Pharmacy Prior Authorization GMH/SA and Non-Title XIX/XXI SMI Non-Formulary, Prior Authorization and Step-Therapy Guidelines

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1 Pharmacy Prior Authorization GMH/SA and Non-Title XIX/XXI SMI Non-Formulary, Prior Authorization and Step-Therapy Guidelines Scroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name Policy Requirements Duration of Approval if Requirements Are Met ADHD medications for children under 6 years old Stimulants (amphetamines, methylphenidates) Strattera guanfacine ER FDA Approved Indication: Treatment of Attention Deficit Hyperactivity Disorder (ADHD) 1. The requesting clinician has documented that the child has a diagnosis of ADHD 2. Psychosocial issues and non-medical interventions are being addressed by the clinical team. 3. Documentation of psychosocial evaluation occurring before request for ADHD medications. 4. Documentation of non-medication alternatives that have been attempted before request for ADHD medications. Children under 6 years old will be monitored in accordance with the ADHS/DBHS Clinical Practice Protocol on Psychiatric Best Practice Guidelines for Children: Birth to Five Years of Age. 1. Indications other than ADHD. 2. Doses greater than FDA recommended maximum daily dosage. Note: All requests are sent to Medical Director for review. 6 months 2. Manufacturer Product Information 3. Pliska SR, Greenhill LL, Crismon ML, et al. The Texas children s medication algorithm project: report of the Texas census conference panel on medication treatment of childhood deficit/hyperactivity disorder. Part 1. J Am Academy Child Adolescent Psychology. 200;39(7):

2 Antidepressants with CYP450 mediated drug interactions TCA with fluoxetine (strong 2D6 inhibitor) TCA with paroxetine (strong 2D6 inhibitor) TCA with bupropion (moderate 2D6 inhibitor) TCA with duloxetine (moderate 2D6 inhibitor) TCA with sertraline (moderate-weak 2D6 inhibitor) Clomipramine with fluvoxamine (strong 1A2 inhibitor) Bupropion, clomipramine, duloxetine, fluoxetine, fluvoxamine, paroxetine, sertraline, tricyclic antidepressants Approved Behavioral Health Indications: Treatment Resistant Depression Obsessive Compulsive Disorder (clomipramine with fluvoxamine) 1. Approval will be granted when a member is transitioning from one medication to another. 2. Evidence of adequate trials of at least three (3) individual formulary antidepressants, from at least two (2) different therapeutic classes, for 4-6 weeks at maximum tolerated doses. Failure is due to: a. Break through symptoms or an inadequate response at maximum tolerated doses, or b. Adverse reaction(s) And 3. Documentation confirming that trials of at least two (2) evidenced based augmentation strategies have been tried for an adequate trial and failed, resulted in significant side effects, or arec ontraindicated. Examples of augmentation strategies include lithium, thyroid hormone, bupropion, mirtazapine, quetiapine, or aripiprazole. Failure is due to: a. Inadequate response at maximum tolerated doses, b. Adverse reaction(s), or c. Break through symptoms 4. Initial TCA treatment should be initiated at the lowest possible dosage. 5. Supporting clinical documentation must be provided with the initial prior authorization request. These parameters include the following: a. Assessment showing there is no evidence of cardiovascular conduction delays, b. Heart rate, c. Blood pressure and d. TCA levels. 1. Provider must provide supporting documentation that: 2

