HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES

Transcription

1 Generic Brand HICL GCN Exception/Other DEFLAZACORT EMFLAZA If the caller wishes to initiate a request then a MRF must be completed. This drug requires a written request for prior authorization. All requests for high-impact medications require review by a pharmacist prior to final approval. GUIDELINES FOR USE INITIAL CRITERIA (FOR RENEWAL CRITERIA SEE BELOW) 1. Is the request for a male patient of at least 5 years of age? If yes, continue to #2. DENIAL TEXT: Per your health plan's guideline, Emflaza is only covered for male patients at least 5 years of age. Your provider did not indicate that the request is for a male at least 5 years of age and therefore your request was not approved. 2. Is the request for the treatment of Duchenne Muscular Dystrophy (DMD), confirmed by documentation (submitted by the provider) of a mutation in the dystrophin gene? If yes, continue to #3. is only covered for the treatment of Duchenne Muscular Dystrophy (DMD), confirmed by documentation of a mutation in the dystrophin gene. Your provider did not [indicate that you are being treated for Duchenne Muscular Dystrophy (DMD) / submit documentation of a mutation in the dystrophin gene confirming Duchenne Muscular Dystrophy (DMD)] and therefore your request was not approved. 3. Has the drug been prescribed by, or in consultation with, a neurologist specializing in the treatment of DMD at a DMD treatment center? If yes, continue to #4. is only covered when prescribed by a neurologist specializing in the treatment of Duchenne Muscular Dystrophy (DMD) at a Duchenne Muscular Dystrophy (DMD) treatment center. Your provider did not indicate that he or she is a neurologist, or is in consultation with a neurologist specializing in the treatment of Duchenne Muscular Dystrophy (DMD) at a Duchenne Muscular Dystrophy (DMD) treatment center, and therefore your request was not approved. 4. Is the patient part of a Connecticut-based group? If yes, continue to #5. If no, continue to #6. Page 1

2 INITIAL CRITERIA (CONTINUED) 5. Has the patient previously tried a 2-month course of therapy with prednisone? If yes, continue to #8. If no, continue to #7. 6. Has the patient previously tried a 6-month course of therapy with prednisone? If yes, continue to #8. If no, continue to #7. 7. Did the provider submit documentation, (i.e., medical notes) that the patient experienced a severe intolerable adverse effect, such as harmful aggressive behavior, with prednisone therapy that would preclude a 2 or 6-month trial? If yes, continue to #9. is only covered for patients who have previously tried a [enter 2 or 6]-month course of therapy with prednisone or whose provider submitted medical notes indicating there was a severe intolerable adverse effect, such as harmful aggressive behavior, with prednisone therapy. Your provider did not indicate that you have tried prednisone for at least [enter 2 or 6] months or had a severe intolerable adverse effect with prednisone, and therefore your request was not approved. 8. Did the provider submit documentation indicating the patient had at least one of the following intolerable adverse effects with prednisone therapy? Cushingoid appearance/cushing syndrome Significant weight gain (i.e., at least a 10% increase in baseline weight over a 6-month period) Behavioral disturbances If yes, continue to #9. If no, do not approve. Please use status code #238 and the provided denial text. is only covered for patients with documentation of intolerable adverse effects with prednisone therapy, such as Cushingoid appearance, significant weight gain or behavioral disturbances. Your provider did not provide documentation that you had intolerable adverse effects with prednisone therapy and therefore your request was not approved. Page 2

