Hepatitis C Prior Authorization Criteria and Policy Texas Medicaid Vendor Drug Program

Transcription

1 Hepatitis C Prior Authorization Criteria and Policy Texas Medicaid Vendor Drug Program I. Patient Eligibility Patient is a Texas Medicaid Patient greater than or equal to 18 years of age Patient must have the diagnosis of Chronic Hepatitis C Virus (HCV) with a confirmed genotype of 1, 2, 3, or 4. Other genotypes will not be approved. In the previous 3 months, the patient does not have a history of substance use disorder or has documentation of substance use disorder treatment. Negative drug test, that includes both legal and illegal, which are not verifiable by prescription, confirmed at least 15 days prior to the start of treatment and 4 weeks after the start of treatment Negative alcohol screening at least 15 days prior to the start of treatment and 4 weeks after the start of treatment Prescriber must be Board Certified Gastroenterologist, Hepatologist, or Infectious Disease physician. Patient has at minimum, METAVIR score F4 Patient or if applicable, patient's female partner is not pregnant or attempting conception. o Confirmed by pregnancy test within the last 30 days o Use of two forms of contraception during treatment and until 6 months after treatment Prescriber confirms that the patient is mentally competent and able to make appropriate decisions about treatment and capable of completing therapy. Prescriber agrees to provide required tests to monitor therapy including but not limited to: o Height and weight o Liver function tests, bilirubin, CBC o Serum creatinine, albumin o INR o HCV RNA levels at baseline, 4 weeks after the start of therapy, at the end of treatment, and at 12 and 24 weeks after completion of therapy. o Negative drug screen test performed at week 4 of treatment.(see additional requirements on Prescriber Certification page) II. Treatment approval Prior authorization is granted for 4 weeks per approval. Refills will not be granted unless required documentation is received. Regimen is based on genotype in addition to disease related conditions Last revision: 12/12/2014 Page 1

2 III. Criteria for Denial Patients with METAVIR scores of 1, 2, or 3. Patient or patient's female partner is pregnant or attempting conception Patient has not abstained from alcohol or illicit drugs. Patient is not sofosbuvir-naïve (does not apply to clients who become Medicaid eligible after the start of initial therapy). Patient is genotype 5 or 6. Patient refuses treatment with interferon, but does not meet definition of interferon ineligible. Interferon ineligible is defined as: o Documentation of severe hypersensitivity to interferon or any of its components. o Autoimmune hepatitis and other autoimmune disorder o Baseline neutrophil count <1500/µL, baseline platelets <90,000 µl, baseline hemoglobin <10 g/dl in patients without cardiac disease, and <12 g/dl in patients with history of cardiac disease, creatinine clearance (CrCl) < 30 ml/min or patients on hemodialysis o History of preexisting severe and uncontrolled cardiac disease o Major uncontrolled depressive illness Patient s non-adherence to therapy for more than 5 days will result in discontinuation of prior authorization and no further refills will be allowed. Patient is currently taking a medication with a moderate or severe drug interaction with the prescribed HCV treatment. IV. Additional Considerations Treatment coverage will be once per lifetime. Lost or stolen medications will not be replaced. Dosing for sofosbuvir is one tablet per day Prescriptions will be approved for a maximum of 4 weeks at a time Last revision: 12/12/2014 Page 2

3 Agents for Hepatitis C Prior Authorization Request Form Texas Medicaid Vendor Drug Program Please review the Hepatitis C Prior Authorization Criteria and Policy and submit Prescriber Certification document. Please fax all required documents to (866) Date: INITIAL request RENEWAL - please complete sections 1, 2, 6, and 7 only 1. Client Information Client Name: Gender: Client Medicaid ID Number: Date of Birth: Patient Weight: lb / kg Patient Height: in / cm 2. Provider Information (Must be a Board Certified Gastroenterologist, Hepatologist, or Infectious Disease Specialist) Provider Name: Specialty: Provider Phone Number: Provider Fax Number: Provider ID (State License / NPI): 3. Labs Labs (For initial approval, labs must be drawn within last 30 days) Yes/No Results Date AST ALT Alk phos GGT Total bilirubin WBC RBC Hgb Hct Plt SCr BUN Albumin INR Pregnancy test if applicable Baseline HCV RNA level If prescribing simeprevir, Q80K polymorphism screening METAVIR Score* *A liver biopsy that is done less than 3 years ago, or two non-invasive methodologies are required. Please submit documentation of results. Examples of non-invasive methodologies include: Fibroscan, Hepa-Index, PGA, FIB4 HCV Genotype (please circle) 1a 1b Confirmed negative illicit drug test and negative alcohol screening test at least 15 days prior to the start of therapy 4. Hepatitis C related Conditions Patient current condition (please add ): METAVIR Score 4 Hepatocellular carcinoma Awaiting liver transplant Number of previous liver transplant date(s) Serious/life threatening extra-hepatic manifestations of HCV (leukocytoclastic vasculitis, membranoproliferative glomerulonephritis, or symptomatic cryoglobulinemia ) Last reviewed 12/12/2014

