Olysio Pegasys Ribavirin
|
|
- Delilah Hicks
- 5 years ago
- Views:
Transcription
1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Olysio Pegasys Ribavirin Page: 1 of 8 Last Review Date: December 18, 2017 Olysio Pegasys Ribavirin Description Pegasys (peginterferon alfa-2a) with Ribavirin (Copegus, Moderiba, Rebetol, RibaPak, Ribasphere, RibaTab, ribavirin tablets/capsules - all strengths) and Olysio (simeprevir) 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 the hepatitis C virus have no symptoms of the disease until liver damage becomes apparent, which may take several years. Most individuals then develop chronic hepatitis C (CHC). Some will also develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. Olysio is a protease inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. It is to be used as a component of a combination antiviral treatment regimen. (1). Regulatory Status FDA-approved indications: Olysio is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of CHC in combination with peginterferon alfa and ribavirin in patients with HCV genotype 1 or 4 without cirrhosis or with compensated cirrhosis. Olysio must not be used as monotherapy (3).
2 Subject: Olysio Pegasys Ribavirin Page: 2 of 7 Pegasys, as part of a combination regimen, is an antiviral indicated for the treatment of CHC in patients with compensated liver disease. Pegasys in combination with ribavirin and an approved hepatitis C virus (HCV) NS3/4A protease inhibitor is indicated in adult patients (18 years of age and older) with HCV genotype 1 infection (2-5). Ribavirin is a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with Pegasys in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients coinfected with HIV (2, 4-5). Screening patients with HCV genotype 1a infection for the presence of virus with the NS3 Q80K polymorphism at baseline is strongly recommended. Alternative therapy should be considered for patients infected with HCV genotype 1a containing the NS3 Q80K polymorphism (3). Limitations of use: Olysio: (3) Efficacy of Olysio in combination with peginterferon alfa and ribavirin is substantially reduced in patients infected with HCV genotype 1a with an NS3 Q80K polymorphism. Olysio is not recommended in patients who have previously failed therapy with a treatment regimen that included Olysio or other HCV protease inhibitors. Pegasys: (2) Pegasys may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders. Ribavirin may cause birth defects and fetal death. Pregnancy should be avoided in female patients and female partners of male patients (2, 4-5). Additionally, Olysio has a boxed warning for Hepatitis B virus reactivation, occasionally fulminant, during or after Hepatitis C virus (HCV) therapy which have been reported in HBV/HCV coinfected patients who were not already on HBV suppressive therapy. In light of these observations, all patients initiating HCV therapy should be assessed for HBV coinfection with testing for HBsAg, anti-hbs, and anti-hbc (3). Rash has been observed during combination therapy with Olysio, peginterferon alfa and ribavirin. Discontinue Olysio if severe rash occurs (3).
3 Subject: Olysio Pegasys Ribavirin Page: 3 of 7 To prevent treatment failure, the dose of Olysio must not be reduced or interrupted. If treatment with Olysio is discontinued because of adverse reactions or inadequate on-treatment virologic response, Olysio treatment must not be reinstated (3). The safety and efficacy of Olysio in pediatric patients have not been established (3). The safety and efficacy of Olysio alone or in combination with peginterferon alfa and ribavirin have not been studied in liver transplant patients (3). Related policies Hepatitis C, PegIntron, Technivie Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Olysio in combination with Pegasys and ribavirin may be considered medically necessary in patients that are 18 years of age and older with chronic Hepatitis C if the conditions indicated below are met. Olysio in combination with Pegasys and ribavirin is considered investigational in patients less than 18 years of age and for all other indications. Prior-Approval Requirements Age 18 years of age or older Diagnosis Patient must have the following: Chronic Hepatitis C AND ALL of the following: 1. Viral genotype 1 or 4 and if subtype 1a does NOT have NS3 Q80k polymorphism 2. Detectable viral load in the serum
