Attn: Pharmacy Services P.O. Box 30196 Salt Lake City, UT 84130-0196 801-442-9988 or 855-442-9988 Fax: 801-442-3006 MEDICARE PRIOR AUTHORIZATION FORM VictrelisTM and IncivekTM (boceprevir) and (telaprevir) Therapeutic use: Treatment of chronic Hepatitis C genotype 1 Quantity Limit: Victrelis: 360 capsules per month Incivek: 180 capsules per month Authorization Period: Incivek: treatment for a total of 12 weeks Victrelis: treatment initially approved for 24 weeks, extension will depend on virologic response. Patient’s Name: _____________________________________________________ DOB: ___ ___ / ___ ___ / ___ ___ ___ ___ Patient’s ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ Patient’s Phone #: ( ___ ___ ___ ) - ___ ___ ___ - ___ ___ ___ ___ Diagnosis Code(s) / ICD-9 Code(s): ___ ___ ___ ___ ___; ___ ___ ___ ___ ___; ___ ___ ___ ___ ___; ___ ___ ___ ___ ___ Physician’s name: ________________________________________________________________________________________ Phone #: ( ___ ___ ___ ) - ___ ___ ___ - ___ ___ ___ ___ Fax #: ( ___ ___ ___ ) - ___ ___ ___ - ___ ___ ___ ___ Address: ________________________________________________________________________________________________ Physician’s Signature: ________________________________________________ Date: ___ ___ / ___ ___ / ___ ___ ___ ___ Supervising Physician: ____________________________________________________________________________________ (Only required if requesting provider bills under a different provider) Urgent Request (24 hours) 1. 2. 3. 4. 5. 6. 7. 8. Standard Request (72 hours) Please check “Yes” or “No” and respond to the following requests: Which protease inhibitor is being requested? Victrelis Incivek Is the prescribing physician a gastroenterologist or an infectious disease Yes No physician (or has a GI specialist been consulted)? Is the patient diagnosed with chronic hepatitis C virus (HCV)? Yes No What is the HCV genotype? 1 2 3 4 5 6 Has the patient been treated previously with pegylated interferon-alfa? If yes, Yes No please check one: Partial responder Relapser Null responder Has the patient been treated previously with a protease inhibitor? Yes No Has the patient had a liver biopsy showing bridging fibrosis or cirrhosis? Yes No What is the HCV RNA viral load at baseline? _________________ Date: _______________ What is the HCV RNA viral load at T4W? ____________________ Date: _______________ What is the HCV RNA viral load at T8W? ____________________ Date: _______________ What is the HCV RNA viral load at T12W? ___________________ Date: _______________ What is the HCV RNA viral load at T24W? ___________________ Date: _______________ This form is intended for SelectHealth Advantage members only. All requests for prior authorization should be sent via fax to 1-801-442-3006. Missing, inaccurate, or incomplete information may cause a delay or denial of authorization. Last Updated: 01/01/2013 © 2013 SelectHealth. All rights reserved. #### ##/## Drug name Brand name: Victrels; generic name: boceprevir Brand name: Incivek; generic name: telaprevir Unique Handling Pharmacist review required for approval and denial. AWD Research Notes Medication: Victrelis or Incivek Eligible: Primary Policy: Formulary: Group Exceptions: PEC: Duplicate: PHS History: No research required Genotype (#4): HCV RNA (#9): Reauth: If Yes, initially reported HCV RNA _________ and Genotype ___________ Diagnosis: Review Outcome: Letter: Note: Pharmacist review required for approval and denial. AWD Outcome Note (Note: All denials must be forwarded to a pharmacist for review) Approved or Denied Participating/Non-Participating PA Number: Date Range: Spoke w/Faxed: Letter Cost Avoidance Grounds for denial Criteria for approval Note: Pharmacist review required for approval and denial. Does not meet criteria for approval listed below Hepatitis C: Genotype 1 Treatment meets criteria if YES to #2 and #3 AND #4 type 1 is checked AND AND NO to #5. Incivek can be approved for a total of 12 weeks Victrelis can be initially approved for 24 weeks and may be extended to 32 or 44 weeks of therapy (total) depending