4 5. Treatment Options Please add for the treatment regimen requested based on viral genotype and other disease conditions Diagnosis Treatment Regimen Regimen Duration Treatment Naïve or Relapse: Peginterferon (IFN) Eligible Genotype 1, 3, or 4 sofosbuvir + IFN + ribavirin With compensated cirrhosis with or without hepatocellular carcinoma Genotype 2 With compensated cirrhosis, with or without hepatocellular carcinoma Treatment Naïve or Relapse: Peginterferon (IFN) Ineligible HCV genotype 1, 3, or 4 ^ 24 weeks HCV genotype 2 48 weeks HCV genotype 1, 2, 3, or 4 or until the time of liver With decompensated cirrhosis (moderate transplantation, whichever to severe hepatic impairment; CTP occurs first class B or C) Previous Treatment Failure* HCV genotype 1 sofosbuvir + simeprevir + ribavirin HCV genotype 2 sofosbuvir + IFN + ribavirin HCV genotype 3 or 4 HCV genotype 1! sofosbuvir + IFN + ribavirin IFN and ribavirin may be With previous telaprevir or boceprevir continued for up to 24 weeks treatment failure Therapy for unique patient populations not listed above such as those with severe renal impairment, post-transplant, etc. will be reviewed on a case by case basis. ^Per simeprevir package insert, dosage recommendations for cirrhotic patients include 24 weeks of simeprevir + sofosbuvir. The simeprevir + sofosbuvir regimen is not approved at this time. *Treatment failure is defined as partial or null response to treatment with IFN/ribavirin. Relapse to prior therapy should be treated the same as treatment-naïve! No approved regimens are available at this time for genotypes 2, 3, or Renewal Refill week of weeks regimen Confirmed negative illicit drug test 4 weeks after the start of therapy. Confirmed negative alcohol screening test 4 weeks after the start of therapy Treatment start date: HCV RNA level during therapy HCV RNA level post therapy Week 4 Date Week 12 Date Week 8 Date Week 24 Date Week 12 Date Week 24 Date 7. Signature Provider Signature: Date: Provider signature indicates provider attests to all information outlined in the Hepatitis C Prior Authorization Criteria and Policy and Patient Education for Hepatitis C Treatment Prescriber Certification documents. Reference: 1) European Association for the Study of the Liver, EASL, 2) World Health Organization, WHO, 3) American Association for the Study of Liver Diseases, AASLD, Last reviewed 12/12/2014

5 Patient Education for Hepatitis C Treatment Prescriber Certification Please sign and fax to (866) with the Hepatitis C Prior Authorization Criteria and Policy and Agents for Hepatitis C Prior Authorization Request Form. As the prescriber I agree to provide verbal and written educational information regarding Hepatitis C Virus (HCV) and current treatment options, including but not limited to the following: Prevention of HCV re-infection and Human Immunodeficiency Virus (HIV) transmission Patients should abstain from intravenous drug use and understand other methods of transmission include needle sharing, sex with infected partners, sharing personal items that might have blood on them such as razors or toothbrushes, exposure to infected blood and body fluids via cuts or sores on the skin, or potentially via infected breast milk. Patients should understand the impact of alcohol and illicit drugs and their ability to impair judgments and alter decision making. If appropriate, patient should be educated on the importance of maintaining enrollment with a drug use disorder recovery program and compliance with related drug use disorder treatment medications Prevention of liver disease progression HCV-positive persons should be advised to avoid alcohol because it can accelerate cirrhosis and end-stage liver disease. HCV-positive persons should check with a health care professional before taking any new prescription pills, over the counter drugs, or supplements. Drug treatment process Patient should provide accurate contact information. Medicaid may deny a refill or authorization request due to failure to refill the medication in a timely manner, defined as a refill that is greater than 5 days late. Appropriate education regarding dosage, therapy, side effects and adverse events related to selected treatment regimen, and therapy duration. Treatment compliance as well as laboratory testing during and after the end of treatment are required. Pregnancy is contraindicated during treatment. Two methods of contraception are recommended. Additional information Prescriber agrees to provide any documentation outlined on the prior authorization form if requested by patient's health plan provided the request is in compliance with HIPAA. Failure to provide required labs or requested documents in the requested time period may result in treatment denial. Patient education information and printable documents may be found at and Physician Signature Date Physician Printed Name Patient acknowledgment By signing below, I agree that the doctor has explained the contents of this letter and answered any questions I have regarding my Hepatitis C treatment. Patient Signature Date Last revised 12/16/2015