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Mclaren Health Plan Medicaid Prior Authorization Guidelines

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Mclaren Health Plan Medicaid Prior Authorization Guidelines MCLAREN HEALTH PLAN MEDICAID PRIOR AUTHORIZATION GUIDELINES MCLAREN HEALTH PLAN MEDICAID PRIOR AUTHORIZATION GUIDELINES Administered by Revised: 1/24/2019 Page 1 MCLAREN HEALTH PLAN MEDICAID PRIOR AUTHORIZATION GUIDELINES ABALOPARATIDE (MICHIGAN MEDICAID) Generic Brand HICL GCN Exception/Other ABALOPARATIDE TYMLOS 44231 This drug requires a written request for prior authorization. GUIDELINES FOR USE INITIAL CRITERIA: The guideline named ABALOPARATIDE (Tymlos) requires a diagnosis of osteoporosis. In addition, the following must be met: • The patient is 18 years of age or older • The patient is female and postmenopausal • The requested medication is intended for the treatment of osteoporosis • The patient has documentation (e.g. Labs, Medical Record, Special Studies and/or Physician Attestation) for ALL the following: o The patient has a baseline T-score less than or equal to -3 with a previous low-impact fracture o The patient has documented failure despite compliance for at least 2 years, intolerance or contraindication to an oral bisphosphonate o The patient has documented failure or intolerance to a compliant (at least 12 months) regimen of Reclast (zoledronic acid) RENEWAL CRITERIA: The guideline named ABALOPARATIDE (Tymlos) requires a diagnosis of osteoporosis. In addition, the following must be met with documentation (e.g. labs, medical records, special studies and/or physician attestation): • Total duration of parathyroid hormone (e.g., Forteo, Tymlos) therapy has not exceeded a total of 24 months during the patient’s lifetime • The patient is responding to treatment with evidence of maintenance or improved T-Score on DEXA scan RATIONALE To ensure appropriate use of abaloparatide (Tymlos) is consistent with FDA-approved indications and Michigan Medicaid requirements. FDA APPROVED INDICATIONS TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. TYMLOS reduced the risk of vertebral fractures and nonvertebral factures in postmenopausal women with osteoporosis. CONTINUED ON NEXT PAGE Revised: 1/24/2019 Page 2 MCLAREN HEALTH PLAN MEDICAID PRIOR AUTHORIZATION GUIDELINES ABALOPARATIDE (MICHIGAN MEDICAID) Limitation of Use: Cumulative use of TYMLOS and parathyroid hormone analogs (e.g. teriparatide) for more than 2 years during a patient’s lifetime is not recommended, due to unknown relevance of the rodent osteosarcoma findings to humans. DOSAGE AND ADMINISTRATION • The recommended dose of TYMLOS is 80 mcg subcutaneously once daily. • Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. For further dosing and administration instructions, please refer to the Prescribing Information for Tymlos. CONTRAINDICATIONS/EXCLUSIONS/DISCONTINUATION • Therapy may be discontinued if patient is noncompliant with medical or pharmacologic therapy. • No demonstrable clinically significant improvement in condition has occurred after initiation of drug therapy REFERENCES • Tymlos [Prescribing Information]. Waltham, MA: Radius Health Inc.; July 2018. • Michigan Health Plan Common Formulary Prior Authorization Criteria. Available at: https://www.michigan.gov/documents/mdhhs/MCO_Common_Formulary_PA_Criteria_FINAL_5228 28_7.pdf [Accessed October 1, 2018]. Created: 10/18 Effective: 01/01/19 Client Approval: 10/15/18 P&T Approval: N/A Revised: 1/24/2019 Page 3 MCLAREN HEALTH PLAN MEDICAID PRIOR AUTHORIZATION GUIDELINES ACITRETIN (MICHIGAN MEDICAID) Generic Brand HICL GCN Exception/Other ACITRETIN SORIATANE 07827 INITIAL CRITERIA: The guideline named ACITRETIN (Soriatane) requires a diagnosis of moderate to severe psoriasis. In addition, the following criteria must be met: • The patient is 18 years of age or older • The requested medication is prescribed by or in consultation with a dermatologist • There is documentation (e.g. labs, medical record, special studies and/or physician attestation) for BOTH of the following: o The patient has had a 90-day trial of methotrexate AND o The patient has had a trial of high dose topical steroid (e.g. betamethasone augmented, clobetasol, or halobetasol) RENEWAL CRITERIA: The guideline named ACITRETIN (Soriatane) requires a diagnosis of moderate to severe psoriasis. In addition, the following criterion must be met as documented by labs, medical record, special studies and/or physician attestation: • The patient has experienced a positive response to Soriatane therapy RATIONALE To ensure appropriate use of Soriatane is consistent with FDA-approved indications and Michigan