4 Subject: Olysio Pegasys Ribavirin Page: 4 of 7 3. A viral load will be drawn at treatment weeks 4, 12, and Olysio will NOT be used as monotherapy 5. Olysio dose will NOT be reduced or interrupted 6. Compensated liver disease (i.e. stable liver problems; a diseased liver that is functional) 7. Patient has NOT been previously treated with a triple therapy regimen containing a hepatitis C virus protease inhibitor 8. Patient has NOT had a liver transplant 9. Neither the patient nor the partner of the patient is pregnant 10. If patient or their partner are of child bearing age, the patient has been or will be instructed to practice effective contraception during therapy and for 6 months after stopping ribavirin therapy 11. Must be prescribed by a board-certified gastroenterologist, hepatologist, oncologist, or infectious disease specialist 12. NO history of alcohol and/or substance abuse in the past 6 months 13. If the patient has a history of Hepatitis B (HBV) infection a. Prescriber agrees to monitor for HBV reactivation Prior Approval Renewal Requirements Age 18 years of age or older Diagnosis Patient must have ALL of the following: 1. Completed 12 weeks of Olysio 2. UNDETECTABLE hepatitis C viral load at treatment weeks 12 & Patient had prior interferon-based therapy (dual therapy without a protease inhibitor) and relapsed or had a non-response (partial or null) Policy Guidelines Pre - PA Allowance None Prior - Approval Limits Duration
5 Subject: Olysio Pegasys Ribavirin Page: 5 of 7 Previously untreated patient (treatment naïve) or relapse HCV mono-infected patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) OR HCV/HIV-1 co-infected patients without cirrhosis 12 weeks for Olysio 24 weeks for Pegasys, and ribavirin Previously untreated patient (treatment naïve) or relapse HCV/HIV-1 co infected patients with compensated cirrhosis (Child-Pugh A) 12 weeks for Olysio 48 weeks for Pegasys, and ribavirin Previous non-responder (partial or null response) HCV/HIV-1 co-infected or HCV mono-infected patients without cirrhosis or with compensated cirrhosis 12 weeks for Olysio 48 weeks for Pegasys, and ribavirin Prior - Approval Renewal Limits Age 18 years of age or older Duration Previously untreated patient (treatment naïve) or a relapser NO additional authorization for Olysio, Pegasys, and ribavirin Previous non-responder (partial or null response) 20 weeks for Pegasys, and ribavirin
6 Subject: Olysio Pegasys Ribavirin Page: 6 of 7 Rationale Summary Olysio is to be used in combination with Pegasys and ribavirin in patients that are 18 years of age and older in the treatment of chronic Hepatitis C genotype 1 or 4 with compensated liver disease and no history of previous triple therapy. Olysio is not intended to be used as monotherapy. The safety and efficacy of Olysio alone or in combination with peginterferon alfa and ribavirin have not been studied in liver transplant patients. Ribavirin may cause birth defects and fetal death. Pregnancy should be avoided in female patients and female partners of male patients. Efficacy of Olysio in combination with peginterferon alfa and ribavirin is substantially reduced in patients infected with HCV genotype 1a with an NS3 Q80K polymorphism. Alternative therapy should be considered for patients infected with HCV genotype 1a containing the NS3 Q80K polymorphism (2-5). Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Pegasys, ribavirin, and Olysio while maintaining optimal therapeutic outcomes. References 1. Hepatitis. Medically reviewed by Judith Marcin, MD. May 9, Accessed on September 13 th, Pegasys [package insert]. South San Francisco, CA: Genentech USA, Inc; March Olysio [package insert]. Titusville, NJ: Janssen Therapeutics; May Copegus [package insert]. South San Francisco, CA: Genentech USA, Inc; August Rebetol capsules [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc; January AASLD and IDSA: Recommendations for Testing, Managing, and Treating Hepatitis C; April Accessed on September 13 th, Policy History Date December 2013 March 2014 Action New addition to PA Annual review. Addition to criteria requirements that if the patient is Genotype 1 subtype 1a, the patient does NOT have NS3 Q80k polymorphism
7 Subject: Olysio Pegasys Ribavirin Page: 7 of 7 October 2014 Addition of specialist, and no alcohol or substance abuse in the last 6 months. Addition of Moderiba March 2015 Annual editorial review and reference update December 2015 Annual review Addition of genotype 4 March 2016 Annual editorial review and reference update Policy code changed from to December 2017 Annual editorial review and reference update Addition of HBV requirement Updated dosing based on package insert Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on December 8, 2017 and is effective January 1, 2018.
