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New York State Medicaid Preferred Drug Program Fax Number: (800) 268-2990 Peginterferon and Ribavirin Combination Therapy with/without Olysio™ Prior Authorization Worksheet If your fax includes the standardized fax form, only the Member Name, ID, Date of Birth, and Clinical Criteria need to be completed and faxed as an attachment to process your request If requesting Olysio in combination with Sovaldi, please use the Sovaldi Combination Therapy Prior Authorization Worksheet. to initiate the PA request. Enrollee Information ENROLLEE NAME: ENROLLEE MEDICAID ID NUMBER (2 LETTERS, 5 NUMBERS, 1 LETTER): ENROLLEE DATE OF BIRTH: Prescriber Information PRESCRIBER NAME: CONTACT PERSON: 10-DIGIT NPI NUMBER: OFFICE PHONE NUMBER: ( ) OFFICE FAX NUMBER: - ( ) - Clinical Criteria DIAGNOSIS (PLEASE CHECK ALL THAT APPLY): CHRONIC HEPATITIS C INFECTION HEPATOCELLULAR CARCINOMA AWAITING LIVER TRANSPLANTATION HEPATITIS C VIRUS (HCV) GENOTYPE: PLEASE PROVIDE PREVIOUS HCV THERAPY COMPLETED PRIOR TO THE DATE OF THIS REQUEST? (IF APPLICABLE): DRUG: DOSAGE FORM: STRENGTH: DIRECTIONS: DRUG: DOSAGE FORM: STRENGTH: DIRECTIONS: DRUG: DOSAGE FORM: STRENGTH: DIRECTIONS: HOW MANY WEEKS OF PREVIOUS THERAPY HAVE BEEN COMPLETED PRIOR TO THE DATE OF THIS REQUEST? BASELINE RNA LEVEL: DATE TAKEN: PLEASE PROVIDE HCV RNA LEVEL AT THE APPROPRIATE WEEK, BASED ON CURRENT THERAPY: WEEK 4 HCV RNA LEVEL: DATE TAKEN: WEEK 8 HCV RNA LEVEL: DATE TAKEN: WEEK 12 HCV RNA LEVEL: DATE TAKEN: WEEK 24 HCV RNA LEVEL: DATE TAKEN: PLEASE CHECK THE BOX THAT BEST DESCRIBES THE PATIENT: Treatment-naïve Without cirrhosis Compensated liver disease including cirrhosis Decompensated liver disease. Prior relapser (achieved undetectable HCV RNA at end of previous treatment with peginterferon and ribavirin but detectable within 24 weeks after treatment) Prior partial responder (≥2 log decrease in HCV RNA at week 12 of previous treatment with peginterferon and ribavirin but did not achieve undetectable HCV RNA at end of treatment) Prior null responder (achieved <2 log decrease in HCV RNA at week 12 of previous treatment with peginterferon and ribavirin) For billing questions, call 1-800-343-9000. For clinical concerns or Preferred Drug Program questions, visit www.nyhealth.gov and http://newyork.fhsc.com or call 1-877-309-9493. © 2016, Magellan Health, Inc. All Rights Reserved. Magellan Medicaid Administration Peginterferon and Ribavirin Combination Therapy with/without Olysio Prior Authorization Worksheet Answer the following if requesting a nonpreferred Ribavirin product (Form Cannot be Processed without Required Explanation): Patient has experienced a treatment failure with a preferred drug. Yes No Patient has experienced an adverse drug reaction with a preferred drug. Yes No There is a documented history of successful therapeutic control with a nonpreferred drug and transition to a preferred drug is medically contraindicated. Yes No Other (Please specify the clinical reason the patient is unable to use a preferred agent in the same drug class. If necessary, fax additional pages): COMPLETE ALL QUESTIONS IN ONLY ONE OF THE FOLLOWING TWO BOXES TRIPLE THERAPY: OLYSIO, PEGINTERFERON, AND RIBAVIRIN Olysio STRENGTH: DIRECTIONS: Pegasys STRENGTH: DOSAGE FORM: STRENGTH: DIRECTIONS: Ribavirin Other QUANTITY: DIRECTIONS: QUANTITY: REFILLS: QUANTITY: REFILLS: REFILLS: Has the patient previously failed therapy with Incivek, Olysio, or Victrelis? Yes No Has the patient previously failed therapy with Sovaldi? Yes No Will the patient be on peginterferon and ribavirin in combination with Olysio? Yes No Is HCV RNA ≤25 IU/mL at week 4? Yes No Is HCV RNA ≤25 IU/mL at week 12? Yes No Was screening for evidence of current or prior Hepatitis B virus (HBV) infection completed? Yes No Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up Please note: Olysio efficacy in combination with peginterferon & ribavirin is substantially reduced in patients infected with HCV genotype 1a with