3 a. Adherence to the treatment regimen is not a contributing factor to the inadequate response to the medication trials, 1. Members with known hypersensitivity to the requested medication(s). 2. Prior Authorization Requests that do not meet the above stated criteria. 3. Members currently taking an MAOI medication. Antipsychotic medications in children under 6 years old 2. American Psychiatric Association Practice Guideline for the Treatment of patients with Major Depressive Disorder, 3 rd edition. American Psychiatric Association; October accessed 7/2/13 3. Preskorn, Sheldon H. The Potential for Clinically Significant Drug-Drug Interactions involving the CYP 2D6 system: Effects with Fluoxetine and Paroxetine versus Sertraline. Journal of Psychiatric Practice. Jan 2007: ( ), 13(1) Spina E; Trifiro G; Caraci F. Clinically Significant Drug Interactions with Newer Antidepressants.CNS Drugs Jan 1;26(1): Indiana University Division of Clinical Pharmacology P450 Drug Interaction Table. Accessed 7/2/13 6. Wagner W; Vause EW; Fluvoxamine: A Review of Global Drug-Drug Interaction Data. Clin Pharmacokinet. 1995;29 Suppl 1:26-31; discussion Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study 8. Rush AJ; Trivedi MH; Stewart JW; et al. Combining Medications to Enhance Depression Outcomes (CO-MED): Acute and Long-Term Outcomes of a Single-Blind Randomized Study. Am J Psychiatry 2011; 168: Trivedi MH, Fava M, Wisniewski SR, et al. Medication augmentation after the failure of SSRIs for depression. N Engl J Med. 2006;354(12): FDA Approved Indication: With the exception of risperidone, antipsychotics have not been approved for use in children less than 6 years old. There are few randomized controlled trials to demonstrate safety and efficacy in this population. 1. Child diagnosed, per current DSM criteria, with one of the following disorders: a. Bipolar Spectrum Disorder b. Schizophrenic Spectrum Disorder c. Tourette s or other tic disorder d. Autism Spectrum Disorder Note: All requests are sent to Medical Director for review. 6 months. 3

4 2. Psychosocial issues and non-medical interventions are being addressed by the clinical team. 3. Documentation of psychosocial evaluation occurring before request for antipsychotic medications. 4. Documentation of non-medication alternatives that have been attempted to address symptoms before request for antipsychotic medications. 5. Documentation must include information on the expected outcomes and an evaluation of potential adverse events. Children under 6 years old will be monitored in accordance with the ADHS/DBHS Clinical Practice Protocol on Psychiatric Best Practice Guidelines for Children: Birth to Five Years of Age. 1. Members with known hypersensitivity to requested agent. 2. Members not meeting above stated criteria. Brand Name Antipsychotic Augmentation of Antidepressant Therapy 1. ADHS/DBHS: Practice Parameter for the Use of Atypical Antipsychotic Medications in Children and Adolescents 2. Pliska SR, Greenhill LL, Crismon ML, et al. The Texas children s medication algorithm project: report of the Texas census conference panel on medication treatment of childhood deficit/hyperactivity disorder. Part 1. J Am Academy Child Adolescent Psychology. 200;39(7): Correll CU, Manu P, et al. Cardiometabolic risk of second-generation antipsychotic medications during first time use in children and adolescents. JAMA. 2009: 302(16): McClellan J, Kowatch R, Findling RL. Practice parameter for the assessment and treatment of children and adolescent with bipolar disorder. J AM Child Adolesc Psychiatry. 2007;46: Schur S, Sikich L, Findling, et al. Treatment recommendations for the use of antipsychotics for aggressive youth (TRAAY) Part I: Review. J AM Acad Child Adolesc Psychiatry. 2003;2: Pappadoulos E, MacIntyre J, Crismon L, et al Treatment recommendations for the use of antipsychotics for aggressive youth (TRAAY) Part II: Review. J AM Acad Child Adolesc Psychiatry. 2003;42 (2): Kowatch R, DelBello M. The use of mood stabilizers and atypical antipsychotics in children and adolescents with bipolar disorders. CNS Spectrums. 2003; 8(4): Approved Indications: Treatment Resistant Major Depression; Bipolar Disorder, Depression Special Considerations: This Prior Authorization guideline only applies to the addition of an antipsychotic to an antidepressant when the addition is to achieve augmentation of the antidepressant response. Approval is not needed when an antidepressant is added to the ongoing antipsychotic regimen 4

