HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES

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1 Generic Brand HICL GCN Exception/Other CERTOLIZUMAB PEGOL CIMZIA GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Is the request for a patient with a diagnosis of moderate to severe rheumatoid arthritis (RA) and does the request meet ALL of the following criteria? o At least one disease-modifying antirheumatic drug (DMARD) such as: methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine o An alternative biologic agent approved for RA Previous trial with two of the following: Enbrel, Humira, or Xeljanz If no, continue to #2. 2. Is the request for a patient with a diagnosis of psoriatic arthritis (PsA) and does the request meet ALL of the following criteria? or dermatologist o An oral disease-modifying antirheumatic drug (DMARD) such as: methotrexate, leflunomide, sulfasalazine o An alternative biologic agent approved for PsA Previous trial with two of the following: Enbrel, Humira, Stelara or Xeljanz If no, continue to #3. 3. Is the request for a patient with a diagnosis of ankylosing spondylitis (AS) and does the request meet ALL of the following criteria? o At least one prescription-strength NSAID (non-steroidal anti-inflammatory drug), such as, celecoxib, diclofenac, ibuprofen, naproxen or meloxicam o An alternative biologic agent approved for AS Previous trial with Enbrel or Humira If no, continue to #4. Page 1

2 INITIAL CRITERIA (CONTINUED) 4. Is the request for a patient with a diagnosis of moderate to severe plaque psoriasis (PsO) and does the request meet ALL of the following criteria? Prescribed by (or in consultation with) a dermatologist Previous trial with at least one of the following: o A course of systemic therapy for psoriasis, such as, acitretin, cyclosporine, methotrexate, oral methoxsalen plus UVA light (PUVA) o An alternative biologic agent approved for PsO Previous trial with two of the following: Enbrel, Humira, or Stelara If no, continue to #5. 5. Is the request for a patient with moderate to severe Crohn's disease (CD) and does the request meet ALL of the following criteria? Prescribed by (or in consultation with) a gastroenterologist Previous trial with an alternative biologic agent approved for CD or a previous trial with at least two of the following conventional therapies: o Corticosteroids (such as prednisone, prednisolone, methylprednisolone, budesonide) o 5-Aminosalicylates (such as sulfasalazine, mesalamine, olsalazine, balsalazide), o Immunosuppressants/Immunomodulators (such as 6-mercaptopurine, azathioprine, methotrexate) Previous trial with Humira and Stelara If no, do not approve. Please use status code #238 and the denial text provided. DENIAL TEXT (if diagnosis is not met): Per your health plan's Certolizumab (Cimzia) guideline, this medication is only covered for one of the following conditions: Rheumatoid Arthritis, Psoriatic Arthritis, Plaque Psoriasis, Ankylosing Spondylitis, or Crohn s Disease. Your provider did not indicate that you are being treated for any of these conditions and therefore your request was (Denial text continued on next page) Page 2

3 DENIAL TEXT (RA): Per your health plan's Certolizumab (Cimzia) guideline, this medication is only covered for moderate to severe Rheumatoid Arthritis when you meet all of the following conditions: o At least one disease-modifying antirheumatic drug (DMARD) such as: methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine o An alternative biologic agent approved for RA Previous trial with two of the following medications: Enbrel, Humira, or Xeljanz DENIAL TEXT (PsA): Per your health plan's Certolizumab (Cimzia) guideline, this medication is only covered for Psoriatic Arthritis when you meet all of the following conditions: or dermatologist Previous trial with an oral disease-modifying antirheumatic drug (DMARD) such as, methotrexate, leflunomide, sulfasalazine, or with an alternative biologic medication approved for psoriatic arthritis Previous trial with two of the following medications: Enbrel, Humira, Stelara or Xeljanz DENIAL TEXT (AS): Per your health plan's Certolizumab (Cimzia) guideline, this medication is only covered for Ankylosing Spondylitis (AS) when you meet all of the following conditions: Previous trial with at least one prescription-strength NSAID (non-steroidal anti-inflammatory drug), such as celecoxib, diclofenac, ibuprofen, naproxen, or meloxicam, or with an alternative biologic agent approved for AS Previous trial with Enbrel or Humira (Denial text continued on next page) Page 3

4 DENIAL TEXT (PsO): Per your health plan's Certolizumab (Cimzia) guideline, this medication is only covered for moderate to severe plaque psoriasis when you meet all of the following conditions: 18 years of age or older Prescribed by (or in consultation with) a dermatologist Previous trial with an alternative biologic agent approved for plaque psoriasis or with at least one course of systemic therapy for psoriasis, such as, acitretin, cyclosporine, methotrexate, oral methoxsalen plus UVA light (PUVA) Previous trial with at least two of the following: Enbrel, Humira, or Stelara Your provider did not indicate [specific criteria not met], and therefore your request was not approved. DENIAL TEXT (CD): Per your health plan's Certolizumab (Cimzia) guideline, this medication is only covered for moderate to severe Crohn's disease when you meet all of the following conditions: Prescribed by (or in consultation with) a gastroenterologist Previous trial with an alternative biologic medication approved for CD or with at least two of the following conventional therapies: o Corticosteroids (such as prednisone, prednisolone, methylprednisolone, budesonide) o 5-Aminosalicylates (such as sulfasalazine, mesalamine, olsalazine, balsalazide), o Immunosuppressants/Immunomodulators (such as 6-mercaptopurine, azathioprine, methotrexate) Previous trial with Humira and Stelara Page 4

