Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, category 1, 2a, or 2b. o Micromedex DrugDex o Clinical Pharmacology • The dose prescribed is within the Food and Drug Administration (FDA)-approved range for the indication and patient specific factors (for example, age, weight, or Body Surface Area, renal function, Evidence Levels. 3. The patient has an FDA labeled indication, or an indication supported in AHFS, DrugDex with 1 or 2a level of evidence, or NCCN with 1 or 2a level of evidence for the requested agent AND 4. The requested agent has formulary alternatives (any … The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Labeling for Human Prescription Drug and Biological Products … The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist) or … agent OR Otezla for the same FDA labeled or DrugDex 1 or 2a level of evidence indication as the requested agent OR C. The patient has an FDA labeled diagnosis for the requested agent however the patient’s age is outside of FDA labeling and the prescriber attests treatment is clinically appropriate i. indication is a Category 1 or 2A in NCCN, or Class I, Class IIa, or Class IIb in DrugDex; or, 2. narrative text in AHFS or Clinical Pharmacology is supportive. ONE of the following: a. Level 1: High Strength/Quality. Evidence consists of at least one randomized, double-blind trial without important limitations (i.e., large treatment effect); intent-to-treat analysis used, confidence intervals reported.If more than one trial … Compendium Category Levels 1 and 2A Thomson Micromedex DrugDex Meets requirements for BOTH of the following: • Strength of recommendation: Class I (Recommended) or IIa (Recommended, In Most Cases) • Efficacy: Class I (Effective) or IIa (Evidence Favors Efficacy) Clinical Pharmacology Narrative text is supportive o NCCN Drugs and Biologics Compendium - indication is a Category 1 or 2A o Micromedex DrugDex® – indication is Class I, Class IIa, or Class IIb o Clinical Pharmacology – indication is supportive o Lexi-Drugs - indication is rated as “Evidence Level A” The patient has another indication that is supported in compendia [AHFS, or DrugDex 1 or 2a level of evidence for the requested agent and route of administration AND 2. 1. indication is a Category 1 or 2A in NCCN, or Class I, Class IIa, or Class IIb in DrugDex; or, 2. narrative text in AHFS-DI or Clinical Pharmacology is supportive, or 3. indication is listed in Lexi-Drugs as “Use: Off-Label” and rated as “Evidence Level A” Dosage (2.1): Weight based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter. • NCCN Drugs and Biologics Compendium - indication is a Category 1 or 2A • Micromedex DrugDex® – indication is Class I, Class IIa, or Class IIb or • Clinical Pharmacology – indication is supportive • Lexi-Drugs - indication is rated as “Evidence Level A” a.
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