Download Non-Formulary, Prior Authorization and Step

Last updated: 05/03/2017
Pharmacy Prior Authorization
Title 19/21 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
General Guidelines
Requirements
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.
Medications requiring
Prior Authorization
Medications requiring
Step Therapy
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.
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,
Duration of Approval if
Requirements Are Met
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
As documented in the
individual guideline
Initial Approval:
 Indefinitely
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Brand Name Medication
Requests
Specialist Prescriber
Medication Requests
Behavioral Health
Medications
Behavioral Health
Guidelines
Non-Formulary
Behavioral Health
Medications
the prescription will automatically process at the pharmacy. Prior Authorization will be required for
prescriptions that do not process automatically at the pharmacy.
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.pd
f
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.
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.pdf
For treatment of other behavioral or mental health conditions, members will be referred to the
Regional Behavioral Health Authority (RBHA).
Requirements
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.
Initial Approval:
 Indefinitely
Initial Approval:
 Indefinitely
N/A
Duration of Approval if
Requirements Are Met

Hospital Discharge:
60 days

Initial Approval:
12 months
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3. The dose of the requested medication must not be greater than the FDA recommended
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 undertreated co-morbid disorder.
v. The treatment plan must include ongoing safety monitoring.
Brand Name
Behavioral Health
Medications
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.
Aplenzin
Edluar
Emsam
Fanapt
Gralise
Horizant
Intermezzo SL
Intuniv
Lamictal XR
Pexeva
Quillivant XR
Saphris
Seroquel XR
Silenor
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.
Initial Approval for HighDose:
 3 months

Renewal:
12 months

Hospital Discharge:
60 days
Initial Approval
 Indefinite
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
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Suboxone Film
Viibryd
Zolpimist
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
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
2. Manufacturer Product Information
Approved Behavioral Health Indications:
Treatment Resistant Depression
Obsessive 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, or
b. 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), 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.
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 Not Authorized 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: Provider Manual Section 3.15: Psychotropic Medication: Prescribing and Monitoring
2. American Psychiatric Association Practice Guideline for the Treatment of patients with Major
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3.
4.
5.
6.
7.
8.
9.
Concomitant
Antidepressant
Treatment
2 SSRIs
an SSRI in combination
with an SNRI
2 SNRIs
2 Tricyclics (TCAs)
Depressive Disorder, 3rd edition. American Psychiatric Association; October 2010.
http://psychiatryonline.org/content.aspx?bookid=28&sectionid=1667485 accessed 7/2/13
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.
Spina E; Trifiro G; Caraci F. Clinically Significant Drug Interactions with Newer
Antidepressants.CNS Drugs. 2012 Jan 1;26(1):39-67
Indiana University Division of Clinical Pharmacology P450 Drug Interaction Table.
http://medicine.iupui.edu/clinpharm/ddis/table.aspx Accessed 7/2/13
Wagner W; Vause EW; Fluvoxamine: A Review of Global Drug-Drug Interaction Data. Clin
Pharmacokinet. 1995;29 Suppl 1:26-31; discussion 31—2
Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study
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.
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.
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)
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.

Hospital Discharge:
60 days
Initial Approval:
 60 days for cross
taper

6 months for noncross taper
Renewal:
 1 year
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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
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 Not Authorized 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: Provider Manual Section 3.15: Psychotropic Medication: Prescribing and Monitoring
2. American Psychiatric Association Practice Guideline for the Treatment of patients with Major
Depressive Disorder, 3rd edition. American Psychiatric Association; October 2010.
http://psychiatryonline.org/content.aspx?bookid=28&sectionid=1667485 accessed 7/2/13
3. Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study
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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; 168:689-701
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):5161
Concomitant
Antipsychotic
Treatment
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

Hospital Discharge:
60 days
Initial Approval:
 60 days for cross
taper

6 months for noncross taper
Renewal:
 1 year
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:
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a. Inadequate response to maximum tolerated dose
b. 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 Not Authorized for:
1. Members with known hypersensitivity to requested medication(s).
2. Prior Authorization Requests not meeting the above stated criteria.
References:
1. ADHS/DBHS: Provider Manual Section 3.15: Psychotropic Medication: Prescribing and
Monitoring
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
natural
practice- A longitudinal perspective. Schizophr. Res. 2011;130:40-46.
6. Zink M., Englisch S, Meyer-Lindberg A. Polypharmacy in schizophrenia. Curr. Opin. Psychiatry,
2010;23:103111.s
7. Yatham LN, Kennedy SH, Schaffer A, et al, Canadian Network for Mood and Anxiety Treatments
(CANMAT)
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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:
http://www.pbhcare.org/pubdocs/upload/documents/TIMABDman2007.pdf Accessed July 15,
2013.
Injectable
antipsychotics
Abilify Maintenna
Invega 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, and
2. Documentation of noncompliance on oral medications, and/or documentation supporting
the benefit of long acting medication in achieving clinical stability.

Hospital Discharge:
60 days
Initial Approva:
 6 months
Renewal:
 1 year
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.
Coverage is Not Authorized 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 Maintena
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3. Individuals under the age of 18
References:
1. ADHS/DBHS: Provider Manual Section 3.15: Psychotropic Medication: Prescribing and Monitoring
2. Manufacturer Product Information
Vivitrol
Physical Health
Guidelines
Somatostatin Analogs
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; or
b. 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
Authorization Guidelines/Criteria
Octreotide, Sandostatin LAR, Signifor, Signifor LAR
See Detailed document: https://www.mercymaricopa.org/providers/mmic/pharmacy
Growth Hormone
Antagonist
Somavert
Afinitori
Last reviewed: 10/22/2015
See Detailed document on pharmacy website
Afinitor may be authorized when the following criteria are met:
 Prescribed by an oncologist
 Patient has ONE of the following diagnoses:
o Recurrent or stage IV hormone receptor positive (ER/PR +) breast cancer that
progressed or recurred while on letrozole or anastrozole:
 Patient is postmenopausal OR premenopausal and has had ovarian
ablation/suppression
 Must be used in combination with exemestane
o Pancreatic neuroendocrine tumors (PNET) that are locally advanced, metastatic or
unresectable
o Tuberous sclerosis complex (TSC) with ONE of the following manifestations:
Initial Approval: 1 year
Renewal: 3 years
For members with stable
disease (tumor size within
25% of baseline).
Discontinuation is
appropriate when there is
evidence of disease
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o
o
 Renal angiomyolipoma
 Subependymal giant cell tumor that is unresectable
Relapsed or stage IV, unresectable, renal cell carcinoma (RCC) of predominant clear cell
histology following treatment with a tyrosine kinase inhibitor (i.e., Sutent, Nexavar,
Inlyta, or Votrient)
Relapsed or stage IV, unresectable, renal cell carcinoma (RCC) of non-clear cell histology
progression.
Afinitor Disperz may be authorized when the following criteria are met:
 Prescribed by an oncologist
 Pediatric patient at least 1 year old
 Diagnosis of tuberous sclerosis complex (TSC) with subependymal giant cell tumor that is
unresectable
Ampyraii
Last reviewed: 10/22/2015
May be approved when the following criteria are met:
 Prescribed by, or in consultation with a neurologist
 Patient is between 18 and 70 years old
 Diagnosis of multiple sclerosis with impaired walking ability defined as a baseline 25-ft
walking test between 8 and 45 seconds OR Expanded Disability Status Scale (EDSS) between
4.5 and 6.5
 Patient is stabilized on disease modifying therapy for MS (i.e., no recent exacerbations)
 Patient is NOT wheelchair-bound
 Patient does not have a history of seizures
 Patient does not have moderate to severe renal impairment (Crcl < 50 ml/min)

Initial Approval:
 2 months
Renewal:
 1 year
Requires:
At least 20% improvement
in timed walking speeds
on 25-ft walk within 4
weeks of starting
medication
Note: Less than 50% of
patients respond to
treatment
Antidementia Drugs
donepezil 5mg,10mg, ODT, galantamine, -ER,
For Patients who meet all of the following:

Initial Approval:
 Indefinitely
Diagnosis of Alzheimer’s disease
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Namenda, rivastigmine
capsules


Potential causes for cognitive dysfunction. (eg, cerebrovascular disease, cobalamin [vitamin
B-12] deficiency, syphilis, thyroid disease) has beeen ruled out.
Cognitive assessment to evaluate for the presence of dementia;
o Mini-Mental Status Exam (MMSE) score below 22
OR
o Mini-Cog score of ≤ 2 and abnormal CDT (clock drawing test)
o Age restriction: must be at least 18 years old
ARBs
Benicar
Edarbi
For patients who meet the following:
 Prescribed by a cardiologist OR
 2 fills of a first-line agent (or any combination of first-line agents) in the last 130 days OR
 Documented intolerance to formulary ARBs
 Age restriction
o Benicar – must be at least 6 years old and weigh at least 20 kg
o Edarbi – must be at least 18 years old
First-line Agents include:
 ACE inhibitors
 Formulary ARBs:
o Losartan, losartan/HCTZ
o Irbesartan, irbesartan/HCTZ
o Valsartan, valsartan/HCTZ
o Amlodipine/valsartan, amlodipine/valsartan/HCTZ
 Diabetes medication
Botulinum Toxins
Botox, Myobloc, Dysport, Xeomin
Initial Approval:
Indefinite


See Detailed document: https://www.mercymaricopa.org/providers/mmic/pharmacy
Cambia[ii]
Last reviewed: 10/21/2015
May be authorized for patients who meet the following criteria:
 Diagnosis of migraine headaches
Initial Approval:
Indefinite
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


Capecitabineiii
Last reviewed: 1/19/2016
Caprelsaiv
Last reviewed: 10/22/15
18 years of age or older
Tried and failed at least 2 formulary triptans (e.g., sumatriptan, naratriptan) or has a
contraindication to triptans
Tried and failed at least 2 formulary NSAIDs (e.g., Ibuprofen, naproxen, diclofenac)
May be authorized when prescribed by an oncologist for patients who are at least 18 years old
who have ANY of the following indications:
 Metastatic colorectal cancer
 Adjuvant (post-surgery) treatment of Dukes’ C colon cancer
 Metastatic breast cancer that is refractory to both paclitaxel and an anthracycline-containing
chemotherapy regimen
 Metastatic breast cancer that is refractory to paclitaxel when the patient is not appropriate for
anthracycline therapy
 Metastatic breast cancer that has progressed on an anthracycline-containing chemotherapy
when used in combination with docetaxel
 Locally advanced anal/rectal cancer when used in combination with radiation
 Pancreatic cancer when used in combination with radiation
 HER2 positive advanced/recurrent or metastatic breast cancer:
o Disease has progressed after receiving prior therapy with an anthracycline (doxorubicin,
daunorubicin, epirubicin, idarubicin), a taxane (paclitaxel, docetaxel), AND trastuzumab
(Herceptin)
o Must be used in combination with Tykerb
 Note: Capecitabine is contraindicated in severe renal impairement (Crcl <30mL/min).
Note: Patients with baseline neutrophil counts of <1.5 × 109/L or platelet counts of <100 × 109/L
should not be treated with capecitabine
May be authorized for adults when the following criteria are met:
 Prescribed by an oncologist
 Patient is at least 18 years old
 No history of congenital long QT syndrome (Black Box Warning)
 Patient meets ONE of the following:
Limit of 9 packets (1 box
per month)
Initial Approval: 1 year
Renewal: 3 years based on
therapeutic response.
Required:
 Crcl >30mL/min
 neutrophils >1 × 109/L
platelets >50 × 109/L
Initial: 1 year
Renewal: 3 years
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o
o
Celecoxib[iii]
Last reviewed: 09/09/2015
Cialis for BPH
Diagnosis of locally recurrent or metastatic differentiated thyroid carcinoma
(including papillary, follicular, and Hurthle cell) after surgical resection that is
progressive or symptomatic AND is refractory to radioactive iodine treatment
AND Nexavar or Lenvima
Diagnosis of medullary thyroid cancer and one of the following:
 Local disease progression or recurrence after surgery which is unresectable
 Symptomatic disease progression or recurrence after surgery with distant
metastases
 Asymptomatic disease progression or recurrence after surgery with distant
metastases that is unresectable
May be authorized for patients who meet the following criteria:
 Patient meets ONE of the following:
o Was unable to achieve clinical benefit with 3 formulary NSAIDs
o Has a history of NSAID-induced gastritis confirmed by EGD
o Is at high-risk for adverse GI events (e.g., >65 years of age, concomitant corticosteroid
or anticoagulant use, or history of GI bleed, PUD, GERD, or gastritis) AND not currently
taking a daily aspirin
 No recent history (in the past 6 months) of acute coronary syndrome (ACS) or CABG
 Age >2 years old for juvenile rheumatoid arthritis (JRA) OR >18 years old for all other
indications
 Dose does not exceed FDA recommended maximum for indication
o OA: 200 mg/day
o RA, acute moderate pain, dysmenorrhea, moderate to severe pain associated with
orthopedic surgery, ankylosing spondylitis, psoriatic arthritis: 400 mg/day
o JRA:
 >25 kg: 100mg BID
 10-25 kg: 50mg BID

