PRIOR AUTHORIZATION
CRITERIA
June 2014
SOUTH REGION PRIOR AUTHORIZATION CRITERIA AFINITOR (everolimus) Tablet: 2.5mg, 5mg, 7.5mg, 10mg STATUS Requires PA PA CRITERIA FOR APPROVAL
• Diagnosis of one of the following:
-Advanced hormone receptor–positive, human epidermal growth receptor 2–negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole
-Advanced neuroendocrine tumors of pancreatic origin with unresectable, locally advanced, or metastatic disease -Advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib
-Renal angiomyolipoma with tuberous sclerosis complex not requiring immediate surgery
-Subependymal giant cell astrocytoma require therapeutic intervention but are not candidates for curative surgical resection AND
• Prescriber must be an oncologist.
If the above conditions are met, the request will be approved with a 12 month duration; if the above conditions are not met, the request will be referred for medical necessity review.
FDA INDICATIONS
• -Advanced hormone receptor–positive, human epidermal growth receptor 2–negative breast cancer -Advanced neuroendocrine tumors of pancreatic origin
-Advanced renal cell carcinoma
-Renal angiomyolipoma with tuberous sclerosis complex -Subependymal giant cell astrocytoma
DOSAGE AND ADMINISTRATION
• Recommended Dose in Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer, Advanced PNET, Advanced RCC, and Renal Angiomyolipoma with TSC: The recommended dose is 10 mg, to be taken once daily at the same time every day. Administer either consistently with food or consistently without food. Tablets should be swallowed whole with a glass of water. Do not break or crush tablets. Continue treatment until disease progression or unacceptable toxicity occurs
• Dose Modifications in Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer, Advanced PNET, Advanced RCC, and Renal Angiomyolipoma with TSC: Management of severe or intolerable adverse reactions may require temporary dose reduction and/or interruption of therapy. If dose reduction is required, the suggested dose is approximately 50% lower than the daily dose previously administered.
Adverse Drug
Reaction Severitya AFINITOR Dose Adjustmentb and Management Recommendations Non-infectious
pneumonitis Grade 1 Asymptomatic, radiographic findings only
No dose adjustment required. Initiate appropriate monitoring. Grade 2
Symptomatic,
not interfering with ADLc
Consider interruption of therapy, rule out infection and consider treatment with corticosteroids until symptoms improve to ≤ grade 1.
Re-initiate AFINITOR at a lower dose.
Discontinue treatment if failure to recover within 4 wks. Grade 3
Symptomatic, interfering with ADLc; O2 indicated
Interrupt AFINITOR until symptoms resolve to ≤ grade 1.
Rule out infection, and consider treatment with corticosteroids.
Consider re-initiating AFINITOR at a lower dose. If toxicity recurs at grade 3, consider discontinuation.
Grade 4
Life-threatening,
ventilatory support indicated
Discontinue AFINITOR, rule out infection, and consider treatment with corticosteroids. Stomatitis Grade 1
Minimal symptoms, normal diet
No dose adjustment required.
Manage with non-alcoholic or salt water (0.9%) mouth wash several times a day. Grade 2
Symptomatic but can eat and swallow modified diet
Temporary dose interruption until recovery to grade ≤1. Re-initiate AFINITOR at the same dose.
If stomatitis recurs at grade 2, interrupt dose until recovery to grade ≤1. Re-initiate AFINITOR at a lower dose.
Manage with topical analgesic mouth treatments (e.g. benzocaine, butyl
aminobenzoate, tetracaine hydrochloride, menthol or phenol) with or without topical corticosteroids (i.e. triamcinolone oral paste).d
Grade 3
Symptomatic and unable to adequately aliment or hydrate orally
Temporary dose interruption until recovery to grade ≤1. Re-initiate AFINITOR at a lower dose.
Manage with topical analgesic mouth treatments (i.e. benzocaine, butyl
aminobenzoate, tetracaine hydrochloride, menthol or phenol) with or without topical corticosteroids (i.e. triamcinolone oral paste).d
Grade 4
Symptoms associated with life-threatening
consequences
Discontinue AFINITOR and treat with appropriate medical therapy.
Other non-hematologic toxicities (excluding metabolic events)
Grade 1 If toxicity is tolerable, no dose adjustment required. Initiate appropriate medical therapy and monitor.
Grade 2 If toxicity is tolerable, no dose adjustment required. Initiate appropriate medical therapy and monitor.
If toxicity becomes intolerable, temporary dose interruption until recovery to grade ≤1. Re-initiate AFINITOR at the same dose.
If toxicity recurs at grade 2, interrupt AFINITOR until recovery to grade ≤1. Re-initiate AFINITOR at a lower dose.
Grade 3 Temporary dose interruption until recovery to grade ≤1. Initiate appropriate medical therapy and monitor.
Consider re-initiating AFINITOR at a lower dose. If toxicity recurs at grade 3, consider discontinuation.
Grade 4 Discontinue AFINITOR and treat with appropriate medical therapy. Metabolic events
(e.g.
hyperglycemia, dyslipidemia)
Grade 1 No dose adjustment required.
Initiate appropriate medical therapy and monitor.
Grade 2 No dose adjustment required.
Manage with appropriate medical therapy and monitor.
Grade 3 Temporary dose interruption.
Re-initiate Afinitor at a lower dose.
Manage with appropriate medical therapy and monitor. Grade 4 Discontinue AFINITOR and treat with appropriate medical therapy. a Severity grade description: 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms; 4 = life-threatening symptoms. b If dose reduction is required, the suggested dose is approximately 50% lower than the dose previously administered.
c Activities of daily living (ADL)
d Avoid using agents containing alcohol, hydrogen peroxide, iodine, and thyme derivatives in management of stomatitis as they may worsen mouth ulcers.
• Hepatic Impairment:
• Mild hepatic impairment (Child-Pugh class A) – The recommended dose is 7.5 mg daily; the dose may be decreased to 5 mg if not well tolerated.
• Moderate hepatic impairment (Child-Pugh class B) – The recommended dose is 5 mg daily; the dose may be decreased to 2.5 mg if not well tolerated.
• Severe hepatic impairment (Child-Pugh class C) – If the desired benefit outweighs the risk, a dose of 2.5 mg daily may be used but must not be exceeded.
