HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES HUMIRA PEDIATRIC

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1 Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA HUMIRA PEDIATRIC GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Is the patient currently taking Humira? If yes, continue to the Renewal Criteria. If no, continue to #2. 2. Is the patient 18 years of age or older with moderately to severely active rheumatoid arthritis? If yes, continue to #3. If no, continue to #5. 3. Has this drug been prescribed by (or in consultation with) a rheumatologist? If yes, continue to #4. covered for moderately to severely active Rheumatoid Arthritis when prescribed by (or in consultation with) a rheumatologist. Your physician did not indicate that they specialize in this area, or are in consultation with a specialist, and therefore your request was not approved. 4. Has the patient previously tried or does the patient have a contraindication to at least one DMARD such as: methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine? covered for moderately to severely active Rheumatoid Arthritis after a trial of at least one DMARD (disease-modifying antirheumatic drug) such as methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine. Your physician did not indicate that you have tried one of these drugs and therefore your request was not approved. 5. Is the patient 18 years of age or older with active psoriatic arthritis? If yes, continue to #6. If no, continue to #8. Page 1

2 6. Has this drug been prescribed by (or in consultation with) a rheumatologist or dermatologist? If yes, continue to #7. covered for active Psoriatic Arthritis when prescribed by (or in consultation with) a rheumatologist or dermatologist. Your physician did not indicate that he or she specializes in one of these areas, or is in consultation with a specialist, and therefore your request was not approved. 7. Has the patient previously tried or does the patient have a contraindication to an oral DMARD such as: methotrexate, leflunomide, sulfasalazine? If yes, approve for 12 months by HICL up to 13 fills. Please use status code #057 and the covered for active Psoriatic Arthritis after a trial of at least one oral DMARD (disease-modifying antirheumatic drug) such as methotrexate, leflunomide, or sulfasalazine. Your physician did not indicate that you have tried one of these drugs and therefore your request was not approved. 8. Is the patient 18 years of age or older with ankylosing spondylitis? If yes, continue to #9. If no, continue to # Has this drug been prescribed by (or in consultation with) a rheumatologist? If yes, continue to #10. covered for Ankylosing Spondylitis when prescribed by (or in consultation with) a rheumatologist. Your physician did not indicate that he or she specializes in this area, or is in consultation with a specialist, and therefore your request was not approved. Page 2

3 10. Has the patient previously tried or does the patient have a contraindication to at least one prescription-strength NSAID (non-steroidal anti-inflammatory drug), such as celecoxib, diclofenac, diflunisal, etodolac, flurbiprofen, ibuprofen, ketoprofen, or meloxicam? covered for Ankylosing Spondylitis after a trial of at least one prescription-strength NSAID (nonsteroidal anti-inflammatory drug), such as celecoxib, diclofenac, diflunisal, etodolac, flurbiprofen, ibuprofen, ketoprofen, or meloxicam. Your physician did not indicate that you have tried one of these drugs and therefore your request was not approved. 11. Is the patient 2 years of age or older with juvenile idiopathic arthritis? If yes, continue to #12. If no, continue to # Has this drug been prescribed by (or in consultation with) a rheumatologist? If yes, continue to #13. covered for Juvenile Idiopathic Arthritis when prescribed by (or in consultation with) a rheumatologist. Your physician did not indicate that he or she specializes in this area, or is in consultation with a specialist, and therefore your request was not approved. 13. Has the patient previously tried or does the patient have a contraindication to at least one DMARD such as: methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine? covered for Juvenile Idiopathic Arthritis after a trial of at least one DMARD (disease-modifying antirheumatic drug) such as methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine. Your physician did not indicate that you have tried one of these drugs and therefore your request was not approved. Page 3