an NS3 Q80K polymorphism. Screening for NS3 Q80K polymorphism is strongly recommended prior to initiation of therapy; alternative therapy should be considered in patients with the polymorphism. DUAL THERAPY: PEGINTERFERON AND RIBAVIRIN Pegasys Ribavirin Other STRENGTH: DOSAGE FORM: STRENGTH: DIRECTIONS: DIRECTIONS: QUANTITY: QUANTITY: REFILLS: REFILLS: Will the patient be on ribavirin in combination with the Injectable Hepatitis C Agent? Yes No Yes No Yes No Please check the box that demonstrates the patient’s response at week 12: No early virologic response (EVR) [HCV RNA decreased < 2 log] Partial EVR [HCV RNA decreased ≥2 log] Complete EVR [HCV RNA negative] Please check the box that demonstrates the patient’s response at week 24: HCV RNA negative HCV RNA positive If requesting Injectable Hepatitis C treatment for genotype 2 or 3 beyond 24 weeks, please answer the following: Does the patient have a comorbidity requiring adjustment to the expected duration of therapy for patients with genotype 2 and 3? If yes, list comorbid condition(s): If requesting Injectable Hepatitis C treatment beyond 48 weeks, please answer the following: Has the patient demonstrated a delayed virologic response(partial EVR at week 12 and HCV RNA negative at week 24)? Revision Date: November 2016 For billing questions, call 1-800-343-9000. For clinical concerns or Preferred Drug Program questions, visit www.nyhealth.gov and http://newyork.fhsc.com or call 1-877-309-9493. Page 2 Magellan Medicaid Administration Peginterferon and Ribavirin Combination Therapy with/without Olysio Prior Authorization Worksheet I attest that this is medically necessary for this patient and that all of the information on this form is accurate to the best of my knowledge. I attest that documentation of the above diagnosis and medical necessity is available for review if requested by New York Medicaid. PRESCRIBER’S SIGNATURE Revision Date: November 2016 DATE For billing questions, call 1-800-343-9000. For clinical concerns or Preferred Drug Program questions, visit www.nyhealth.gov and http://newyork.fhsc.com or call 1-877-309-9493. Page 3 Simeprevir (Olysio®) Approved by the Food and Drug Administration (FDA) in November 2013, simeprevir is an oral hepatitis C virus (HCV) NS3/4A protease inhibitor intended for use in combination with peginterferon alfa and ribavirin (PR) for genotype (GT) 1- or 4-infected patients or in combination with sofosbuvir in HCV GT 1-infected patients.1 Advantages of simeprevir Simeprevir is taken once daily with food in combination with PR or sofosbuvir (Sovaldi®).1 Simeprevir is a direct acting antiviral (DAA) agent that inhibits HCV NS3/4A, preventing the cleavage of viral polyproteins during HCV replication. Use of simeprevir in combination with PR or sofosbuvir has been shown to increase rates of sustained virologic response (SVR) in both treatment-naïve and treatment-experienced patients with or without cirrhosis. In phase III trials, the primary endpoint was defined as undetectable HCV RNA (<25 IU/mL) at 12 weeks post treatment (SVR12). Phase III Trials: Trial Subjects Treatment arm* QUEST 1 and 22 (pooled analysis) 785 Treatment-naïve PROMISE2 393 Treatment-experienced SMV12+PR24/48 PR48 (control) SMV12+PR24/48 PR48 (control) Overall SVR rate (%) 80% 50% 79% 37% Genotype 1a SVR rate (%) Genotype 1b SVR rate (%) 75% 47% 70% 28% 85% 53% 86% 43% *By weeks on each component; PR=peginterferon alfa and ribavirin; SMV=simeprevir The combination of simeprevir and sofosbuvir in HCV-infected patients (COSMOS) trial, a phase 2, randomized, open-label trial, demonstrated the safety and efficacy of this treatment regimen when administered for 12 or 24 weeks. 