For patients that meet all of the following:
 Diagnosis of BPH
 Trial and failure of all of the following:
Initial Approval:
 Indefinite
Initial Approval:
 3 months
15
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o
o
o
Colony-Stimulating
Factors (CSF)
Cometriqv
Last reviewed: 10/22/2015
Compounds
Doxazosin
Alfuzosin
Tamsulosin
Renewal:
 3 months
Requires demonstration of
improvement in BPH
symptoms
Granix, Leukine, Neupogen, Neulasta, Zarxio
See Detailed document: https://www.mercymaricopa.org/providers/mmic/pharmacy

May be authorized when the following criteria are met:
 Prescribed by an oncologist
 Patient is at least 18 years old
 Documented diagnosis of medullary thyroid cancer AND ONE of the following:
o Local disease progression or recurrence after surgery which is unresectable
o Symptomatic disease progression or recurrence after surgery with distant metastases
o Asymptomatic disease progression or recurrence after surgery with distant metastases
that is unresectable
 No evidence of moderate or severe hepatic impairment
Patient is not currently taking a strong CYP3A4 inducer or inhibitor
Compounds are not a covered benefit with the following exceptions:
 If each active ingredient is FDA-approved (non-bulk chemicals aka Active Pharmaceutic
Ingredient “API” )
 If each active ingredient is used for an indication that is FDA-approved or compendia
supported
 The final route of administration of the compound is the same as the FDA-approved or
compendia supported route of administration of each active ingredient. (i.e., oral baclofen
tablets should not be covered for topical use)
 Patient meets ONE of the following:
o Has an allergy and requires a medication to be compounded without a certain
active ingredient (e.g. dyes, preservatives, fragrances). This situation requires
submission of an FDA MedWatch form consistent with DAW1 guidelines.
Initial: 1 year
Recommended dose: 140
mg ORALLY once daily
Renewal: 3 years
Discontinuation
is
appropriate upon disease
progression or drug toxicity
Initial Approval:
• For market shortages: 3
months
• All others: 1 year
Renewals:
• For market shortages: 3
months
• All others: 1 year
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o
o
o
o
Cannot consume the medication in any of the available formulations and the
medication is medically necessary.
Commercial prescription product is unavailable due to a market shortage (or
discontinued) and it is medically necessary.
Request is for 17-alpha hydroxyprogesterone caproate (even if bulk ingredients are
used) for the prevention of preterm birth in women who are pregnant with a
singleton pregnancy and have history of a prior spontaneous preterm birth.
Request is for a formulary antibiotic or anti-infective for injectable use
NOTE: All compounds will require authorization and clinical review if total submitted cost exceeds
$200.
The following compounds are examples of preparations that Aetna considers to be experimental
and investigational, because there is inadequate evidence in the peer-reviewed published medical
literature of their effectiveness.
 Bioidentical hormones and implantable estradiol pellets
 Nasal administration of nebulized anti-infectives for treatment of sinusitis
 Topical Ketamine, Muscle Relaxants, Antidepressants, NSAIDS, and
 Anticonvulsants products typically use for pain
 Proprietary bases: PCCA Lipoderm Base, PCCA Custom Lipo-Max Cream, Versabase Cream,
Versapro Cream, PCCA Pracasil Plus Base, Spirawash Gel Base, Versabase Gel, Lipopen Ultra
Cream, Lipo Cream Base, Pentravan Cream/Cream Plus, VersaPro Gel, Versatile Cream Base,
PLO Transdermal Cream, Transdermal Pain Base Cream, PCCA Emollient Cream Base,
Penderm, Salt Stable LS Advanced Cream, Ultraderm Cream, Base Cream Liposome,
Mediderm Cream Base, Salt Stable Cream.
Cystic Fibrosis
(pulmonary)
Medications
Last reviewed: 4/22/15
Pulmozyme
Pulmozyme will be authorized for patients that meet the following:
 Age >/= 5 years (Per label: Pulmozyme was studied in patients 3 months to 5 years of age;
while clinical trial data are limited in patients <5 years, the use of Pulmozyme should be
considered for pediatric patients with CF who may experience potential benefit in pulmonary
function or who may be at risk of respiratory tract infection.
 Diagnosis of moderate to severe cystic fibrosis OR
Initial Approval:
Kalydeco/Orkambi:
3 months
All others : indefinite
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Bethkis
Cayston
Kalydeco
Orkambi

Diagnosis of mild cystic fibrosis after failure of inhaled hypertonic saline
Kitabis and Bethkis are the preferred formulary agents and may be authorized when the following
are met:
 Diagnosis of cystic fibrosis
 Age >/= 6 years
 FEV1 between 25-80% predicted
 Sputum cultures positive for P.aeruginosa
 NOT colonized with Burkholderia cepacia
 Tobi Podhaler and tobramycin inhaled solution are non-formulary and require trial and failure
of Kitabis AND Bethkis
Renewal
(Kalydeco/Orkambi):
6 months
Requires documentation to
support response to
therapy including current
lab results to
support ALT/AST and
bilirubin levels (for
Orkambi)
Cayston will be authorized for patients that meet the following:
 Diagnosis of cystic fibrosis
 Age >/= 7 years
 FEV1 between 25-75% predicted
 Sputum cultures positive for P.aeruginosa
 NOT colonized with Burkholderia cepacia
 Contraindication/intolerance to tobramycin
Kalydeco can be recommended for approval for patients who meet the following:
 Diagnosis of cystic fibrosis with one of the following CFTR gene mutations: G551D, G1244E,
G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H
 NOT homozygous for the F508del mutation in the CFTR gene
 Age >/=2 years
 Note: all reviews must be sent to MDR for final decision
Orkambi can be recommended for approval for patients who meet the following:
 Prescribed by a pulmonologist
 Member is 12 years of age and older
 Diagnosis of Cystic Fibrosis and lab results to support homozygous F508Del at the CFTR gene. (If
18
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



Daliresp
Last
reviewed: 06/15/15
Direct Renin Inhibitors
Last reviewed: 06/15/15
Tekturna
Tekturna HCT
Tekamlo
Amturnide
the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect
the presence of the F508del mutation on both alleles of the CFTR gene)
Current lab results to support normal ALT/AST and bilirubin
NOT taking strong CYP3A inducers such as rifampin, rifabutin, phenobarbital, carbamazepine,
phenytoin, and St. John’s wort
NOTE: Patients should be on other CF agents to manage and control symptoms (i.e., dornase
alpha, tobramycin, hypertonic saline, or Cayston)
Note: all reviews must be sent to MDR for final decision
For patients who meet all of the following:
 Adult 40 years of age or older
 Prescribed by or in consultation with a pulmonologist
 Diagnosis of severe COPD with chronic bronchitis with FEV1<50% predicted based on postbronchodilator FEV1
 Documented symptomatic exacerbations within the last year while compliant with dual
long-acting bronchodilator treatment [long-acting beta-agonist (LABA) plus long-acting
muscarinic antagonist (LAMA)] for at least 3 months
 Daliresp will be used in conjunction with a LABA and LAMA unless
contraindicated/intolerant
 Will not be used in combination with theophylline
For patients that meet the following:
 Treatment of HTN
 At least 18 years old
 Inadequate response or inability to tolerate a trial of a formulary ARB and ACE inhibitor and
at least one other formulary antihypertensive agent from a different class:
o Thiazide-type diuretic
o Calcium channel blocker
o Beta-blocker
 Will not be used in combination with an ACE inhibitor or an ARB
Initial Approval:
6 months
Renewals:
 Indefinite; requires
improvement in the
number of COPD
exacerbations
Initial Approval:
Indefinite
Note: The long-term benefit on major cardiovascular or renal outcomes with direct renin inhibitors
19
Last updated: 05/03/2017
Duavee
Last reviewed: 4/22/15
Elidel
(pimecrolimus)
Protopic
(tacrolimus)
in the treatment of HTN has not been established, therefore it is recommended to use medications
from other classes first.
Duavee can be approved for adult women who have an intact uterus and who meet ONE of the
following:
 Treatment of vasomotor symptoms associated with menopause (VMS):
o Patient has failed (or has contraindication/intolerance to) at least 2 formulary
estrogen/progestin products (e.g., estradiol tablets/patch, Prempro, Estrace)
 Prevention of postmenopausal osteoporosis:
o Patient is at significant risk of osteoporosis
 Patient has tried and failed (or has contraindication/intolerance to) raloxifene and
alendronate (non-estrogen medication is preferred)
Elidel is covered for patients between 2 and 10 years of age. For other age groups, Elidel requires
step therapy with topical corticosteroids.
 If patient has filled 2 topical corticosteroids in the last 60 days, 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, Elidel will be reviewed based upon the affected area being treated:
o Body/extremities - after trial and failure or intolerance to at least 2 different formulary
topical corticosteroids.
o Face – after trial and failure of one formulary low-potency topical corticosteroid
o Eyelid or other sensitive area – Elidel will be approved without trial and failure of topical
corticosteroids
Initial Approval:
5 years
Initial Approval:
 Indefinitely
Protopic is covered after trial and failure of Elidel
Anti-TNFS
Enbrel, Humira, Remicade, Cimzia, Simponi
See Detailed document:
https://www.mercymaricopa.org/assets/pdf/providers/pharmacy/PA%20Guidelines/Anti-TNFsMMIC.PDF
20
Last updated: 05/03/2017
ErythropoiesisStimulating Agents