4 14. Is the patient 18 years of age or older with chronic moderate to severe plaque psoriasis? If yes, continue to #15. If no, continue to # Has this drug been prescribed by (or in consultation with) a dermatologist? If yes, continue to #16. covered for chronic moderate to severe Plaque Psoriasis when prescribed by (or in consultation with) a dermatologist. Your physician did not indicate that he or she specializes in this area, or is in consultation with a specialist, and therefore your request was not approved. 16. Has the patient previously tried at least one course of systemic therapy for psoriasis including (but not limited to) acitretin, cyclosporine, methotrexate, oral methoxsalen plus UVA light (PUVA)? covered for Plaque Psoriasis after a trial of at least one course of systemic therapy for psoriasis including (but not limited to) acitretin, cyclosporine, methotrexate, oral methoxsalen plus UVA light (PUVA). Your physician did not indicate that you have tried at least one course of systemic therapy for psoriasis and therefore your request was not approved. 17. Is the patient 6 years of age or older with moderately to severely active Crohn's disease or is the patient 18 years of age or older with moderately to severely active ulcerative colitis? If yes, continue to #18. If no, continue to # Has this drug been prescribed by (or in consultation with) a gastroenterologist? If yes, continue to #19. covered for moderately to severely active Crohn's Disease or moderately to severely active Ulcerative Colitis when prescribed by (or in consultation with) a gastroenterologist. Your physician did not indicate that he or she specializes in this area, or is in consultation with a specialist, and therefore your request was not approved. Page 4

5 19. Has the patient tried or does the patient have a contraindication to at least two of the following conventional therapies? Corticosteroids (such as prednisone, prednisolone, methylprednisolone, budesonide), 5-Aminosalicylates (such as sulfasalazine, mesalamine, olsalazine, balsalazide), or Immunosuppressants/Immunomodulators (such as 6-mercaptopurine, azathioprine, methotrexate) covered for moderately to severely active Crohn's Disease or moderately to severely active Ulcerative Colitis after a trial of at least two conventional therapies including Corticosteroids (such as prednisone, prednisolone, methylprednisolone, budesonide), 5-aminosalicylates (sulfasalazine, mesalamine, olsalazine, balsalazide), or Immunosuppressants/Immunomodulators (6-mercaptopurine, azathioprine, methotrexate). Your physician did not indicate that you have tried at least two of the conventional therapies and therefore your request was not approved. 20. Is the patient 18 years of age or older with moderate to severe hidradenitis suppurativa (HS)? If yes, continue to #21. If no, continue to # Has this drug been prescribed by (or in consultation with) a dermatologist? covered for moderately to severely active Hidradenitis Suppurativa when prescribed by (or in consultation with) a dermatologist. Your physician did not indicate that he or she specializes in this area, or is in consultation with a specialist, and therefore your request was not approved. Page 5

6 22. Is the patient 18 years of age or older and have a diagnosis of Uveitis (non-infectious intermediate, posterior or panuveitis)? If yes, continue to #23. covered for patients 18 years of age and older who are being treated for one of the following conditions: moderately to severely active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, chronic moderate to severe Plaque Psoriasis, moderately to severely active Ulcerative Colitis, Hidradenitis Suppurativa, Uveitis; patients 6 years of age and older with moderately to severely active Crohn's Disease; and patients 2 years of age and older with Juvenile Idiopathic Arthritis. Your physician did not indicate that you are being treated for any of these conditions and/or that you have met the age requirement and therefore your request was not approved. 23. Has this drug been prescribed by (or in consultation with) an ophthalmologist? covered for Uveitis (non-infectious intermediate, posterior and panuveitis) in adult patients when prescribed by (or in consultation with) an ophthalmologist. Your physician did not indicate that he or she specializes in this area, or is in consultation with a specialist, and therefore your request was not approved. RENEWAL CRITERIA 1. Has this drug been prescribed by (or in consultation with) a dermatologist, rheumatologist, gastroenterologist or ophthalmologist? If yes, continue to #2. covered when prescribed by (or in consultation with) a dermatologist, a rheumatologist, gastroenterologist or ophthalmologist. Your physician did not indicate that he or she specializes in one of these areas, or is in consultation with a specialist, and therefore your request was not approved. Page 6