3 Cautions Prior to initiating therapy with any HCV direct acting antiviral (DAA) agent, all patients should be tested for evidence of current or prior hepatitis B virus (HBV) infection by measuring hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (antiHBs) and hepatitis B core antibody (anti-HBc). In patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during treatment with a DAA agent and during post-treatment follow-up. Simeprevir efficacy in combination with PR is substantially reduced in patients infected with HCV genotype 1a with an NS3 Q80K polymorphism. Screening for NS3 Q80K polymorphism is strongly recommended prior to initiation of therapy; alternative therapy should be considered in patients with the polymorphism due to reduced efficacy observed in clinical trials. Simeprevir should not be used as monotherapy. Additionally, the dose must not be reduced nor should treatment be interrupted. Simeprevir should not be used if a patient has previously failed therapy that included simeprevir or another HCV NS3/4A protease inhibitor (e.g., boceprevir or telaprevir). Simeprevir is not recommended for patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. Hepatic laboratory testing before and during therapy is recommended. Therapy should be discontinued if an elevation in bilirubin is accompanied by liver transaminase increases or clinical signs and symptoms of hepatic decompensation. Higher rates of rash (including photosensitivity), pruritus, and nausea occurred in simeprevir-treated patients vs. patients receiving PR alone. If a severe rash develops, simeprevir should be discontinued and not restarted. Simeprevir is metabolized by cytochrome P450 (CYP) 3A; co-administration with a moderate or strong inducer or inhibitor of CYP3A is not recommended. Simeprevir inhibits organic anion transporting polypeptide (OATP) 1B1/3 and P-glycoprotein (P-gp) transporters; therefore, co-administration of drugs that are substrates for OATP1B1/3 and P-gp transporters may result in increased plasma concentration of those drugs. Symptomatic bradycardia can occur when simeprevir is co-administered with sofosbuvir and amiodarone. The combination is not recommended, but if the combination cannot be avoided cardiac monitoring is recommended. Where does simeprevir fit into therapy and how should it be used? In January 2014, the American Association for the Study of Liver Diseases and Infectious Diseases Society of America, in collaboration with the International Antiviral Society – USA, launched www.hcvguidelines.org for the purpose of disseminating expert opinion on management of HCV as newer HCV DAA agents become available and treatment evidence emerges. There are no comparative efficacy data available to date among the HCV DAA agents, but it is likely that guidelines for optimal regimens will continue to evolve. Updated: 3/15/17 Patient-specific factors and economic factors must be taken into consideration when deciding to initiate therapy. The goal of treatment is undetectable HCV RNA at SVR12. Olysio® treatment regimen and duration recommendations: Simeprevir and sofosbuvir for mono-infected patients with HCV GT 1 infection1 GT 1 TN and TE* Treatment regimen and duration Without cirrhosis simeprevir + sofosbuvir for 12 weeks With cirrhosis simeprevir + sofosbuvir for 24 weeks GT=genotype; TN=treatment naïve; TE=treatment experienced; *treatment experienced patients include prior relapsers, prior partial responders, and prior null responders who failed pegylated interferon-based therapy Simeprevir and PR therapy in patients with HCV GT 1 or 4 infection1 GT 1 or 4 infection Treatment regimen and duration TN patients and prior relapsers* Without cirrhosis and with/without HIV co-infection OR with cirrhosis and without HIV co-infection Simeprevir + PR for 12 weeks FOLLOWED by an additional 12 weeks of PR (for a total treatment duration of 24 weeks) With cirrhosis and with HIV co-infection Simeprevir + PR for 12 weeks FOLLOWED by an additional 36 weeks of PR (for a total treatment duration of 48 weeks) Prior non-responders (including partial§ and null responders¥) With/without cirrhosis and with/without HIV co-infection Simeprevir + PR for 12 weeks FOLLOWED by an additional 36 weeks of PR (for a total treatment duration of 48 weeks) GT=genotype; HIV=human immunodeficiency virus; PR=peginterferon alfa + ribavirin; TN=treatment naïve *Prior relapse=HCV RNA not detected at the end of prior peginterferon alfa therapy and HCV-RNA detected during follow-up §Prior partial responder=prior on-treatment ≥2 log10 HCV RNA reduction from baseline at week 12 and HCV RNA detected at end of pegylated interferon therapy ¥Null responder=prior on-treatment ≥2 log10 HCV RNA reduction from baseline at week 12 during prior pegylated interferon therapy References: 1. Simeprevir (Olysio®) product information. Janssen Corporation, a subsidiary of Johnson & Johnson (J&J); 2016. 