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 informationOlysio 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 informationSECTION 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 informationSovaldi (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 informationSovaldi (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 informationTechnivie. 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 informationSovaldi 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 informationPegasys Ribavirin
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.08 Subsection: Anti-infective Agents Original Policy Date: January 1, 2006 Subject: Pegasys Ribavirin
More informationZepatier 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 informationPegasys 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 informationIntron 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 informationZepatier. 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 informationTechnivie. 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 informationDaklinza 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 informationDaklinza 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 informationIntron 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 informationPEGINTRON (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 informationInfergen (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 informationDaklinza 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 informationIntron 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 informationRATIONALE 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 informationHepatitis 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 informationHepatitis 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 informationHarvoni. 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 informationIntron 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 informationHarvoni. 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 informationHarvoni. 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 informationHarvoni. 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 informationPegylated 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 informationInfergen 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 informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Hepatitis C First Generation Agents Page 1 of 16 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Hepatitis C First Generation Agents - Through Preferred
More informationExpress 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 informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Hepatitis C First Generation Agents Page 1 of 18 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Hepatitis C First Generation Agents - Through Preferred
More informationMedical 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 informationPegasys 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 informationYescarta. 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 information2017 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 information2017 United Healthcare Services, Inc.
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2055-10 Program Prior Authorization/Medical Necessity Medication Olysio (simeprevir) P&T Approval Date 4/2015, 11/2015, 8/2016,
More informationClinical Policy: Simeprevir (Olysio) Reference Number: CP.CPA.289 Effective Date: Last Review Date: Line of Business: Commercial
Clinical Policy: (Olysio) Reference Number: CP.CPA.289 Effective Date: 11.01.16 Last Review Date: 08.18 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important
More informationCircle Yes or No Y N. [If yes, skip to question 13 REAUTHORIZATION REQUESTS]
04/30/2014 Prior Authorization AETA BETTER HEALTH OF ILLIOIS MEDICAID Peginterferon (IL88) This fax machine is located in a secure location as required by HIPAA regulations. Complete/review information,
More informationKymriah. Kymriah (tisagenlecleucel) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.101 Subject: Kymriah Page: 1 of 5 Last Review Date: September 20, 2018 Kymriah Description Kymriah
More informationIntron 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 informationOdomzo. 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 informationSUMMACARE 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 informationRibavirin (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 informationHepatitis 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 informationClinical 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 informationUnitedHealthcare 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 informationCriteria for Indiana Medicaid Hepatitis C Agents
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
More informationSee 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 informationAddress: City: State: ZIP code: Inferferon Product Requested (Include Strength):
Please complete this entire form and fax it to: 866-940-7328. If you have questions, please call 800-310-6826. This form contains multiple pages. Please complete all pages to avoid a delay in our decision.
More informationPrior Authorization Guideline
Prior Authorization Guideline Guideline Name Olysio (simeprevir) Formulary UnitedHealthcare Community & State Formulary Note Approval Date 2/19/2014 Revision Date 7/9/2014 1. Indications Drug Name: Olysio
More informationPharmacy Medical Necessity Guidelines: Medications for the Treatment of Hepatitis C
Pharmacy Medical Necessity Guidelines: Medications for the Treatment of Hepatitis C Effective: July 1, 2018 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical
More informationUnitedHealthcare 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 informationIntron 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 information2018 UnitedHealthcare Services, Inc.
