New York State HCV Provider Webinar Series. HCV Medication Prior Authorization

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2 New York State HCV Provider Webinar Series HCV Medication Prior Authorization

3 Objectives Describe the prior authorization process Review the required clinical criteria for medication prior authorization (PA) Identify ways to educate the patient on the prior authorization process Illustrate the barriers to access Define the key to a successful appeal process State the available resources for financial assistance

4 Direct Acting Antiviral (DAAs) Abbreviation Generic Name Brand Name Cost of Treatment (Wholesale Acquisition Cost WAC) Approved (year) Generic Price LDV/ SOF Sofosbuvir/ Ledipasvir Harvoni 12 week ($94,500) 8 week ($63,000) 2014 $24,000 Elb/Grz Elbasvir and Grazoprevir Zepatier 12 week ($65,520) 2016 N/A Sof/Vel Sof/Vel/ Vox Sofosbuvir/ velpatasvir Sofosbuvir/ velpatasvir/ voxilaprevir Epclusa 12 week ($74,760) 2016 $24,000 Vosevi 12 week ($74,760) 2018 N/A G/P Glecaprevir/ Pribrentasvir Mavyret 12 week ($39,600) 8 weeks($26,400) 2018 N/A

5 What is a Specialty Medication? Complex/life-threatening health conditions Complex to manufacture or require special handling and administration Injectable or oral, self-administered or administered by a health care provider Difficult for patients to take without ongoing clinical support; also challenging for providers to manage Costly treatment taken by a relatively small share of the population who have complex medical conditions The growth of specialty pharmacy. UnitedHealth Center for Health Reform & Modernization. April 2014.

6 Prior Authorization Process *** Approval time 1 week to >3 months***

7 Prescription sent to a pharmacy Approved Denied Which pharmacy? Copay > $50 Financial Assistance

8 If Prescription Denied Exceeds max amount Non-formulary drug Not preferred location (pharmacy) Step therapy More clinical info required Plan may cover a certain $ amount Call Rx insurance to inquire further Rx to Preferred Pharmacy (Mailorder) Try the cheaper regimen Call Rx insurance to inquire further Try other drug High co-pay Both drugs not covered at all Prior auth req Appeal 2-3 times Appeal 2-3 times Pt not sick enough Appeal 2-3 times Financial assistance program

9 Treatment Health Care Costs In Chronic HCV Increase After Development Of Cirrhosis HCV-related costs per year $17,277 $22,752 $59,995 $112,547 $145,056 Non-cirrhotic Compensated Decompensated Hepatocellular Liver liver disease cirrhosis cirrhosis carcinoma Transplant Gordon. Hepatology

10 Documents To Be Sent To Insurance Company About pages thick Chart note Labs Fibrosis Score Drug Resistance Tx Readiness Attestment form Medical necessity Illicit Drug test Manual process Fax Electronic PA Follow up 3-7 days after

11 Prior Authorization Packet Diagnosis code ICD 10 Chronic Hepatitis C = B18.2 Acute vs Chronic hepatitis C Treatment History Treatment Naïve Possibly shorter duration Treatment Experienced Historically Non-responder/ Relapser/Partialresponder Interferon / Protease Inhibitor / NS5A +/- Ribavirin CBC (Complete Blood Count) Anemic? Ribavirin ok? CMP (Comprehensive Metabolic) Renal failure? Decompensated Liver? Hepatitis C genotype Not all medications treat all genotypes! Viral load 6 month apart?

