AETNA Texas Medicaid Prior Authorization Criteria and Policy Antiviral Agents for Hepatitis C Virus

Transcription

1 I. Patient Eligibility 1. Patient is a Texas Medicaid patient greater than or equal to 18 years of age 2. Patient must have the diagnosis of Chronic Hepatitis C Virus (HCV) with a confirmed genotype of 1a, 1b, 2, 3, or Patient must have at least one negative drug screening within 30 days prior to the start of HCV treatment. 4. Patient with diagnosis of illicit drug use disorder must have initiated a substance use disorder treatment program at least 6 months prior to the start of HCV treatment. 5. Patient is not consuming alcohol. 6. Prescriber must be a Board Certified Gastroenterologist, Hepatologist, or Infectious Disease physician for initial approval. a. A prescriber other than the above specialists may prescribe refills and assume responsibility and care for the patient when written consult is provided by the specialist within the last 3 months. Documentation of consult must be submitted. 7. Patient with METAVIR scores 3 or 4. a. or hepatocellular carcinoma regardless of METAVIR score. b. or post liver transplant regardless of METAVIR score. 8. Patient or if applicable, patient's female partner, is not pregnant or attempting conception. a. Patient's pregnancy status must be confirmed by a pregnancy test within 30 days prior to the start of HCV treatment. 9. Prescriber confirms that the patient is mentally competent and able to make appropriate decisions throughout treatment and is capable of completing therapy. 10. Prescriber agrees to provide required lab results at baseline and as required to monitor therapy including but not limited to: a. Height, weight, liver function tests, serum creatinine, creatinine clearance, hemoglobin, white blood cell count, absolute neutrophil count, and platelets. b. HCV RNA levels at baseline, treatment weeks 4 and 12, and week 24 if applicable. c. Documentation of labs used in the calculation of METAVIR Score must be provided if requested by the patient's health care plan. II. Treatment approval 1. Prior authorization is granted for 6 weeks per approval. 2. Prescriptions may be dispensed for a maximum of 28 day supply. 3. Labs are required at weeks 4, 12, and 24. Refill authorization may be refused if patient or prescriber are unable to provide required documents. 4. Regimen approval is based on METAVIR score, genotype, disease related conditions, concurrent drug therapies, and previous HCV treatment regimens. 5. Clients who transition to Medicaid from another health care plan while currently undergoing active HCV treatment will be allowed to continue the HCV treatment regimen without interruption regardless of drug status (preferred or non-preferred). 6. The current preferred direct acting antiviral product on the Texas Preferred Drug List is Viekira Pak. Viekira Pak is FDA approved for treatment of patients with genotype Approval of non-preferred products may be considered for patients in whom Viekira Pak is not indicated. Rev. 03/2015 Page 1 of 6

2 III. Criteria for Denial 1. Patient with METAVIR scores 0-2 without hepatocellular carcinoma or previous liver transplant. 2. Patient or patient's female partner is pregnant or attempting conception. 3. Patient has not abstained from alcohol or illicit drugs. 4. Patient has previously failed to complete therapy with direct acting antiviral agents for HCV, due to patient lack of adherence or health care plan denial. 5. Patient is genotype 5 or Patients has end stage renal disease (CrCl < 30ml/min/1.73m 2 ) 7. Patient s non-adherence to therapy for more than 7 days will result in discontinuation of prior authorization and further refills will not be allowed. Exceptions may be considered in circumstances which are beyond patient or prescriber control. IV. Additional Considerations 1. Coverage for HCV treatment will be once per lifetime. 2. Lost or stolen medications will not be replaced. Rev. 03/2015 Page 2 of 6

3 Please sign and fax to (866) with the Prior Authorization Form-Initial Request. Please read the Hepatitis C prior to signing this document. 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, including needle sharing, sex with infected partners, sharing personal items that might have blood on them such as razors or toothbrushes, or exposure to infected blood and body fluids via cuts or sores on the skin. 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 liver disease. The CDC recommends Hepatitis A and B vaccines for those with chronic liver disease as well as a yearly influenza vaccine. All HCV patients should be up to date on vaccines according to the CDC Adult Immunization Schedule. Take only medications approved by your doctor. Prescription drugs as well as over the counter medications and herbal medicines may cause further damage to the liver. A buildup of fat in the liver can cause further liver damage. Eating healthy and working out can help patients lose weight and maintain a healthy weight. Drug treatment process Prescriber must evaluate patient's mental status prior to start of treatment. Patient should provide accurate contact information with a secondary contact for backup. 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 7 days late. Treatment coverage for HCV is once per lifetime. Failure to comply with therapy may result in treatment denial now or in the future. Appropriate education regarding dosage, therapy, side effects and adverse events related to selected treatment regimen, and therapy duration must be provided prior to treatment initiation. Pregnancy is contraindicated during treatment. Two methods of contraception are recommended. Estrogen based therapies are contraindicated. Estrogen therapy should be replaced with progestin therapy if appropriate. HCV-positive persons should check with a health care professional before taking any new prescription drug, over the counter drugs, or herbal or nutritional supplements. Rev. 03/2015 Page 3 of 6

