UnitedHealthcare® Oxford Clinical Policy Drug Coverage Guidelines Policy Number: PHARMACY 098.213 T0 Effective Date: July 1, 2021 Instructions for Use Table of Contents Page Related Policies Conditions of Coverage............................................................................................. 1 Refer to Payment Guidelines below Description of Services ............................................................................................. 1 Definitions .................................................................................................................. 4 Payment Guidelines ................................................................................................... 4 Policy History/Revision Information ..................................................................... 243 Instructions for Use ............................................................................................... 247 Conditions of Coverage This policy applies to Oxford plan membership. Note: Not all Oxford groups have selected the same pharmacy benefits. Refer to the group's pharmacy plan number for specific exclusions, exceptions, and dispensing limitations. New Jersey Small group plan members should refer to their Certificate of Coverage for prior authorization and quantity limit guidelines. Description of Services The Drug Coverage Guidelines table of medications contains medications that: o Have a quantity limit in place; and/or o Require prior authorization through Oxford's Pharmacy Benefit Manager (PBM); and/or o Require prior authorization through Oxford's Medical Management; and/or o Are standard exclusions (such as weight loss medications, fluorides, vitamins) Medications are listed alphabetically with an explanation of how prior authorization is obtained and under which benefit it is covered. While a medication by itself may not require prior authorization, Home Care for the administration of a medication does require prior authorization. Exception: The first seven days of therapy with low molecular weight heparin are an exception to the Home Care prior authorization requirement. Drug Coverage Guidelines Page 1 of 247 UnitedHealthcare Oxford Clinical Policy Effective 07/01/2021 ©1996-2021, Oxford Health Plans, LLC Overview Oxford's PBM provides a nationwide network of participating pharmacies that administers prescription drugs on a retail level. Groups that purchase the Pharmacy Rider and Medicare Members with a Pharmacy benefit will have their retail pharmacy benefit administered by the PBM. For information regarding medication coverage related to the Member's pharmacy benefit, providers may contact Oxford's PBM. For issues of medication coverage unrelated to the Member's pharmacy benefit (Intravenous infusions, intramuscular injections, etc), Oxford may be contacted directly. Pharmacy Guideline Pharmacy Guideline Details New FDA-Approved New FDA-approved drug products may require prior authorization immediately upon launch of the medication. Drugs For information on coverage of recent FDA-approved drug products for which drug-specific criteria are unavailable, refer to Interim New Product Coverage Criteria. Also refer to the Clinical Policy titled Review at Launch for New to Market Medications. For oral chemotherapy, refer to Oral Chemotherapeutic Agents. New Jersey (NJ) Members who are enrolled in a New Jersey group Product with a 3-Tier Prescription Drug Benefit and for whom the NJ Formulary Regulations Formulary apply should refer to Prior Authorization/Notification Non-Formulary (i.e., Tier 3 or higher) Copay Adjustment – New Jersey. Regulations Opioid Overutilization The Center for Disease Control (CDC) recommends that clinicians should prescribe the lowest effective dosage when opioids are started. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to 50 morphine equivalent doses (MED) or more per day, and should avoid increasing dosage to 90 MED or more per day or carefully justify a decision to titrate dosage to 90 MED or more per day. • This includes all salt forms, single and combination ingredient products, all long- and short-acting formulations, and all brand and generic formulations, including but not limited to: codeine, buprenorphine (for pain), dihydrocodeine, fentanyl, methadone, meperidine, morphine, hydrocodone, hydromorphone, levorphanol, oxycodone, oxymorphone, pentazocine, tapentadol, tramadol. • For additional coverage criteria for the above drugs, refer to the Utilization Review Guideline titled Opioid Overutilization Cumulative Drug Utilization Review Criteria. Also refer to Short-Acting Opioid Review Criteria for Opioid Naïve Members and Supply Limits - Greater than 34 Day Supply for Opioids at