12 HCV Testing New York State (January 1, 2014) Public Health Law Age cohort between 1945 and 1965 New York City (October 27, 2017) The Board of Health adopted an amendment to the Health Code Laboratories to automatically perform an HCV RNA confirmatory test after a positive HCV antibody Annual Report, Hepatitis B and C in New York City 23% of the 11, 847 newly reported cases of HCV in 2016 never received HCV RNA confirmatory testing New York City is the first in the nation to mandate HCV antibody to reflex RNA testing by laboratories, an important health policy advancement strategy that may be replicable across the nation. Hepatitis C Antibody (HCV Ab) Check HCV RNA (Viral load) POSITIVE (+)

13 Liver Fibrosis Score Direct Tests Liver Biopsy needle procedure Fibroscan ultrasound-like procedure Indirect Tests Fibrosure (FibroTest-ActiTest) Blood test APRI (AST to Platelet Ratio Index) Calculation Ultrasound may not be enough Shaheen et al Am J Gastroenterol 2007;102: Emblem Health Hepatitis C Prior Authorization Form

14 Compensated vs Decompensated Cirrhosis Cirrhosis Severity Compensated Decompensated Child Pugh Score A or B C Liver function Normal Failing Presentation Asymptomatic Symptomatic Prognosis Good Poor Encephalopathy Ascites Bilirubin (mg/dl) Contraindication Protease inhibitors can not be used in decompensated cirrhosis! Albumin (g/dl) International Normalized Ratio

15 Ns5a Resistance Testing Baseline Ns5a resistance testing Not needed for all HCV treatment regimens or genotypes Consult with medication package insert and AASLD treatment guidelines Resistance testing in treatment-experienced patients Recommended for patients with HCV genotype 1 infection, regardless of subtype, in whom prior treatment with the HCV protease inhibitor simeprevir plus sofosbuvir has failed (no prior NS5A treatment).¹ RASs or RAVs Recommended for patients with HCV genotype 1, regardless of subtype, in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed, and who have compensated cirrhosis. 1. AASLD HCV Treatment Guidelines:

16 Treatment Readiness NYS Medicaid require the completion of one of the following assessments: DAST-10 (10 Items) AUDIT (10 Items) AUDIT- C (3 Items) CAGE-AID (4 Items) PREP-C Above questionnaires can be found:

17 Drug Test Urine test Not required by all insurances, review specific plan criteria Ensure the test performed lists all toxins 3 Ion-1 study of sofosbuvir/ledipasvir Treatment illicit drug use did not impact treatment outcome¹ 1. Grebely et al EASL 2016

18 Extrahepatic Manifestations of HCV Strongly associated Mixed cryoglobulinemia Sjögren (sicca) syndrome Lymphoproliferative disorders Porphyria cutanea tarda Neuropathy Membranoproliferative glomerulonephritis Cryoglobulinemic vasculitis 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 Ali A, Zein NN. Cleve Clin J Med. 2005;72:

19 Barriers to HCV Cure Communication! Communication! Communication! Additional blood test Patient attestment required Last fill at mail order pharmacy Screened Received test results Linked to care Linked, received diagnostic test results Initiated therapy Adhered to therapy Achieved SVR Wrong contact Info Illicit drug use Refer to specialist Alcohol abuse On treatment viral load PA extension Lost to Follow up Adapted from Linas BP et al. PLoS ONE. 2014;9:e97317.

20 Setting The Tone Manage patient expectations Patient will get the medication tomorrow! Realistic wait time Patient involvement Designate point person Specialty pharmacy Insurance company

21 Timeline PA denied 3-7 days Can take from 3 days to >4 months! Appeal denied Internal appeal days Internal external appeal 3-5 days NYS FD Approved! Expedited 3 days Standard 30 days

22 Role of Specialty Pharmacy Provide providers and patients additional support system Specialty pharmacy accreditation(s) Trained staff Drug interaction check Assist with Prior Authorization process in its entirety Local pharmacies do not stock HCV medications

23 Role of Specialty Pharmacy Appeal process Guide providers office through appeal process Appeal letter templates Assist in the follow up Patient education Primary contact for HCV prescription update Medication counseling

24 Communication is an Art!

25 Barriers to Medication Access

26 Barriers to Medication Access

27 HCV State of Medicaid Access stateofhepc.org

28 HCV: State of Medicaid Access Overall Grade

29 Reasons for Denials Approved providers only F3-4 disease (advanced fibrosis) Step therapy required Approval for 14 or 30 days only Strict ETOH and drug policy Limit coverage to once in a lifetime Apply for reauthorization at end of first month Approval for 14 or 30 days only