• CYP3A4 and/or P-glycoprotein (PgP) Inhibitors: Avoid the use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole). Use caution when co-administered with moderate CYP3A4 and/or PgP inhibitors (e.g., amprenavir, fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem). If patients require co-administration of a moderate CYP3A4 and/or PgP inhibitor, reduce the AFINITOR dose to 2.5 mg daily. The reduced dose of AFINITOR is predicted to adjust the area under the curve (AUC) to the range observed without inhibitors. An AFINITOR dose increase from 2.5 mg to 5 mg may be considered based on patient tolerance. If the moderate inhibitor is discontinued, a washout period of approximately 2 to 3 days should be allowed before the AFINITOR dose is increased. If the moderate inhibitor is discontinued, the AFINITOR dose should be returned to the dose used prior to initiation of the moderate CYP3A4 and/or PgP inhibitor. Grapefruit, grapefruit juice, and other foods that are known to inhibit cytochrome P450 and PgP activity may increase everolimus exposures and should be avoided during treatment.
• Strong CYP3A4 Inducers: Avoid the use of concomitant strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital). If patients require co-administration of a strong CYP3A4 inducer, consider increasing the AFINITOR dose from 10 mg daily up to 20 mg daily, using 5 mg increments. This dose of AFINITOR is predicted, based on pharmacokinetic data, to adjust the AUC to the range observed without inducers. However, there are no clinical data with this dose adjustment in patients receiving strong CYP3A4 inducers. If the strong inducer is discontinued, the AFINITOR dose should be returned to the dose used prior to initiation of the strong CYP3A4 inducer. St. John’s Wort (Hypericum perforatum) may decrease everolimus exposure unpredictably and should be avoided.
• Recommended Dose in SEGA with TSC: The recommended starting dose is 4.5 mg/m2, once daily. The recommended starting dose for patients with severe hepatic impairment (Child-Pugh class C) or requiring moderate CYP3A4 and/or PgP inhibitors is 2.5 mg/m2, once daily. The recommended starting dose for patients requiring a concomitant strong CYP3A4 inducer is 9 mg/m2. Use therapeutic drug monitoring to guide subsequent dosing. Adjust dose at two week intervals as needed to achieve and maintain trough concentrations of 5 to 15 ng/mL. Continue treatment until disease progression or unacceptable toxicity occurs. The optimal
duration of therapy is unknown.
• Dose Modifications in SEGA with TSC: Reduce dose or withhold for severe or intolerable adverse reactions. Reduce the dose by approximately 50%. If dose reduction is required for patients receiving the lowest available strength, administer every other day. • Hepatic Impairment: Reduce the starting by approximately 50% in patients with SEGA who have severe hepatic impairment (Child-Pugh class C). Adjustment to the starting dose for patients with SEGA who have mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment may not be needed. Subsequent dosing should be based on therapeutic drug monitoring. Assess everolimus trough concentrations approximately two weeks after commencing treatment, a change in dose, or any change in hepatic function.
• CYP3A4 and/or P-glycoprotein (PgP) Inhibitors: Avoid the use of concomitant strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole). For patients who require treatment with moderate CYP3A4 and/or PgP inhibitors (e.g., amprenavir, fosamprenavir, aprepitant,
erythromycin, fluconazole, verapamil, diltiazem): Reduce dose by approximately 50%. Administer every other day if dose reduction is required for patients receiving the lowest available strength.Assess everolimus trough concentrations approximately two weeks after dose reduction. Resume the dose that was used prior to initiating the CYP3A4 and/or PgP inhibitor 2 to 3 days after discontinuation of a moderate inhibitor. Assess the everolimus trough concentration approximately two weeks later. Do not ingest foods or nutritional supplements (e.g., grapefruit, grapefruit juice) that are known to inhibit cytochrome P450 or PgP activity.
• Strong CYP3A4 Inducers: Avoid the use of concomitant strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) if alternative therapy is available. For patients who require treatment with a strong CYP3A4 inducer: Double the dose. Assess the everolimus trough concentration two weeks after doubling the dose and adjust the dose if necessary to maintain a trough concentration of 5 to 15 ng/mL. Return the dose to that used prior to initiating the strong CYP3A4 inducer if the strong inducer is discontinued, and assess the everolimus trough concentrations approximately two weeks later. Do not ingest foods or nutritional supplements (e.g., St. John’s Wort (Hypericum perforatum)) that are known to induce cytochrome P450 activity.
REFERENCES
1. Facts and Comparisons, St. Louis, 2013 eFacts CliniSphere Version ISBN 1-57439-036-8. 2. Afinitor. Prescribing Information. Novartis Pharmaceuticals Corporation. August 2012. Revision/Review Date: 7/2013
Associated Policy: Prior Authorization of Medications 236.200
TRUE HEALTH PRIOR AUTHORIZATION PROTOCOL FOR INJECTABLE 5- HYDROXYTRYPTAMINE-3 (5HT3) SEROTONIN RECEPTOR ANTAGONISTS
FORMULARY STATUS: Generic Ondansetron or Granisetron Preferred
Aloxi® palonosetron hydrochloride: 0.25 mg in 5 ml, is supplied as a single-use vials ready for intravenous
injection
Anzemet® dolasetron mesylate: 20mg/ml supplied as 12 .5mg/0.625ml single-use vial, 12.5mg/0.625ml fill in
single-use 2ml cartridge, 100mg/5ml single-use vial, 500mg/25ml multi-dose vial
Kytril® granisetron hydrochloride: 1 mg/1 ml, is supplied in 1 ml single-use vials and 4 ml multi-use vials and 0.1
mg/1 ml, is supplied in 1 ml single-use vials
Zofran® ondansetron: 2 mg/ml is supplied as follows: 2 ml single-dose vials and 20 ml multidose vials (singles) Initial Approval:
• The request for the medication is for an Food and Drug Administration (FDA) approved indication, and/or is used for a medical condition that is supported by the medical compendium (Micromedex, American Hospital Formulary Service (AHFS), Drug Points , Drug Package Insert) as defined in the Social Security Act 1927 and/or per the National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology (ASCO), National Cancer Institute {NCI} (a Division of the U.S. National Institutes of Health) and the Multinational Association of Supportive Care in Cancer (MASCC) standard of care guidelines for antiemetic therapy.
• Patients receiving an antineoplastic agent classified as Level 4 or greater per the Hesketh classification (see appendix1) can receive Aloxi® (palonosetron hydrochloride) as a first line antiemetic agent.
• For all other patients, if the medication request is for any other 5-hydroxytryptamine-3 (5HT3) serotonin
receptor antagonist other than generic Ondansetron or generic Granisetron, the patient has a documented (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) treatment failureafter receiving an adequate trial of generic Ondansetron or generic Granisetron and/or has another documented medical reason ( intolerance, hypersensitivity, contraindication, etc) for not utilizing these medications to treat their medical condition.
• Prescribed dosing of the 5HT3 serotonin receptor antagonist is within FDA approved indications and/or is
supported by the medical compendium as defined by the Social Security Act and/or per the NCCN, ASCO, NCI or MASCC standard of care guidelines.
