BARICITINIB TAB
Clinical Criteria Summary
Document 48
Patient Selection & Diagnosis
- Moderate to severe active rheumatoid arthritis
- Prescribed and monitored by a VA/VA Community Care rheumatologist or locally designated expert
- Dosing at the FDA-recommended dose for rheumatoid arthritis, adjusting for strong organic anion transporter 3 inhibitor interactions, moderate renal impairment (GFR 30 to 60 mL/min/1.73 m2), and hematocytopenias
Infectious Disease Screening & Management
- Exclusion: Uncontrolled active infection (may start/restart once treatment for the infection is initiated)
- Exclusion: Untreated latent or active tuberculosis infection
- Exclusion: Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may initiate after starting antiviral prophylaxis)
- Exclusion: HBsAg-negative but antibody-to-hepatitis-B-core-antigen (anti-HBc)-positive and not on antiviral prophylaxis (may initiate after starting antiviral prophylaxis)
- Exclusion: Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients may be treated)
- Exclusion: Congenital or acquired immunodeficiency
- Exclusion: Malignancy in the previous 5 years other than successfully treated nonmelanoma skin cancer or successfully treated cervical cancer (unless treating rheumatologist and oncologist agree risk-benefits favor use)
- Inclusion: Completed tuberculosis test using tuberculin skin test or interferon-gamma release assay [IGRA]
- Inclusion: Completed hepatitis B screening (HBsAg, total antibody to hepatitis B core antigen [anti-HBc], and antibody to hepatitis B surface antigen [anti-HBs])
- Inclusion: Current or past completion of hepatitis C screening (may initiate while waiting for test results)
Laboratory Parameters & Organ Function
- Exclusion: Lymphocytes < 500 cells/mm3 confirmed by repeat testing, absolute neutrophils < 1000 cells/mm3, or hemoglobin < 8 g/dL (may start/restart once lymphopenia, neutropenia, and/or anemia resolve)
- Exclusion: Severe renal impairment (GFR < 30 mL/min/1.73 m2)
- Exclusion: Severe hepatic impairment (Child-Pugh class C)
Concomitant Medications & Interactions
- Exclusion: Concomitant therapy with immunosuppressive biologics or potent immunosuppressants (e.g., azathioprine, cyclosporine, tacrolimus) except during overlaps in treatment transition
- Exclusion: Concomitant therapy with strong CYP3A4 inducers (e.g., rifampin)
Vaccination Requirements
- Inclusion: Offered all age-appropriate vaccinations prior to initiating therapy
- Unless contraindicated, recombinant zoster (SHINGRIX) vaccine should be completed or at least initiated by the end of the first year of treatment, preferably when dosage is low, disease is stable, or at other times when a robust immune response can be expected
TNF-Inhibitor Prerequisites
- Inclusion: Tumor necrosis factor inhibitor (TNFI) therapy is medically inadvisable, not tolerated, or not adequate (NO response to ONE TNFI after 3 months, partial response to 3-month trials of TWO TNFIs = total 6 months, or loss of initial response)
Special Populations & Counseling
- Exclusion: Pregnancy
- Exclusion: Breastfeeding
- For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and use of effective contraception
- For females who are breastfeeding/providing breastmilk to an infant: Counseling provided on potential risks vs benefits
- For HBsAg-negative but anti-HBc-positive patients where consult is deemed indicated: GI/liver or infectious diseases expert consultation for advice on starting antiviral prophylaxis or preemptive monitoring for HBV reactivation
Monitoring & Retesting
- Routine retesting is not required for prescription renewals; retesting in high-risk patients should be considered
Document 491
Indication & Patient Selection
- Treatment of adults with severe alopecia areata (AA)
- Patients should have a SALT score ≥ 50
- Current episode of alopecia > 6 months to < 8 years without spontaneous improvement (≤ 10-point reduction in SALT score) in the previous 6 months, or episodes lasting ≥ 8 years if episodes of hair regrowth were observed on affected areas in the previous 8 years
Dosing Regimen
- Recommended dose: 2 mg orally once daily with or without food
- If response is inadequate, increase to 4 mg once daily
- For patients with nearly complete or complete scalp hair loss (with or without substantial eyelash or eyebrow hair loss), consider treating with 4 mg once daily
- After an adequate response is obtained with 4 mg once daily, decrease to 2 mg once daily
- Available dosage forms: 1 mg, 2 mg, and 4 mg tablets
Dosage Modifications & Interruptions
- Hematocytopenias: Dosage interruptions recommended for absolute lymphocyte counts < 500 cells/μL, absolute neutrophil count < 1000 cells/μL, or hemoglobin < 8 g/dL
- Renal Impairment: Dosage modification recommended for moderate renal impairment (eGFR 30 to ≤ 60 mL/min/1.73 m2); not recommended in severe renal impairment (eGFR < 30 mL/min/1.73 m2)