Epogen, Procrit, Aranesp
=
See Detailed document: https://www.mercymaricopa.org/providers/mmic/pharmacy
GnRH Analogs
For patients who meet the following based on diagnosis:
Last reviewed: 7/1/15
Leuprolide acetate
Lupron Depot Lupron
Depot-PED
Eligard
Trelstar
Vantas
Synarel
Supprelin LA
Zoladex
Endometriosis
(Lupron Depot, Synarel, Zoladex [3.6 mg dose only])
 Prescribed by or in consultation with a gynecologist or obstetrician
 18 years of age or older
 Trial and failure of at least one formulary hormonal cycle control agent (such as Portia,
Ocella, Previfem), medroxyprogesterone, or Danazol
 Patient is not pregnant or breastfeeding
Uterine Leiomyoma (fibroids)
(Lupron Depot, Synarel, Zoladex [3.6 mg dose only])
 Prescribed by or in consultation with a gynecologist or obstetrician
 18 years of age or older
 Prescribed to improve anemia and/or reduce uterine size for 3-6 months prior to planned
surgical intervention
 Patient is not pregnant or breastfeeding
Dysfunctional Uterine Bleeding
(Zoladex [3.6mg dose only])
 Prescribed by or in consultation with a gynecologist or obstetrician
 18 years of age or older
 Prescribed to thin endometrium prior to planned endometrial ablation or hysterectomy
within the next 4-8 weeks
 Patient is not pregnant or breastfeeding
Initial Approval:
Central Precocious Puberty
 Supprelin LA: 12
months
 All others: 6
months
Endometriosis
 6 months
Uterine Leiomyoma
(fibroids)
 6 months
Dysfunctional uterine
bleeding
 2 months
Prostate/Breast Cancer
 2 years
Renewal:
Central Precocious Puberty
 6 months - 1
year (up to age 11
for females and
age 12 for males)
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Last updated: 05/03/2017

Central Precocious Puberty (CPP)
(Lupron Depot-PED, leuprolide acetate solution, Synarel, Supprelin LA)
 Prescribed by, or in consultation with an Endocrinologist
 MRI or CT Scan has been performed to rule out lesions
 Onset of secondary sexual characteristics earlier than 8 years in females and 9 years in
males
 Response to a GnRH stimulation test (or if not available, other labs to support CPP such as
luteinizing hormone levels, estradiol and testosterone level)
 Bone age advanced 1 year beyond the chronological age
 Baseline height and weight
 Age restriction (leuprolide acetate solution for injection [once daily regimen]): must be at
least 1 year old
 Age restriction (Lupron Depot-Ped [1-month or 3-month regimen]): must be at least 2 years
old
Advanced Prostate Cancer
(Lupron Depot, Leuprolide acetate solution, Eligard, Zoladex,Vantas Trelstar)
 Prescribed by, or in consultation with oncologist or urologist
 Age restriction: must be at least 18 years old
Advanced Breast Cancer
(Zoladex [3.6mg dose only])
 Prescribed by, or in consultation with oncologist
 Age restriction: must be at least 18 years old
Requires clinical
response to
treatment (i.e.,
pubertal slowing or
decline, height
velocity, bone age,
LH, or estradiol and
testosterone level)
Endometriosis
Retreatment
 Lupron only
(treatment with
Synarel and
Zoladex not
recommended
beyond 6 months):
6 months
 Requires:
o Bone mineral
density within
normal limits
o Use in
combination
with
norethindrone
acetate
Uterine Leiomyoma
(fibroids) or Dysfunctional
Uterine Bleeding
 Long-term use is
22
Last updated: 05/03/2017

Growth Hormone
not recommended
Retreatment may
be considered on a
case by case basis
Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Tev-Tropin, Zorbtive
See Detailed document: https://www.mercymaricopa.org/providers/mmic/pharmacy
Hepatitis C Agents
Sovaldi and Harvoni are the preferred agents
Please click here for full Policy:
http://mercymaricopa.org/assets/pdf/providers/pharmacy/Hepatitis_C_Treatment_Criteria_MMIC.
pdf
Initial Approval
Full course/ treatment
duration dependent upon
genotype
Hetlioz
Last reviewed: 4/22/15
For patients that meet all of the following:
 At least 18 years old
 Diagnosis of non-24 sleep-wake disorder
 Completely blind with NO light perception
 History of at least 3 months of difficulty initiating sleep, difficulty awakening in the morning,
or excessive daytime sleepiness
 No other concomitant sleep disorder (i.e., sleep apnea, insomnia)
Initial Approval
Indefinite
Hyaluronic Acid Agents
Injection: Euflexxa, Hyalgan, Synvisc, Synvisc-ONE, Orthovisc, Supartz
Topical: Bionect, HyGel,
Hylira,XClair
See detailed document posted separately on website.
When used for treatment of burns, dermal ulcers, wounds, radiation dermatitis:
 Prescriber must be a dermatologist
 Patient must be at least 18 years old
When used for treatment of xerosis:
Topical agents:
Intial Approval:
Burns or dermatitis:
 3 fills of generic
agent
Xerosis:
 Up to 1,000 grams
of equivalent
generic agent per
23
Last updated: 05/03/2017

Hyperlipidemia
Medications
Last reviewed: 6/15/15
Crestor
Zetia
Lovaza
Vascepa
Epanova
Repatha
Praluent
Juxtapid
Kynamro
 Prescriber must be a dermatologist
 Trial and failure of ammonium lactate or a topical corticosteroid
Patient must be at least 18 years old
Crestor can be approved when the following criteria are met:
 Patient is at least 10 years old; AND
 Patient has failed to achieve LDL goal on a compliant regimen of maximum tolerated dose
of atorvastatin; OR
 Patient requires a high intensity statin (i.e., diagnosis of familial hypercholesterolemia or
high ASCVD risk per provider evaluation) AND patient had a trial and failure of atorvastatin
Zetia requires step therapy:
 If member has filled 2 prescriptions for 2 different statins (specifically atorvastatin,
simvastatin or Crestor) within the last 130-days, 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, Zetia will be authorized upon receipt of documentation to support the
diagnosis of hyperlipidemia and failure of, or contraindication to atorvastatin, simvastatin,
and Crestor.
Non-formulary medications for hypertriglyceridemia (Lovaza, Vascepa, and Epanova) can be
approved when the following criteria are met:
 Patient is at least 18 years old
 Drug will be used as an add-on to lifestyle interventions to include diet and exercise
 Treatment of severe hypertriglyceridemia (triglyceride level greater than or equal to 500
mg/dL)
 Trial and failure of OTC fish oil and at least ONE other formulary medication such as
fenofibrate, fenofibric acid, gemfibrozil, or niacin or contraindication to all formulary agents
PCSK9 Inhibitors (Repatha and Praluent) can be approved when ALL of the following criteria are
met:
30 days for three
months
Renewal:
3 months
Initial Approval:
PSCK9 inhibitors: 3 months
Juxtapid, Kynamro: 3
months
All others: 6 months
Renewal:
PSCK9 inhibitors: 6 months
Juxtapid, Kynamro: 6
months
All others: indefinite
Renewals require
improvement in fasting
lipids and documentation
of recommended safety
monitoring parameters
(such as liver enzymes)
24
Last updated: 05/03/2017






Lab results support an LDL ≥300 mg/dL (within the past 90 days)
Failure of a compliant, 60 day trial of 2 different high potency statins* (atorvastatin and
Crestor) at maximum tolerated doses used in combination with Zetia, niacin, or a bile acid
sequestrant
The PCSK9 will be used in combination with maximum tolerated doses of a statin* in
combination with Zetia, niacin, or a bile acid sequestrant
In addition for diagnosis of Familial Hypercholesterolemia (FH):
o Patient has tried and failed or is not a candidate for LDL apheresis
In addition for diagnosis of Primary Hypercholesterolemia non FH:
o Chart notes support evidence of ASCVD or high CVD risk (i.e., history of AMI, MI,
PCI, or CABG)
NOTE: All requests must be forwarded to MDR for final approval
Juxtapid and Kynamro can be approved when ALL of the following criteria are met:
 Diagnosis of homozygous familial hypercholesterolemia with a documented LDL of >300
mg/dl (within the past 90 days)
 Failure of a compliant, 60 day trial of 2 different high potency statins* (atorvastatin and
Crestor) at maximum tolerated doses used in combination with Zetia, niacin, or a bile acid
sequestrant
 Juxtapid or Kynamro will be used in combination with maximum tolerated doses of a statin*
in combination with Zetia, niacin, or a bile acid sequestrant AND lifestyle interventions to
include diet and exercise (low-fat diet recommended, <20% of calories from fat)
 Patient has tried and failed or is not a candidate for LDL apheresis
 Patient is at least 18 years old
 Recommended baseline labs are submitted: Fasting lipid panel, ALT, AST, alk phos, total bili,
and negative pregnancy test (if applicable)
 Patient does not have moderate to severe hepatic impairment (Child-Pugh B or C) or active
liver disease
 NOTE: All requests must be forwarded to MDR for final approval
25
Last updated: 05/03/2017
* Exception to statin therapy trials requires documentation of intolerance to at least 2 statins (at
least one trial being a moderate to high potency statin). Documentation will include chart notes
supporting skeletal muscle related symptoms that resolved when statin therapy was discontinued;
and documentation the member has been rechallenged at a lower dose or with a different statin.
Idiopathic Pulmonary
Fibrosis Agents
Last reviewed: 06/16/15
Esbriet
Ofev
Imatinibvi
Last reviewed: 10/22/2015
Non-formulary use of Esbriet or Ofev can be approved when the following are met:
 Diagnosis of mild to moderate idiopathic pulmonary fibrosis
o Confirmed by high resolution computed tomography (HRCT), lung biopsy, or
bronchoscopy
o Interstitial lung disease cannot be attributed to another cause (i.e., rheumatoid
arthritis, lupus, systemic sclerosis, asbestos exposure, or hypersensitivity
pneumonitis)
o Forced vital capacity (FVC) between 50 and 80% predicted
 Documentation of baseline liver function tests (LFT’s) prior to initiating treatment
 Patient age must be 18 years or greater
 Patient is not a current smoker
 Prescribed by, or in consultation with, a pulmonologist
Note: There is no conclusive evidence to support the use of any drugs to increase the survival of
people with idiopathic pulmonary fibrosis.
Can be authorized for patients who meet the following:
 Prescribed by an oncologist
 Prescribed to treat one of the following FDA-approved or NCCN compendium listed indications:
o Primary treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+
CML)
o Newly diagnosed Ph+ acute lymphoblastic leukemia (Ph+ ALL) in combination with
chemotherapy or corticosteroids
o Relapsed or refractory acute lymphoblastic leukemia (Ph+ ALL)
o Myelodysplastic / myeloproliferative diseases (MDS/MPD) associated with PDGFR
(platelet-derived growth factor receptor) gene rearrangements in adults
Initial Approval: 3 months
Renewal: 6 months
Criteria for renewal:
 Documentation of
stable FVC
(recommended to
discontinue if there is a
>10% decline in FVC
over a 12 month
period)
Attestation that LFT’s are
being monitored
Approval Duration:
GIST, CML, ASM, or
HES/CEL: Yearly
In the presence of
disease progression or a
demonstrated
insufficient response to
therapy, a dose increase
may be considered in
the absence of severe
adverse reactions
26
Last updated: 05/03/2017
o
o
o
o
o
o
o
Aggressive systemic mastocytosis (ASM)
Adults with Hypereosinophilic syndrome (HES) and / or chronic eosinophilic leukemia
(CEL)
Unresectable, recurrent and / or metastatic dermatofibrosarcoma protuberans (DFSP)
in adults
Soft tissue sarcoma – Desmoid tumors
Recurrent bone cancer- chordoma
Unresectable, recurrent, or metastatic gastrointestinal stromal tumors (GIST)
Kit (CD117) positive gastrointestinal stromal tumors (GIST) after surgical resection
*This list is not inclusive. All off-label use will be reviewed in nationally recognized compendia for
the determination of medically-accepted indications.
Increlex
Last reviewed: 4/22/15
Inlytavii
Last reviewed: 1/19/2016
For patients that meet the following:
 Prescribed by or in consultation with pediatric endocrinologist
 Patient is ≥ 2 years old
 No evidence of epiphyseal closure
 No evidence of neoplastic disease
 Documentation supports a diagnosis of Severe, Primary IGF-1 deficiency
o Height standard deviation score less than or equal to −3
o Basal IGF-1 standard deviation score less than or equal to −3
o Normal or elevated growth hormone (GH) levels
o No evidence of secondary forms of IGF-1 deficiency, such as GH deficiency,
malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of
corticosteroids.
OR