• The medication is recommended and prescribed by a specialist in the field to treat the patient’s respective medical condition
If all of the above conditions are met, the request will be approved for up to 3 months or as recommended per FDA approved indications and/or as defined by the medical compendium as defined above and/or per the NCCN, ASCO, NCI or MASCC standard of care guidelines; if all of the above criteria are not met, the request is referred to a
Medical Director for medical necessity review.
Reauthorization of Medication:
• The prescribing physician has provided documentation as to the clinical benefits of the medication supporting continued treatment, OR the medication is being continued in accordance with the recommended time as defined by FDA drug package insert, and/or per recommendations of the medical compendium as described above, and/or per the NCCN, ASCO, NCI or MASCC standard of care guidelines.
If all of the above conditions are met, the request will be approved for up to 3 months or as recommended per FDA approved indications and/or as defined by the medical compendium as defined above and/or per the NCCN, ASCO, NCI or MASCC standard of care guidelines; if all of the above criteria are not met, the request is referred to a
Medical Director for medical necessity review.
FDA Approved Indications, Dosing and Administration: Palonosetron (Aloxi®)
Highly or moderately emetogenic chemotherapy-induced [acute or delayed] nausea and vomiting prophylaxis:
• 18 y/o and older: single dose of 0.25 mg administered IV over 30 seconds given approximately 30 minutes before the start of chemotherapy. No safety or efficacy established for repeat doses, therefore, administration of an additional dose within a 7-day period is not recommended.
Postoperative Nausea and Vomiting
• 18 y/o and older: single dose of 0.25 mg administered IV over 10 seconds given immediately before the induction of anesthesia.
Dolasetron (Anzemet®)
Highly or moderately emetogenic chemotherapy-induced nausea and vomiting prophylaxis in adults or children:
• For patients 2-16 y/o:1.8 mg/kg IV given over a period of up to 15 minutes, beginning approximately 30 minutes before administration of emetogenic chemotherapy drug. (Maximum pediatric dose is 100 mg).
• For patients 17 y/o and older: 1.8mg/kg given as a single dose approximately 30 minutes before chemotherapy. Alternatively, for most patients, a fixed dose of 100mg can be administered over 30 seconds.
Post-Operative nausea and vomiting:
• 17 y/o and older (prophylaxis): 12.5 mg IV as a single dose approximately 15 minutes before cessation of anesthesia.
• 17 y/o and older (treatment): 12.5 mg IV as a single dose as soon as nausea and/or vomiting presents.
• 2-16 y/o (prophylaxis and treatment): 0.35 mg/kg as a single dose approximately 15 minutes before cessation of anesthesia or as soon as nausea and/or vomiting develops to a maximum dose of 12.5 mg per dose.
Granisetron (Kytril®)
Highly or moderately emetogenic chemotherapy-induced nausea and vomiting prophylaxis in adults or children:
• 10 mcg/kg IV administered within 30 minutes before initiation of emetogenic chemotherapy. The dose may be administered undiluted over 30 seconds, or diluted in 5% dextrose or NSS and infused over 5 minutes. Pediatric patients under 2 years of age have not been studied.
Post-Operative nausea and vomiting:
• 4 y/o and older (prophylaxis): single IV dose of 1 mg is given undiluted over 30 seconds before induction of anesthesia or immediately before reversal of anesthesia.
• 4 y/o and older (treatment): 1 mg undiluted IV is given over 30 seconds.
Ondansetron (Zofran®)
Highly or moderately emetogenic chemotherapy-induced nausea and vomiting prophylaxis: {several regimens exist}
18 y/o and older
• single-dose of 32mg given as a 15 minute infusion IV 30 minutes before administration of single day chemotherapy agent. Do not repeat. This dosing is typically reserved for highly emetogenic chemotherapy • 0.15mg/kg as 15 minute infusion begin 30 minutes before administration of chemotherapy and subsequent
doses given at 4 and 8 hours after first dose.
• 8 mg IV over 15 minutes begin 30 minutes prior to chemotherapy followed immediately by a continuous infusion of 1mg/hr for up to 24 hrs.
6 mos to 18 y/o:
• 0.15mg/kg as 15 minute infusion begin 30 minutes before administration of chemotherapy and subsequent doses given at 4 and 8 hours after first dose.
• 3-5mg/m2 given over 15 minutes begin immediately prior to chemotherapy followed after chemotherapy by oral ondansetron 4 mg Q8hrs for up to 5 days.
Post-Operative nausea and vomiting:
• 12 y/o and older (prophylaxis): single IV dose of 4 mg preferably over 2-5 minutes beginning immediately prior to induction of anesthesia OR 4mg as a single undiluted IM injection given immediately prior to induction of anesthesia.
• 12 y/o and older (treatment): if patient experiences nausea and/or vomiting shortly after surgery can give single IV dose of 4 mg.
• 1month -12y/o (prophylaxis and treatment): single IV dose of 0.1 mg/kg for patient weight of 40kg or less OR if weight is between 40-80 kg give single IV dose of 4mg IV. Administer over 2-5 minutes immediately prior to or following anesthesia induction or shortly after surgery if nausea and/or vomiting occurs.
• Per the manufacturer of ondansetron, if the patient does not achieve adequate control of postoperative nausea and vomiting with a single 4 mg IV dose given prior to induction of anesthesia they will not benefit from a 2nd
4mg dose given postop.
References:
1. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Antiemesis. Version 3.2009.
2. American Society of Clinical Oncology Guidelines for Antiemetics in Oncology: Update 2006. Journal of Clinical Oncology.2006; 24(18):2932-2947. Erratum pages 5341-5342.
3. Perugia International Cancer Conference VII. Multinational Association of Supportive Care in Cancer (MASCC). Consensus Conference on Antiemetic Therapy. Last Updated 9/1/2005. Available at www.mascc.org
4. US National Institutes of Health. National Cancer Institute. Nausea and vomiting PDQ. Health Professional Version. Treatment of acute/delayed emesis. Available at www.cancer.gov/cancertopics/pdq/supportivecare/nausea/HealthProfessional. Last modified 10/19/2006.
5. Roila F. Warr D. Clark-Snow RA. Et al . Delayed emesis: moderately emetogenic chemotherapy. Supportive Cancer Care. 2005;13:104-108.
6. Prescribing information Kyril®. Roche Pharmaceuticals. 11/2005. 7. Prescribing information Anzemet ® Sanofi-aventis. 10/2009. 8. Prescribing information Aloxi®. Helsinn. 02/2008.
9. Prescribing information Zofran®. GlaxoSmithKline. 10/2009.
10. Hesketh PJ, Kris MG, Grunberg SM, et al. Proposal for Classifying the Acute Emetogenicity of Cancer Chemotherapy. Journal of Clinical Oncology.1997;15(1): 103-09.