Medicaid requirements. FDA APPROVED INDICATIONS SORIATANE is indicated for the treatment of severe psoriasis in adults. DOSAGE AND ADMINISTRATION The recommended dose of Soriatane is as follows: • Initiate with 25mg to 50mg orally once daily, given as a single dose with the main meal. • Maintenance doses of 25mg to 50mg per day may be given dependent upon an individual patient’s response to initial treatment. • Individualizing the dosage is required to achieve sufficient therapeutic response while minimizing side effects, as a number of the more common side effects as dose-related. For further dosage and administration details, please refer to the Prescribing Information for Soriatane. CONTRAINDICATIONS/EXCLUSIONS/DISCONTINUATION • Soriatane must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. • Soriatane is contraindicated in patients with impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values. • Therapy may be discontinued if patient is noncompliant with medical or pharmacologic therapy. • The patient demonstrated no clinically significant improvement in condition that has occurred after initiation of drug therapy with Soriatane. CONTINUED ON THE NEXT PAGE Revised: 1/24/2019 Page 4 MCLAREN HEALTH PLAN MEDICAID PRIOR AUTHORIZATION GUIDELINES ACITRETIN (MICHIGAN MEDICAID) SPECIAL CONSIDERATIONS • Pregnancy Category X • Soriatane should not be taken with methotrexate or tetracyclines • Soriatane should not be used in patients with known alcohol abuse REFERENCES • Soriatane [Prescribing Information]. Research Triangle Park, NJ: Stiefel Laboratories Inc.; October 2018. • Michigan Health Plan Common Formulary Prior Authorization Criteria. Available at: https://www.michigan.gov/documents/mdhhs/MCO_Common_Formulary_PA_Criteria_FINAL_5228 28_7.pdf [Accessed October 1, 2018]. Created: 10/18 Effective: 01/01/19 Client Approval: 10/17/18 P&T Approval: N/A Revised: 1/24/2019 Page 5 MCLAREN HEALTH PLAN MEDICAID PRIOR AUTHORIZATION GUIDELINES ADALIMUMAB (MICHIGAN MEDICAID) Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA 37262 99439 97005 18924 GUIDELINES FOR USE INITIAL CRITERIA: The guideline named ADALIMUMAB (Humira) requires a diagnosis of ankylosing spondylitis, hidradenitis suppurativa, plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, crohn’s disease, ulcerative colitis, pediatric crohn’s disease or non- infectious uveitis. In addition, the following criteria must also be met: For patients with active ankylosing spondylitis (AS), approval requires: • The patient is 18 years of age or older • Therapy is prescribed by or given in consultation with a rheumatologist • The patient has documentation (e.g. labs, medical record, chart notes, special studies and/or physician attestation) of ALL the following: o The patient has a negative TB test within the last 12 months o The patient must not have heart failure o The patient must have the presence of active disease for at least 4 weeks o The patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or more o The patient has had a previous trial and failure to at least TWO NSAIDs (non-steroidal anti-imflamatory drugs) totaling 90 consective days o The patient has had a previous trial and failure of steroid products, sulfasalazine OR methotrexate for at least 90 consective days in the previous 120 day period For patients with a diagnosis of severe and refractory hidradenitis suppurativa (HS) approval requires: • Therapy is prescribed by or given in consultation with a dermatologist • The patient has documentation (e.g. labs, medical record, chart notes, special studies and/or physician attestation) of ALL the following: o The patient has severe and refractory hidradenitis suppurativa (i.e. Hurley Stage II or III) o The patient has a negative TB test within the last 12 months o The patient must not have heart failure o Patient understanding of general healthy habits and measures (e.g., education and support, avoidance of skin trauma, hygiene, dressings, smoking cessation, weight management, diet) o The patient has had inadequate response to intralesional corticosteroids o The patient has had inadequate response to procedural interventions (punch debridement) in combination with pharmacologic therapies CONTINUED ON THE NEXT PAGE Revised: 1/24/2019 Page 6 MCLAREN HEALTH PLAN MEDICAID PRIOR AUTHORIZATION GUIDELINES ADALIMUMAB (MICHIGAN MEDICAID) o The patient has had a previous trial and failure of systemic AND topical antibiotic therapythat includes BOTH of the following: . 3 months of topical antibiotics . 3 months of doxycycline OR 3 months of clindamycin plus rifampin o The patient has had a previous
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