UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 1041-8 Program Prior Authorization/Notification Medication Humira (adalimumab) P&T Approval Date 1/2007, 6/2008, 4/2009, 6/2009, 12/2009, 7/2010, 11/2010, 7/2011, 11/2011, 7/2012, 11/2012, 2/2014, 2/2015, 11/2015, 3/2016, 8/2016, 8/2017 Effective Date 11/1/2017; Oxford only: 11/1/2017 1. Background: Humira (adalimumab) is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. 1 It is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in pediatric patients 2 years of age and older. 1 Humira is also indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. 1 It is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Humira is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn s disease who have had an inadequate response to conventional therapy. 1 It is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. 1 Humira is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate. 1 Examples of conventional therapy include anti-inflammatory drugs, corticosteroids, and oral immunosuppressive agents. 2,3 Humira is also indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6- mercaptopurine (6-MP). 1 Humira is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Humira is indicated for the treatment of moderate to severe hidradenitis suppurativa. 1 Finally, Humira is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients. 1 1
2. Coverage Criteria: A. Rheumatoid Arthritis (RA) (1) Diagnosis of moderately to severely active rheumatoid arthritis B. Polyarticular Juvenile Idiopathic Arthritis (PJIA) (1) Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis 2
C. Psoriatic Arthritis (PsA) (1) Diagnosis of active psoriatic arthritis (2) Patient is not receiving Humira in combination with any of the following: (c) Phosphodiesterase 4 (PDE4) inhibitor [e.g. Otezla (apremilast)] (2) Patient is not receiving Humira in combination with any of the following: (c) Phosphodiesterase 4 (PDE4) inhibitor [e.g. Otezla (apremilast)] D. Plaque Psoriasis 3
(1) Diagnosis of moderate to severe chronic plaque psoriasis (2) Patient is not receiving Humira in combination with any of the following: (c) Phosphodiesterase 4 (PDE4) inhibitor [e.g. Otezla (apremilast)] (2) Patient is not receiving Humira in combination with any of the following: (c) Phosphodiesterase 4 (PDE4) inhibitor [e.g. Otezla (apremilast)] E. Ankylosing Spondylitis (AS) (1) Diagnosis of active ankylosing spondylitis 4
F. Crohn s Disease (CD) a. Humira will be approved based on all of the following criteria: (1) Diagnosis of moderately to severely active Crohn s disease (2) One of the following: (a) Member has had an inadequate response to conventional therapies (examples include anti-inflammatory drugs, corticosteroids, or oral immunosuppressive agents) for Crohn s disease (b) Member has lost response/intolerance to Remicade (infliximab) therapy (3) Patient is not receiving Humira in combination with either of the following: G. Ulcerative Colitis 5
a. Humira will be approved based on all of the following criteria: (1) Diagnosis of moderately to severely active ulcerative colitis 1 (2) Patient has had prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6- mercaptopurine) 1 (3) Patient is not receiving Humira in combination with either of the following: Authorization will be issued for 12 weeks. H. Hidradenitis Suppurativa (HS) (1) Diagnosis of moderate to severe hidradenitis suppurativa 6
H. Uveitis (UV). (1) Diagnosis of non-infectious uveitis. 3. Additional Clinical Rules: Supply limits may be in place. 7
4. References: 1. Humira [package insert]. North Chicago, IL: AbbVie Inc.; May 2017. 2. Kornbluth A, et al; Ulcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters Committee, Am J Gastroenterol 2010;105:501-23. 3. Lichtenstein GR, Abreu MT, Cohen R, Tremaine W. American Gastroenterological Association Institute medical position statement on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease. Gastroenterology 2006 Mar;130(3):935-9. Program Prior Authorization/Notification - Humira (adalimumab) Change Control 2/2014 Background updated. Concomitant therapy criterion condensed to list four biologic DMARDs and revised to include Xeljanz. Reauthorization criteria revised to standard verbiage and to include concomitant therapy criterion. Extended reauthorization duration to 24 months. 9/2014 Administrative change - Tried/Failed exemption for State of New Jersey removed. 2/2015 Annual review with no change to coverage criteria. Minor reformatting. Updated background and references. 11/2015 Added the indication and criteria for hidradenitis suppurativa. Updated criteria to align with the Indication Section of the FDA label. Updated background and references. 3/2016 Annual review. Added criteria back with language that Humira cannot be used in combination with biologic DMARDs, a Janus Kinase Inhibitor, or a Phosphodiesterase 4 inhibitor for the applicable indications. Added polyarticular to juvenile idiopathic arthritis. Updated reference. 8/2016 Added the indication and criteria for uveitis. Updated background and references. 8/2017 Annual review. Reformatted criteria for Crohn s Disease without changes in clinical intent. Updated reference. 8