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Pharmacy Prior Authorization Title 19/21 SMI

Non-Formulary, Prior Authorization and Step-Therapy GuidelinesScroll down to see PA Criteria by drug class, or Ctrl+F to search document by drug name

General Guidelines Requirements Duration of Approval if Requirements Are Met

Non-Formulary Medication Guideline

Requests for Non-Formulary Medications that do not have specific Prior Authorization Guidelines will be reviewed based on the following: An appropriate diagnosis/indication for the requested medication, An appropriate dose of medication based on age and indication, Documented trial of at least 2 formulary agents for an adequate duration have not been

effective or tolerated, OR All other formulary medications are contraindicated based on the patient’s diagnosis, other

medical conditions or other medication therapy, OR There are no other medications available on the formulary to treat the patient’s condition

Mercy Maricopa Integrated Care determines patient medication trials and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review.

Initial Approval: Minimum of 3 months,

depending on the diagnosis, to determine adherence, efficacy and patient safety monitoring

Renewal: Minimum of 6 months Maintenance

medications may be approved indefinitely

Medications requiring Prior Authorization

Requests for Medications requiring Prior Authorization (PA) will be reviewed based on the PA Guidelines/Criteria for that medication. Scroll down to view the PA Guidelines for specific medications. Medications that do not have a specific PA guideline will follow the Non-Formulary Medication Guideline. Additional information may be required on a case-by-case basis to allow for adequate review.

As documented in the individual guideline

Medications requiring Step Therapy

Medications that require Step Therapy (ST) require trial and failure of formulary agents prior to their authorization. If the prerequisite medications have been filled within the specified time frame, the prescription will automatically process at the pharmacy. Prior Authorization will be required for

Initial Approval: Indefinitely

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prescriptions that do not process automatically at the pharmacy.Brand Name Medication Requests

Mercy Maricopa Integrated Care requires use of generic agents that are considered therapeutically equivalent by the FDA. For authorization of a brand name medication, please submit a copy of the FDA MedWatch form detailing trial and failure of, or intolerance/adverse side effect to generic formulations made by 2 different manufacturers. The completed form should also be submitted to the FDA. The FDA MedWatch form is available at: http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/UCM082725.pdf

Initial Approval: Indefinitely

Specialist Prescriber Medication Requests

Some medications are covered when prescribed by a Specialist provider. If the medication is prescribed by the appropriate Specialist, the prescription will automatically process at the pharmacy. Prior Authorization will be required for prescriptions that do not process automatically at the pharmacy. In those cases, authorization will be given upon receipt of a Specialist Consult or after trial and failure of 2 formulary medications.

Initial Approval: Indefinitely

Behavioral Health Medications

Primary care providers, within the scope of their practice, who wish to provide psychotropic medications and medication adjustment and monitoring services may do so for members diagnosed with Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder, depressive (including postnatal depression) and/or anxiety disorders. AHCCCS provides guidance in two appendices, Appendix E for children and adolescents and Appendix F for adults. For each of the three named diagnoses there are clinical guidelines that include assessment tools and algorithms. The clinical guidelines are to be used by the PCPs as an aid in treatment decisions. http://www.azahcccs.gov/shared/Downloads/MedicalPolicyManual/Chap300.pdfFor treatment of other behavioral or mental health conditions, members will be referred to the Regional Behavioral Health Authority (RBHA).

N/A

Behavioral Health Guidelines

Requirements Duration of Approval if Requirements Are Met

Non-Formulary Behavioral Health Medications

Guidelines for Approval:1. The patient must have a diagnosis for which the requested medication is FDA approved for

or the requested medication is included in treatment guidelines.2. The patient has previously tried and had an inadequate response, experienced adverse

reactions, or developed breakthrough symptoms with at least 2 other formulary mediations in the same class at maximum tolerated doses.

3. The dose of the requested medication must not be greater than the FDA recommended

Hospital Discharge: 60 days

Initial Approval: 12 months

Initial Approval for High-

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maximum daily dosage.a. If the dose requested exceeds the FDA recommended maximum, documentation to

support the following must also be submitted:i. The dosing requested must be supported by peer-reviewed literature.ii. The Behavioral Health Medical Provider (BHMP) has evaluated and

determined that medication non-adherence is not the reason for the dose escalation.

iii. Supporting documentation indicates that use of the medication at a lower dose (or within the plan quantity limit) has been ineffective and a clinically significant trial was completed.

iv. The BHMP has ruled out a non-response due to an unrecognized or under-treated co-morbid disorder.

v. The treatment plan must include ongoing safety monitoring.