Documentation supports diagnosis of GH gene deletion and development of neutralizing
antibodies to GH
May be authorized when the following criteria are met:
 Patient is 18 years of age or older
and/or cytopenias.
Indications other than
GIST, CML, ASM, or
HES/CEL: Yearly as long
as there is no evidence
of progressive disease
or unacceptable
toxicity.
Initial Approval:
6 months
Renewal:
 6 months if at least
doubling of
pretreatment
growth velocity
 1 year if growth
velocity ≥ 2.5 cm/yr
and epiphyses are
open
Initial: 1 year
27
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



Integrin Receptor
Antagonists for
Inflammatory Bowel
Diseases[ii]
Last reviewed: 10/22/2015
Tysabri
Entyvio
Prescribed by an oncologist
Patient does not have uncontrolled blood pressure
Patient is not taking a strong CYP3A4 inducer or inhibitor
Patient has relapsed or stage IV, unresectable, renal cell carcinoma (RCC) of predominant clear
cell histology and has failed treatment with a formulary tyrosine kinase inhibitor (Nexavar,
Sutent, or Votrient). Note: the formulary TKI’s require PA.
This guideline describes the criteria for use of Tysabri and Entyvio in inflammatory bowel
diseases. To see the criteria for use in of Tysabri in MS, refer to the section titled, “MS Agents.”
General Criteria:
 Prescribed by a gastroenterologist
 18 years of age or older
 Will be used as monotherapy and NOT in combination with antineoplastic,
immunosuppressive, or immunomodulating agents (e.g., azathioprine, 6-mercaptopurine
cyclosporine, methotrexate, TNF-inhibitors)
Additional Criteria for Inducing Remission in Crohn’s Disease: (Tysabri or Entyvio)
STEROID-DEPENDENT CROHN’S :
 Patient meets ONE of the following:
o Relapse occurs within three months of stopping glucocorticoids
o Glucocorticoids cannot be tapered to <10 mg/day within three months without
symptom recurrence
 Patient has failed a compliant, 3-month trial of ONE of the following:
o 6-mercaptopurine(6-MP) or azathioprine (AZA)
o Methotrexate (for patients with a contraindication to 6-MP and AZA)
 Patient has failed a compliant, 3-month trial of ONE formulary anti-TNF
Renewal: 3 years with
evidence of stable disease
(tumor size within 25% of
baseline)
QLL: #120 tablets per 30
days
Initial Approval:
 3 months
First Renewal:
 3 months
 Requires at least
20% symptom
improvement
Additional Renewals:
 6 months (if
patient is
responding)
NOTE: If member is unable
to taper off of steroids in
the first 6-months, d/c
Tysabri
STEROID-REFRACTORY CROHN’S:
 Inadequate response to IV glucocorticoids within 7-10 days (NOTE: it is recommended to
switch to IV glucocorticoids for patients who are not responding to oral glucocorticoids)
 Patient has failed a compliant, 3-month trial of ONE formulary anti-TNF
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Additional Criteria for Steroid-Dependent Ulcerative Colitis: (Entyvio)
 Relapse occurs within three months of stopping glucocorticoids OR tapering prednisone
to <10 mg/day
 Patient has failed a compliant, 3-month trial of ONE of the following:
o 6-mercaptopurine(6-MP) or azathioprine (AZA)
o Sulfasalazine 4-6g per day, mesalamine 4.8g per day, or balsalazide 6.75g per day
(if patient has a contraindication to 6-MP and AZA)
 Patient has failed a 3-month trial of ONE formulary anti-TNF
Additional Criteria for Steroid-Refractory Ulcerative Colitis: (Entyvio)
 Inadequate response to IV glucocorticoids within 7-10 days (NOTE: it is recommended to
switch to IV glucocorticoids FIRST for patients who are not responding to oral
glucocorticoids)
 Patient meets ONE of the following:
o Patient had a previous failure on 6-MP and AZA or a contraindication to both
medications and is therefore not a candidate for treatment with these agents for
current episode
o Patient has symptoms after surgical intervention
o Patient is not a surgical candidate or refuses surgery AND had an inadequate
response to cyclosporine (NOTE: Switching to anti-TNF’s after cyclosporine failure
is NOT recommended by clinical practice guidelines)
o Patient has a contraindication to cyclosporine (NOTE: cyclosporine is used as a
bridge therapy for patients who will be started on the slower acting 6-MP or AZA)
 Patient has failed a 3-month trial of ONE formulary anti-TNF
IL-17 Antagonistsviii
Last reviewed:10/22/2015
Cosentyx
May be authorized for Plaque Psoriasis when the following criteria is met:
 Patient is at least 18 years old
 Prescribed by a dermatologist
 Patient is up to date with all recommended vaccinations
 Patient has been screened for latent TB
 Symptoms are not controlled with topical therapy
Initial Approval:
6 months
Renewal:
2 years, with clinical notes
documenting an
29
Last updated: 05/03/2017





Anticoagulants Injectable[i]
Disease has a significant impact on physical, psychological or social wellbeing
Patient has failed a 3-month compliant trial with MTX or cyclosporine or has a true
contraindication to both
Psoriasis is severe and extensive (for example, more than 10% of body surface area
affected or a PASI score of more than 10)
Phototherapy has been ineffective, cannot be used or has resulted in rapid relapse
(rapid relapse is defined as greater than 50% of baseline disease severity within 3
months)
Patient has failed a compliant, 3-month trial of BOTH Enbrel and Humira or has
contraindications to both
Fragmin, fondaparinux, and enoxaparin should pay at the point of sale for an initial duration of
21days without a PA.
Last reviewed: 10/21/2015
Enoxaparin
Fondaparinux
Fragmin
Iprivask
For prescriptions of enoxaparin, fondaparinux, and Fragmin that do not pay at the point of sale,
prior authorization requests can be authorized for the following indications:
 All 3 agents:
o VTE prophylaxis in patients undergoing hip or knee replacement or hip fracture
surgery
o VTE treatment in patients who are taking warfarin until the INR is in therapeutic
range for 2 days
o Bridge therapy for perioperative warfarin discontinuation
o Prophylaxis or treatment of thrombotic complications in a high risk pregnancy
o VTE prophylaxis in patients with restricted mobility during acute illness
o Treatment of superficial vein thrombosis (SVT) of the lower limb of at least 5 cm in
length
o Treatment of acute upper-extremity DVT (UEDVT) that involves the axillary or more
proximal veins
 Fragmin and enoxaparin only:
o VTE treatment after trial and failure of warfarin or for patients who are not
candidates for warfarin
o VTE treatment in patients who have cancer
improvement (e.g.,
reduction in PASI,
decreased swollen/painful
joints)
Initial Approval:
Prophylaxis post ortho
surgery)
 Up to 35 days
Prophylaxis (non-ortho
surgery and major trauma)
 Up to 14 days
Prophylaxis (post-surgery
with CA)
 4 weeks
VTE treatment, bridge
therapy, acute illness
 10 days or as
requested
High risk pregnancy
 Until 6 weeks after
delivery (EDC
30
Last updated: 05/03/2017
o
o
o
o
o
VTE prophylaxis in cancer patients with solid tumors who are at high risk of
thrombosis (i.e., previous VTE, immobilization, hormonal therapy, angiogenesis
inhibitors, thalidomide, and lenalidomide)
VTE prophylaxis in patients with AFib undergoing cardioversion (up to 3 weeks
before and 4 weeks after)
VTE prophylaxis in patients with acute ischemic stroke and restricted mobility
VTE prophylaxis in patients undergoing general and abdominal-pelvic surgery who
are at moderate to high risk for VTE
VTE prophylaxis in patients with major trauma
Iprivask may be authorized if all the following criteria are met:
 VTE prophylaxis in patients undergoing hip replacement surgery
 Patient had therapeutic failure or intolerance to enoxaparin or Fragmin and fondaparinux
OR
 Patient has contraindication to enoxaparin, fondaparinux, and Fragmin (i.e., allergic to pork,
history of heparin induced thrombocytopenia)
required for
authorization)
Prophylaxis in cancer
 6 months
Upper extremity DVT
 3 months
Lower-limb SVT
 45 days
VTE treatment for warfarin
failure or in cancer
 6 months
Renewal:
Length of renewal
authorization based on
anticipated length of
therapy, indication and/or
recent INR if on warfarin
Injectable Osteoporosis
Agents
Forteo, zoledronic acid, Prolia
See Detailed document:
https://www.mercymaricopa.org/assets/pdf/providers/pharmacy/PA%20Guidelines/Injectable-OPAgents-MMIC.PDF
Insulin Pens
Humalog Pen
Humalog Mix
Note: Insulin Pens will process without PA for members age <19
For patients who meet the following:
Initial Approval:
 Adults: Indefinite
 Children: through 18
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Last updated: 05/03/2017
PenHumulin 500U/M
Pen Lantus Solostar Pen
Levemir Pen
Interferonsix
Last reviewed: 10/22/2015
α-Interferon
Infergen
Intron A
Pegasys
Pegintron
Sylatron
β-Interferon
See Multiple Sclerosis
Agents
γ-Interferon
Actimmune
o
Patient is a school-aged child requiring multiple daily injections of insulin
OR
o Patient is unable to effectively use insulin vials and syringes to self-administer insulin
due to at least one of the following:
o Member has uncorrectable visual disturbances (e.g., macular degeneration,
retinopathy, vision uncorrectable by prescription glasses)
OR
o Member is a brittle diabetic or has a physical disability or dexterity problems
due to stroke, peripheral neuropathy, trauma, or other physical condition
AND
o Member does not have a caregiver who can administer insulin using vials and syringes.
Chronic Hepatitis B Infection: (Intron A, Pegasys)
 Patient has HBeAg-positive or HBeAg-negative chronic hepatitis B (HBsAg positive for more
than six months)
 Prescribed by, or in consultation with an infectious disease physician, HIV specialist,
gastroenterologist, hepatologist, or transplant physician
 Patient has compensated liver disease (e.g., normal bilirubin, albumin within normal limits, no
cytopenias)
 There is evidence of viral replication (HBeAg titer and/or HBV DNA levels >20,000 IU/mL for
HBeAg-positive patients and >2000 IU/mL for HBeAg-negative patients)
 There is evidence of liver inflammation (e.g., elevated ALT, inflammation or fibrosis on liver
biopsy)
 Age restriction (Pegasys): Must be at least 18 years old
 Age restriction (Intron A): Must be at least 1 year old
AIDS-related Kaposi's sarcoma: (Intron A [powder for solution ONLY])
 Prescribed by, or in consultation with an infectious disease physician or HIV specialist
 Not being used for the treatment of visceral AIDS-related Kaposi's sarcoma associated with
rapidly progressive disease
 Patient must be at least 18 years old
Hairy-cell Leukemia: (Intron A)
years of age
Hairy cell leukemia:
 6 months
Condylomata acuminate:
 3 weeks
All other indications:
 1 year
Renewal:
Hepatitis B:
 Intron A: additional 16
weeks if still HBeAgpositive
 Intron A: up to 2 years
for HBeAg-negative
patients
Osteopetrosis:
 1 year if no evidence
32
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