30 Special Circumstances Self-funded or self insured plans No jurisdiction from NYS Finance Department Human Resource Department Union plans Learn the union s process Union office is the independent reviewer of the medication approval Patients with no prescription coverage Required to utilize manufacturer assistance program

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32 Appeal Letters to Insurance Companies Be specific Address the insurance company Patient name, date of birth, ID or reference # States objective and subjective information Back it up with supportive data

33 Approval Process Process HCV HIV/HCV co-infected Prescription 22 (5%) Prior Authorization 299 (73%) Appeal 79 (19%) Patient Assistance Program 5 (1%) Not approved 5 (1%) TOTAL Approved 405 (99%) Total Not Approved DC 37 = 5 (1%) 4 (17%) 17 (73%) 2 (8%) (100%) 0 Northwell Health data analysis of 410 patients

34 Approved May Not Mean Approval Deductible Insurance pays $10,000 annually for all prescription medications Coverage only 75%

35 Copayments Type of Insurance Average of 1 st month copayment Minimum copayment Maximum copayment Medicaid $2.33 $0.00 $23.00 Medicare $ $0.00 $16, Commercial $ $0.00 $26, Northwell Health data analysis of 300 patient reported first copayment

36 Financial Assistance via Manufacturers Coupons Not applicable to patients with Medicaid and Medicare insurance

37 Manufacturer Financial Assistance Medication Harvoni Sovaldi Epclusa Vosevi Daklinza Ribasphere RibaPak Viekira Technivie Mavyret Zepatier Financial Assistance Resources SupportPath (P) BMS Patient Assistance Foundation (P) Patient Assistance Program (P) Proceed (P) Merck Access Program (P)

38 Financial Assistance Diagnosis Medication Name Insurance coverage Financial qualifications Household size and income, demographics, etc. U.S. citizenship (via SSN) Patient Access Network (PAN) (P) Healthwell Foundation (P) The Assistance Fund (TAF) (P) Patient Advocate Foundation (P) Gooddays (P)

39 No Other Options Change of prescription insurance plan Patient has to do homework Bench time Hoping next year copay will be less Clinical trials Very difficult to find NYS Attorney General s office

40 After Approval Insurance mandates preferred pharmacy to fill mid-treatment 14 days supply at a time While on treatment Insurance may require: Viral load - to prove patient is on treatment Prior authorization to extend approval period Unexpected hospitalization Remind patients to bring medication Subsequent copayment costs BEWARE! Copay of each fill EXAMPLE Bottle # 1 = $1.00 Bottle # 2 =$2,000 Bottle # 3=$4,000

41 Summary PA clinical criteria Complete PA check list, it will save you time PA process Complete PA check list, it will save you time Setting the tone with the patient No, you won t have the medication tomorrow! Appeal process Get it to New York State Finance Department Appeal! Financial assistance/resources Utilize all possible resources

42 Resources Medication and Disease Education Drug interaction Tool: Clinical Education Initiative: Hep Free NYC: NYS Department of Health National Viral Hepatitis Roundtable:

43 New York Hepatitis C Resources

44 Training and Resources Intro to Viral Hep, Hep C Patient Navigation, Hep C Point of Care Testing: CME live/online trainings/webinars on HCV care, treatment and prior authorization: HCV clinical consultation hotline HCV clinical training preceptorships For more information Meg Chappell, Program Manager at ELF megchappell@empireliverfoundation.org

45 Linkage to Care Support Find testing and care: Check Hep C Patient Navigation Program: free navigation services at multiple sites in NYC: Text LIVER to Call Farma Pene, Health Care Access Specialist,

46 Contact Us Meg Chappell, MPH Program Manager Empire Liver Foundation on.org Nirah Johnson, LCSW Director for Capacity Building NYC Health Department Subscribe to the New York Hepatitis Clinical Provider Mailing List: