COLORADO - MEDICATION AUTHORIZATION GUIDELINES CORTICOTROPIN Generic Brand HICL GCN Exception/Other CORTICOTROPIN ACTHAR HP GEL 02830 GUIDELINES FOR USE 1. Does the patient have a contraindication† to Acthar? (See contraindication list at the end of this guideline) If yes, do not approve. If no, continue to #2. 2. Will the Acthar injections be administered in a medical office? If yes, do not approve. This will be a medical benefit. If no, continue to #3. 3. Is the patient less than 2 years old and diagnosed with infantile spasms? If yes, approve for 28 days with a maximum of 8 vials (each 5mL vial contains 400 units). If no, continue to #4. 4. Does the patient have a diagnosis of nephrotic syndrome? If yes, continue to #10. If no, continue to #5. 5. Is the patient being treated for acute exacerbation of multiple sclerosis? If yes, continue to #6. If no, do not approve. 6. Does the patient have a contraindication (documented hypersensitivity) to prednisone, methylprednisolone, and dexamethasone? If yes, approve up to 120 units/day for up to 21 days (each 5mL vial contains 400 units). If no, continue to #7. 7. Has the patient failed a 3-day course of PO prednisone of at least 500mg daily, with or without a short PO prednisone taper afterwards, for this current exacerbation? If yes, continue to #8. If no, do not approve. Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year COLORADO - MEDICATION AUTHORIZATION GUIDELINES 8. Has the patient failed a 7-day course of IV or PO dexamethasone of at least 8mg daily, with or without a short PO prednisone or dexamethasone taper afterwards, for this current exacerbation? If yes, continue to #9. If no, do not approve. 9. Has the patient failed a 3-day course of IV methylprednisolone of at least 500mg daily, with or without a short oral prednisone taper afterwards, for this current exacerbation? If yes, approve up to 120 units/day for up to 21 days (each 5mL vial contains 400 units). If no, do not approve. 10. Is this prescribed by a nephrologist? If yes, continue to #11. If no, do not approve. 11. Has the patient previously been approved by Kaiser Permanente Colorado for this medication? If yes, continue to #17. If no, continue to #12. 12. Has the patient failed prednisone or prednisolone due to side effects or failure to achieve sustained partial* or complete** remission of nephrotic syndrome after 6 months of treatment? (See definitions of partial and complete remission at the end of this guideline) If yes, continue to #13. If no, do not approve. 13. Has the patient failed cyclosporine or tacrolimus due to side effects or failure to achieve sustained partial* or complete** remission of nephrotic syndrome after 6 months of treatment? (See definitions of partial and complete remission at the end of this guideline) If yes, continue to #14. If no, do not approve. 14. Has the patient failed mycophenolate mofetil or azathioprine due to side effects or failure to achieve sustained partial* or complete** remission of nephrotic syndrome after 6 months of treatment? (See definitions of partial and complete remission at the end of this guideline) Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year COLORADO - MEDICATION AUTHORIZATION GUIDELINES If yes, continue to #15. If no, do not approve. 15. Has the patient failed cyclophosphamide or chlorambucil due to side effects or failure to achieve sustained partial* or complete** remission of nephrotic syndrome after 6 months of treatment? (See definitions of partial and complete remission at the end of this guideline) If yes, continue to #16. If no, do not approve. 16. Has the patient failed rituximab due to side effects or failure to achieve sustained partial* or complete** remission of nephrotic syndrome after 6 months of treatment? (See definitions of partial and complete remission at the end of this guideline) If yes, approve up to 160 units/week for 6 months (each 5mL vial contains 400 units). If no, do not approve. 17. Did the patient achieve sustained partial* or complete** remission of nephrotic syndrome after 6 months of treatment? (See definitions of partial and complete remission at the end of this guideline) If yes, approve up to 160 units/week for 6 months (each 5mL vial contains 400 units). If no, do not approve. *A partial response in patients presenting with nephrotic range proteinuria is a reduction of ≥50 percent (either protein:cr or albumin:cr ratio), and to less than 3.5 g/day confirmed by 2 values at least 2 weeks apart AND accompanied by an improvement in creatinine (value less than before treatment started). **A complete response is a reduction in proteinuria to <200 to 300 mg/day (either protein:cr or albumin:cr ratio) confirmed by 2 values at least 2 weeks apart and accompanied with a normal creatinine (<1.1). †Contraindications to Acthar A. concomitant use of live or live attenuated vaccines when receiving immunosuppressive corticotropin dose (also a contraindication to prednisone and methylprednisolone) B. congenital infection in infants C. congestive heart failure D. hypertension, uncontrolled E. intravenous administration F. ocular herpes simplex infection G. osteoporosis Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year COLORADO - MEDICATION AUTHORIZATION GUIDELINES H. peptic ulcers, history or presence of I. primary adrenocortical insufficiency or adrenocortical hyperactivity J. scleroderma K. sensitivity to porcine protein L. surgery, recent M. systemic fungal infection (also a contraindication to prednisone, methylprednisolone and dexamethasone) Creation date: 10/25/2013 Effective date: 11/6/2013 Reviewed date: 7/1/2019 Revised date: 11/1/2016 Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year COLORADO - MEDICATION AUTHORIZATION GUIDELINES DROXIDOPA Generic Brand HICL GCN Exception/Other DROXIDOPA NORTHERA 40936 GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Is this being prescribed by a neurologist or cardiologist? If yes, continue to #2. If no, do not approve. 2. Is the patient 18 years of age or older? If yes, continue to #3. If no, do not approve. 3. Does the patient have a confirmed diagnosis of neurogenic hypotension due to Parkinson’s disease, pure autonomic failure, multisystem atrophy, non-diabetic autonomic neuropathy, or dopamine-β-hydroxylase deficiency? If yes, continue to #4. If no, do not approve. 4. Does the patient have ischemic heart disease, arrhythmias, congestive heart failure, or sustained, severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg sitting or supine)? If yes, do not approve. If no, continue to #5. 5. Does the patient have aspirin hypersensitivity or a yellow dye allergy? If yes, do not approve. If no, continue to #6. 6. Does the patient have severe renal impairment (CrCl less than 30 mL/min)? If yes, do not approve. If no, continue to #7. 7. Is the patient currently breastfeeding? Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year COLORADO - MEDICATION AUTHORIZATION GUIDELINES If yes, do not approve. If no, continue to #8. 8. Is the patient currently utilizing a non-selective MAO inhibitor, linezolid, or tedizolid*? If yes, do not approve. If no, continue to #9. 9. Is the patient symptomatic despite using non-pharmacological interventions (getting up slowly, wearing elastic stockings, adequate salt and fluid intake, elevating the head of the bed, leg-crossing, thigh contraction, etc.)? If yes, continue to #10. If no, do not approve. 10. Has the patient tried and failed fludrocortisone and midodrine individually and as a combination? If yes, approve x3 months, max daily dose #6. If no, do not approve. RENEWAL CRITERIA 1. Has the patient developed symptoms of neuroleptic malignant syndrome; ischemic heart disease; arrhythmias; congestive heart failure; sustained, severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg sitting or supine); severe renal impairment (CrCl less than 30 mL/min); or has the patient started a non-selective MAO inhibitor, linezolid, tedizolid*, or breast-feeding? If yes, do not approve. If no, continue to #2. 2. Have the patient’s symptoms improved? If yes, approve x6 months, max daily dose #6. If no, do not approve. *Possible theoretical interaction for tedizolid. Creation date: 11/16/2016 Effective date: 1/1/2017 Reviewed date: 7/1/2019 Revised date: 11/1/2016 Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year COLORADO - MEDICATION AUTHORIZATION GUIDELINES SOMATROPIN Generic Brand HICL GCN Exception/Other SOMATROPIN GENOTROPIN 02824 HUMATROPE NORDIFLEX NORDITROPIN NUTROPIN NUTROPIN AQ NUTROPIN DEPOT OMNITROPE (FORMULARY) SAIZEN SEROSTIM TEV-TROPIN ZOMACTON ZORBTIVE GUIDELINES FOR USE 1. Is the requested medication for Serostim, prescribed for the treatment of HIV/AIDS- wasting syndrome? If yes, continue to #15. If no, continue to #2. 2. Is the requested medication for Zorbtive, prescribed for the treatment of short-bowel syndrome? If yes, continue to #21. If no, continue to #3. 3. Is the requested medication Omnitrope? If yes, continue to #5. If no, continue to #4. 4. Has the patient tried or does the patient have a contraindication to Omnitrope? If yes, continue to #5. If no, do not approve. 5. Does the patient have a diagnosis of Idiopathic Short Stature (not growth hormone- deficient short stature), or is somatropin being prescribed for athletic enhancement or anti-aging purposes? Effective: June 2020 NOTE: These guidelines are subject to change at any time throughout the year COLORADO - MEDICATION AUTHORIZATION GUIDELINES If yes, do not approve. If no, continue to #6.