5 when the antipsychotic is being used to manage a psychotic spectrum disorder. The antipsychotic requested must have an FDA approval for the specific depression indication. 1. The member must have either a diagnosis of Major Depressive Disorder or Bipolar Disorder with an episode of depression. 2. The member must have demonstrated at least partial response to the primary antidepressant. 3. Evidence of trials of at least two (2) individual formulary evidenced based augmentation strategies at accepted effective doses for a minimum trial of 2 weeks and failed, or the trials resulted insignificant side effects, or other augmentation agents are contraindicated. Failure is due to: a. An inadequate response at maximum tolerated doses, b. Adverse reaction(s), or c. Break through symptoms. Provider must provide supporting documentation that adherence to the treatment regimen is not a contributing factor to the inadequate response to the medication trials. 1. Members with known hypersensitivity to the requested agent(s). 2. Members not meeting the above stated criteria. 2. American Psychiatric Association Practice Guideline for the Treatment of patients with Major Depressive Disorder, 3 rd edition. American Psychiatric Association; October accessed 7/2/13 3. Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study 4. Rush AJ; Trivedi MH; Stewart JW; et al. Combining Medications to Enhance Depression Outcomes (CO-MED): Acute and Long-Term Outcomes of a Single-Blind Randomized Study. Am J Psychiatry 2011; 168: Trivedi MH, Fava M, Wisniewski SR, et al. Medication augmentation after the failure of SSRIs for depression. N Engl J Med. 2006;354(12): Debonnel G; Saint-Andre E; Hebert C; et al. Differential Physiological Effects of a Low Dose and 7. High Doses of Venlafaxine in Major Depression. Int J Neuropsychopharmacol Feb; 10(1):

6 Brand Name Behavioral Health Medications Abilify Aplenzin Edular Gralise Horizant Intermezzo SL Pexeva Seroquel XR Silenor Suboxone Film Vivitrol Zolpimist FDA Approved Indication: For adults, BHR has a diagnosis for which requested medication is an FDA approved treatment indication. For individuals under the age of 18, the BHR must have a diagnosis for which the requested medication meets the community standard of care. 1. Documentation of intolerance, non-adherence, or nonresponse to at least two generic formulary medications in the same medication class at maximal tolerated doses for at least 4 weeks. 2. Documentation of intolerance, nonresponse or non-adherence to a generic formulation of the requested medication. 3. For individuals with Autism Spectrum Disorder, aripiprazole will be approved if the BHR has failed a therapeutic trial of risperidone. 4. For individuals dually diagnosed with an intellectual disability and enrolled with the Arizona Department of Economic Security/Division of Developmental Disabilities (ADES/DDD), Kapvay will be available without need for Prior Authorization. If BHR preference interferes with compliance to generic formulation, brand name request will be reviewed on a case by case basis. If a BHR has been stabilized in another setting on a brand only medication for which there is no generic equivalent, then the brand name medication will be approved. 1. Indications that have not received FDA approval. 2. Doses greater than FDA recommended maximum daily dosage without meeting prior authorization guidelines for exceeding maximum daily dosage. 6 months 2. Manufacturer Product Information 6

7 Concomitant Antidepressant Treatment 2 SSRIs an SSRI in combination with an SNRI 2 SNRIs 2 Tricyclics (TCAs) Approved Indication: Treatment Resistant Depression Special Considerations: Cross tapers may be approved for up to 60 days per each RBHA s policy. For greater than 60 days, Providers must submit a prior authorization request for continued utilization of concomitant use of two (2) antidepressants for the following: 1. Two SSRIs 2. An SSRI in combination with an SNRI 3. Two SNRIs 4. Two Tricyclics (TCAs) 1. Approval will be granted when a member is transitioning from one medication to another. 2. Evidence of adequate trials of at least three (3) individual formulary antidepressants, from at least two (2) different therapeutic classes, for 4-6 weeks at maximum tolerated doses. Failure is due to: a. An inadequate response at maximum tolerated doses, b. Adverse reaction(s), or c. Break through symptoms. And 3. Documentation confirming that trials of at least four (4) evidenced based augmentation strategies have been tried for an adequate trial and failed, resulted in significant side effects, orare contraindicated. Examples of augmentation strategies include lithium, thyroid hormone, bupropion, mirtazapine, quetiapine, or aripiprazole). Failure is due to: a. Inadequate response at maximum tolerated doses, b. Adverse reaction(s), or c. Break through symptoms 1. Provider must provide supporting documentation that: a. Adherence to the treatment regimen is not a contributing factor to the inadequate response to the medication trials, b. Appropriate clinical monitoring of target symptoms, adverse reactions including signs and symptoms of serotonin syndrome, adherence to treatment, suicide risk, heart rate, blood pressure, and weight has been completed, and c. Appropriate clinical monitoring has been completed for TCAs, which includes but isnot 6 months 7

