Applicable Coding: GCN: Solvaldi ; Harvoni ; Viekira Pak ; Daklinza , ; Technivie

Transcription

1 Policy Subject: Policy Number: Classification: Hepatitis C Agents (new) SHS PBD38 Anti-virals: Hepatitis C Policy Type: Medical Pharmacy Department: Pharmacy Product (check all that apply): Group HMO/POS ASO Medicaid PPO MIChild Healthy Michigan Plan Individual HMO/POS s: Effective : June 26, 2014 Revision : October 21, 2015 Approval : October 28, 2015 Next Review : April 2016 Clinical Approval By: Medical Directors PHP: Peter Graham, MD; SPHN: Harman Nagler, MD Pharmacy and Therapeutics Committee PHP: Peter Graham, MD; Sparrow ASO: Harman Nagler, MD Policy Statement: Physicians Health Plan, PHP Insurance & Service Company, and Sparrow PHP will cover Harvoni, Viekira Pak, Sovaldi, Technivie, and/or Daklinza through the Pharmacy Benefit based on approval by the Clinical Pharmacist or Medical Director using the following determination guidelines Applicable Coding: GCN: Solvaldi ; Harvoni ; Viekira Pak ; Daklinza , ; Technivie Clinical Determination Guidelines: Document the following with chart notes: A. General Criteria (must meet all of the following) 1. Age > Chronic Hepatitis C with detectable HCV RNA and documented genotype a. Disease severity (See Appendix I) METAVIR fibrosis score: F3 or F4 o Comparable FibroScan > 12.5 kpa or FibroTest score >0.74 METAVIR activity score: A2 or A3 3. Prescribing physician: ID, GI, hepatologist 4. No previous treatment course: Sovaldi, Harvoni, Viekira Pak, Technivie, or Daklinza (maximum 1 treatment course/lifetime) 5. Patient Lifestyle a. Negative urine & blood drug screening (10 panel) within a month of treatment initiation b. Alcohol abstinence attestation Page 1 of 5

2 B. Coverage considerations 1. Dosage regimens to be FDA approved, recommended by the current AASLD/IDSA HCV guidelines, and supported by clinical trial literature 2. For genotypes with multiple treatment regimens that have similar efficacy, preferred regimens will be determined by: a. Most cost effective and/or shortest treatment duration, then by b. Preferred agents: Viekira Pak, Technivie c. Must have clinical documented contraindication for approval of non-preferred regimens 3. Vendor: Obtain exclusively through Accredo for all plans with the exception of SPHN a. Starting 1/1/2016 SPHN plans will obtain exclusively through Accredo 4. Medicaid: Harvoni, Sovaldi, Viekira Pak, Daklinza, and Technivie are currently not a covered formulary benefit (contractually excluded) C. Exclusions 1. Non-FDA approved: indications, dosage, frequency, duration, or routes of administration 2. Child-Pugh score > 6 a. Variceal hemorrhage, ascites, spontaneous bacterial peritonitis, hepatocellular CA, hepatorenal syndrome, hepatopulmonary syndrome 3. Impaired renal function a. Harvoni - CrCl < 20 ml/min b. Sovaldi - CrCl < 30 ml/min 4. Regimens with ribavirin: a. Pregnancy: pregnant/breast-feeding women, men with pregnant female partners b. Comorbid or history of disease: severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis; hemoglobinopathies 5. Regimens with Technivie: a. Cirrhosis and/or liver scarring 6. Drug interactions (see appendix III) Page 2 of 5