clinical scenario and virologic response. For specific regimens please refer to the tables below. Discontinuation based on futility includes: Detectable HCV-RNA at treatment week 24, HCV-RNA ≥ 100 IU/mL at treatment week 12 (Victrelis), HCV-RNA ≥ 1000 IU/mL at treatment week 4 or 12 (Incivek) INCIVEK Treatment-naïve and prior relapse patients (NO to #5 or YES to #5 and relapse checked) HCV-RNA Incivek Pegylated Interferon Undetectable at weeks 4 & 12 Detectable at weeks 4 and/or 12 Total Treatment Weeks 1-12 Weeks 1-24 24 weeks Weeks 1-12 Weeks 1-48 48 weeks Last Updated: 01/01/2013 © 2013 SelectHealth. All rights reserved. #### ##/## Prior partial, null responder, and cirrhotic patients (YES to #5 and partial responder or null responder OR YES to #7) All Patients Weeks 1-12 Weeks 1-48 48 weeks VICTRELIS Treatment-naïve patients (NO to #5) HCV-RNA Victrelis Pegylated Interferon Undetectable at Weeks 4-28 Weeks 1-28 weeks 8 & 24 Detectable at Weeks 4-36 Weeks 1-48 weeks 8 and/or 24 Prior partial responder and relapse patients (YES to #5 and partial responder or relapse checked) Undetectable at Weeks 4-36 Weeks 1-36 weeks 8 & 24 Detectable at Weeks 4-36 Weeks 1-48; weeks 8 and/or 24 Cirrhotic patients (YES to #7) All patients Week 4-48 1-48 Total Treatment 28 weeks 48 weeks 36 weeks 48 weeks 48 Genotype 2, 3, 4, 5, or 6 marked - DENIED Chart notes required in addition to PA form? Physician prescribing requirements Step therapy required? Benefit coverage (medical/Rx) Quantity limit Approval- Facets Entry (Pegasys and Peg Intron only) *2 log 10 drop e.g., original HCV RNA = 476,000. New score must be below 4,760 (move 2 digits over). Varies Physician is a gastroenterologist or an infectious disease physician (or is working in conjunction with one of these physicians) (see #1 on form) No RX Victrelis 360 capsules per month Service Provider = PHARMACY/OTHER (103006669101) or HOMECARE/PATIENT’S HOME (103001926101) Code: Hep C for Genotype 1, 4, 5 ,6 Initial approval for 24 weeks (6 kits), 28 weeks (7 kits) for Genotype 1 in combination with Victrelis. 1st preauthorization extension is for weeks 25-48 or 25-72. Hep C for Genotype 2 and 3- Approved for 24 weeks maximum Approval- PHS Entry (On Select- Approval only needs to be entered in PHS for Victrelis and Incivek) Denial- PHS Entry (on Select- Denial only needs to be entered in PHS for Victrelis and Incivek) AuthTab Error Category Override Flags Drug Max Cost Limitations Tab Max Days = 30 Number of Fills = 3 (Incevik); 6 (Victrelis) Notes Tab Initials, date, drug, approved, approval period (if specified) Note: If applicable, enter into PHS for adjudication under T4 benefit Authorization Tab Auth Type D Denied Notes Tab: Initials, date, drug, denied Criteria not met Denial- Facets Entry Description: Pegasys or Peg-Intron Denied Last Updated: 01/01/2013 © 2013 SelectHealth. All rights reserved. #### ##/## Code: See above Criteria not met Description: Incivek and Victrelis Denied From Date = Prime Date To Date = the Date you are entering it in Facets Service provider = pharmacy 103006669101 Code J8499 Criteria not met RxCore- PHS Approval (T4) AuthTab Error Category Override Flags Drug flag Max Cost Flag Limitations Tab Days 30 Notes Tab Initials, date, drug, approved Approval period (if specified) Authorization Tab Auth Type D Denied Notes Tab: Initials, date, drug, denied RxCore- PHS Denial (T4) Letter Text Authorization Tab Auth Type D Denied Notes Tab: This medication has been approved as a medical benefit for __ kits. Per SelectHealth Pharmacy criteria and the American Gastroenterological Association (AGA) guidelines, the patient has already used the recommended length of treatment which is ___ weeks of therapy. Therefore, the request for Peg-Intron has been denied. Per SelectHealth Pharmacy criteria, the requested medication Pegasys has been denied. HCV RNA does not indicate an active infection. Per SelectHealth Pharmacy criteria, the patient must have documented response to treatment, specifically a significant drop in their viral load, to be approved for continuation of therapy. The chart