Dose: 3 months

Renewal: 12 months

Brand Name Behavioral Health Medications

AplenzinEdluarEmsamFanaptGraliseHorizantIntermezzo SLIntunivLamictal XRPexevaQuillivant XRSaphrisSeroquel XRSilenorSuboxone Film

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.

Guidelines for Approval:1. Documentation of intolerance, nonresponse or non-adherence to a formulary generic

equivalent formulation of the requested medication at maximal tolerated doses for at least 4 weeks.

2. Documentation of intolerance, nonresponse or non-adherence to a formulary generic pharmaceutical alternative formulation of the requested medication at maximal tolerated doses for at least 4 weeks.

3. Documentation of intolerance, non-adherence, or non-response to at least two generic formulary medications in the same medication class at maximal tolerated doses for at least 4 weeks.

Guidelines for Exceptions:1. Documentation of intolerance/contraindication to other formulary medications (including

documentation of the risk of metabolic syndrome, obesity, diabetes), and documentation for

Hospital Discharge: 60 days

Initial Approval Indefinite

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ViibrydZolpimist

the reason why the requested medication will ameliorate the risks

2. Documentation that the individual has responded to a generic immediate release formulary medication, but requires the brand name extended release formulation to maintain adherence.

Additional Requirements:If BHR preference interferes with compliance to generic equivalent formulation or generic pharmaceutical alternative 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 or generic pharmaceutical alternative formulation, then the brand name medication will be approved.

Coverage is Not Authorized for: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.

References:1. ADHS/DBHS: Provider Manual Section 3.15: Psychotropic Medication: Prescribing and Monitoring

2. Manufacturer Product Information

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

Approved Behavioral Health Indications:

Treatment Resistant DepressionObsessive Compulsive Disorder (clomipramine with fluvoxamine)

Guidelines for Approval: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, orb. Adverse reaction(s)

Hospital Discharge: 60 days

Initial Approval: 6 months

Renewal: 1 year

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(moderate-weak 2D6 inhibitor) Clomipramine with fluvoxamine (strong 1A2 inhibitor)

Bupropion, clomipramine, duloxetine, fluoxetine, fluvoxamine, paroxetine, sertraline, tricyclic antidepressants

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), orc. 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 andd. TCA levels.

Additional Requirements: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,

Coverage is No t A u t h o r i z e d for: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.

References:1. ADHS/DBHS: P r o v id e r M a nu a l S e c t i o n 3 .1 5 : P s y ch o t r o pic M e di c at i on : P r e s c ri b i n g a n d

Mo n i t o r i n g

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2. American Psychiatric Association Practice Guideline for the Treatment of patients with Major

Depressive Disorder, 3rd edition. American Psychiatric Association; October 2010. h t tp :/ / p s y ch i a t r y o n l i n e . o r g / c o n te n t . a s p x ? b oo k i d =2 8 & s e c t i o n i d =166748 5 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: (1527-4160), 13(1) 5.

4. Spina E; Trifiro G; Caraci F. Clinically Significant Drug Interactions with Newer Antidepressants.CNS Drugs. 2012 Jan 1;26(1):39-67

5. Indiana University Division of Clinical Pharmacology P450 Drug Interaction Table. h tt p : //me di c i n e .i u p u i. e d u / cl i n p h a r m/ ddi s /ta bl e . a s p x A cc e ss e d 7 / 2 / 1 3

6. Wagner W; Vause EW; Fluvoxamine: A Review of Global Drug-Drug Interaction Data. Clin Pharmacokinet. 1995;29 Suppl 1:26-31; discussion 31—2

7. Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study8. 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; 168:689-701.

9. Trivedi MH, Fava M, Wisniewski SR, et al. Medication augmentation after the failure of SSRIs for depression. N Engl J Med. 2006;354(12):1243-52.

Concomitant Antidepressant Treatment

2 SSRIsan SSRI in combination with an SNRI2 SNRIs2 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 SSRIs2. An SSRI in combination with an SNRI3. Two SNRIs4. Two Tricyclics (TCAs)

Guidelines for Approval: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

Hospital Discharge: 60 days

Initial Approval: 60 days for cross

taper

6 months for non-cross taper

Renewal: 1 year

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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), orc. 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), orc. Break through symptoms

Additional Requirements: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 limited to, pupillary reactive response, thyroid function, liver function, abdominal girth, TCA levels and an ECG at baseline and follow up.

Coverage is No t A u t h o r i z ed for: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.

References:1. ADHS/DBHS: P r o v id e r M a nu a l Secti o n 3 .1 5 : P s y ch o t r o pic M e di c at i on : P r e s c ri b i n g a n d

Mo n ito r i n g 2. American Psychiatric Association Practice Guideline for the Treatment of patients with Major

Depressive Disorder, 3rd edition. American Psychiatric Association; October 2010.