Review Date: 7/2012
Associated Policy: Prior Authorization of Medications 236.200
NOTE: Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
APPENDIX
1Emetogenic Potential of Single Chemotherapy Agents
Level
Frequency of Emesis (%)
5 >90 4 60-90 3 30-60 2 10-30 1 < 10
Agent
Carmustine > 250mg/m2, Cisplatin > 50mg/m2, Cyclophosphamide >
1,500 mg/m2, Dacarbazine, Mechlorethamine, Streptozocin Carboplatin, Carmustine < 250mg/m2, Cisplatin <50mg/m2 ,
Cyclophosphamide > 750mg/m2 < 1,500 mg/m2, Cytarabine > 1g/ m2,
Doxorubicin > 60 mg/m2, Methotrexate > 1,000 mg/m2, Procarbazine
(oral)
Cyclophosphamide < 750mg/m2, Cyclophosphamide (oral),
Doxorubicin 20 - 60 mg/m2, Epirubicin < 90 mg/m2,
Hexamethylmelmine (oral), Idarubicin, Methotrexate 250-1,000 g/ m2,
Mitoxantrone < 15 mg/m2
Docetaxel, Etoposide, 5-FU <1,000 mg/ m2, Gemcitabine, Methotrexate >
50 < 250 mg/ m2, Mitomycin, Paclitaxel
Bleomycin, Busulfan, Chlorambucil (oral), 2-Chlorodeoxyadenosine, Fludarabine, Hydroxyurea, Methotrexate < 50 mg/ m2, L-phenylalanine
mustard (oral), Thioguanine (oral), Vinblastine, Vincristine, Vinorelbine
Hesketh PJ, Kris MG, Grunberg SM, et al.. Proposal for Classifying the Acute Emetogenicity of Cancer Chemotherapy. Journal of Clinical Oncology.199715(1): 103-09
APPENDIX
2:
EMETIC RISK GROUPS
High Risk in nearly all patients (> 90%)
Moderate Risk in 30% to 90% of patients
Low Risk in 10% to 30% of patients
Minimal Fewer than 10% at risk
Perugia International Cancer Conference VII. Multinational Association of Supportive Care in Cancer (MASCC). Consensus Conference on Antiemetic Therapy. Last Updated 9/1/2005. Available at www.mascc.org
Emetic Risk of Intravenously Administered Antineoplastic Agents
without antiemetics)
High (>90%) Cisplatin ≥ 50 mg/m2, Mechlorethamine, Streptozocin,
Cyclophosphamide ≥ 1500mg/m2, Carmustine, Dacarbazine, Dactinomycin, Altretamine, AC combination defined as either Doxorubicin or Epirubicin with Cyclophosphamide
Moderate (30-90%) Cisplantin < 50mg/m2, Oxaliplatin, Cytarabine >1g/m2, Carboplatin, Ifosfamide, Cyclophosphamide <1500mg/m2, Doxorubicin,
Daunorubicin, Epirubicin, Idarubicin, Irinotecan, Aldesleukin >12-15 milllion units/m2, Amifostine >300 mg/m2, Arsenic Trioxide, Azacitidine, Bisulfan >4mg/day, Dactinomycin, Lomustine, Melphalan >50mg/m2, Methotrexate 250->1000 mg/m2,
Low (10-30%) Amifostine <300 mg/m2, Bexarotene,Paclitaxel, Paclitaxel-albumin, Docetaxel, Mitoxantrone, Topotecan, Etoposide, Pemetrexed, Methotrexate >50mg/m2<250mg/m2, Mitomycin, Doxorubicin Liposomal, Gemcitabine, Cytarabine ≤ 1000mg/m2, 5-Fluorouracil, Bortezomib, Cetuximab, Trastuzumab
Minimal (<10%) Alemtuzumab, Alpha Interferon, Asparaginase, Bevacizumab, Bleomycin, Bortezomib, Busulfan, 2-Chlorodeoxyadenosine (Cladribine), Decitabine, Denileukin difititox, Dexrazoxane, Fludarabine, Gemtuzumab ozogamicin, Methotrexate ≤ 50mg/m2, Nelarabine, Pentostatin, Rituximab, Trastuzumab, Vinblastine, Vincristine, Vinorelbine
American Society of Clinical Oncology Guidelines for Antiemetics in Oncology: Update 2006. Journal of Clinical Oncology.2006;24(18):2932- 2947. Erratum pages 5341-5342.; National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Antiemesis. Version 1.2007.
Emetic Risk of Orally Administered Antineoplastic Agents
Emetic Risk (incidence of emesis
without antiemetics)
High (>90%) Moderate (30-90%) Low (10-30%) Minimal (<10%)Agent
Hexamethylmelamine, ProcarbazineCyclophosphamide, Etoposide, Temozolomide, Vinorelbine, Imatinib Capecitabine, Fludarabine
Chlorambucil, Hydroxyurea, L-Phenylalanine mustard, 6-Thioguanine, Methotrexate, Gefitinib, Dasatinib, Erlotinib, Lenalidomide, Melphalan, Sorafenib, Sunitinub, Thalidomide, Thioguanine,
Perugia International Cancer Conference VII. Multinational Association of Supportive Care in Cancer (MASCC). Consensus Conference on Antiemetic Therapy. Last Updated 9/1/2005. Available at www.mascc.org
Emetic Risk with Radiation Therapy
Emetic Risk (incidence of emesis
Agent
without antiemetics)
High (>90%) Total Body Irradiation
Moderate (30-90%) Upper Abdomen
Low (10-30%) Lower thorax region, Pelvis, Cranium (radiosurgery), Craniospinal Minimal (<10%) Head and Neck, Extremities, Cranium, Breast
Perugia International Cancer Conference VII. Multinational Association of Supportive Care in Cancer (MASCC). Consensus Conference on Antiemetic Therapy. Last Updated 9/1/2005. Available at www.mascc.org; American Society of Clinical Oncology Guidelines for Antiemetics in Oncology: Update 2006. Journal of Clinical Oncology.2006;24(18):2932-2947. Erratum pages 5341-5342
TRUE HEALTH PRIOR AUTHORIZATION PROTOCOL FOR ALPHA-1 PROTEINASE INHIBITORS (HUMAN)
Alpha1-Proteinase Inhibitor (human) (Prolastin ®) approximately 500 mg vial with 20 mL diluent, approximately 1000 mg vial with 40 mL.
Alpha1-Proteinase Inhibitor (human) (Aralast ®) approximately 500 mg vial (not less than 400 mg) with 25 mL diluent, 1000 mg vial (not less than 800 mg) with 50 mL diluent.
Alpha1-Proteinase Inhibitor (human) (Zemaira ®) approximately 1000 mg with 20 mL diluent.
