HCV: How Do We Get the Medications to Our Patients? Liver Institute of Virginia Bon Secours Health system Richmond, Richmond Virginia Liver Institute of Virginia Education, Research and Treatment IVer for Patients with Liver Disease Bon Secours Health System Cost of HCV Treatment O S Sofosbuvir-Ledipasvir f b i L di i (Harvoni) (H i) O ~$94,500 (12 weeks) O Ombitasvir, paritaprevir + ritonavir with dasabuvir (Viekira Pak) O ~$83,000 (12 weeks) 1
Cost of HCV Treatment O Peg-interferon O ~$10,000 (12 weeks) O Ribavirin O ~$900-$2700 (12 weeks) O ~$2700-$8100 (24 weeks) O Sofosbuvir (Sovaldi) O $1000/pill O $84,000-$168,000 (12 wks-24 weeks) O Simeprevir (Olysio) O $66,000 for 12 weeks of treatment Cost of HCV Treatment O Bristol-Myers B i t lm S Squibb ibb (d (daclatasvir l t i + sofosbuvir) August 2015 (genotype 3) O $??? O Merck (elbasvir/grazoprevir)- 1st quarter 2016 O Single tablet, once daily treatment O $??? 2
Getting Meds-Step 1 O Make M k sure patients ti t h have h had d allll required i d blood tests and procedures O Blood work O Liver biopsy/fibroscan O EGD and abdominal ultrasound completed if patient is cirrhotic Getting Meds-Step 2 O Submit S b it iinformation f ti tto your dedicated d di t d specialty pharmacy. This should include: O Current insurance card O Recent lab results including HCV RNA and HCV genotype O Fibrosis score results O Most recent office note O Prescriptions for all medications 3
Getting Meds-Step 3 O Keep K a folder/file f ld /fil for f each h patient ti t O Prior authorization is usually needed for some or all medications O PA forms or PA phone number will be provided by the specialty pharmacy O Approval is quicker over the phone if you have time to answer questions O Call insurance company first thing in the morning (shorter hold time) What is Prior Authorization? O Noun N {prah-yer { h aw-ther-uh-zey-shuh th h h h n}} 1. Voluminous paperwork that turns relatively simple, all oral regimens into an administrative nightmare 2. An obstacle created to discourage providers from treating patients with HCV 4
What is Prior Authorization? (cont.) O 3. 3 A system t that th t frequently f tl removes treatment decisions from the provider/patient and places it within the realm of an anonymous voice at the other end of the telephone O See: Appeals Process O Also Al see: T Twilight ili ht Z Zone Courtesy: Michael Fried, MD Getting Meds-Step 4 O If medications are approved, approved a letter of approval will be sent to your office via fax O Fax letter of approval with prescriptions to specialty pharmacy (mandated or preferred) O Call patient to give update regarding approval O Make an appointment for teaching if needed 5
Getting Meds-Step 5 O If patients ti t are initially i iti ll d deniedi d O Develop a form letter for each common patient situation to use for appeals O Support staff can personalize it for each patient and providers can review, sign it and send it off with clinical information and supporting data O Too much information is better than too little O Include AASLD/IDSA recommendations Common Reasons for Denials O Many insurance carriers now restrict treatment to only patients with F3-F4 fibrosis scores O Medicaid now requires regular drug testing (at least 3 over a 3 month period) and documentation of negative results O Insurance carriers may have a preferred regimen on formulary 6
Patient Example O 75 y.o. Caucasian C i ffemale l O Liver transplant recipient in June 2010 O Mild renal insufficiency (creatinine ~1.5) O HCV RNA 4.5 mil IU/mL O Genotype 1a O All other labs are stable O Fibrosis score in 2012: F1 Patient Example (cont.) O Submitted S b itt d prescription i ti for f ledipasvir/sofosbuvir x 24 weeks O Insurance approved 8 weeks of therapy due to mild liver disease and HCV RNA <6 mil O A letter was written to her insurance explaining patient s case and rationale for longer therapy O Patient was approved for 24 weeks 7
Fight For Your Patients! O Special S i l populations l ti should h ld ggett an exception ti for treatment O Cryoglobulinemia (even with mild liver disease) O Liver transplant recipients should be approved for longer therapy (not 8 weeks!) O Patients with previous decompensated liver disease that subsequently stabilized and can now tolerate treatment Know Criteria for Common Insurance Companies O Familiarize F ili i yourself lf with ith th the criteria it i th thatt common insurance companies require to get patients approved. For example: O Drug testing O Labs performed in a certain time frame O Fibrosis score O HCV genotype and viral load 8
Know Criteria for Common Insurance Companies Know Criteria for Common Insurance Companies 9
Know Criteria for Common Insurance Companies Support Staff O Have H enough h supportt staff t ff to t assist i t with ith PAs PA and patient/provider needs O An alternate option is to use your dedicated smaller specialty pharmacy to help O Take time to train nurses and/or medical assistants about HCV including genotypes, viral i l lloads, d fib fibrosis i score, and d other th llab b values to assist with insurance and pharmacy calls 10
Stay Organized O EMR EMR-now now very common O Paper records for HCV treatment will be more helpful to stay organized O Patient packets O Keep a file for each patient. This should include: O Prescription referral O Insurance information O Recent labs ((including g ggenotype yp and viral load)) O PA paperwork with approval/denial documentation O Keep track of prior authorization expiration dates Delivery of Medication O Depending on the patient: O Medications will usually be mailed directly to patient s home O Medications can be mailed to the provider s office if there is a concern regarding patient s understanding of treatment O Closer monitoring of patient- they have to make each follow up appointment to get medication O Storage of meds can be an issue (refrigeration, locked med room) 11
The Long and Winding Road to Treating a Patient with HCV Office staff completes Specific Prior Authorization Request Provider discusses treatment with patient and writes prescription FAX Form to Pharmacy Benefits Manager Wait Need More Info : ReFAX Denied Call to find out what happened: on hold 30-60 min Approved Courtesy of Michael Fried, MD Take Home Points O Train T i and d use your supportt staff t ff O Accept help from a small specialty pharmacy O Organization is key O Keep a packet for each patient until they complete treatment O Know the approval criteria for common insurance companies in your area 12
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