notes submitted show an increase in their viral load, therefore the request for continuation of therapy has been denied. Per SelectHealth Pharmacy criteria, the requested medication Peg-Intron has been denied. Extending treatment to 72 weeks does not result in an overall improvement in Sustained Viral Response. Cost Avoidance Important drug distribution information HPI reviewers References Per SelectHealth Pharmacy criteria, the requested medication Pegasys has been denied. Retreatment is not recommended for non-Genotype 1 previous failed treatment with peginterferon and ribavirin. $15,532 Pegasys- 24 weeks $20,160 Peg-Intron- 12 weeks Incivek: $49,200 for 12 weeks of therapy Victrelis: $26,400 for 24 weeks of therapy Members can enroll in Be In Charge program (Schering; 1-888-HEP-2608) or PegAssist program (Roche; 1-877 734-2797 or www.pegasys.com). Department pharmacist. Ghany MC, Strade DB, Thomas DL, Seeff LB. American Association of the Study of Liver Diseases (AASLD) Practice Guidelines: Diagnosis, Management, and Treatment of Hepatitis C: An Update. Hepatology 2009; vol 49(4): 1335-1374. Strader DB, Wright T, Thomas DL et al. American Association of the Study of Liver Diseases (AASLD) Practice Guidelines: Chronic Hepatitis C. Hepatology 2004;vol 39 (4):1147-1170. Last Updated: 01/01/2013 © 2013 SelectHealth. All rights reserved. #### ##/## Disease state Background drug information Authorization period Chopra S, Bisceglie AM. Pegylated interferon in the treatment of chronic hepatitis C virus infection. UpToDate: www.uptodate.com (accessed 6/22/2007). Lok AS, McMahon BJ. American Association of the Study of Liver Diseases (AASLD) Practice Guidelines: Chronic Hepatitis B. Hepatology 2007;vol 45 (2):508-539. Lok AS. Standard and pegylated interferon for chronic hepatitis B virus infection. UpToDate: www.uptodate.com (accessed 6/22/2007). Hepatitis C virus (HCV): A diagnosis of chronic HCV is made based on the presence of HCV RNA, elevated ALT, and inflammation on liver biopsy There are 6 different HCV genotypes (1,2,3,4,5,6), with genotype 1 being the most common and most difficult to treat Definitions: Rapid virological response (RVR): HCV RNA negative at treatment week 4 Early virological response (EVR): >2 log 10 reduction in HCV RNA compared to baseline at treatment week 12 Sustained virological response: HCV RNA negative 24 weeks after cessation of treatment Hepatitis C: PEG-Intron (PEG interferon alpha-2b) or Pegasys (PEG interferon alpha2a), in combination with the oral antiviral Ribavirin, is currently the treatment of choice for chronic HCV Dosing: PEG-Intron: 1.5 µg/kg injected subcutaneously once weekly (in combination with Rebetol™) Ribavirin (Rebetol) in combination with Peg-Intron: <75kg: 1000 mg/day in 2 divided doses >75kg: 1200 mg/day in 2 divided doses Pegasys: 180 µg (1.0 mL) injected subcutaneously once weekly Ribavirin (Copegus™) in combination with Pegasys: Genotype 1,4; <75kg: 1000 mg/day in 2 divided doses Genotype 1,4; >75kg: 1200 mg/day in 2 divided doses Genotype 2,3: 800 mg/day in 2 divided doses Protease Inhibitors are indicated in the treatment of HCV Genotype 1 infection in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy, including prior null responders, partial responders, and relapsers Dosing: Victrelis: 800 mg (four 200-mg capsules) three times daily (every 7-9 hours) with food Incivek: 750 mg (two 375-mg capsules) three times daily (every 7-9 hours) with food Hepatitis C: Initial treatment: Duration of therapy is dependent on viral genotype and achievement of a virologic response : Genotypes 1 refer to duration of therapy tables above Genotype 4,5,6 treated for 48 weeks if EVR , 72 weeks if viral clearance between 12 and 24 weeks Genotype 2 and 3 for 24 weeks This form is intended for SelectHealth members only. All requests for preauthorization should be sent via fax to 1-801-442-3006. Missing, inaccurate, or incomplete information may cause a delay or denial of authorization. Preauthorization Internal Documentation Last Updated: 01/01/2013 © 2013 SelectHealth. All rights reserved. #### ##/##