5 6. Please approve for 12 months by HICL up to 13 fills. (Cimzia is hard-coded for one kit (two 200 mg vials/syringes) per 28 days, and one Starter kit (six 200 mg syringes) per year). Please use status code #056 and the approval text provided. NOTE: For RA, PsA, AS and CD and for members who are new to therapy, please enter two PAs as follows: First PA: Approve three kits (6 syringes) for the first month; fill count = 1. (Enter 'F' in the restriction field with a Max Quantity of 3.) Second PA: Approve for 11 months; fill count = 12. (NOTE: Please enter a start date 3 weeks after the initial PA.) APPROVAL TEXT (RA, PsA, AS, CD; new starts): Your request for Cimzia has been approved for a 12-month period for one starter kit (up to six syringes) for the first 28 days and then one kit (two vials or syringes) per 28 days for the remaining 11 months. APPROVAL TEXT (RA, PsA, AS, CD; continue Cimzia therapy without a loading dose): Your request for Cimzia has been approved one kit (two syringes) per 28 days for a 12-month period. NOTE: If the request is for Plaque Psoriasis (PsO), please enter 'F' in the restriction field with a Max Quantity of two kits (#4 syringes) per 28 for 12 months. APPROVAL TEXT (PsO): Your request for Cimzia has been approved with a quantity limit of two kits (four syringes) per 28 days for a 12-month period. Page 5

6 RENEWAL CRITERIA 1. Does the request meet ALL of the following criteria? Prescribed for one of the following diagnoses: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or Crohn's disease Prescribed by (or in consultation with) a dermatologist, rheumatologist, or gastroenterologist Documentation that the patient experienced improvement while on therapy If yes, approve for 12 months by HICL up to 13 fills. (Cimzia is hard-coded for one kit (two 200 mg syringes) per 28 days). Please use status code #056 and the approval text provided. APPROVAL TEXT (RA, PsA, AS, CD): Your request for Cimzia has been approved for one kit (two vials/ syringes) per 28 days for a 12-month period. NOTE: If the request is for Plaque Psoriasis (PsO), please enter 'F' in the restriction field with a Max Quantity of two kits (#4 syringes) per 28 for 12 months. APPROVAL TEXT (PsO): Your request for Cimzia has been approved with a quantity limit of two kits (four syringes) per 28 days for a 12-month period. If no, do not approve. Please use status code #238 and the denial text provided. DENIAL TEXT: Per your health plan's Certolizumab (Cimzia) guideline, authorization for renewal requires that you meet all of the following conditions: Prescribed for one of the following diagnoses: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or Crohn's disease Prescribed by (or in consultation with) a dermatologist, rheumatologist, or gastroenterologist Documentation that you experienced improvement while on therapy Your provider did not indicate that [specific criteria not met], and therefore your request was Page 6

7 RATIONALE Ensure appropriate diagnostic, utilization and safety criteria are used for the management of prior authorization requests for Cimzia. Promote use of preferred products Enbrel, Humira, Stelara and Xeljanz, when appropriate. FDA APPROVED INDICATIONS Cimzia is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. Treatment of adults with moderately to severely active rheumatoid arthritis. Treatment of adult patients with active psoriatic arthritis. Treatment of adults with active ankylosing spondylitis Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy Dosing: Cimzia is administered by subcutaneous injection. The initial dose of Cimzia is 400 mg (given as two subcutaneous injections of 200 mg). Crohn's Disease: 400 mg initially and at weeks 2 and 4. If response occurs, follow with 400 mg every four weeks Rheumatoid Arthritis: 400 mg initially and at weeks 2 and 4, followed by 200 mg every other week; for maintenance dosing, 400 mg every 4 weeks can be considered Psoriatic Arthritis: 400 mg initially and at week 2 and 4, followed by 200 mg every other week; for maintenance dosing, 400 mg every 4 weeks can be considered. Ankylosing Spondylitis: 400 mg initially and at weeks 2 and 4, followed by 200 mg every other week or 400 mg every 4 weeks. Plaque Psoriasis: 400 mg (given as 2 subcutaneous injections of 200 mg each) every other week. For some patients (with body weight 90 kg), a dose of 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at Weeks 2 and 4, followed by 200 mg every other week may be considered. REFERENCES UCB, Inc. Cimzia product information, Smyrna, GA. January Created: 09/14 Effective: 10/01/18 Client Approval: 07/18/18 P&T Approval: 09/27/18 Page 7

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