PA CRITERIA FOR INITIAL APPROVAL:
• The member is an adult (≥ 18 y/o) and has a documented diagnosis of a congenital deficiency of alpha-1 antitrypsin (ATT) [serum level < 11μM or 80mg/dl].
• Documentation was submitted indicating the member has undergone genetic testing for ATT deficiency by isoelectric focusing in polyacrylamide gel and is classified as phenotype PiZZ, PiZ(null) or Pi(null)(null) variant of alpha-1-antitrypsin deficiency [NOTE: phenotypes PiMZ or PiMS are not candidates for treatment with Alpha1-Proteinase Inhibitors].
• Documentation was submitted indicating the member does not have selective IgA deficiency (IgA level < 15 mg/dL) with known antibodies against IgA.
• The Alpha1-Proteinase Inhibitor (human) is being prescribed by a pulmonologist.
• The Alpha1-Proteinase Inhibitor (human) is being prescribed at an FDA approved dosage.
• If the medication request is for an Alpha1-Proteinase Inhibitor (human) product other than Prolastin, the patient has
a documented medical reason (intolerance, hypersensitivity, contraindication, treatment failure, etc) for not using Prolastin to treat their medical condition.
If all of the above conditions are met, the request will be approved up to a 6-month duration; if all of the above criteria are not met, the request is referred to a Medical Director for medical necessity review.
PA CRITERIA FOR RE-AUTHORIZATION:
• The Alpha1-Proteinase Inhibitor (human) is being prescribed by a pulmonologist.
• Documentation was submitted indicating the member has clinically benefited from therapy (i.e. improved lung function tests {pulmonary function tests}), alpha-1 antitrypsin serum level maintained above 80 mg/dL, improved quality of life).
• The Alpha1-Proteinase Inhibitor (human) is being prescribed at an FDA approved dosage.
If all of the above conditions are met, the request will be approved up to a 6-month duration; if all of the above criteria are not met, the request is referred to a Medical Director for medical necessity review.
FDA INDICATION:
Alpha 1 Proteinase Inhibitors (HUMAN) are indicated for chronic augmentation therapy in patients having congenital deficiency of alpha1 PI (alpha1 antitrypsin deficiency) and clinical evidence of emphysema. DOSAGE AND ADMINISTRATION:
Alpha 1 Proteinase Inhibitors (HUMAN) are dosed at 60mg/kg body weight and are administered once weekly via IV infusion at a rate of approximately 0.08ml/kg/min. The infusion rate may be adjusted based on the patient’s tolerability (i.e. tolerance of prior dosing schedule).
REFERENCES:
1. Alpha-1 Antitrypsin Deficiency Task Force of the Clinical Problems Assembly. American Thoracic Society/European Respiratory Society Statement: Standard for the diagnosis and management of
individuals with alpha-1 antitrypsin deficiency. Statement developed jointly by an ATS/ERS task force. American Journal of Respiratory & Critical Care Medicine. 2003;168:818-900.
2. Teckman JH. Lindblad D. Alpha-1 antitrypsin deficiency: diagnosis, pathophysiology, and management. Current Gastroenterology Reports. 2006;8:14-20.
3. Sandhaus RA. Alpha-1 antitrypsin deficiency: a history through the medical literature. A compendium of classic papers. Cambridge Medical Publications. 2006.
4. Middleton ET. Morice AH. Breath carbon monoxide as an indication of smoking habit. Chest. 2000;117(3):758-763.
5. Prolastin Prescribing Information. Talecris Biotherapeutics, Inc. June 2008. 6. Zemaira Prescribing Information. ZLB Behring LLC. January 2007. 7. Aralast Prescribing Information. Baxter Healthcare Corporation. May 2009. Review Date: 7/2012
Associated Policy: Prior Authorization of Medications 236.200
NOTE: Physician reviewer must override criteria when, in his/her professional judgement, the requested item is medically necessary.
TRUE HEALTH PRIOR AUTHORIZATION CRITERIA AMPYRATM (dalfampridine): 10 mg tablets, extended-release
Formulary Status: Non-Formulary requiring prior authorization
PA CRITERIA FOR INITIAL AUTHORIZATION FOR USE IN MULTIPLE SCLEROSIS (MS):
•Documentation submitted indicates that the member is an adult (≥18 y/o) and has a clinical diagnosis of multiple sclerosis.
•Baseline diagnostic and/or clinical documentation was submitted (e.g. 12-item MS walking scale, timed 25-foot walk, Ashworth score for spasticity, lower extremity manual muscle test, quality of life etc.) that documents member’s baseline walking dysfunction
•For patients who have a clinical diagnosis of relapsing remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS) then that patient has documented (consistent with pharmacy claims data OR for new members to the health plan consistent with medical chart history) concurrent use of one of the following immunomodulating therapies: Avonex® (Interferon beta-1b), Betaseron® (Interferon beta-1b), Copaxone® (glatiramer acetate), Extavia® (Interferon
beta-1b), Rebif® (Interferon beta-1a), or has a some other documented medical reason (intolerance, hypersensitivity, etc) for not
utilizing one of these therapies to manage their medical condition.
•AMPYRA is being prescribed or recommend by a neurologist at an FDA-approved dosage
If all of the above conditions are met, the request will be approved for up to a 6-month duration; if all of the above criteria are not met then, based on professional judgment, the Physician reviewer will issue a denial for the medication requested.
PA CRITERIA FOR REAUTHORIZATION FOR USE IN MS:
•Diagnostic or clinical documentation was submitted (e.g. 12-item MS walking scale, timed 25-foot walk, Ashworth score for spasticity, lower extremity manual muscle test, quality of life etc.) indicating that member has demonstrated improvement in walking while receiving AMPYRA therapy
•AMPYRA is being prescribed or recommend by a neurologist at an FDA-approved dosage
If all of the above conditions are met, the request will be approved for up to a 12-month duration; if all of the above criteria are not met then, based on professional judgment, the Physician reviewer will issue a denial for the medication requested.
PA CRITERIA FOR INITIAL AUTHORIZATION FOR USE IN OTHER MEDICALLY ACCEPTED INDICATIONS:
•The medication is recommended and prescribed by a specialist in the member’s disease state
•The medication is prescribed for a medically accepted use at a medically accepted dose per the medical compendia (i.e. Micromedex, Drug Points, AHFS drug information) as defined by the Social Security Act
•Documentation was submitted indicating that the member has a documented (consistent with pharmacy claims data) adequate trial (including dates, doses of medications) of all first line medical therapies as recommended by the medical compendia and standard of care guidelines and/or has a documented medical reason (i.e. intolerance, contraindications, etc.) for not receiving or trying all first line medical treatment(s)
If all of the above conditions are met, the request will be approved for up to a 6-month duration; if all of the above criteria are not met then, based on professional judgment, the Physician reviewer will issue a denial for the medication requested.