8 Concomitant Antipsychotic Treatment limited to, pupillary reactive response, thyroid function, liver function, abdominal girth, TCA levels and an ECG at baseline and follow up. 1. Members with known hypersensitivity to the requested agent(s). 2. Members not meeting the above stated criteria. 3. Members currently taking an MAOI medication. 2. American Psychiatric Association Practice Guideline for the Treatment of patients with Major Depressive Disorder, 3 rd edition. American Psychiatric Association; October accessed 7/2/13 3. Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study 4. Rush AJ; Trivedi MH; Stewart JW; et al. Combining Medications to Enhance Depression Outcomes (CO-MED): Acute and Long-Term Outcomes of a Single-Blind Randomized Study. Am J Psychiatry 2011; 168: Trivedi MH, Fava M, Wisniewski SR, et al. Medication augmentation after the failure of SSRIs for depression. N Engl J Med. 2006;354(12): Debonnel G; Saint-Andre E; Hebert C; et al. Differential Physiological Effects of a Low Dose and High Doses of Venlafaxine in Major Depression. Int J Neuropsychopharmacol Feb; 10(1):51-61 Approved Indications: Treatment Refractory 1. Schizophrenia spectrum disorders or 2. Bipolar disorder, with psychosis and/or severe symptoms Special Considerations: Cross tapers will automatically be approved for 60 days. Providers must submit a prior authorization request for continued utilization of concomitant use of any 2 antipsychotics beyond the 60 days allowed for cross tapering. Guidelines for Approval for refractory schizophrenia spectrum disorder: 1. Evidence of adequate trials of at least three (3) individual formulary antipsychotics, one of which is clozapine, 4-6 weeks of maximum tolerated doses, and failure due to: a. Inadequate response to maximum tolerated dose b. Adverse reaction(s), c. Break through symptoms 6 months 8

9 Guidelines for Approval for refractory bipolar disorder with psychosis and/or severe symptoms: 1. Evidence of adequate trials of at least four (4) evidence based treatment options dependent upon the episode type. Trials may include lithium, divalproex, atypical antipsychotic monotherapy, carbamazepine, haloperidol, lamotrigine, lithium + an anticonvulsant, lithium + an antipsychotic, or an anticonvulsant + an antipsychotic. Trials should be 4-6 weeks of maximum tolerated doses, with failure due to: a. Inadequate response to maximum tolerated dose b. Adverse reaction(s), c. Break through symptoms Provider must provide supporting documentation that adherence to the treatment regimen has not been a contributing factor to the lack of response in the medication trials. 1. Members with known hypersensitivity to requested medication(s). 2. Prior Authorization Requests not meeting the above stated criteria. 2. Correll CU, Rummel-Kluge C, Corves C, et al. Antipsychotic combinations vs monotherapy in schizophrenia: A metaanalysis of randomized controlled trials. Schizophrenia Bulletin, 2009;35: Essock SM, Schooler NR, Stroup TS, et al. Effectiveness of switching from antipsychotic polypharmacy to monotherapy. Am. J. Psychiatry, 2011;168: Tandon R, Belmaker RH, Gattaz WF, et al. World Psychiatric Association Pharmacopsychiatry Section statement on comparative effectiveness of antipsychotics in the treatment of schizophrenia. Schizophrenia Research, 2008;100: Tsutsumi C, Uchida H, Suzuki T, et al. The evolution of antipsychotic switch and polypharmacy in natural practice- A longitudinal perspective. Schizophr. Res. 2011;130: Zink M., Englisch S, Meyer-Lindberg A. Polypharmacy in schizophrenia. Curr. Opin. Psychiatry, 2010;23: s 7. Yatham LN, Kennedy SH, Schaffer A, et al, Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of CANMAT guidelines for the management of patients with bipolar disorder: update Bipolar Disorder May;11(3): Hirschfeld R., Bowden C., Gitlin M, et al. Practice Guideline for the Treatment for Patients With Bipolar Disorder (Revision). Am J Psychiatry. 2003: 1(1)