Prescribed by, or in consultation with a hematologist/oncologist
Patient has demonstrated less than complete response to cladribine or pentostatin or has
relapsed within 1 year of demonstrating a complete response
Patient has indications for treatment such as:
o Systemic symptoms – fatigue, weakness, weight loss, fever, night sweats, recurrent
infection
o Symptomatic splenomegaly or adenopathy
o Significant cytopenias – hemoglobin < 12 g/dL, platelets < 100,000/mcL, or ANC <
1000/mcL
Patient is at least 18 years old
Malignant Melanoma: (Intron A, Sylatron)
 Prescribed by, or in consultation with a hematologist/oncologist
 Patient has undergone surgical resection AND is at high risk for recurrence (e.g., primary
tumor > 4 mm thick, presence of ulceration, lymph node involvement)
 Patient is at least 18 years old
of disease progression
CGD:
 1 year if number
and/or severity of
infections has
decreased
Condylomata acuminate:
 16 weeks
All other indications:
 1 year
Chronic Granulomatous Disease: (Actimmune)
 Prescribed by, or in consultation with an immunologist or infectious disease specialist
 Patient is also receiving antifungal and antibacterial prophylaxis (such as itraconazole and
trimethoprim/sulfamethoxazole)
 Patient is at least 1 year old
Malignant Osteopetrosis: (Actimmune)
 Prescribed by, or in consultation with a hematologist/oncologist
 Prescribed for the treatment of severe, malignant osteopetrosis
 Patient is at least 1 year old
Condylomata acuminata (genital or venereal warts): (Intron A, Alferon N-HPV)
 Patient at least 18 years old
 For intralesional use
33
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

Intravaginal
Progesterone products
Last reviewed: 4/22/15
progesterone capsules,
Crinone, Firstprogresterone
suppositories
Jakafix
Last reviewed: 01/19/2016
Lesions are small and limited in number
Trial and failure of topical treatments or surgical technique ( ie imiquimod cream, Condylox,
cryotherapy, laser surgery, electrodessication, surgical excision)
This list is not inclusive. All off-label use will be reviewed in nationally recognized compendia for the
determination of medically-accepted indications.
For patients that meet the following:
 Prescribed by a provider of obstetrical care
 Patient is not on Makena (17-hydroxyprogesterone)
 Patient is pregnant and has 1 of the following:
o Patient has a short cervix
OR
Patient is at high risk for pregnancy loss based on other risk factors
Criteria for the use in myelofibrosis:
 Patient is at least 18 years old
 Prescribed by, or in consultation with, a hematologist/oncologist
 Diagnosis of primary myelofibrosis, post-polycythemia vera myleofibrosis or post-essential
thrombocythemia myelofibrosis
 Intermediate or high risk disease defined as having two or more of the following risk factors
o Age > 65 years
o Constitutional symptoms (weight loss > 10% from baseline or unexplained fever or
excessive sweats persisting for more than 1 month)
o Hemoglobin < 10g/dL
o WBC count > 25 x 109/L
o Peripheral Blood blasts > 1%
 Baseline complete blood count (CBC) with platelet count of at least 100 X 109/L prior to
initiating therapy
Criteria for the use in polycythemia vera:
 Patient is at least 18 years old
 Prescribed by, or in consultation with, a hematologist/oncologist
Initial Approval:
Approve as requested
until 37 weeks gestation
Initial: 6 months
Renewal: 1 year; if benefit
is demonstrated, as
evidenced by spleen size
reduction (at least 35%
decrease), symptom
improvement and absence
of disease progression.
Therapy should be
gradually tapered if patient
fails to achieve at least 35%
decrease from baseline in
spleen volume or
experiences unacceptable
toxicities
34
Last updated: 05/03/2017



Long acting Opioids
Oxycontin
Butrans Patch
Exalgo
Oxymorphone ER
Zohydro ER
Xartemis XR
Nucynta ER)
Previous treatment failure with hydroxyurea
Patient has splenomegaly and requires phlebotomy to control symptoms
Baseline Hct of 40-45%
STEP criteria for Oxymorphone ER:
 Treatment of chronic pain
 At least 18 years old
 Failed a minimum of 2 week trials of maximum tolerated doses of at least TWO formulary
long-acting opioids (i.e., fentanyl patch, morphine sulfate ER, methadone) OR have
contraindications to all formulary agents.
QLL: #60 tablets per 30
days
Initial Approval:
 1 year
Renewal:
 1 year
Criteria for Oxycontin and other Non-Formulary Long-Acting Opioids:
 Treatment of malignant pain and pain due to sickle cell anemia (Oxycontin)
OR
 Treatment of chronic non-malignant pain:
o At least 18 years old
o Failed a minimum of 2 week trials of maximum tolerated doses of at least THREE
formulary long-acting agents (i.e., fentanyl patch, morphine sulfate ER, methadone,
oxymorphone ER) one of which must be oxymorphone ER
OR
o Contraindication to all formulary long-acting agents
OR
 Treatment of diabetic peripheral neuropathy (Nucynta ER only):
o At least 18 years old
o Failed an adequate trial (at least 4 weeks at maximum tolerated doses) of
duloxetine and tramadol and at least ONE additional formulary medication (i.e.,
gabapentin, amitriptyline, nortriptyline, or topical capsaicin)
OR
o Contraindications to all formulary agents
35
Last updated: 05/03/2017
Lyrica[iv]
Last reviewed: 10/21/2015
Lyrica is authorized for members who are 18 years of age or older with a diagnosis of post herpetic
neuralgia or partial onset seizures.
Initial Approval:
 Indefinite
Criteria for the diagnosis of fibromyalgia:
 Patient is 18 years of age or older
 Failure of a compliant 3-month trial of BOTH of the following:
o Duloxetine at maximum tolerated doses
o Gabapentin OR a tricyclic antidepressant (i.e., amitriptyline or nortriptyline) at
maximum tolerated doses
Modafinil/Nuvigil[v]
Last reviewed: 10/21/2015
Criteria for the diagnosis of neuropathic pain associated with diabetic peripheral neuropathy,
spinal cord injury, or cancer-related neuropathic pain:
 Patient is 18 years of age or older
 Trial and failure of a compliant 3-month trial of duloxetine AND at least 1 other generic
formulary agent such as topical capsaicin, tricyclic antidepressants, tramadol, venlafaxine,
or gabapentin at maximum tolerated doses

Modafanil is the preferred formulary agent, however still requires PA. Nuvigil is non-formulary
and may be authorized if the patient meets criteria and also has a documented trial and failure of
modafanil.
May be authorized for patients at least 17 years old for excessive daytime sleepiness associated
with narcolepsy when the following is met:
 Diagnostic testing, such as multiple sleep latency test (MSLT) or polysomnography, supports
diagnosis of narcolepsy
May be authorized for patients at least 17 years old for excessive daytime sleepiness associated
with Obstructive Sleep Apnea (OSA) when the following is met:
 Prescribed by, or in consultation with, a sleep specialist
 Polysomnography has confirmed the diagnosis of OSA
 Patient remains symptomatic despite compliance with CPAP or BIPAP for at least 1 month
Initial Approval:
 6 months
Renewal:
 1 year
Requires a response to
treatment
For OSA: patient must be
compliant with CPAP or
BIPAP
For SWD: patient must still
be a shift-worker
36
Last updated: 05/03/2017


CPAP or BIPAP will be continued after modafinil or Nuvigil is started
The daytime fatigue is significantly impacting, impairing, or compromising the patient’s ability
to function normally
May be authorized for patients at least 17 years old for excessive daytime sleepiness associated
with Shift-Work Disorder (SWD) when the following is met:
 Prescribed by, or in consultation with, a sleep specialist
 Polysomnography has ruled out other types of sleep disorders
 Symptoms have been present for >3 months
 The sleepiness is significantly impacting, impairing, or compromising the patient’s ability to
function normally
May be authorized for patients at least 17 years old for the treatment of excessive sleepiness
associated with idiopathic hypersomnia when the following criteria is met:
 Prescribed by, or in consultation with, a sleep specialist
 Trial and failure of 2 formulary stimulants (e.g., amphetamine/dextroamphetamine,
methylphenidate)
 Diagnosis is supported by polysomnography, MSLT, and clinical evaluation including the
following:
o Daily periods of irrepressible need to sleep or daytime lapses into sleep for at least
three months
o MSLT documents fewer than two sleep-onset rapid eye movement periods (SOREMPs),
or no SOREMPs if the REM sleep latency on the preceding polysomnogram was ≤15
minutes
o The presence of at least one of the following:
 MSLT shows a mean sleep latency of ≤8 minutes
 Total 24-hour sleep time is ≥660 minutes (typically 12 to 14 hours) on 24-hour
polysomnography or by wrist actigraphy in association with a sleep log
o Other causes of sleep disorder have been ruled out
 The sleepiness is significantly impacting, impairing, or compromising the patient’s ability to
function normally
37
Last updated: 05/03/2017
Multaq
Multaq will be authorized when prescribed by, or in consultation with a cardiologist. If not
prescribed by or in consultation with a cardiologist, the following must be met:
 Diagnosis is atrial fibrillation
 Patient has tried and failed amiodarone
 Age restriction: must be at least 18 years old
Multiple Sclerosis
Agents
Aubagio, Avonex, Betaseron, Copaxone, Extavia, Gilenya, Glatopa, glatiramer, Lemtrada,
Mitoxantrone, Plegridy, Rebif, Tecfidera, Tysabri
Initial Approval:
Indefinite
See Detailed document: https://www.mercymaricopa.org/assets/pdf/providers/pharmacy/MSDisease-Modifying-Agents-MMIC.pdf
Neumegaxi
Last reviewed: 10/22/2015
May be authorized for the treatment of chemotherapy-induced thrombocytopenia when the
following are met:
 Prescribed by a hematologist/oncologist
 Patient is at least 12 years old
 Patient has a non-myeloid malignancy and is receiving myelosuppressive chemotherapy
 Patient is at high risk of severe thrombocytopenia or has experienced severe thrombocytopenia
with a previous chemotherapy cycle
 Administered 6 – 24 hours after the completion of chemotherapy
Initial Approval:
 Up to 21 days’
supply
 Refills if number of
cycles provided
Renewal:
 Approval up to 1
38
Last updated: 05/03/2017

Nexavarxii
Last reviewed: 1/19/2016
Concurrently with agents associated with delayed myelosuppression (e.g., nitrosoureas, mitomycin
C)
Nexavar, when prescribed by an oncologist for patients at least 18 years old, can be authorized
for the following indications:
 Treatment of relapsed or unresectable stage IV predominantly clear cell renal cell carcinoma
(RCC) after treatment failure with Sutent or Votrient
 Treatment of relapsed or unresectable stage IV NON-clear cell renal cell carcinoma (RCC) after
treatment failure with Sutent
 Treatment of unresectable hepatocellular carcinoma in a patient who is not a transplant
candidate
 Treatment of metastatic hepatocellular carcinoma
 Treatment of differentiated thyroid carcinoma that is refractory to radioactive iodine treatment