PA CRITERIA FOR RE-AUTHORIZATION FOR USE IN OTHER MEDICALLY ACCEPTED INDICATIONS: •The medication is recommended or prescribed by a specialist in the member’s disease state
•Diagnostic and/or clinical documentation was submitted (e.g. improved disease activity index, quality of life, blood work, radiographic evidence) that indicates the member has significantly clinically benefited from receiving AMPYRA therapy
•The medication is prescribed for a medically accepted use at a medically accepted dose per the medical compendia (i.e. Micromedex, Drug Points, AHFS drug information) as defined by the Social Security Act.
If all of the above conditions are met, the request will be approved for up to a 6-month duration; if all of the above criteria are not met then, based on professional judgment, the Physician reviewer will issue a denial for the medication requested.
FDA INDICATIONS: Multiple Sclerosis:
AMPYRA (dalfampridine) is a potassium channel blocker indicated to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed.
The use of AMPYRA is contraindicated in the following conditions: history of seizure, moderate or severe renal impairment (CrCl ≤ 50 mL/minute).
DOSAGE AND ADMINISTRATION:
The maximum recommended dose of AMPYRA is one 10 mg tablet twice daily, taken with or without food, and should not be exceeded. Doses should be taken approximately 12 hours apart. Patients should not take double or extra doses if a dose is missed.
No additional benefit was demonstrated at doses greater than 10 mg twice daily and adverse reactions and discontinuations because of adverse reactions were more frequent at higher doses.
REFERENCES:
1.Fischer JS, Jak AJ, Kniker JE, Rudick RA et al. Multiple sclerosis functional composite administration and scoring manual. National Multiple Sclerosis Society, Oct 2001.
2.Hobart JC, Riazi A, Lamping DL, Fitzpatrick R. Measuring the impact of MS on walking ability. Neurology 2003;60:31-36. 3.Katz RT. Spasticity. In: O'Young B, Young MA, Stiens SA. PM&R Secrets. Ed. Sara J Cuccurullo, MD. Philadelphia;
Hanley & Belfus, 1997.
4. Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet.
2009 Feb 28;373(9665):732-8.
5.Kachuck NJ. Sustained release oral fampridine in the treatment of multiple sclerosis. Expert Opin Pharmacother. 2009 Aug;10(12):2025-35.
6.Thompson A, Polman C. Improving function: a new treatment era for multiple sclerosis? Lancet. 2009 Feb 28;373(9665):697-8.
7.Bever CT, Judge SI. Sustained-release fampridine for multiple sclerosis. Expert Opin Investig Drugs. 2009 Jul;18(7):1013-24.
8.Goodman AD, Brown TR, Cohen JA, Krupp LB, Schapiro R, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F202 Study Group. Dose comparison trial of sustained-release fampridine in multiple sclerosis. Neurology. 2008 Oct 7;71(15):1134-41.
9.Kryscio RJ. Fampridine for MS responders: clinically relevant or hypothesis generating? Neurology. 2008 Oct 7;71(15):1130-1.
Revision/Review Date: 02/2013
Associated Policy: Prior Authorization of Medications 236.200
NOTE: Clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
APPENDIX 1: The 12-Item Multiple Sclerosis Walking Scale (MSWS-12) In the past two weeks, how much has your
MS Not at all A little Moderately Quite a bit Extremely
1. Limited your ability to walk? 1 2 3 4 5
2. Limited your ability to run? 1 2 3 4 5
3. Limited your ability to climb up and
down stairs? 1 2 3 4 5
4. Made standing when doing things
difficult? 1 2 3 4 5
5. Limited your balance when standing or
walking? 1 2 3 4 5
6. Limited how far you are able to walk? 1 2 3 4 5
7. Increased the effort needed for you to
walk? 1 2 3 4 5
8. Made it necessary for you to use support when walking indoors (e.g. holding onto furniture, using a stick, etc.)?
1 2 3 4 5
9. Made it necessary for you to use support when walking outdoors (e.g. using a stick, a frame, etc.)?
1 2 3 4 5
10. Slowed down your walking? 1 2 3 4 5
11. Affected how smoothly you walk? 1 2 3 4 5
12. Made you concentrate on your
walking? 1 2 3 4 5
Adapted from: Hobart JC, Riazi A, Lamping DL, Fitzpatrick R. Measuring the impact of MS on walking ability. Neurology 2003;60:31-36.
APPENDIX 2: The Timed 25-Foot Walk (T25FW)
DESCRIPTION
The Timed 25-Foot Walk (T25FW) is a quantitative measure of lower extremity function. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. In clinical trials, it is recommended that the treating neurologist select the appropriate assistive device for each patient.
TIME LIMIT PER TRIAL 3 minutes (180 seconds) per trial. ADMINISTRATION
Trial 1
The subject should be directed to one end of a clearly marked 25-foot course (clearly defined on the floor or on the wall) and instructed to stand just behind the starting line. Point out where the 25-foot course ends, then instruct the patient as follows: “I’d like you to walk 25 feet as quickly as possible, but safely. Do not slow down until after you’ve passed the finish line. Ready? Go.”
Begin timing when the lead foot is lifted and crosses the starting line. Stop timing when the lead foot crosses the finish line.
Trial 2
After completing the first timed walk, position the patient just behind the line where s/he is now standing, repeat the same instructions, and have the patient complete the walk again.
Assistive Devices
In clinical trials and other serial studies, the goal is to use the same assistive device at each study visit. The treating neurologist should select an assistive device at the beginning of the study for each patient who needs one, keeping in mind that the patient may deteriorate modestly over the course of a trial. In general, patients should use their customary assistive device(s), NOT the least assistance possible to complete the test. For patients with significant gait impairment, the treating neurologist should have the patient use a rolling walker even if this is not the patient’s customary device. In general, non-wheeled walkers should not be used. If a patient does use an assistive device, this should be noted on the Record Form.
Completing the Record Form
Record only the times for the two successfully completed trials of the Timed 25-Foot Walk. If the patient could not complete one or both of the trials of the Timed 25-Foot Walk, record this in the appropriate section of the Record Form. For example, if the patient’s disease has progressed and/or physical limitations prohibit him or her from completing the trial, you should indicate “Unable to complete trial due to physical limitations”, and record any specifics that you can observe (i.e., patient in a wheelchair now and unable to walk, etc.).
If the patient did not complete a trial for any other reason, specify this as well (e.g., patient fell and was too fatigued to complete another trial; patient refused to complete trial).
Adapted from: Fischer JS, Jak AJ, Kniker JE, Rudick RA et al. Mutiple sclerosis functional composite administration and scoring manual. National Multiple Sclerosis Society, Oct 2001.