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h tt p: //p s y c h i a t r y o n l i n e .o r g / c o n t e nt . a s p x ? boo k i d = 2 8 & s e c t i o n i d = 166748 5 accessed 7/2/133. Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study4. 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; 168:689-701

5. Trivedi MH, Fava M, Wisniewski SR, et al. Medication augmentation after the failure of SSRIs for depression. N Engl J Med. 2006;354(12):1243-52.

6. 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. 2007 Feb; 10(1):51-61

Concomitant Antipsychotic Treatment

Approved Indications:Treatment Refractory

1. Schizophrenia spectrum disorders or2. 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 doseb. Adverse reaction(s),c. Break through symptoms

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,

Hospital Discharge: 60 days

Initial Approval: 60 days for cross

taper

6 months for non-cross taper

Renewal: 1 year

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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 doseb. Adverse reaction(s),c. Break through symptoms

Additional Requirements:

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.

Coverage is No t A u t h o r i z e d for:1. Members with known hypersensitivity to requested medication(s).2. Prior Authorization Requests not meeting the above stated criteria.

References:1. ADHS/DBHS: P r o v i d e r M a nu a l S e c ti o n 3 . 15: Psy c h o tr o p ic M e d i c a ti o n: P r es c ri b ing a nd

M o ni t o ring 2. Correll CU, Rummel-Kluge C, Corves C, et al. Antipsychotic combinations vs monotherapy in

schizophrenia: A meta-analysis of randomized controlled trials. Schizophrenia Bulletin, 2009;35:443-457.

3. Essock SM, Schooler NR, Stroup TS, et al. Effectiveness of switching from antipsychotic polypharmacy to monotherapy. Am. J. Psychiatry, 2011;168:702-708.

4. 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;100:20-38.

5. Tsutsumi C, Uchida H, Suzuki T, et al. The evolution of antipsychotic switch and polypharmacy in naturalpractice- A longitudinal perspective. Schizophr. Res. 2011;130:40-46.

6. Zink M., Englisch S, Meyer-Lindberg A. Polypharmacy in schizophrenia. Curr. Opin. Psychiatry, 2010;23:103-

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111.s7. 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 2009. Bipolar Disorder. 2009 May;11(3):225-55.

8. 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) 64-110.9. 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: htt p ://w w w. pb h c a r e .o r g / p u bdoc s / u p l o ad / d oc um e nt s /T IMABDm a n2007 . pd f Accessed July 15, 2013.

Injectable antipsychoticsAbilify MaintennaInvega Sustenna

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 18.

Guidelines for Approval:1. BHR must demonstrate sustained clinical improvement and tolerability on the short acting

form of the requested Brand Name Long Acting agent, and2. Documentation of noncompliance on oral medications, and/or documentation supporting

the benefit of long acting medication in achieving clinical stability.

Additional Requirements: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.

Hospital Discharge: 60 days

Initial Approva: 6 months

Renewal: 1 year

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Coverage is No t A u t h o r i z e d for: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 Maintena3. Individuals under the age of 18

References:1. ADHS/DBHS: P r o v id e r M a nu a l S e c t i o n 3 .1 5 : P s y ch o t r o pic M e di c at i on : P r e s c ri b i n g a n d

Mo n i t o r i n g 2. Manufacturer Product Information

Vivitrol Patient must have a diagnosis of alcohol or opioid use disorder and either:a. Patient has failed a trial of oral medication indicated for alcohol or opioid use disorder; orb. The patient’s clinical status indicates instability or non-adherence such that oral medication will not be taken consistently or a trial will likely fail.

Initial Approval: 3 months

Renewal: 12 months

Physical Health Guidelines

Authorization Guidelines/Criteria

Somatostatin Analogs Octreotide, Sandostatin LAR, Signifor, Signifor LAR

See Detailed document: https://www.mercymaricopa.org/providers/mmic/pharmacy

Growth Hormone AntagonistSomavert

See Detailed document on pharmacy website

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1. Afinitori[ii][iii][ii][i]

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i Afinitor References:1. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomized placebo-controlled phase III trial. The

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http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Version 3.2015. Accessed September 8, 2015.4. Besalga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N

Engl J Med. 2012 Feb 9;366(6):520-9.5. National Guideline Clearinghouse (NGC). Guideline summary: Guidelines on renal cell carcinoma. In: National Guideline

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7. Torres, Vicente. Renal angiomyolipomas. In UpToDate, Post TW (Ed.), Waltham, MA, (accessed on August 10, 2015).8. Chan Ang, Jennifer. Metastatic pancreatic neuroendocrine tumors and poorly differentiated gastroenteropancreatic

neuroendocrine carcinomas: Systemic therapy options to control tumor growth and symptoms of hormone hypersecretion. In UpToDate, Post TW (Ed.), Waltham, MA, (accessed August 10, 2015).