10 9. Crimson, L., Argo T., Bendele S., Suppes T., Texas Medication Algorithm Project Procedural Manual- Bipolar Disorder Algorithms. Texas Department of State Health Services. Web address: Accessed July 15, Exceeds FDA Recommended Daily Dose Antidepressants, Antipsychotics Documentation to support symptom improvement is required for reauthorization. FDA Approved Indication: The Behavioral Health Recipient must have a diagnosis for which the requested medication is FDA approved for or the requested medication is included on treatment guidelines. 1. The Behavioral Health Medical Provide (BHMP) has evaluated and determined that medication nonadherence is not the reason for the dose escalation. 2. Supporting documentation indicates that use of the medication at specified dosage(s) has been ineffective and a clinically significant trial was completed. 10

11 3. The BHMP has ruled out a non-response due to an unrecognized or under-treated co-morbid disorder. Initial approval for a higher-dose trial shall be granted for no longer than 120 days. Continued authorization approval will be based on additional supporting documentation of symptom improvement. Injectable antipsychotics Abilify Maintenna Invega Sustenna 2. Manufacturer Product Information 3. Miller AL, Moore TA, Crimson ML, Argo TR, Bendele SD, Suehs B. TIMA (Texas Implementation of Medication Algorithms) Procedure Manual: Schizophrenia Module. Version: April Casey DE, Daniel DG, Wassef AA, et al. Effect of divalproex combined with olanzapine or risperidone in patients with acute exacerbation of schizophrenia. Neuropsychopharmacology 2003;28: Marder SR, Essock SM, Miller AL, et al. Physical health monitoring of patients with schizophrenia. American Journal of Psychiatry 2004;161: Lehman AF, et al. Practice guideline for the treatment of patients with schizophrenia. American Psychiatric Association. Feb Stahl, SM. Essential psychopharmacology. Second Edition, pg Trivedi MH, et al. Medication augmentation after the failure of SSRIs for depression. New England Journal of Medicine. 2006;354: FDA Approved Indication: BHR has a diagnosis for which the requested medication has an approved FDA indication. These medications are not approved for use in individuals under the age of BHR must demonstrate sustained clinical improvement and tolerability on the short acting form of the requested Brand Name Long Acting agent, and 2. Documentation of noncompliance on oral medications, and/or documentation supporting the benefit of long acting medication in achieving clinical stability. Prior Authorization for medications covered under this guideline will not continue beyond 60 days for members receiving oral antipsychotics concomitantly with Brand Name Long Acting Injectable Antipsychotics Initial Prior Authorization for Abilify Maintena and Invega Sustenna will be for 6 months. Subsequent Prior Authorization frequency may be determined by the (T)RBHA, and will be contingent upon evidence of clinical efficacy and appropriate clinical monitoring. 6 months Documentation to support clinical efficacy and appropriate clinical monitoring are required for reauthorization. 11

12 1. Doses greater than FDA recommended maximum daily dosage without meeting prior authorization guidelines for exceeding maximum daily dosage. 2. Concomitant use of cytochrome p450 inducers (eg, carbamazepine) and Abilify Maintena 3. Individuals under the age of Manufacturer Product Information 12