Non-Calcium Based
Phosphate Binders
Last reviewed: 4/22/15
Fosrenol
Non-Formulary Diabetic
Supplies
NOT being used in the following situations:
o After myeloablative therapy
o Chemotherapy regimen longer than 5 days
year
Requires recent platelet
count
Initial: 1 year
Renewal: 3 years if
evidence of stable disease
(tumor size within 25% of
baseline)
Note: Patients with advanced cardiac conditions should not receive Nexavar.
Note: Nexavar should not be used in combination with a strong CYP3A4 inducer (e.g.,
dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St.
John's Wort) unless there is no alternative to the CYP3A4 inducer
For patients that meet all of the following:
 Treatment of hyperphosphatemia due to ESRD
 Receiving dialysis
 At least 18 years old
Failed Renvela or Renagel (sevelamer) AND failed a calcium-based phosphate binder or has
contraindications to both. (Note: Patients with elevated total serum calcium after correcting for
albumin should not receive a calcium-based product)
Diabetic Test Strip and Glucometer Quantity Limits:
 All diabetic test strips are limited to #150 per/30 days
Initial Approval:
Indefinite
Initial Approval:
 Indefinite
39
Last updated: 05/03/2017
 Glucometers are limited to 1 glucometer/12 months
Criteria to Receive Non-Formulary Diabetic Supplies
 Member with hematocrit level that is chronically less than 30% or greater than 55%
 Member with physical limitation (manual dexterity or visual impairment) that limits
utilization of formulary product
 Member with an insulin pump that requires a specific test strip
Criteria to Receive >150 Test Strips Per Month
 Members newly diagnosed with diabetes or with gestational diabetes
 Children with diabetes (age ≤ 12 )
 Members on insulin pump
 Members on high intensity insulin therapy with documentation of need to routinely test
more than 4-5 times daily
Criteria to Receive >1 Glucometer Per Year

Current glucometer is unsafe, inaccurate, or no longer appropriate based on patients
medical condition
o Current glucometer no longer functions properly, has been damaged, or was lost or stolen.
Northera
Last reviewed: 4/22/15
Onychomycosis and
Tinea
Last reviewed: 4/22/15
For patients that meet all of the following:
 At least 18 years old
 Patient has a diagnosis of symptomatic neurogenic orthostatic hypotension (NOH) caused
by primary autonomic failure (e.g., Parkinson's disease, multiple system atrophy, or pure
autonomic failure), dopamine beta-hydroxylase deficiency, or non-diabetic autonomic
neuropathy
 Patient has tried and failed or has contraindication/intolerance to fludrocortisone and
midodrine
Luzu can be approved as non-formulary for members who meet the following:
 Topical treatment of tinea pedis, tinea cruris, and tinea corporis.
 At least 18 years old
 Failure of OR contraindication to terbinafine cream
Initial Approval:
6 months
Renewal:
Indefinite
Initial (Luzu):
 30 days
Renewal (Luzu):
40
Last updated: 05/03/2017

Luzu
Jublia
Kerydin
Orenciaxiii
Last reviewed: 10/22/2015
Failure of at least 1 other formulary topical antifungal agents (ie clotrimazole, ciclopirox,
econazole, ketoconazole, miconazole, etc.) OR contraindication to all formulary agents

30 days if responding
to therapy
Jublia or Kerydin can be approved as non-formulary for members who meet the following:
 Treatment of onychomycosis of the toenails with ONE of the following comorbidities:
o Diabetes
o HIV
o Immunosuppression (i.e. receiving chemotherapy, taking long term oral
corticosteroids, taking anti-rejection medications)
o Peripheral vascular disease
o Pain caused by the onychomycosis
 At least 18 years old
 Failure of 2 OR contraindication to all formulary antifungal agents indicated for
onychomycosis (ie ciclopirox, griseofulvin, itraconazole and terbinafine tablets)
General authorization criteria for all indications:
 Prescribed by a rheumatologist
 Patient is NOT on another biological DMARD
 Patient is up to date with all recommended vaccinations
 Patient has been screened for latent TB and hepatitis B
Jublia or Kerydin:
In addition, May be authorized for Rheumatoid Arthritis (RA) when the following are met:
 Patient is at least 18 years old
 If patient has COPD, the prescriber confirms that the benefit of using Orencia outweighs
the risk in the patient
 Patient has moderate or high disease activity despite an adequate 3-month trial of BOTH of
the following:
o 2 different oral DMARD regimens (1 of which must include methotrexate (MTX)
unless contraindicated)
 Monotherapy: MTX, sulfasalazine (SSZ), or leflunomide (LEF)
 Combination: MTX+SSZ+hydroxychloroquine (HCQ), MTX+HCQ, MTX+LEF,
MTX+SSZ, SSZ+HCQ
o Humira AND Enbrel (Note: these agents also require PA)
Renewals require at least
20% symptom
improvement
48 weeks
Initial Approval:
 4 months
Renewals:
 Indefinite
41
Last updated: 05/03/2017
In addition, May be authorized for Juvenile Idiopathic Arthritis (JIA) when the following are
met:
 Patient is at least 6 years old
 Request is for the IV formulation
 For SEVERE Polyarticular JIA:
o Patient has failed an adequate 3-month trial with BOTH Humira and Enbrel
 For MODERATE Polyarticular JIA:
o Patient has failed an adequate 3-month trial of MTX
o Patient has failed an adequate 3-month trial of BOTH Enbrel and Humira
 For Systemic JIA:
o Patient does NOT have currently ACTIVE systemic features (i.e., fever, evanescent
rash, lymphadenopathy, hepatomegaly, splenomegaly, or serositis)
o Patient has continued synovitis in >1 joint despite treatment for 3 months with
MTX or leflunomide AND both Humira and Enbrel
Otezla
Last reviewed: 4/22/15
For moderate to severe psoriatic arthritis:
 Age is 18 years or older
 Prescribed by or in consultation with a rheumatologist
 Trial and failure of methotrexate for three consecutive months (or documentation showing
contraindication)
 Trial and failure of Humira or Enbrel for three consecutive months (or documentation
showing contraindication, non-responsiveness or diminished response over time)
For moderate to severe plaque psoriasis:
 Age is 18 years or older
 Prescribed by or in consultation with a dermatologist
 Trial and failure of UVB or PUVA therapy or documentation showing contraindication)
 Trial and failure of methotrexate for three consecutive months (or documentation
 showing contraindication)
 Trial and failure of Humira or Enbrel for three consecutive months (or documentation
showing contraindication, non-responsiveness or diminished response over time)
Initial Approval:
3 months
Renewal:
12 months
Requires:
 Patient experiencing
positive response to
therapy.
 Patient is not
experiencing
depression and/or
suicidal thoughts.
 Patient has no
significant weight loss.
42
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Oral Platelet Inhibitors
Last reviewed: 07/1/15
Effient
Brilinta
Zontivity
Promacta
Last reviewed: 4/22/15
Effient or Brilinta can be approved for patients who meet the following:
 Diagnosis of ACS (unstable angina, STEMI, NSTEMI)
 Failure or contraindication/intolerance to clopidogrel, including patients identified as
CYP2C19 poor metabolizers
 No active pathological bleeding, history of intracranial hemorrhage, or planned CABG
 In addition, for Effient:
1. Age <75 unless patient is considered high thromboembolic risk
2. Taking concomitant 75-325mg/day aspirin
3. No history of TIA or stroke
 In addition, for Brilinta:
1. Taking concomitant 75-100mg/day aspirin
2. No severe hepatic impairment
3. No concomitant use with medications known to interact with Brilinta (i.e., potent
CYP3A4 inhibitors/inducers and simvastatin or lovastatin in doses >40mg/day)
without provider documentation that benefit outweighs the risk
Zontivity can be approved for patients who meet the following:
 Prescribed for the secondary prevention of atherothrombosis in patients with PAD or
history of MI (drug NOT indicated for ACS)
 Must be used with aspirin and/or clopidogrel according to the standard of care for the
patient’s diagnosis
 No evidence of contraindications: history of stroke, transient ischemic attack (TIA), or
intracranial hemorrhage (ICH); or active pathological bleeding

Chronic idiopathic thrombocytopenic purpura (ITP):
 Patient is at least 18 years old
 Patient had insufficient response to corticosteroids, immunoglobulins, or splenectomy
 Promacta is being used to prevent major bleeding (not in an attempt to achieve platelet
counts in the normal range i.e., 150,000-450,000/mm3)
Initial Approval (Effient
and Brilinta):
12 months
Indefinite approval can be
given to patients with a
history of stent
thrombosis/restenosis
Initial Approval (Zontivity):
Indefinite
Renewals (Effient and
Brilinta):
12 months; requires
documentation from
cardiologist that risk of
thrombosis outweighs
bleeding risk with longterm use of antiplatelets
Initial Approval:
1 month
Renewal:
ITP and aplastic anemia:
Indefinite
Interferon-induced thrombocytopenia:
HCV: 1 year
43
Last updated: 05/03/2017


Patient is at least 18 years old
Patient has chronic hepatitis C with severe thrombocytopenia which prevents initiation or
ability to maintain interferon-based therapy
Severe aplastic anemia
 Patient is at least 18 years old
 Patient has a diagnosis of severe aplastic anemia defined by at least 2 of the following:
o Neutrophil count < 0.5 x 109 /L
o Platelet count <20 x 109/L
o Reticulocyte count < 20 x 109/L (value may be given as percent of RBCs)

Trial of or contraindication to first line treatment including allogeneic stem cell
transplantation from an appropriate sibling donor or immunosuppressive therapy with a
combination of cyclosporine A and antithymocyte globulin (ATG)
Proton Pump Inhibitors
(PPI)
Aciphex, Nexium,
Dexilant
Omeprazole OTC tablets, omeprazole rx capsules, First-omeprazole suspension, First-lansoprazole
suspension, lansoprazole caps, and pantoprazole are available on the formulary without priore
authorization.
Authorization of Non-Formulary Proton Pump Inhibitors requires trial and failure of 2 formulary
PPIs.
Pulmonary Arterial
Hypertension
(PAH)
Adcirca, Adempas, epoprostenol, Letairis, Opsumit, Remodulin, Revatio (sildenafil), Tracleer,
Tyvaso, Ventavis, Uptravi
Renewal requirements:
 Platelet count of at least
50,000/mm3 (response
rates should be seen at
least 1 week after initiation
of therapy with a maximum
response seen at 2 weeks)
Severe aplastic anemia
response to treatment
would be indicated by
hematologic response in at
least one lineage –
platelets, RBC or WBC.
Initial Approval:
 Adults: indefinitely
 Children: 3-6 months
Renewal:
Children: 3-6 months at a
time
See Detailed Document: https://www.mercymaricopa.org/providers/mmic/pharmacy
Ranexa[vi]
Last reviewed: 10/22/2015
For patients age 18 years of age or older who meet all of the following:
 Diagnosis of chronic angina
 Patient meets ONE of the following:
- Ranexa is prescribed as ADD-on therapy after failure to achieve therapeutic benefit on
at least 1 formulary agent from EACH of the following 3 drug classes:
 Beta blockers: acebutolol, atenolol, carvedilol, metoprolol, nadolol,
propranolol
Initial Approval:
Indefinite
44
Last updated: 05/03/2017