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10. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Neuroendocrine Tumors. http://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf. Version 1.2015. Accessed September 8, 2015.

Ampyra References1. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically2. National Multiple Sclerosis Society Disease Management Consensus Statement-Recommendations from the MS Information

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1. Xeloda [capecitabine] prescribing information. South San Francisco, CA: Genentech, inc. Updated: March, 2015.2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Colon Cancer.

http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Version 2.2016. Accessed December 17, 2015.3. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Anal Carcinoma.

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http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Version 1.2016. Accessed December 17, 2015.5. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Pancreatic Adenocarcinoma.

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1. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Thyroid Carcinoma. http://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf. Version 2.2015. Accessed September 8, 2015.

2. Aetna CPB: Antineoplastics Accessed August 20153. Vandetanib. In: Clinical Pharmacology Online. Atlanta, GA: Elsevier / Gold Standard; [Updated 7/30/2014;Accessed August

2015] http://clinicalpharmacology-ip.com/Forms/Monograph/monograph.aspx?cpnum=3722&sec=monindi&t=0[iii][iii] Celecoxib References

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Cometriq References1. Cabozantinib. [Prescribing Information]. Exelixis. San Francisco, CA. November 2012.2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Thyroid Carcinoma.

http://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf. Version 2.2015. Accessed September 8, 2015.3. Medullary thyroid cancer: management guidelines of the American Thyroid Association, accessed September 20154. American Thyroid Association Guidelines Task Force, Kloos RT, Eng C, Evans DB, Francis GL, Gagel RF, Gharib H, Moley JF,

Pacini F, Ringel MD, Schlumberger M, Wells SA Jr. Thyroid. 2009;19(6):565.

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In UpToDate, Post TW (ed.), Waltham, MA (accessed on August 31, 2015).2. Imatinib: Drig Information. In UpToDate, Post TW (Ed), UpToDate, Waltham, MA. (Accessed on August 31, 2015.

http://www.uptodate.com/contents/imatinib-drug-information?source=search_result&search=gleevec&selectedTitle=1%7E128.

3. National Guideline Clearinghouse (NGC). Guideline summary: The role of cytotoxic therapy with hematopoietic stem cell transplantation in the treatment of adult acute lymphoblastic leukemia: update of the 2006 evidence-based review. In National Guideline Clearinghouse (NGC). http://www.guideline.gov/content.aspx?id=36630&search=imatinib. Rockville (MD): Agnecy for Healthcare Research and Quality (AHRQ); cited 2015 August 31. Available : http://www.guideline.gov.

4. Gleevec [full prescribing information]. East Hanover, NJ: Novartis U.S.; Revised 02/20135. NCCN Drugs and Biologics Compendium http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/

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09/17/20158. National Comprehensive Cancer Network. Practice Guidelines in Oncology – Bone Cancer, Version 1.2015 09/17/20159. National Comprehensive Cancer Network. Practice Guidelines in Oncology – Soft Tissue Sarcoma, Version 1.2015 09/17/2015.10. Alvarado Y, Apostolidou E, Swords R, Giles FJ. Emerging therapeutic options for Philadelphia-positive acute lymphocytic

leukemia. Expert Opin Emerg Drugs. 2007 Mar;12(1):165-7911. National Institute for Clinical Excellence (NICE). Imatinib for the treatment of unresectable and/or metastatic gastro-intestinal

stromal tumours. London (UK): National Institute for Clinical Excellence (NICE); 2004 Oct. 38 p.12. Pardanani A, Ketterling RP, Brockman SR, et al: CHIC2 deletion, a surrogate for FIP1L1-PDGFRA fusion, occurs in systemic

mastocytosis associated with eosinophilia and predicts response to imatinib mesylate therapy. Blood 2003 Nov 1; 102(9): 3093-6

13. McArthur G. Dermatofibrosarcoma Protuberans: Recent Clinical Progress. Ann Surg Oncol. 2007 Jul 2414. Fletcher S, Bain B. Diagnosis and treatment of hypereosinophilic syndromes. Curr Opin Hematol. 2007 Jan;14(1):37-42

Inlyta References:1. Inlyta (axitinib) [package insert]. NY, NY; Pfizer: Revised January 2012.2. Rini BI, Escudier B, Tomczak P, et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma

(AXIS): a randomized phase 3 trial. Lancet 2011;378:1931-39.3. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Kidney Cancer.

http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf Version 3.2015. Accessed September 8, 2015.4. Inlyta. In: Clinical Pharmacology online. Gold Standard: [Updated June 24, 2015; Accessed August 26, 2015].

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