- Hepatic Impairment: Dosage interruption recommended if increases in ALT or AST occur and drug-induced liver disease is suspected; not recommended in severe hepatic impairment
- Strong OAT3 Inhibitors (e.g., probenecid): Dosage reduction recommended if recommended daily dosage is 2 mg or 4 mg; if recommended dose is 1 mg daily, consider discontinuing the inhibitor
Contraindications & Limitations of Use
- Not recommended for use in combination with other JAKIs, biologic immunomodulators, cyclosporine, or other potent immunosuppressants
- Boxed warnings, contraindications, and other warnings/precactions are the same as for rheumatoid arthritis
VA-Specific Formulary Criteria
- May be used in patients with severe AA (≥ 50% scalp hair loss)
- Patients should have tried and had intolerance or an inadequate response to a systemic corticosteroid unless it is medically inadvisable
- Should not be used in patients with severe AA who had no hair regrowth with previous systemic JAKI therapy
Document 492
Exclusion Criteria
- Uncontrolled active infection (may start/restart once treatment for infection is initiated)
- Untreated latent or active tuberculosis infection
- Hepatitis B surface antigen (HBsAg)-positive and not on antiviral prophylaxis (may initiate after starting antiviral prophylaxis)
- Untreated HIV infection (treated, well-controlled, asymptomatic HIV-positive patients may be treated)
- Congenital or acquired immunodeficiency
- Malignancy within the previous 5 years other than successfully treated nonmelanoma skin cancer or successfully treated cervical cancer (unless treating dermatologist and oncologist agree risk-benefits favor use)
- At increased risk of thrombosis or major adverse cardiovascular events where potential harms are expected to outweigh anticipated benefits
- Lymphocytes < 500 cells/mm3, absolute neutrophils < 1000 cells/mm3, or hemoglobin < 8 g/dL (may start/restart once lymphopenia, neutropenia, and/or anemia resolve)
- Severe renal impairment (eGFR < 30 mL/min/1.73 m2)
- Severe hepatic impairment (Child-Pugh class C)
- Concomitant therapy with immunosuppressive biologics or potent immunosuppressants (except overlaps during treatment transition)
- Concomitant therapy with strong CYP3A4 inducers (e.g., rifampin)
- Pregnancy
- Breastfeeding
- Concomitant live or live-attenuated vaccines or administration of inactivated, live, or live-attenuated vaccines less than 2 weeks before initiation
- NO hair regrowth with previous use of a systemic Janus kinase inhibitor
Inclusion Criteria
- Prescribed and monitored by a VA/VA Community Care dermatologist or locally designated expert
- Diagnosis of severe alopecia areata based on ≥ 50% scalp hair loss
- Offered all age-appropriate vaccinations prior to initiating therapy
- Completed tuberculosis (TB) test using tuberculin skin test or interferon-gamma release assay (IGRA)
- Completed hepatitis B screening (HBsAg, total antibody to hepatitis B core antigen [anti-HBc] and antibody to hepatitis B surface antigen [anti-HBs])
- Current or past completion of hepatitis C screening (may initiate while waiting for test results)
Additional Inclusion Criteria
- If HBsAg-negative but anti-HBc-positive and consult deemed indicated: GI/liver or infectious diseases expert consulted for advice on starting antiviral prophylaxis or preemptively monitoring for HBV reactivation
- For females who can become pregnant: Pregnancy status checked; counseling provided on potential risks vs benefits of treatment and use of effective contraception
- For females who are breastfeeding/providing breastmilk to an infant: Counseling provided on potential risks vs benefits of treatment
Dosing & Monitoring Requirements
- Prescribed at the FDA-recommended dose for severe alopecia areata, adjusting for strong organic anion transporter 3 inhibitor drug interactions, moderate renal impairment (eGFR 30 to < 60 mL/min/1.73 m2), and hematocytopenias
- Routine retesting is not required for prescription renewals; retesting in high-risk patients should be considered
- Antiviral prophylaxis for HBV should use agents with a high genetic barrier to resistance (e.g., entecavir or tenofovir)
- Vaccinations should be updated before initiation when possible; recombinant zoster vaccine should be completed or initiated by the end of the first year, preferably at low dosage, stable disease, or times when robust immune response is expected
Clinical Policy & Context
- Alopecia areata is NOT a cosmetic condition; Directive 1108.08 policy on Cosmetic and Enhancement Drugs does NOT apply
- Individual cases that are exceptions to exclusion and inclusion criteria should be adjudicated at the local facility according to P&T Committee and Pharmacy Services policy