Retail. Over-the-Counter • New Jersey (NJ) Plans: Prescription drugs for which there is a therapeutic over-the-counter (OTC) equivalent are not excluded from (OTC) Medications coverage. Refer to specific drug policies where applicable. • Connecticut (CT) and New York (NY) Plans: A prescription drug product that is therapeutically equivalent to an over-the-counter (OTC) drug may be covered if it is determined to be medically necessary. In order for a prescription drug to be deemed "medically necessary" when there is an equivalent OTC drug available, the physician must show that there is something about the prescription drug that is superior to the OTC drug, and likely to be more beneficial to the Member than the OTC drug. Documentation supporting medical necessity must be submitted by the provider. Pharmacy Benefit Oxford's PBM provides a nationwide network of participating pharmacies that administers prescription drugs on a retail level. Groups that Manager (PBM) purchase the Pharmacy Rider and Medicare Members with a Pharmacy benefit will have their retail pharmacy benefit administered by the PBM. • For information regarding medication coverage related to the Member's pharmacy benefit, providers may contact Oxford's PBM. Drug Coverage Guidelines Page 2 of 247 UnitedHealthcare Oxford Clinical Policy Effective 07/01/2021 ©1996-2021, Oxford Health Plans, LLC Pharmacy Guideline Pharmacy Guideline Details • For issues of medication coverage unrelated to the Member's pharmacy benefit (Intravenous infusions, intramuscular injections, etc), Oxford may be contacted directly. Quantity Duration Quantity duration (QD) and quantity level limitations (QLL) may be in place for certain medications. To request coverage for a greater quantity (QD) and Quantity of a medication with a QLL, providers must call Oxford's Pharmacy Benefit Manager (PBM). For information regarding QD or QLL supply Level Limitations limits, refer to the following documents on UHCProvider.com > Drug Lists and Pharmacy > Supply Limits: (QLL) • QD Supply Limits (defines the maximum quantity of medication that can be covered in a specified time period) • QLL Supply Limits (defines the maximum quantity of medication that is covered for one prescription or copayment) Review at Launch The Review at Launch program provides Oxford the ability to review, evaluate, and implement programs for new to market medications. The medication may move to a covered status once the medication has been evaluated by the UnitedHealthcare Pharmacy and Therapeutics Committee and the appropriate system specifications have been implemented to ensure suitable utilization management strategies are in place. A medication will be subject to review at launch when the medication is listed on the Review at Launch Medication List. Refer to the Clinical Policy titled Review at Launch for New to Market Medications. Specialty Pharmacy Participating hospitals in CT, NJ and NY are required to obtain certain specialty medications from the Optum Specialty Pharmacy. The for Certain Specialty specialty medications included are: Medications • Actemra® (tocilizumab) injection for intravenous infusion Administered in an • Cimzia (certolizumab pegol) Outpatient Hospital • Entyvio® (vedolizumab) Setting • Infliximab (Avsola™, Inflectra®, Remicade®, Renflexis®) • Krystexxa® (Pegloticase) • Lemtrada (alemtuzumab) • Ocrevus® (ocrelizumab) • Orencia® (abatacept) injection for intravenous infusion • Simponi Aria® (golimumab) injection for intravenous infusion • Stelara® (ustekinumab) • Tysabri (natalizumab) Participating hospitals located in CT, NJ and NY must obtain the above specialty medications from Optum when they are administered in an outpatient hospital. Optum will bill Oxford directly for these medications. Outpatient Hospital is defined by the following CMS/AMA Place of Service codes: • 19 Off-Campus - Outpatient Hospital; and • 22 On-Campus - Outpatient Hospital Drug Coverage Guidelines Page 3 of 247 UnitedHealthcare Oxford Clinical Policy Effective 07/01/2021 ©1996-2021, Oxford Health Plans, LLC Pharmacy Guideline Pharmacy Guideline Details Exceptions: This does not apply to: • Hospitals that have contracted their separately reimbursable drugs at 165% of CMS or less. • Hospitals whose aggregate reimbursement for the specialty drugs listed above are less than Oxford’s designated specialty pharmacy’s contracted rates for the same specialty drugs. • Hospitals that are located outside of CT, NJ and NY. • Oxford members that have Medicare or another health benefit plan as the primary payer and Oxford is the secondary payer. Refer to the following documents for additional information: • Reimbursement Policy: Specialty Pharmacy for Certain Specialty