RATIONALE FOR INCLUSION IN PA PROGRAM RATIONALE FOR INCLUSION IN PA PROGRAM Background Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with

More information

Hepatitis C Agents

Hepatitis C Agents Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.41 Subject: Hepatitis C Agents Page: 1 of 20 Last Review Date: March 16, 2018 Hepatitis C Agents Description

More information

Hepatitis C Agents

Hepatitis C Agents Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.41 Subject: Hepatitis C Agents Page: 1 of 19 Last Review Date: December 8, 2017 Hepatitis C Agents

More information

Limitations of Use: (1) Duzallo is not recommended for the treatment of asymptomatic hyperuricemia.

Limitations of Use: (1) Duzallo is not recommended for the treatment of asymptomatic hyperuricemia. Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.63 Subject: Duzallo Page: 1 of 5 Last Review Date: December 8, 2017 Duzallo Description Duzallo (lesinurad

More information

See Important Reminder at the end of this policy for important regulatory and legal information.

See Important Reminder at the end of this policy for important regulatory and legal information. Clinical Policy: Ribavirin () Reference Number: CP.HNMC.252 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Medicaid - HNMC Revision Log See Important Reminder at the end of this policy

More information

Nuplazid. Nuplazid (pimavanserin) Description

Nuplazid. Nuplazid (pimavanserin) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.60.03 Subject: Nuplazid Page: 1 of 4 Last Review Date: June 22, 2018 Nuplazid Description Nuplazid (pimavanserin)

More information

Viberzi. Viberzi (eluxadoline) Description

Viberzi. Viberzi (eluxadoline) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subsection: Gastrointestinal Agents Original Policy Date: July 24, 2015 Subject: Viberzi Page: 1 of 5 Last

More information

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

UnitedHealthcare Pharmacy Clinical Pharmacy Programs UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2132-1 Program Prior Authorization/Medical Necessity Medication Mavyret (glecaprevir/pibrentasvir) P&T Approval Date 9/2017 Effective

More information

Pegylated Interferons and Ribavirins

Pegylated Interferons and Ribavirins Pegylated Interferons and Ribavirins Goal(s): Cover drugs only for those clients where there is evidence of effectiveness and safety Length of Authorization: 16 weeks plus 12-36 additional weeks or 12

More information

Clinical Criteria for Hepatitis C (HCV) Therapy

Clinical Criteria for Hepatitis C (HCV) Therapy Diagnosis Clinical Criteria for Hepatitis C (HCV) Therapy Must have chronic hepatitis C (HCV infection > 6 months), genotype and sub-genotype specified to determine the length of therapy; Liver biopsy

More information

Limitations of Use: Imlygic has not been shown to improve overall survival or have an effect on visceral metastases (1).

Limitations of Use: Imlygic has not been shown to improve overall survival or have an effect on visceral metastases (1). Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.66 Subject: Imlygic Page: 1 of 5 Last Review Date: June 22, 2017 Imlygic Description Imlygic (talimogene

More information

Iressa. Iressa (gefitinib) Description

Iressa. Iressa (gefitinib) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Iressa Page: 1 of 5 Last Review Date: June 22, 2018 Iressa Description Iressa (gefitinib) Background

More information

from 29 March 2012 Effect estimates [95% CI] Telaprevir + PegIFN/RBV vs. PegIFN/RBV

from 29 March 2012 Effect estimates [95% CI] Telaprevir + PegIFN/RBV vs. PegIFN/RBV Resolution by the Federal Joint Committee on an amendment to the Pharmaceutical Directive (AM-RL): Appendix XII Resolutions on the benefit assessment of pharmaceuticals with new active ingredients, in

More information

Regulatory Status FDA-approved indication: Orencia is a selective T cell costimulation modulator indicated for: (1)

Regulatory Status FDA-approved indication: Orencia is a selective T cell costimulation modulator indicated for: (1) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.18 Subject: Orencia Page: 1 of 6 Last Review Date: December 8, 2017 Orencia Description Orencia (abatacept)

More information

Gazyva. Gazyva (obinutuzumab) Description

Gazyva. Gazyva (obinutuzumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.29 Subject: Gazyva Page: 1 of 7 Last Review Date: March 16, 2018 Gazyva Description Gazyva (obinutuzumab)

More information

Lyrica. Lyrica, Lyrica CR (pregabalin) Description

Lyrica. Lyrica, Lyrica CR (pregabalin) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.75.18 Subject: Page: 1 of 7 Last Review Date: March 16, 2018 Description, CR (pregabalin) Background

More information

Aubagio. Aubagio (teriflunomide) Description

Aubagio. Aubagio (teriflunomide) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.07.09 Subsection: Endocrine and Metabolic Drugs Original Policy Date: April 1, 2013 Subject: Aubagio