7 RENEWAL CRITERIA (CONTINUED) 2. Does the patient have active rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, chronic plaque psoriasis, Crohn's disease, ulcerative colitis, hidradenitis suppurativa or uveitis (non-infectious intermediate, posterior or panuveitis)? If yes, continue to #3. covered for the treatment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease, Ulcerative Colitis, Juvenile Idiopathic Arthritis, Hidradenitis Suppurativa or uveitis (non-infectious intermediate, posterior or panuveitis). Your physician did not indicate that you are being treated for one of these conditions and therefore your request was not approved. 3. Has the patient experienced improvement while on therapy? DENIAL TEXT: Per your health plan's Adalimumab (Humira) guideline, authorization for renewal requires documentation of improvement of symptoms while on therapy with Humira. Your physician did not indicate that your symptoms have improved with Humira therapy and therefore your request was not approved. RATIONALE Ensure appropriate diagnostic, utilization and safety criteria are used for the management of requests for adalimumab. FDA APPROVED INDICATIONS HUMIRA 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 and psoriatic arthritis. HUMIRA can be used alone or in combination with methotrexate or other DMARDs. Page 7

8 FDA APPROVED INDICATIONS (CONTINUED) HUMIRA is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in children 6 years of age and older and in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. HUMIRA 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. HUMIRA is indicated for the treatment of adults 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 reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical functions in patients with psoriatic arthritis. Humira can be used alone or in combination with DMARDs. HUMIRA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HUMIRA can be used alone or in combination with methotrexate. HUMIRA is 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). The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers. HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa. HUMIRA is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients. Dosing: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis 40 mg every other week. Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week. Juvenile Idiopathic Arthritis 10 kg (22 lbs) to <15 kg (33 lbs): 10 mg every other week 15 kg (33 lbs) to <30 kg (66 lbs): 20 mg every other week 30 kg (66 lbs): 40 mg every other week Crohn's Disease and Ulcerative Colitis Initial dose (Day 1) is 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a maintenance dose of 40 mg every other week. Page 8

9 FDA APPROVED INDICATIONS (CONTINUED) Plaque Psoriasis 80 mg initial dose followed by 40 mg every other week starting one week after initial dose. Hidradenitis Suppurativa 160 mg subcutaneously on day 1 (four 40 mg injections in 1 day or two 40 mg injections per day for 2 consecutive days), followed by 80 mg subcutaneously 2 weeks later (day 15). Maintenance dosage: 40 mg subcutaneously every week beginning on day 29 Uveitis 80 mg initial dose followed by 40 mg every other week starting one week after initial dose. DOSAGE FORMS AND STRENGTHS 40 mg/0.8 ml in a single-use prefilled pen (HUMIRA Pen) 40 mg/0.8 ml in a single-use prefilled glass syringe 20 mg/0.4 ml in a single-use prefilled glass syringe 10 mg/0.2 ml in a single-use prefilled glass syringe REFERENCES Abbott Laboratories. Humira product information. North Chicago, IL. June Bristol-Myers Squibb. Orencia product information. Princeton, NJ. November, Felson D, Anderson J, Boers M, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995; 38: Mease P, Gladman D, Ritchlin C, et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis. Arthritis and Rheumatism 2005; 52: Braun J, Davis J et al. First update of the international ASAS consensus statement for the use of anti-tnf agents in patients with ankylosing spondylitis. Ann Rheum Dis. 2006; 65(3): Hanauer SB, Sandborn WJ, Rutgeerts P, et al. Human Anti-Tumor Necrosis Factor Monoclonal Antibody (Adalimumab) in Crohn's Disease: the CLASSIC-I Trial. Gastroenterology. 2006; 130: Colombel JF, Sandborn WJ, Rutgeerts P, et al. Adalimumab for Maintenance of Clinical Response and Remission in Patients With Crohn's Disease: The CHARM Trial. Gastroenterology. 2007; 132: Created: 09/14 Effective: 10/01/17 Client Approval: 06/30/17 P&T Approval: 09/11/17 Page 9