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2018 P 1127-9 Program Prior Authorization/Notification Medication Sovaldi (sofosbuvir) P&T Approval Date 2/2014, 4/2014, 5/2014, 8/2014,
More informationPHARMACY PRIOR AUTHORIZATION Hepatitis C Clinical Guideline
Preferred Regimen Based on Diagnosis: Mavyret (glecaprevir/pibrentasvir) PHARMACY PRI AUTHIZATION Hepatitis C Clinical Guideline Non-Preferred: Daklinza (daclatasvir) Epclusa (sofosbuvir/velpatasvir) Harvoni
More informationMolina Healthcare of Texas Hepatitis C Drugs (Medicaid)
Texas Standard Prior Authorization Form Addendum Molina Healthcare of Texas Hepatitis C Drugs (Medicaid) This fax machine is located in a secure location as required by HIPAA Regulations. Complete / Review
More informationHepatitis C Virus Management
Hepatitis C Virus Management FDA-Approved Medications Hepatitis C is caused by a virus and results in liver inflammation, which can lead to advanced liver disease and/or liver cancer. An estimated 3 to
More informationVosevi (sofosbuvir/velpatasvir/voxilaprevir)
Vosevi (sofosbuvir/velpatasvir/voxilaprevir) Policy Number: 5.01.646 Last Review: 10/2017 Origination: 10/2017 Next Review: 11/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide
More informationIntron 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 22, 2018 Intron A Description Intron A (interferon
More informationHepatitis C Medications Hawaii PRIOR AUTHORIZATION REQUEST FORM
Please complete this entire form and fax it to: 866-940-7328. If you have questions, please call 800-310-6826. This form contains multiple pages. Please complete all pages to avoid a delay in our decision.
More informationPHARMACY PRIOR AUTHORIZATION Hepatitis C Clinical Guideline
PHARMACY PRIOR AUTHORIZATION Hepatitis C Clinical Guideline Preferred Regimen Based on Diagnosis: Mavyret (glecaprevir/pibrentasvir ) Non-Preferred: Daklinza (daclatasvir) Epclusa (sofosbuvir/velpatasvir)
More informationTargretin. 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 informationTreatment of Hepatitis C with simeprevir (Olysio ) PLUS sofosbuvir (Sovaldi ) Archived Medical Policy
Treatment of Hepatitis C with simeprevir (Olysio ) PLUS sofosbuvir (Sovaldi ) Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana,
More informationJOHNS HOPKINS HEALTHCARE
JOHNS HOPKINS HEALTHCARE Subject: Clinical Criteria for Hepatitis C (HCV) Therapy Department: Pharmacy Lines of Business: PPMCO Policy Number: MEDS92 Effective Date: 04/15/2015 Revision Date: 08/15/2015
More informationHARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES
HARVARD PILGRIM HEALTH CARE Generic Brand HICL GCN Exception/Other DACLATASVIR DAKLINZA 41377 ELBASVIR/GRAZOPREVIR ZEPATIER 43030 GLECAPREVIR/PIBRENTASVIR MAVYRET 44453 OMBITASVIR/PARITAPREVIR/ RITONAVIR
More informationSummary of the risk management plan (RMP) for Olysio (simeprevir)
EMA/191406/2014 Summary of the risk management plan (RMP) for Olysio (simeprevir) This is a summary of the risk management plan (RMP) for Olysio, which details the measures to be taken in order to ensure
More informationPharmacy Medical Necessity Guidelines: Medications for the Treatment of Hepatitis C
Pharmacy Medical Necessity Guidelines: Medications for the Treatment of Hepatitis C Effective: March 13, 2018 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical
More informationSovaldi (sofosbuvir)
Market DC Sovaldi (sofosbuvir) Override(s) Prior Authorization Quantity Limit Approval Duration Based on Genotype, Treatment status, Cirrhosis status, or Ribavirin Eligibility status **IN, SC, WA Medicaid
More informationTreatment of Hepatitis C with sofosbuvir/ledipasvir (Harvoni )
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
More informationClinical Policy: Glecaprevir/Pibrentasvir (Mavyret) Reference Number: HIM.PA.SP36 Effective Date: Last Review Date: 06.18
Clinical Policy: (Mavyret) Reference Number: HIM.PA.SP36 Effective Date: 08.01.17 Last Review Date: 06.18 Line of Business: HIM Revision Log See Important Reminder at the end of this policy for important
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Epclusa) Reference Number: CP.CPA.286 Effective Date: 11.01.16 Last Review Date: 08.18 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important
More informationRegulatory 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 information2017 UnitedHealthcare Services, Inc.