More information

Promacta. Promacta (eltrombopag) Description

Promacta. Promacta (eltrombopag) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.85.15 Subject: Promacta Page: 1 of 6 Last Review Date: September 20, 2018 Promacta Description Promacta

More information

BVHG/BASL/BSG/BHIVA/BIA/CVN Guidelines for management of chronic HCV infection

BVHG/BASL/BSG/BHIVA/BIA/CVN Guidelines for management of chronic HCV infection BVHG/BASL/BSG/BHIVA/BIA/CVN Guidelines for management of chronic HCV infection Headline Recommendations 1. We recommend that NHSE considers commissioning pan-genotypic regimens for use in the community

More information

Tagrisso. Tagrisso (osimertinib) Description

Tagrisso. Tagrisso (osimertinib) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.69 Subject: Tagrisso Page: 1 of 5 Last Review Date: September 15, 2016 Tagrisso Description Tagrisso

More information

Yescarta. Yescarta (axicabtagene ciloleucel) Description

Yescarta. Yescarta (axicabtagene ciloleucel) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.105 Subject: Yescarta Page: 1 of 5 Last Review Date: September 20, 2018 Yescarta Description Yescarta

More information

Medical Policy An independent licensee of the Blue Cross Blue Shield Association

Medical Policy An independent licensee of the Blue Cross Blue Shield Association Hepatitis B / Hepatitis C Peg-interferon Page 1 of 20 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Hepatitis B / Hepatitis C Peg-interferon Hepatitis

More information

2. Treatment of patients with metastatic, squamous NSCLC progressing after platinumbased

2. Treatment of patients with metastatic, squamous NSCLC progressing after platinumbased Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.39 Subject: Gilotrif Page: 1 of 5 Last Review Date: September 15, 2017 Gilotrif Description Gilotrif

More information

Siliq. Siliq (brodalumab) Description

Siliq. Siliq (brodalumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.90.28 Subject: Siliq Page: 1 of 5 Last Review Date: December 8, 2017 Siliq Description Siliq (brodalumab)

More information

Nucala. Nucala (mepolizumab) Description

Nucala. Nucala (mepolizumab) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.45.07 Subject: Nucala Page: 1 of 5 Last Review Date: December 2, 2016 Nucala Description Nucala (mepolizumab)

More information

Xifaxan. Xifaxan (rifaximin) Description

Xifaxan. Xifaxan (rifaximin) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.34 Subject: Xifaxan Page: 1 of 6 Last Review Date: December 8, 2017 Xifaxan Description Xifaxan (rifaximin)

More information

Iclusig. Iclusig (ponatinib) Description

Iclusig. Iclusig (ponatinib) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.30 Subject: Iclusig Page: 1of 5 Last Review Date: June 24, 2016 Iclusig Description Iclusig (ponatinib)

More information

Simponi / Simponi ARIA (golimumab)

Simponi / Simponi ARIA (golimumab) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.51 Subject: Simponi / Simponi ARIA Page: 1 of 6 Last Review Date: September 15, 2016 Simponi / Simponi

More information

Tykerb. Tykerb (lapatinib) Description

Tykerb. Tykerb (lapatinib) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Tykerb Page: 1 of 5 Last Review Date: June 24, 2016 Tykerb Description Tykerb (lapatinib) Background

More information

Topic: Sovaldi, sofosbuvir Date of Origin: March 14, Committee Approval Date: August 15, 2014 Next Review Date: March 2015

Topic: Sovaldi, sofosbuvir Date of Origin: March 14, Committee Approval Date: August 15, 2014 Next Review Date: March 2015 Medication Policy Manual Policy No: dru332 Topic: Sovaldi, sofosbuvir Date of Origin: March 14, 2014 Committee Approval Date: August 15, 2014 Next Review Date: March 2015 Effective Date: October 1, 2014

More information

Amantadine Extended-Release. Gocovri, Osmolex ER. Description

Amantadine Extended-Release. Gocovri, Osmolex ER. Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.75.21 Subject: Amantadine ER Page: 1 of 5 Last Review Date: June 22, 2018 Amantadine Extended-Release

More information

Corlanor. Corlanor (ivabradine) Description

Corlanor. Corlanor (ivabradine) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.40.05 Subject: Corlanor Page: 1 of 5 Last Review Date: June 24, 2016 Corlanor Description Corlanor (ivabradine)

More information

Hepatitis C Virus Clinical Criteria Update September 18, For: New York State Medicaid

Hepatitis C Virus Clinical Criteria Update September 18, For: New York State Medicaid Hepatitis C Virus Clinical Criteria Update September 18, 2014 For: New York State Medicaid 1 Purpose Characterize the place in therapy for the agents utilized for management of chronic hepatitis C (CHC)

More information