-
xiv
Revlimid
Last reviewed: 1/19/2016
Second Generation
Tyrosine Kinase
Inhibitors for CML and
ALLxv
Calcium channel blockers: amlodipine, diltiazem, felodipine, isradipine,
nifedipine, nicardipine, verapamil
 Long acting nitrates: Isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
patch
Has a documented contraindication or intolerance to beta blockers, calcium channel
blockers, AND long-acting nitrates
May be authorized when prescribed by an oncologist for patients at least 18 years old for any of
the following diagnoses:
 Multiple myeloma (MM) when used with dexamethasone
 Mantle cell lymphoma (MCL) after relapse or progression with two prior therapies, one of which
includes Velcade®(bortezomib)
 Transfusion-dependent anemia associated with low- or intermediate-1 risk myelodysplastic
syndrome (MDS) POSITIVE for the del(5q) cytogenetic abnormality. (Transfusion dependence is
defined as having ≥ 2 units of red blood cells within 8 weeks of treatment)
 Transfusion-dependent anemia associated with low- or intermediate-1 risk MDS that is
NEGATIVE for the del(5q) cytogenetic abnormality AND
o serum EPO >500 mU/mL AND
o Patient has any of the following characteristics:
 Age >60 years old
 >5% marrow blasts
 Non-hypocellular marrow
 HLA-DR15 negative
 PNH clone negative
Gleevec (a first generation TKI) is the preferred agent for CML and ALL (see Gleevec guideline for PA
coverage criteria). Gleevec should NOT be used in patients who have had a treatment failure with a
second generation TKI. Tasigna is the formulary preferred second generation TKI and is subject to
the PA criteria included below.
Last reviewed: 10/30/2015
Bosulif
Second Generation TKI’s when prescribed for adult patients (at least 18 years of age) by an
oncologist may be authorized when the following criteria are met:
Initial Approval: 6 months
Renewal:
MDS: 6 months if benefit is
demonstrated, as
evidenced by transfusion
independence within the
past two months.
Multiple Myeloma, Mantle
Cell Lymphoma: 3 years if
benefit is demonstrated, as
evidenced by absence of
disease progression.
Initial: 1 year
Renewal: 3 years
approved as long as there
is no evidence of disease
progression or
unacceptable toxicity.
45
Last updated: 05/03/2017
Iclusig
Sprycel
Tasigna
Stelaraxvi
Last
reviewed:10/5/2015

Patient has ONE of the following diagnoses:
o Philadelphia chromosome positive or BCR-ABL1 positive chronic myeloid leukemia
(Ph+ CML) in chronic phase or accelerated phase
o Relapsed, refractory Ph+ CML in blast phase when it is of lymphoid type (not
myeloid)
o Relapsed, refractory Ph+ acute lymphoblastic leukemia (Ph+ ALL)
o NOTE: The efficacy of TKI’s has not been evaluated in clinical trials for the treatment
of acute myeloid leukemia (AML)
 In addition for Tasigna (formulary with PA) patient has ONE of the following:
o Intolerance, disease progression, or resistance to prior therapy with Gleevec
o Intolerance, disease progression, or resistance to prior therapy with a second
generation TKI (Sprycel, Bosulif, or Iclusig)
o Presence of any of the following mutations that are resistant to Gleevec:
F317L/V/I/C, T315A, V299L
 In addition for Sprycel or Bosulif (non-formulary) patient has ONE of the following:
o Intolerance, disease progression, or resistance to prior therapy with Gleevec AND
Tasigna
o Intolerance, disease progression, or resistance to prior therapy with a second
generation TKI (Tasigna, Bosulif, Sprycel or Iclusig)
o Presence of any of the following mutations that are resistant to Gleevec and
Tasigna: Y253H, E255K/V, F359V/C/I
 In addition for Iclusig (non-formulary) patient has ONE of the following:
o Intolerance, disease progression, or resistance to prior therapy with all other TKI’s
(Gleevec, Tasigna, Sprycel, and Bosulif)
Presence of the T315I mutation that is resistant to other TKI’s
May be authorized for Plaque Psoriasis when the following criteria is met:
 Patient is at least 18 years old
 Prescribed by a dermatologist
 Symptoms are not controlled with topical therapy
 Disease has a significant impact on physical, psychological or social wellbeing
 Patient has failed a 3-month compliant trial with MTX or cyclosporine or has a true
contraindication to both
Renewals should be based
on documentation of major
cytogenetic response
(≤35% Ph+ metaphases)
and until disease
progression or death
Initial Approval:
6 months
Renewal:
2 years, with clinical notes
documenting an
improvement (e.g.,
46
Last updated: 05/03/2017



Psoriasis is severe and extensive (for example, more than 10% of body surface area
affected or a PASI score of more than 10)
Phototherapy has been ineffective, cannot be used or has resulted in rapid relapse
(rapid relapse is defined as greater than 50% of baseline disease severity within 3
months)
Patient has failed a compliant, 3-month trial of BOTH Humira and Enbrel
May be authorized for Psoriatic Arthritis when the following criteria is met:
 Patient is at least 18 years old
 Prescribed by a dermatologist or rheumatologist
 Patient is currently on an NSAID which will be continued when Stelara is initiated OR
has a contraindication to NSAID use
 Patient meets ONE of the following:
o Has active PsA despite a 3-month trial of adequate dose MTX (or leflunomide
or sulfasalazine if MTX is contraindicated)
o Patient has predominantly axial disease AND active PsA despite a 3-month trial
of TWO different NSIADs at an adequate dose OR has a contraindication to
NSAID use
 Patient has failed a compliant, 3-month trial of BOTH Humira and Enbrel
Sucraidxvii
Last reviewed: 01/19/2016
May be authorized when the following criteria is met:
 Prescribed by a gastroenterologist, endocrinologist, or genetic specialist
 Member does not have secondary (acquired) disaccharidase deficiencies
 Documentation to support the diagnosis of congenital sucrose-isomaltase deficiency has been
submitted:
o Diagnosis of congenital sucrose-isomaltase deficiency has been confirmed by low
sucrose activity on duodenal biopsy and other disaccharidases normal on same
duodenal biopsy
o If small bowel biopsy is clinically inappropriate, difficult, or inconvenient to perform, the
following diagnostic tests are acceptable alternatives (all must be performed and results
submitted):
 Stool pH less than 6; AND
reduction in PASI,
decreased swollen/painful
joints)
NOTE: Safety and efficacy
of ustekinumab have not
been established beyond 2
years of use
Initial Approval: 2 months
Renewal: 12 months
Requires: Documentation
to support a response to
treatment with Sucraid
(weight gain, decreased
diarrhea, increased caloric
intake, decreased
gassiness, abdominal pain).
47
Last updated: 05/03/2017


Sutentxviii
Last reviewed: 1/19/2016
Can be authorized when prescribed by an oncologist for adult patients (at least 18 years old), for
the following indications:
 Treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance
to imatinib
 Treatment of relapsed or unresectable stage IV renal cell carcinoma (RCC)
 Treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in
patients with unresectable locally advanced or metastatic disease in combination with or after
disease progression on a somatostatin analog (i.e. octreotide, Sandostatin LAR)
o Patients with an insulinoma do not require treatment with a somatostatin analog for
approval



Symlin
Breath hydrogen increase greater than 10 ppm following fasting sucrose
challenge; AND
Negative lactose breath test
Initial: 1 year
Renewal: 3 years if stable
disease (tumor size within
25% of baseline)
Note: Patients with advanced cardiac conditions should not receive Sutent.
Note: Sutent should not be used in combination with a strong CYP3A4 inducer (e.g.,
dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St.
John's Wort) unless there is no alternative to the CYP3A4 inducer
Note: Patients receiving strong CYP3A4 inhibitors may require a lower dose to avoid toxicity.
For patients that meet all of the following:
 Diagnosis of Type 1 or Type 2 DM
 Prescribed by, or in consultation with an endocrinologist
 Patient is 18 years of age or older
 Patient is currently on mealtime bolus insulin (e.g., Novolog, Humalog)
 Patient failed to achieve desired glucose control with optimal insulin therapy
 Patient does not have any of the following:
o Hypoglycemia unawareness or recurrent episodes of hypoglycemia
o Gastroparesis
Initial Approval:
Indefinite
48
Last updated: 05/03/2017
Tarcevaxix
Last reviewed: 1/19/2016
o Poorly controlled diabetes (e.g., A1c > 9%)
o Poor adherence to current insulin regimen
When prescribed by an oncologist for patients at least 18 years old, can be authorized for the
following indications:
 Metastatic pancreatic cancer when used in combination with gemcitabine (Gemzar) in patients
with a good performance status
 Metastatic non-small cell lung cancer (NSCLC) that is positive for a sensitizing epidermal growth
factor receptor (EGFR) mutation [i.e., exon 19 deletions or exon 21 (L858R) substitution]
 Locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen
 Locally advanced or metastatic NSCLC that remains stable (no disease progression) after 4 to 6
cycles of platinum-based first-line chemotherapy since platinum-based chemotherapy is NOT
recommended beyond 6 cycles
 Treatment of relapsed or unresectable stage IV NON-clear cell renal cell carcinoma (RCC)
Note: Tarceva should not be used with PPI’s. If taken concomitantly with H2-receptor antagonists
(i.e., ranitidine), Tarceva should be dosed 10 hours after and 2 hours before taking the H2-receptor
antagonist.
Thalomidxx
Last reviewed: 1/19/2016
May be authorized when prescribed by an oncologist for patients at least 12 years old for any of
the following diagnoses:
 Multiple myeloma (MM) when used with dexamethasone OR
 Erythema nodosum leprosum OR
 Chronic or subacute cutaneous systemic lupus erythematosus (SLE) after trial and failure of
Initial: 1 year
Renewal: 3 years if benefit
(control of tumor growth,
or disease-related
symptom improvement)
Tx should be discontinued
if any of the following
occur:
 Interstitial Lung
Disease (ILD)
 Severe hepatic toxicity
that does not resolve
 Severe renal failure
 Severe bullous,
blistering or exfoliating
skin conditions
 Corneal perforation or
severe ulceration
QLL (25mg tablets): #60 per
30 days
QLL (100 and 150mg
tablets): #30 per 30 days
Initial Approval: 6 months
Renewal:
3 years if benefit is
demonstrated, as
49
Last updated: 05/03/2017
Topical NSAIDs
Last reviewed: 07/01/15
Voltaren gel
Pennsaid
Flector patch
topical corticosteroids AND 2 of the following for a duration of at least 12 weeks:
o Hydroxychloroquine
o Chloroquine
o Methotrexate
o Azathioprine
o Cyclosporine
o Cyclophosphamide
o Mycophenolate
Sulfasalazine
Criteria for Approval:
A. Age 18 or older
B History of or high risk for adverse GI effects associated with oral NSAID use AND trial and failure
of celecoxib; OR
C High risk for other adverse effects associated with oral NSAID use (i.e., CHF, renal failure,
concomitant use of lithium); OR
D. Failure on TWO formulary NSAIDs
E. Diagnosis of OA of knee or hand for Voltaren gel
F. Diagnosis of OA of knee for Pennsaid
evidenced by absence of
disease progression.
Initial Approval:
Flector Patch: 1 month
All others: 1 year
Renewal:
Flector Patch: 1 month
All others: 1 year
Note: Flector patch is only FDA approved for acute pain. Requests for Flector patch for chronic pain
should be denied. If patient meets all other criteria above, offer Voltaren Gel or Pennsaid as an
alternative.
The risk factors that correlate strongly to adverse GI effects of oral NSAID use are:
 History of GERD, GI bleed, or ulcer
 Chronic oral steroid use
 Current anticoagulant or antiplatelet use
 Age 65 or greater
Tranexamic acid
(generic Lysteda)
For patients who meet all of the following:
- Premenopausal female with diagnosis of cyclic heavy menstrual bleeding (menstrual flow
>7days)
Initial Approval:
 Indefinite
Maximum of 30 tablets per
50
Last updated: 05/03/2017
Trial and failure, intolerance or contraindication to oral NSAIDs
Trial and failure, intolerance or contraindication to oral hormonal cycle control agents or
refuses oral hormonal cycle control agents
Age restriction: 12 years of age or order
May be authorized when prescribed by an oncologist for patients at least 18 years old who have
ONE of the following indications:
 Hormone-receptor positive, HER2 positive metastatic breast cancer:
o Used in combination with letrozole
o Patient is postmenopausal
 HER2 positive advanced/recurrent or metastatic breast cancer:
o Disease has progressed after receiving prior therapy with an anthracycline (doxorubicin,
daunorubicin, epirubicin, idarubicin), a taxane (paclitaxel, docetaxel), AND trastuzumab
(Herceptin)
o Used in combination with capecitabine or Herceptin
-
Tykerbxxi
Last reviewed: 1/19/2016