4 Additional information Prescriber agrees to provide documentation related to any information supplied 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 may result in treatment denial. Patient education information and printable documents may be found at and ProCeed is a program sponsored by AbbVie that provides personalized treatment support for patients taking Viekira Pak. For more information please call proCeed or visit Prescriber acknowledgment By signing below, I agree that I have explained the contents of this document, provided written and verbal education to the patient, and answered any questions the patient may have regarding their Hepatitis C treatment. Prescriber Signature: Date Prescriber 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 Patient Printed Name: Rev. 03/2015 Page 4 of 6

5 Please complete and fax all required documents to (866) for initial prior authorization) requests. Prior authorization will be granted for 6 weeks duration. Labs are required for weeks 0, 4, 12, and 24 of therapy. For refill authorizations please use the Prior Approval Refill Request Form. 1. Prescriber Materials Checklist Completed Initial Request PA Form Completed Prescriber Certification Copy of METAVIR score results Copy of all hepatitis C virus (HCV) treatment prescriptions 2. Client Information Name (Last, First): Medicaid ID #: Diagnosis: Date of Birth: (mm/dd/ccyy) Gender: Current Weight: lb kg 3. Prescriber Information Name: NPI #: State license #: Height: cm in Phone: Fax: Provider Specialty: 4. Laboratory (All required laboratory values and testing below must be from the previous 30 days) Value Date Critical values ALT > 10 x ULN (400 U/L) SCr > 2 mg/dl CrCl < 30 ml/min/1.73m 2 Hgb WBC ANC Plt Baseline HCV RNA level < 8.5 g/dl < 1,000 cells/µl < 500 cells/µl < 25,000 cells/µl 5. Patient Condition(s) (check all that apply): Hepatocellular carcinoma HIV co-infection Awaiting liver transplant Null responder Previous liver transplant(s) Partial responder Compensated cirrhosis Relapsed Decompensated cirrhosis End stage renal disease requiring hemodialysis Extra-hepatic manifestations (leukocytoclastic vasculitis, membranoproliferative glomerulonephritis, or symptomatic cryoglobulinemia) 6. Required Testing (Results below must be from the previous 30 days with the exception of fibrosis score testing.) HCV Genotype: 1a 1b Date of testing: METAVIR Fibrosis Score # : Date of testing: Pregnancy Test Results: Positive Negative Date of testing: Drug Test Results: Positive Negative Date of testing: Q80K polymorphism* Positive Negative N/A Date of testing: Is the patient currently abusing alcohol? Yes No History of Substance Use Disorder Treatment: Yes No Date of treatment initiation: # Documentation of METAVIR score results must be submitted. Approved documentation includes a single biopsy within previous 5 years, OR two of the following non-invasive tests from the previous 2 years: ActiTest, FIB4, Fibroscan, FibroSURE, and Hepascore. Submittal of other non-invasive tests is subject to denial. *Q80K polymorphism testing required only if requesting simeprevir therapy. Rev. 03/2015 Page 5 of 6

6 7. Prescribing Information Requested Duration of Therapy 8 weeks 12 weeks 24 weeks Greater than 24 weeks Preferred Products ombitasvir/paritaprevir/ritonavir and dasabuvir (Viekira Pak ) 12.5/75/50 mg and 250 mg tabs ribavirin Non-Preferred Products pegylated interferon sofosbuvir (Sovaldi ) 400 mg tab simeprevir (Olysio ) 150 mg cap ledipasvir/sofosbuvir (Harvoni ) mg tab Viekira Pak is the preferred direct acting antiviral drug product on the Medicaid Preferred Drug List. Selection of nonpreferred products may be appropriate for patients in whom Viekira Pak is not indicated. Situations where a nonpreferred product may be considered include patients with decompensated cirrhosis, genotypes 2, 3, or 4, or patients on contraindicated drug therapies where switching to a non-contraindicated medication may be life-threatening. Please see medication prescribing information for guidance regarding dosing adjustments and discontinuation of contraindicated drugs. If selecting a non-preferred product, please explain the reason for doing so below. Selection of a non-preferred product does not guarantee coverage. Provider additional notes: (May attach additional page if needed) 8. Signature Provider signature: Date: Provider signature indicates provider attests to all information outlined in the Prior Authorization Form,, and Patient Education for Hepatitis C Treatment Prescriber Certification documents. Rev. 03/2015 Page 6 of 6