Navigating The Prior Authorization Approval Process

Transcription

1 Navigating The Prior Authorization Approval Process Kristin Webb, RPCA University at Buffalo Disclosures DISCLOSURES Commercial Entity Relevance Role K. Webb Abbvie Merck, AbbVie, Tobira, Gilead Honorarium Research Support Speaker Sub- Investigator 1

2 PA Submission Initial Steps Patient readiness Access: insured? Wait times: on average, maybe up to 6 months Preferred med regimens: be aware up front and save time Patient Stability: will they be in the same place long enough to get through the approval process and Tx? Baseline lab data: PA Requirements HCV Genotype- may need to repeat if prior relapser HCV RNA w/in days depending on payer CMP / GFR Staging assessment Biopsy, fibrosure, fibroscan, imaging with stigmata of cirrhosis (nodularity, splenomegaly, varices) Toxicology screen payer dependent Pregnancy test payer dependent HIV AB testing payer dependent 2

3 Additional PA Requirements Updated demographics Prior treatment history may need documentation If cirrhotic, documentation of compensation (ie. no history of uncontrolled ascites, varices or HE) Specific Wording Need to document in the progress note: - The patient verbally agrees to comply with the treatment regimen. - There is no history of active substance abuse. - He/She is not a transplant candidate. - He/She is SOF naïve (if submitting for harvoni). - Not at risk for pregnancy (tubal ligation, hysterectomy, post-meno etc.) 3

4 Insurance Regulations- Vary by Payer Staging: In general need to be F3 or more No apparent staging criteria for HIV co-infection to date ETOH and narcotic abstinence x 3-6 months Documentation of patient readiness specific assessment tools requested at times Prescriber restrictions Specialty Pharmacy Not a requirement but very helpful Assistance with PA completion, appeals, letters etc. Improved compliance Reduction in treatment lapses Options vary by payer Services vary by pharmacy Helps to use the same pharmacy 4

5 Patient Educator Educational focus has evolved past side effects. Focus now on: - Compliance / adherence - Approval process - Treatment lapses (ie. Refill management, lab follow up) What About My F0-F2 Patient? Case by case consideration is Tx necessary; other co-morbidities; life expectancy Special populations: HIV co-infection; pre-renal transplant Coexisting liver disease (HBV, NAFLD/NASH) Some payers with no staging criteria Extrahepatic HCV manifestations 5

6 Extrahepatic Manifestations of HCV Strongly associated Mixed cryoglobulinemia Sjögren (sicca) syndrome Lymphoproliferative disorders Porphyria cutanea tarda Neuropathy Membranoproliferative glomerulonephritis Cryoglobulinemic vasculitis Adapted from Ali A, Zein NN. Cleve Clin JMed.2005;72: Possibly associated Corneal ulcers (Mooren ulcers) Thyroid disease Lichen planus Pulmonary fibrosis Type 2 diabetes Systemic vasculitis (polyarteritis nodosa, microscopic polyangiitis) Arthralgias, myalgias, inflammatory polyarthritis Autoimmune thrombocytopenia AASLD Extrahepatic Manifestations Warranting Tx Cryo workup: RF, serum cryoglobulins, C3, C4, UA 6

7 AASLD Extra-hepatic Manifestations Warranting Tx Debilitating fatigue (Class IIa, Level B) highlight if severe enough that pt can t work Diabetes Mellitus, Insulin Resistance (Class IIa, level B) glycemic control can be improved with successful HCV therapy; document A1C Porphyria Cutanea Tarda (class IIb, Level C) - rare 13 Dermatological Manifestations Cryoglobulinemic vasculitis in >10% of HCV infected patients with detectable cryoglobulins 1 Porphyria cutanea tarda (<5% of cases) 1 Lichen planus 1,2 Associated with liver disease, especially advanced hepatic disorders The relationship between HCV infection and lichen planus is controversial Lichen planus Cryoglobulinemic vasculitis 1. Ali A, Zein NN. Cleve Clin JMed.2005;72: ; 2. Ko HM, et al. Clin Dev Immunol. 2012;2012:

8 Industry Support - Gilead SUPPORT PATH: A SUITE OF RESOURCES DESIGNED TO HELP PATIENTS START WITH GILEAD HCV MEDICATIONS AND MOVE TOWARD TREATMENT COMPLETION Support Path helps patients access therapy and get off to an efficient start Benefits investigation and prior authorization support Specialty pharmacy finder Co-pay coupon With a co-pay coupon, eligible patients may pay no more than $5 per co-pay (restrictions apply) Not valid for patients enrolled in government healthcare prescription drug programs, such as Medicare Part D and Medicaid. Patients in the coverage gap known as the "donut hole" are also not eligible The HARVONI co-pay coupon program will cover out-of-pocket costs for HARVONI prescriptions up to a maximum of 25% of the catalog price of a 12-week regimen of HARVONI Other financial assistance Support Path A 24/7 help line with nurses on call to provide answers and assistance Ongoing support for access and reimbursement, including refill authorization Educational resources, support for adherence, and progress tracking Helpful ICD-9 and CPT codes CONNECTING TO SUPPORT PATH IS EASY Visit MySupportPath.com Call MYPATH ( ) 8

9 Industry Support - Abbvie proceed: Simplified Access, Coordinated Care. Gain Access - Electronic benefits verification and prior authorization system help expedite the treatment onboarding process Reduce Financial Barriers - Copay assistance and other financial support help eligible patients navigate potential cost obstacles Monitor Adherence and Track Outcomes - Identify patients in need of additional support and view patient activity - 24/7 nursing support Approved! Now What? Obtain the approval letter fax to specialty pharmacy (delivery can not occur until they have the approval letter) Pharmacy coordinates delivery usually FedEx Patient needs to notify clinic once meds received Get labs including HCV RNA two weeks after starting meds payers use the RNA as a surrogate for compliance and often will not refill without a week 4 viral load documented don t wait! 9

10 Additional Tips/Suggestions Utilization of a multidisciplinary team if possible - Case manager - Social work - Pharmacy Single point person - Handle paperwork - Coordinate with insurance, specialty pharmacy, provider, patient Questions? THANK YOU!!! 10