3 INITIAL CRITERIA (CONTINUED) HARVARD PILGRIM HEALTH CARE 9. Did the prednisone dose that resulted in the intolerable adverse effects exceed the recommend dosing regimen (0.75 mg/kg/day), without attempts in dose reduction or an alternative dosing regimen to ameliorate the intolerable adverse effect(s)? If yes, do not approve. Please use status code #238 and the denial text provided. is only covered for patients with documentation of intolerable adverse effects with prednisone that did not exceed the recommended dose for your condition. Your provider did not provide documentation that your dose did not exceed the recommended dose and therefore your request was not approved. If no, continue to # Approve by HICL for 6 months. (A QL of one tablet per day and one ml (22.75 mg/ml) per day of the suspension is hard-coded.) If the request is for a dose requiring more than one tablet or one ml per day and the dose is aligned with FDA-approved dosing, (i.e., 0.9 mg/kg/day), please enter the MDD and enter 'F' in the restriction field to override the quantity limit and account for the package size of the solution. Please use status code #056 and the approval text provided. APPROVAL TEXT: Your request for Emflaza has been approved for a quantity of [ tablets per day / mls per day] for a 6-month period. RENEWAL CRITERIA 1. Has the patient experienced improvement of symptoms, measured in terms of improved motor or pulmonary function? If yes, continue to #2. DENIAL TEXT: Per your health plan's ) guideline, authorization for renewal requires documentation of improvement of symptoms with Emflaza, such as improved motor or pulmonary function. Your provider did not indicate that symptoms have improved with Emflaza therapy and therefore your request was not approved. Page 3

4 RENEWAL CRITERIA (CONTINUED) HARVARD PILGRIM HEALTH CARE 2. Did the provider submit documentation that the intolerable adverse effects that occurred with prednisone therapy resolved or were tolerable with Emflaza therapy? If yes, approve by HICL for 12 months. (A QL of one tablet per day and one ml (22.75 mg/ml) per day of the suspension is hard-coded.) If the request is for a dose requiring more than one tablet or one ml per day and the dose is aligned with FDA-approved dosing, i.e. 0.9 mg/kg/day, please enter the MDD and enter 'F' in the restriction field to override the quantity limit and account for the package size of the solution. Please use status code #056. APPROVAL TEXT: Your request for Emflaza has been approved for a quantity of [ tablets per day / mls per day] for a 12-month period. DENIAL TEXT: Per your health plan's guideline, authorization for renewal requires documentation that the adverse effects that occurred with prednisone therapy did not occur or were tolerable with Emflaza therapy. Your provider did not indicate that the adverse effects you had with prednisone did not occur with Emflaza therapy and therefore your request was not approved. RATIONALE To promote the first line use of prednisone prior to the use of Emflaza. The American Academy of Neurology (AAN) recommends prednisone and deflazacort as the preferred corticosteroids for DMD. Both are considered to be similar in efficacy as measured by slowing decline in motor, respiratory, or cardiac function, but the two agents may differ in their side effect profile. Emflaza is a derivative of prednisone that was designed to cause less adverse effects that are commonly observed with chronic corticosteroid use. This may confer an advantage in the DMD population who are at a disproportionately higher risk of developing osteoporosis or weight gain, which can contribute to an earlier loss of ambulation. AAN notes prednisone may be associated with a greater weight gain within the first 12 months (5kg vs 2kg), with no significant weight gain with longer term use for Emflaza. No differences in behavioral changes have been established, and data are insufficient to assess the risk for fractures, cataracts, or effects on blood glucose metabolism. While both agents improve muscle strength equally well, there is no evidence in the medical literature that deflazacort is superior to prednisone with a delay in loss in ambulation. FDA APPROVED INDICATIONS Emflaza is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Page 4

5 DOSING Emflaza dosing: The recommended once-daily dosage of Emflaza is approximately 0.9 mg/kg/day administered orally. For ambulatory patients, the dose of glucocorticoid is commonly increased as the child grows, with a prednisone cap of approximately mg/day and a deflazacort cap of mg/day. Prednisone dosing: Prednisone 0.75 mg/kg/day has significant benefit in DMD management and should be considered the optimal prednisone dose at this point. Prednisone 10 mg/kg/weekend is equally effective over a 12-month period, although long-term outcomes of this alternate regimen remain to be seen. REFERENCES Emflaza (deflazacort) [prescribing information]. Northbrook, IL. Marathon Pharmaceuticals LLC; February Practice Guideline Update: Corticosteroid Treatment of Duchenne Muscular Dystrophy. American Academy of Neurology. Neurology 2016 Feb 2;86(5): Bushby K, Finkel R, Birnkrant DJ, Case LE, Clemens PR et al. Diagnosis and management of Duchenne muscular dystrophy, part 1: diagnosis, and pharmacological and psychosocial management. The Lancet Neurology 2010 Jan;9(1): Created: 08/18 Effective: 11/01/18 Client Approval: 08/02/18 P&T Approval: 09/18 Page 5