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Mandatory Generic/Member Pays the Difference Exception Prior Authorization Program Summary

Policy Number: PH-91013

This program applies to Blue Partner and Commercial formularies.         

POLICY REVIEW CYCLE

              

Effective Date

Date of Origin   

01-01-2025           

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

The Mandatory Generic benefit requires generic drugs to be chosen when available for the lowest cost share. It excludes coverage of a multisource brand name drug and only provides coverage for the generic equivalent. Requests for a brand exception are reviewed through the prior authorization process.

Member Pays the Difference (MPTD) is a benefit that uses cost-share differentials to drive generic usage. Instead of non-coverage for the multisource brand name drug (as in the Mandatory Generic benefit), members must pay the co-payment for the brand drug plus the difference in cost between the multisource brand and generic price when a multisource brand drug is dispensed. Requests for a brand exception without cost-share penalty are reviewed through the prior authorization process.

Drug products classified as generic/therapeutic equivalents can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed brand product. Drug products are considered to be generic/therapeutic equivalents only if they meet these criteria:

  • They are pharmaceutical equivalents (contain the same active ingredient(s); dosage form and route of administration; and strength).
  • They are assigned by the Food and Drug Administration (FDA) the same therapeutic equivalence codes starting with the letter ‘A’.

OBJECTIVE

The intent of the Mandatory Generic/MPTD program is to encourage the use of cost-effective generic agents over the more expensive brand agents.  The program will allow coverage for brand agents when generic agents cannot be used due to a documented allergic reaction to inactive ingredients in the generic products, a documented adverse reaction to the inactive ingredients in the generic products, or a documented therapeutic failure that has been evaluated and supported in the patient’s medication history (dosing and compliance issues will be evaluated). Requests will be reviewed when patient specific documentation has been provided.

TARGET DRUGS

Multisource brand name drugs with an ‘A’ rated generic/therapeutic equivalent product

EXEMPT DRUGS

Drugs identified by the plan as having a Narrow Therapeutic Index and drugs not classified as multisource brand drugs (no generic equivalent available) will be exempt from prior authorization criteria and will not require brand override authorization for coverage.

Narrow Therapeutic Index Exemptions:

Generic Name

Brand Name(s)

amiodarone

Cordarone®, Pacerone®

carbamazepine

Carbatrol®, Epitol®,Equetro®, Tegretol®-XR

cyclosporine

Gengraf®,Neoral®, Sandimmune®

digoxin

Lanoxin®

disopyramide

Norpace®, Norpace® CR

divalproex

Depacon®, Depakene®, Depakote®, Depakote® ER, Depakote® Sprinkles

ethosuximide

Zarontin®

everolimus

Zortress®

flecainide

Tambocor™

lamotrigine

Lamictal®, Lamictal® ODT™, Lamictal® XR™

levothyroxine

Levothroid®, Levoxyl®, Synthroid®, Unithroid®

lithium carbonate

Eskalith®, Lithobid®

oxcarbazepine

Trileptal®

phenytoin

Dilantin®, Phenytek®

primidone

Mysoline®

quinidine

 

sirolimus

Rapamune®

tacrolimus

Prograf® 

theophylline

Elixophyllin®, Theo-24®, Theochron™, Uniphyl®

thyroid

Armour Thyroid

valproic acid derivatives

Depacon®, Depakene®, Depakote®, Depakote® ER, Depakote® Sprinkles, Stavzor™

warfarin

Coumadin®, Jantoven®

Note: Drugs considered excluded from coverage (benefit exclusions) will not be considered for brand override authorization.

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Brand Products will be approved for coverage or without application of a member cost share penalty when ONE of the following is met and documentation is provided:

  1. The patient has a documented allergic reaction to inactive ingredients in the generic product(s) (medical records required) OR
  2. The patient has a documented adverse reaction to inactive ingredients in the generic product(s) (medical records required) OR
  3. The patient has a documented therapeutic failure to the generic product(s) (medical records required; dosing and compliance issues will be evaluated through medical history)

Length of Approval: 6 months for controlled substances, 12 months for all other targets

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

ALBP _  Commercial _ CS _ Mandatory_Generic_Exception_PA _ProgSum_ 01-01-2025  _ © Copyright Prime Therapeutics LLC. November 2024 All Rights Reserved