Pirfenidone (Esbriet) Form

Pirfenidone (Esbriet®) is a pyridone. FDA Approved Indication(s) Esbriet is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Esbriet is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Idiopathic Pulmonary Fibrosis (must meet all):

1. Diagnosis of IPF;
   2. Prescribed by or in consultation with a pulmonologist;
   3. Age ≥ 18 years;
   4. Member meets (a and b): a. Pulmonary fibrosis on high resolution computed tomography (HRCT) with one of the following (i or ii): i. Usual interstitial pneumonia (UIP) pattern; ii. Probable or indeterminate UIP pattern, and surgical lung biopsy or cellular analysis of bronchoalveolar lavage fluid confirms the diagnosis of IPF; b. Known causes of pulmonary fibrosis have been ruled out (see Appendix D);
2. Baseline forced vital capacity (FVC) ≥ 50% of predicted;
   6. Baseline carbon monoxide diffusing capacity (DLCO) ≥ 30% of predicted;
   7. If request is for brand Esbriet tablets or capsules, member must use generic pirfenidone tablets, unless contraindicated or clinically significant adverse events are experienced;
3. Esbriet is not prescribed concurrently with Ofev®;
   9. Member is not an active smoker as evidenced by recent (within the last 30 days) negative nicotine metabolite (i.e., cotinine) test;

4. Dose does not exceed all of the following (a, b, and c): a. Days 1 through 7 (both i and ii):
   i. 801 mg per day; ii. 3 capsules or 3 tablets per day; Page 1 of 6

   CLINICAL POLICY Pirfenidone b. Days 8 through 14 (both i and ii):
   i. 1,602 mg per day; ii. 6 capsules or 6 tablets per day; c. Day 15 and onward (both i and ii):
   i. 2,403 mg per day; ii. 9 capsules or 3 tablets per day. Approval duration: 6 months B. Other diagnoses/indications (must meet all):

5. If request is for brand Esbriet tablets or capsules, member must use generic pirfenidone tablets, unless contraindicated or clinically significant adverse events are experienced;
6. One of the following (a or b): a. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (i or ii): i. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or ii. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or b. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Idiopathic Pulmonary Fibrosis (must meet all):
   
   1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. If request is for brand Esbriet tablets or capsules, member must use generic pirfenidone tablets, unless contraindicated or clinically significant adverse events are experienced;

7. Esbriet is not prescribed concurrently with Ofev;

   5. If request is for a dose increase, new dose does not exceed 2,403 mg (9 capsules or 3 tablets) per day. Approval duration: 12 months Page 2 of 6

   CLINICAL POLICY Pirfenidone B. Other diagnoses/indications (must meet all):

8. If request is for brand Esbriet tablets or capsules, member must use generic pirfenidone tablets, unless contraindicated or clinically significant adverse events are experienced;

9. One of the following (a or b): a. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (i or ii): i. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or ii. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or b. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key DLCO: carbon monoxide diffusing capacity
   HCRT: high resolution computed tomography FDA: Food and Drug Administration FVC: forced vital capacity IPF: idiopathic pulmonary fibrosis UIP: usual interstitial pneumonia Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindications/Boxed Warnings None reported Appendix D: American Thoracic Society (ATS) 2018 IPF Guidelines • ATS diagnostic criteria for IPF are built around pulmonary fibrosis findings on HRCT and exclusion of known causes of interstitial lung disease (e.g., domestic and occupational environmental exposures, connective tissue disease, drug toxicity). Page 3 of 6

   CLINICAL POLICY Pirfenidone • UIP is the hallmark radiologic pattern of IPF. Honeycombing is a distinguishing feature • of UIP and must be present for a definite HRCT diagnosis of UIP to be made.
   In patients with a probable or indeterminate UIP pattern, surgical lung biopsy or cellular analysis of bronchoalveolar lavage fluid is recommended to confirm the diagnosis of IPF. Appendix E: General Information • Smoking causes decreased exposure to Esbriet, which may alter the efficacy profile of Esbriet. Instruct patients to stop smoking prior to treatment with Esbriet and to avoid smoking when using Esbriet. • The Esbriet pivotal studies included only patients with mild to moderate lung impairment per FVC and DLCO. V. Dosage and Administration
   Indication IPF Dosing Regimen Days 1 through 7: 267 mg PO TID Days 8 through 14: 534 mg PO TID Days 15 onward: 801 mg PO TID Maximum Dose Days 1 through 7: 801 mg/day
   Days 8 through 14: 1,602 mg/day
   Days 15 onward: 2,403 mg/day VI. Product Availability
   • Capsule: 267 mg • Tablets: 267 mg, 534 mg, 801 mg __ Available only as generic VII.