APPENDIX 3: The Modified Ashworth Scale (Bohannon & Smith, 1987)
SCORE DESCRIPTION
0 No increase in muscle tone
1 Slight increase in muscle tone, manifested by a catch and
release or minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension
1+ Slight increase in muscle tone, manifested by a catch,
followed by minimal resistance throughout the remainder (less than half) of the ROM
2 More marked increase in muscle tone through most of the
ROM, but affected part(s) easily moved
3 Considerable increase in muscle tone, passive movement
difficult
4 Affected part(s) rigid in flexion or extension
Adapted from Katz RT. Spasticity. In: O'Young B, Young MA, Stiens SA. PM&R Secrets. Ed. Sara J Cuccurullo, MD. Philadelphia; Hanley & Belfus, 1997.
TRUE HEALTH PRIOR AUTHORIZATION CRITERIA
ANGIOTENSIN II RECEPTOR BLOCKER AND RENIN INHIBITOR MEDICATIONS FORMULARY STATUS: Formulary, Pays at Point-of-Sale (First Line)
Cozaar (Losartan) Tablets: 25 mg, 50 mg, 100 mg
Hyzaar (Losartan/Hydrochlorothiazide) Tablets: 50mg/12.5mg, 100mg/12.5mg, 100mg/25mg FORMULARY STATUS: Formulary, Requires Step Therapy (Second Line)
Amturnide (Aliskiren/Amlodipine/Hydrochlorothiazide) Tablets: 150mg/5mg/12.5mg, 300mg/5mg/12.5mg,
300mg/5mg/25mg, 300mg/10mg/12.5mg, 300mg/10mg/25mg
Diovan(Valsartan) Tablets: 40 mg, 80mg, 160mg, 320mg
Diovan-HCT (Valsartan/Hydrochlorothiazide) Tablets: 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg,320mg/12.5mg,
320mg/25mg
Exforge (Amlodipine Besylate/Valsartan) Tablets: 5mg/160mg, 5mg/320mg, 10mg/160mg, 10mg/320mg Exforge HCT (Amlodipine/Valsartan/Hydrochlorothiazide) Tablets: 5mg/160mg/12.5mg, 10mg/160mg/12.5mg,
5mg/160mg/25mg, 10mg/320mg/25mg
Tekturna (Aliskiren hemifumarate) Tablets: 150mg, 300mg
Tekturna HCT (Aliskiren/Hydrochlorothiazide) Tablets: 150mg/12.5mg, 300mg/12.5mg Valturna (Aliskiren/Valsartan) Tablets: 150mg/160mg, 300mg/320mg
Tekamlo (Aliskiren/Amlodipine) Tablets: 150mg/5mg, 150mg/10mg, 300mg/5mg, 300mg/10mg NOTE: Patient must meet criteria #1 for approval of initial PA request.
FORMULARY STATUS: Non-Formulary, Requires Prior Authorization (Third Line) Atacand(Candesartan Cilexetil) Tablets: 4mg, 8mg, 16mg, 32mg
Avapro (Irbesartan) Tablets: 75mg, 150mg, 300mg
Benicar (Olmesartan Medoxomil) Tablets: 5mg, 20mg, 40mg Micardis(Telmisartan) Tablets: 20mg, 40mg, 80mg
Teveten(Eprosartan Mesylate) Tablets: 400mg, 600mg
AtacandHCT(Candesartan Cilexetil/ Hydrochlorothiazide) Tablets: 8mg/12.5mg, 32mg/12.5mg, 32mg/25mg Avalide (Irbesartan/Hydrochlorothiazide) Tablets: 150mg/12.5mg, 300mg/12.5mg, 300mg/25mg
Azor (Amlodipine Besylate/Olmesartan Medoxomil) Tablets: 5mg/20mg, 5mg/40mg, 10mg/20mg, 10mg/40mg BenicarHCT (Olmesartan Medoxomil/ Hydrochlorothiazide) Tablets: 20mg/12.5mg, 40mg/12.5mg, 40mg/25mg Micardis-HCT (Telmisartan/Hydrochlorothiazide) Tablets: 40mg/12.5mg, 80mg/12.5mg, 80mg/25mg
Teveten-HCT (Eprosartan Mesylate/ Hydrochlorothiazide) Tablets: 600mg/12.5mg, 600mg/25mg
Tribenzor (Olmesartan Medoxomil/Amlodipine/Hydrochlorothiazide) Tablets: 20mg/5mg/12.5mg, 40mg/5mg/12.5mg,
40mg/5mg/25mg,40mg/10mg/12.5mg, 40mg/10mg/25mg
Twynsta (Telmisartan/Amlodipine) Tablets: 40mg/5mg, 40mg/10mg, 80mg/5mg, 80mg/10mg NOTE: Patient must meet criteria #1 & #2 for approval of initial PA request.
PA CRITERIA FOR APPROVAL
1. Documented trial and failure or intolerance with a first line agent for at least 15 days of therapy within the previous 60 days.
2. Documented trial and failure or intolerance with a second line agent for at least 15 days of therapy within the previous 60 days.
If the above conditions are met, the request will be approved with a 12 month duration; if the above conditions are not met, the request will be referred to a Medical Director for medical necessity review.
REFERENCES
1. Amturnide®. Prescribing Information. Novartis Pharmaceuticals Corp. December 2010.
2. Atacand®. Prescribing Information. AstraZeneca Pharmaceuticals, Inc. October 2009.
3. Avapro®. Prescribing Information. Bristol-Myers Squibb Sanofi-Synthelabo Partnership. April 2007.
4. Benicar®.Prescribing Information. Daiichi Sankyo, Inc. February 2010.
5. Cozaar®. Prescribing Information. Merck & Co. June 2010.
6. Diovan®. Prescribing Information. Novartis Pharmaceuticals Corp. June 2010.
7. Micardis®. Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. November 2009.
8. Teveten®. Prescribing Information. Abbott Laboratories. June 2010.
9. Atacand-HCT®. Prescribing Information. AstraZeneca Pharmaceuticals. May 2008.
10. Avalide®. Prescribing Information. Bristol-Myers Squibb Sanofi-Synthelabo Partnership. September 2010.
11. Azor®. Prescribing Information. Daiichi Sankyo, Inc. May 2009.
12. Benicar HCT®. Prescribing Information. Daiichi Sankyo, Inc. July 2007.
13. Diovan-HCT®. Prescribing Information. Novartis Pharmaceuticals Corp. April 2010.
14. Exforge®. Prescribing Information. Novartis Pharmaceuticals Corp. February 2009.
15. Exforge HCT®. Prescribing Information. Novartis Pharmaceuticals Corp. August 2009.
16. Hyzaar®. Prescribing Information. Merck & Co. June 2010.
17. Micardis-HCT®. Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. November 2009.
18. Teveten-HCT®. Prescribing Information. Abbott Laboratories. June 2010.
19. Tribenzor®. Prescribing Information. Daiichi Sankyo Laboratories. July 2010.
20. Twynsta®. Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. August 2010.
21. Micromedex. Available from http://thomsonhc.com. Accessed May 2011.
22. Drugs Facts and Comparisons. Available from http://online.factsandcomparisons.com. Accessed May 2011.
23. Lexi-Comp. Available from: http://online.lexi.com.db.usip.edu/crlsql/servlet/crlonline. Accessed May 2011. 24. Tekturna®. Prescribing Information. Novartis Pharmaceuticals. May 2011.