3 Appendix I: METAVIR Fibrosis Score & Activity Score Fibrosis Score Activity Score No fibrosis F0 No activity A0 Portal fibrosis without septa F1 Mild activity A1 Few Septa F2 Moderate activity A2 Numerous septa w/o cirrhosis F3 Severe activity A3 Cirrhosis F4 *Activity is graded according to the intensity of necro-inflammatory lesions Appendix II: Monitoring & Patient Safety Drug Adverse Reaction Monitoring Parameters REMS Viekira Pak CNS: Fatigue (34%), insomnia (5-26%) Derm: Hypersensitivity rxns (7-24%), pruritus (7%-18%) GI: nausea (7-18%) Neuro/MSK: Weakness (4-14%) Harvoni (ledipasvir + sofosbuvir) Sovaldi (sofosbuvir) Daklinza (daclatasvir) Technivie (ombitasvir, paritaprevir, ritonavir) CNS: Fatigue (13-18%) HA (11-17%) GI: Nausea (6-9%) CNS: Fatigue (30-59%), HA (24-44%), Insomnia (15-29%) Derm: Pruritus (11-27%), skin rash (8-18%) GI: Nausea (22-34%), diarrhea (9-12%) Hem/Onc: Hgb (6-23%), anemia (6-21%) Neuro/MSK: Weakness (5-21%), myalgia (6-14%) Resp: Flu-like Sx (6-16%) Misc: Fever (4-18%), CNS: HA ( 10%), Fatigue ( 10%) GI: Nausea ( 10%) CNS: Fatigue (7 15%), Asthenia 25 29%), insomnia (5 13%) GI: nausea (9 14%) Labs: ALT/SGPT (baseline & during), HCV-RNA (pre & post) Labs: LFT, Cr (Pre,during), HCV-RNA (pre & post) Labs: LFT, Cr (Pre,during), HCV-RNA (pre & post) Pregnancy test: pre & monthly < 6 mons post d/c. Labs: ALT/SGPT (baseline & during), HCV-RNA (pre & post) Needed Page 3 of 5

4 Appendix III: Clinically Significant Drug Interactions Pharmacy Benefit Determination Policy Drug regimen Viekira Pak Harvoni (ledipasvir + sofosbuvir) Sovaldi (Sofosbuvir) Daklinza (Daclatasvir) Technivie ombitasvir, paritaprevir, ritonavir Co-administration not recommended Mod or strong CYP3A4 inducers, 2C8 inducers, 2C8 inhibitors Amiodarone, carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine, rosuvastatin, simeprevir, St John s Wort, tipranavir. Antacids*: Al 2 CO 3 carbonate, Al(HO), Al 2 PO 3, Ca 2 CO 3 cimetidine, dexlansoprazole, esomeprazole, famotidine, lansoprazole, Mg 2 CO 3, Mg(HO), MgO, nizatidine, omeprazole, pantoprazole, rabeprazole, ranitidine, Na bicarb Amiodarone, carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine, St. John s Wort, tipranavir. Atazanavir, carbamazepine, darunavir/ritonavir, dexamethasone, NNRTIs (etravirine, nevirapine), fosphenytoin, lopinavir/ritonavir, mitotane, oxcarbazepine, phenobarb, phenytoin, primidone, rifabutin, rifampin, rifapentine, St John s Wort, tipranavir. Mod or strong CYP3A4 inducers Drugs highly dependent on CYP3A4 for clearance * Separate by < 4 hours or PPIs/ H2-RAs dose, if not adjusted, will ledipasvir exposure & loss of efficacy References and Resources: 1. Viekira Pak oral tablets (ombitasvir/paritaprevir/ritonavir, dasabuvir) Package Insert. AbbVie Inc Micromedex monographs: Viekira Pak, Harvoni, Sovaldi, Daklinza, Technivie. Accessed July All-oral 12 week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology 2015;61(4): Ombitasvir + paritaprevir plus ritonavir w or w/o ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet Diagnosis of cirrhosis by transient elastography (FibroScan). Gut 2006;55: AASLD/IDSA/IAS-USA. Recommendations for testing, managing, and treating hepatitis C. Accessed on July 28, Page 4 of 5

5 Approved By: Pharmacy Benefit Determination Policy Peter Graham, MD PHP Executive Medical Director Harman Nagler, MD SPHN Executive Medical Director Human Resources Page 5 of 5