Velphoro
Viscosupplements
30days
Initial: 1 year
Renewal: 3 years based on
therapeutic response or
until disease progression or
unacceptable toxicity
Requires no evidence of:
 severe hepatotoxicity
 interstitial lung disease
Note: Tykerb should not be given to patients with an abnormal LVEF.
Note: Tykerb should not be used in combination with a strong CYP3A4 inducer (e.g.,
dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St.
John's Wort) unless there is no alternative to the CYP3A4 inducer
For patients that meet all of the following:
 Diagnosis of hyperphosphatemia
 At least 18 years old
 Receiving dialysis
 Failed at least 2 formulary phosphate binding agents such as calcium acetate capsules or
tablets, sevelamer carbonate (Renvela), or Renagel
Initial Approval:
1 year
Renewal:
1 year
Hyalgan, Gel-One, Euflexxa, Synvisc, Orthovisc
See Detailed document:
51
Last updated: 05/03/2017
https://www.mercymaricopa.org/assets/pdf/providers/pharmacy/Viscosupplements-MMIC.pdf
Votrientxxii
Last reviewed: 1/19/2016
Votrient can be authorized when prescribed by an oncologist for a patient at least 18 years old for
any of the following indications:
 Diagnosis of relapsed or unresectable stage IV predominantly clear-cell renal cell carcinoma
(RCC)
 Diagnosis of advanced soft tissue sarcoma after treatment with a prior chemotherapy


Weight Reduction
Medications
Xenical
Belviq
Bontril
Didrex
phentermine
Tenuate
Qsymia
Contrave
Note: Votrient should not be used in combination with a strong CYP3A4 inducer (e.g.,
dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St.
John's Wort) unless there is no alternative to the CYP3A4 inducer
Note: Patients receiving strong CYP3A4 inhibitors may require a lower dose to avoid toxicity.
For patients who meet all of the following:
 BMI ≥ 30 kg/m 2 (obese)
OR
 BMI ≥ 27kg/m2 (overweight) and one of the following obesity-related chronic diseases and
risk factors:
o Coronary heart disease
o Dyslipidemia:
 HDL <35mg/dl or
 LDL ≥ 160mg/dL, or
 Triglycerides ≥ 400mg/dl
o Controlled hypertension (less than> 140/90mm Hg)
o Type II diabetes mellitus
o Sleep apnea
o Polycystic ovary syndrome
o OA
 For Xenical: no contraindications such as chronic malabsorption syndrome, cholestasis,
hepatic disease, hypersensitivity to orlistat, pregnancy
 For Belviq: no contraindications such as pregnancy, concurrent use with (SSRIs), (SNRIs),
Initial: 1 year
Renewal: 3 years if
evidence of stable disease
(tumor size within 25% of
baseline) and ALT is <8
times ULN. Patients with
ALT between 3 and 8 times
ULN should have ALT
monitored weekly until <3
times ULN
Initial Approval:
3 months
Renewal:
Xenical and Belviq:
3 months
Requires documentation of
a weight loss of at least 4
pounds per month
All others:
Treatment beyond 3
months is not
recommended and is
considered “off label”
Additional Renewal:
Xenical and Belviq:
6 months to 1 year (no
52
Last updated: 05/03/2017
(MAOIs), triptans, bupropion, dextromethorphan, St. John’s wort
For Contrave: member has been abstinent from opioids for a minimum of 7 – 10 days (up to
14 days if taking long-acting opioid) prior to starting naltrexone/bupropion, including
treatment of alcohol dependence.
 All others: no contraindications such as uncontrolled cardiovascular disease (cardiac
arrhythmias, stroke, TIA, CHF, advanced artherosclerosis), uncontrolled hypertension
(>140/90), hyperthyroidism, psychiatric disorder (depression, schizophrenia, seizures),
substance abuse, concurrent use or within 14 days of MAOI therapy, pregnancy
 No concurrent use of other weight loss medications
 Patient will be using the requested drug as an adjunct to caloric restriction and
physical activity program
 Age restriction (phentermine, Bontril): must be at least 16 years old
 Age restriction (Xenical, Didrex): must be at least 12 years old
 Age restriction (Tenuate, Qsymia, Belviq, Contrave): must be at least 18 years old
May be authorized for Rheumatoid Arthritis (RA) when the following are met:
 Patient is at least 18 years old
 Prescribed by a rheumatologist
 Patient is NOT on a biological DMARD or azathioprine or cyclosporine
 Patient is up to date with all recommended vaccinations
 Patient has been screened for latent TB and hepatitis B
 Patient has moderate or high disease activity despite an adequate 3-month trial of
BOTH of the following:
o 2 different non-biologic DMARD regimens (1 of which must include
methotrexate (MTX) unless contraindicated)
 Monotherapy: MTX, sulfasalazine (SSZ), or leflunomide (LEF)
 Combination: MTX+SSZ+hydroxychloroquine (HCQ), MTX+HCQ, MTX+LEF,
MTX+SSZ, SSZ+HCQ
o BOTH Humira and Enbrel (Note: both Enbrel and Humira require PA)

For the treatment of moderate-severe persistent asthma:
 Prescribed by, or after consultation with a pulmonologist or allergist/immunologist
 12 years of age or older

Xeljanzxxiii
Last reviewed: 10/22/2015
Xolair
Last reviewed: 07/01/15
more than 4 years)
Requires documentation
showing member continues
weight loss plan and has
maintained at least 67% of
their initial weight loss to
date
Initial Approval:
3 months
Renewal:
Indefinite
Renewals require at least
20% symptom
improvement
Initial Approval:
Asthma: 6 months
53
Last updated: 05/03/2017







Baseline IgE levels between 30-700 IU/ml
Weight is less than 150 kg (330 lbs)
Allergic sensitization demonstrated by positive skin testing or in vitro testing for allergenspecific IgE to an allergen that is present year round (a perennial allergen), such as dust
mite, animal dander, cockroach, or molds
Evidence of reversible disease (12% or greater improvement in FEV1 with at least a 200-ml
increase or 20% or greater improvement in PEF as a result of a short-acting bronchodilator
challenge
Patient should be non-smoking or actively receiving smoking cessation treatment
Patient has tried and failed conventional immunotherapy or immunotherapy is not
indicated. (Immunotherapy has demonstrated efficacy against dust mites, animal dander,
and pollens but not against molds and cockroach allergies).
Asthma symptoms are not adequately controlled by high dose inhaled corticosteroids AND
a long-acting beta agonist (LABA) for 6 months
o Inadequate control is defined as:
 Requirement for systemic corticosteroids (oral, parenteral) to treat asthma
exacerbations
OR
 Daily use of rescue medications (short-acting inhaled beta-2 agonists)
OR
 2 ED visits or 1 hospitalization for asthma in the last 12 months
OR
 2-3 unscheduled office visits with documentation of intensive care for acute
asthma exacerbation
OR
 Nighttime symptoms occurring more than once a week
Chronic urticaria: 3 months
Renewal:
Asthma: 1 year
Requires demonstration of
clinical improvement (e.g.,
↓ use of rescue
medications or systemic
corticosteroids, ↑ in FEV1
from pre-treatment
baseline, ↓ in number of
ED visits or
hospitalizations) and
compliance with asthma
controller medications, and
non-smoking status.
Chronic urticaria: 6 months
 Requires
demonstration of
adequate symptom
control (e.g., ↓ itching)
For the treatment of chronic urticaria:
 Symptoms continuously or intermittently present for at least 6 weeks.
 Prescribed by an allergist/immunologist or dermatologist
 12 years of age or older
 Currently receiving H1 antihistamine therapy
54
Last updated: 05/03/2017




Failure of a 4 week, compliant trial of at least two high dose H1 antihistamines
AND
Failure of a 4-week, compliant trial of at least one of the following medications (used in
addition to H1 antihistamine therapy):
o Leukotriene inhibitor (montelukast or zafirlukast)
o H2 antihistamine (ranitidine or cimetidine)
o Doxepin
AND
Failure of a 4 week, compliant trial of low dose cyclosporine (used in addition to H1
antihistamine therapy) or contraindication to cyclosporine.
NOTE: Anti-inflammatory medications (dapsone, sulfasalazine, or hydroxychloroquine) may
be useful in treating urticaria, however the evidence is limited
**Note: Off-label and not covered for diagnosis of Allergic Rhinitis or food allergy**
i
Afinitor References:
1. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomized placebo-controlled phase III trial. The Lancet. 2008
2. 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.
3. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Breast Cancer.
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 Clearinghouse (NGC).
http://www.guideline.gov/content.aspx?id=45321&search=advanced+renal+cell+carcinoma#Section420. Rockville (MD): Agency for Healthcare Research and Quality
(AHRQ); cited 2015 August 10. Available: http://www.guideline.gov.
6. Owens, James. Tuberous sclerosis complex: Management. In UpToDate, Post TW (Ed.), Waltham, MA, (accessed on August 10,2015).
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).
9. Ellis, Matthew. Treatment approach to metastatic hormone receptor-positive breast cancer: Endocrine therapy. In UpToDate, Post TW (Ed.), Waltham, MA, (accessed
August 10, 2015).
55
Last updated: 05/03/2017
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.
ii Ampyra References
1. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically
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http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Version 1.2016. Accessed October 30, 2015.
3. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Pancreatic Adenocarcinoma.
http://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Version 2.2015. Accessed December 15, 2015.
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4. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Non-Small Cell Lung Cancer.
http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Version 2.2016. Accessed December 15, 2015.
Thalomid References
9. Thalomid® (thalidomide) prescribing information. Celgene Corp., Updated 8/2015.
10. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Multiple Myeloma.
http://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Version 2.2016. Accessed December 10, 2015.
11. Clarke J. Management of refractory discoid lupus and subacute cutaneous lupus. Waltham, MA: UptoDate; Last modified October 22, 2015.
http://www.uptodate.com/contents/management-of-refractory-discoid-lupus-and-subacute-cutaneouslupus?source=search_result&search=thalidomide&selectedTitle=15%7E150#H1088110. Accessed December 15, 2015.
12. Schur PH, Moschella SL. Mucocutaneous manifestations of systemic lupus erythematosus. Waltham, MA: UptoDate; Last modified April 16, 2014.
http://www.uptodate.com/contents/mucocutaneous-manifestations-of-systemic-lupuserythematosus?source=search_result&search=sle&selectedTitle=5%7E150#H18. Accessed December 15, 2015.
13. Scollard D, Stryjewska B. Treatment and prevention of leprosy. Waltham, MA: UptoDate; Last modified December 7, 2015.
http://www.uptodate.com/contents/treatment-and-prevention-ofleprosy?source=search_result&search=erythema+nodosum+leprosum&selectedTitle=2%7E11#H89888451. Accessed December 15, 2015.
xxi Tykerb References
1. Tykerb [lapatinib] Prescribing Information. GlaxoSmithKline. Updated: March, 2015.
2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Brest Cancer.
http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Version 1.2016. Accessed December 17, 2015.
xxii Votrient References
6. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Kidney Cancer.
http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Version 1.2016. Accessed October 30, 2015.
7. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Soft Tissue Sarcoma.
http://www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf. Version 1.2015. Accessed October 30, 2015.
xxiii Xeljanz References:
1. Xeljanz (tafacitinib citrate) [package insert]. NJ, NJ; Pfizer Labs; Revised November 2012.
2. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs
and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639.
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