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2052-10 Program Prior Authorization/Medical Necessity Medication Harvoni (ledipasvir/sofosbuvir) P&T Approval Date 4/2015, 8/2015,
More informationPharmacy Coverage Guidelines are subject to change as new information becomes available.
DIRECT ACTING ANTIVIRAL AGENTS FOR HEPATITIS C VIRUS (HCV): DAKLINZA (daclatasvir) oral tablet EPCLUSA (velpatasvir, sofosbuvir) oral tablet HARVONI (ledipasvir, sofosbuvir) oral tablet MAVYRET (glecaprevir,
More informationPart I. Prior Authorization Criteria and Policy
Texas Vendor Drug Program Antiviral Agents for Hepatitis C Virus Initial Authorization Request (Medicaid) Part I. Prior Authorization Criteria and Policy March 2018-E I. Eligibility 1. Patient is enrolled
More informationSGLT2 Inhibitors
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: SGLT2 Inhibitors Page: 1 of 7 Last Review Date: November 30, 2018 SGLT2 Inhibitors Description
More informationCimzia. Cimzia (certolizumab pegol) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.50.11 Subject: Cimzia Page: 1 of 5 Last Review Date: December 8, 2017 Cimzia Description Cimzia (certolizumab
More informationRegulatory 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 informationRituxan Hycela. Rituxan Hycela (rituximab and hyaluronidase human) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.96 Subject: Rituxan Hycela Page: 1 of 5 Last Review Date: September 15, 2017 Rituxan Hycela Description
More informationSiklos. 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 informationKeytruda. Keytruda (pembrolizumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.50 Subject: Keytruda Page: 1 of 5 Last Review Date: June 24, 2016 Keytruda Description Keytruda (pembrolizumab)
More informationGazyva. 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 informationOlysio (simeprivir) Policy Number: Last Review: 09/2017 Origination: 09/2013 Next Review: 09/2018
Olysio (simeprivir) Policy Number: 5.01.604 Last Review: 09/2017 Origination: 09/2013 Next Review: 09/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for Olysio (simeprivir)
More informationTopic: 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 informationHarvoni (sofosbuvir/ledipasvir
Market DC Override(s) Prior Authorization Quantity Limit (sofosbuvir/ledipasvir) Approval Duration Based on Genotype, Treatment status, Baseline HCV RNA status, Cirrhosis status, Transplant status, or
More informationWARNING 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 informationClinical Policy: Daclatasvir (Daklinza) Reference Number: HIM.PA.SP27 Effective Date: Last Review Date: 06.18
Clinical Policy: (Daklinza) Reference Number: HIM.PA.SP27 Effective Date: 01.01.17 Last Review Date: 06.18 Line of Business: HIM Revision Log See Important Reminder at the end of this policy for important
More informationGazyva. 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 informationIntron 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 informationRegulatory 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 informationCimzia. 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 informationClinical Criteria for Hepatitis C (HCV) Therapy
Clinical Criteria for Hepatitis C (HCV) Therapy Pre-Treatment Evaluation o Must have chronic hepatitis C and HCV genotype and sub-genotype documented; o Patients who have prior exposure to DAA therapy
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Sovaldi) Reference Number: ERX.SPA.127 Effective Date: 10.01.16 Last Review Date: 08.17 Line of Business: Commercial [Prescription Drug Plan] Revision Log See Important Reminder at the
More informationAgents for the Treatment of Hepatitis C
Texas Prior Authorization Program Clinical Edit Criteria Drug/Drug Class Clinical Edit Information Included in this Document Drugs requiring prior authorization: the list of drugs requiring prior authorization
More information