25. Tekturna HCT®. Prescribing Information. Novartis Pharmaceuticals. February 2011.
26. Valturna®. Prescribing Information. Novartis Pharmaceuticals. May 2011.
27. Tekamlo™. Prescribing Information. Novartis Pharmaceuticals. March 2011.
Review Date: 7/2012
Associated Policy: Prior Authorization of Medications 236.200
NOTE: Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
TRUE HEALTH PRIOR AUTHORIZATION CRITERIA ANTIPSYCHOTIC AGENTS for PATIENTS 17 YEARS OLD and YOUNGER FORMULARY STATUS: Preferred and Non-Preferred
PA CRITERIA FOR APPROVAL:
•Appropriate Diagnosis/Indication for requested medication AND
•Appropriate dose of medication based on age (i.e. pediatric and elderly populations) and indication AND
•Documented trial and failure or intolerance with up to three formulary medications used to treat the documented diagnosis. For medications where there is only one formulary agent, only that agent must have been ineffective or not tolerated
OR
• No other formulary medication has a medically accepted use for the patient’s specific diagnosis as referenced in the medical compendia*.
OR
• All other formulary medications are contraindicated based on the patient’s diagnosis, other medical conditions, or other medication therapy.
If the above conditions are met, the request will be approved with up to a 6 month duration depending upon the diagnosis and usual treatment therapies; if the above conditions are not met, the request will be referred to a Medical Director (or Psychiatrist when applicable) for medical necessity review.
*Medical compendia consists of the following: the Food and Drug Administration (FDA) approved
indication(s) (Drug Package Insert), Micromedex, American Hospital Formulary Service (AHFS), DrugPoints (formerly known as USPDI).
Review Date: 11/2012
TRUE HEALTH PRIOR AUTHORIZATION CRITERIA ANTIDEPRESSANT AGENTS for PATIENTS 5 YEARS OLD and YOUNGER FORMULARY STATUS: Preferred and Non-Preferred
PA CRITERIA FOR APPROVAL:
•Appropriate Diagnosis/Indication for requested medication AND
•Appropriate dose of medication based on age (i.e. pediatric and elderly populations) and indication AND
•Documented trial and failure or intolerance with up to three formulary medications used to treat the documented diagnosis. For medications where there is only one formulary agent, only that agent must have been ineffective or not tolerated
OR
• No other formulary medication has a medically accepted use for the patient’s specific diagnosis as referenced in the medical compendia*.
OR
• All other formulary medications are contraindicated based on the patient’s diagnosis, other medical conditions, or other medication therapy.
If the above conditions are met, the request will be approved with up to a 6 month duration depending upon the diagnosis and usual treatment therapies; if the above conditions are not met, the request will be referred to a Medical Director (or Psychiatrist when applicable) for medical necessity review.
*Medical compendia consists of the following: the Food and Drug Administration (FDA) approved
indication(s) (Drug Package Insert), Micromedex, American Hospital Formulary Service (AHFS), DrugPoints (formerly known as USPDI).
Review Date: 11/2012
TRUE HEALTH PRIOR AUTHORIZATION CRITERIA
ANZEMET® (dolasteron) Tablet: 50mg, 100mg FORMULARY STATUS: Formulary PA CRITERIA FOR APPROVAL:
• Current treatment with emetogenic chemotherapy And
• Documented trial and failure with maximum therapeutic doses or intolerance to ondansetron tablet or oral disintegrating tablet (ODT)
If the above condition is met, the request will be approved with quantity limit of 5 tablets/30days with a 3 month duration; if the above condition is not met, the request will be referred to a Medical Director for medical necessity review. If the request is for a quantity greater than 5 tablets/30days, the request will be referred to a Medical Director for medical necessity review.
QUANTITIES GREATER THAN ABOVE LIMITS PER 30 DAYS:
If the request is for a quantity greater than allowed per 30 days, the request will be referred to a Medical Director for medical necessity review.
FDA INDICATIONS:
• Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
• Prevention of postoperative nausea and vomiting.
DOSAGE AND ADMINISTRATION:
Prevention of chemotherapy induced nausea and vomiting:
• Adults: 100 mg within 1 hour before chemotherapy.
• Children (2 to 16 years of age): 1.8 mg/kg within 1 hour before chemotherapy, up to a maximum of 100 mg.
Prevention of postoperative nausea and vomiting:
• Adults: 100mg within two hours before surgery.
• Children (2 to 16 years of age): 1.2mg/kg given within two hours before surgery, up to a maximum of 100mg.
REFERENCE:
1. Bubalo J; Seelig F; Karbowicz S; Maziarz RT. Randomized open-label trial of dolasetron for the control of nausea and vomiting associated with high-dose chemotherapy with hematopoietic stem cell transplantation. Biol Blood Marrow Transplant 2001;7(8):439-45.
2. The National Comprehensive Cancer Network (NCCN) and The American Cancer Society (ACS). Nausea and Vomiting. Treatment Guidelines for Patients with Cancer. Version IV. June 2007.
3. Steiner M, Yorgason RZ, Vermeulen LC, Theisen J. Patient outcomes after therapeutic interchange of dolasteron for granisetron. Am J Health-Syst Pharm 2003;60(10):1023-1028.
4. Markman M. Progress in preventing chemotherapy-induced nausea and vomiting. Cleve Clin J Med 2002 Aug;69(8):609-10, 612, 615-7.
5. Hesketh PI. Prevention and treatment of chemotherapy induced nausea and vomiting. February 2000.
6. American Society of Clinical Oncology Guideline for Antiemetics in Oncology: Update 2006. Amercian Society of Clinical Oncology.J Clin Oncol.2006;24:1-16.
7. Anzemet (dolasetron) Product Information. Sanofi-Aventis, U.S. LLC. January 2011. 8. Facts and Comparisons, St. Louis, 2010 eFacts CliniSphere Version ISBN 1-57439-036-8. Review Date: 7/2012
Associated Policy: Prior Authorization of Medications 236.200
NOTE: Physician reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary.