2. Data on file. Janssen Corporation, subsidiary of J&J; 2013. 3. Lawitz et al. Lancet 2014; 384:1756-65. Updated: 3/15/17 Simeprevir Initiation and Monitoring Once patient readiness for chronic HCV treatment has been determined, the algorithms below outline key decision points for initiating and monitoring combination therapy including simeprevir. Additionally, test for evidence of HBV infection by measuring HBsAg, anti-HBs, and anti-HBc. Note: Ribavirin is contraindicated in pregnancy; therefore, all female patients of childbearing age (or female partners of male patients) should ensure they are not pregnant prior to beginning treatment and should use 2 methods of non-hormonal birth control throughout treatment. Also note, HCV RNA testing should be conducted with a sensitive assay. Algorithm 1: Simeprevir in combination with PR for treatment-naïve prior relapsers and prior non-responders Has the patient been diagnosed with HCV GT 1 without NS3 Q80K polymorphism or GT 4 and received quantitative HCV RNA testing? No Seek alternative treatment options or conduct testing prior to treatment Yes Begin treatment with simeprevir 150 mg once daily with food in combination with PR for 12 weeks Repeat quantitative HCV RNA at the end of treatment week 4. Is HCV RNA ≤25 IU/ml? Yes Is the patient treatment naïve or a prior relapser* without cirrhosis and with/without HIV co-infection OR with cirrhosis and without HIV co-infection? No Is the patient a prior non-responder** including those with/without cirrhosis and with/without HIV co-infection OR treatment naïve or a prior relapser with cirrhosis and HIV co-infected? Yes Continue PR for additional 12 weeks for total treatment duration of 24 weeks Yes Continue PR for additional 36 weeks for total treatment duration of 48 weeks Obtain HCV RNA 12 weeks after the end of treatment to determine SVR12 GT=genotype; HIV=human immunodeficiency virus; PR=peginterferon alfa + ribavirin; SVR12=sustained virological response *Prior relapse=undetectable HCV RNA at the end of prior interferon-based therapy and detectable HCV RNA during follow-up **Non-responder includes partial (prior on- treatment ≥2 log 10 HCV RNA reduction from baseline at week 12 and HCV RNA detected at end of pegylated interferon therapy) and null responder (prior on-treatment ≥2 log 10 HCV RNA reduction from baseline at week 12 during prior pegylated interferon therapy) Updated: 3/15/17 Algorithm 2: Simeprevir in combination with sofosbuvir for treatment-naïve and treatment-experienced* patients mono-infected with genotype 1 Has the patient been diagnosed with HCV GT 1 and is not HIV coinfected? No Seek alternative treatment options or conduct testing prior to treatment Yes Yes Has the patient been diagnosed with cirrhosis? Yes No Simeprevir 150 mg and sofosbuvir 400 mg once daily with food for a total of 24 weeks Simeprevir 150 mg and sofosbuvir 400 mg once daily with food for a total of 12 weeks Repeat quantitative HCV RNA at the end of treatment week 4 and week 12 Repeat quantitative HCV RNA at the end of treatment week 4 Is HCV ≤ 25 IU/mL? No Discontinue therapy Continue therapy Obtain HCV RNA 12 weeks after the end of treatment to determine SVR12 GT=genotype; SVR12=sustained virological response *Treatment experienced patients include prior relapsers, prior partial responders and prior null responders who failed prior peginterferon alfa therapy. Updated: 3/15/17