Vyvanse (lisdexamfetamine dimesylate)

POLICY NUMBER

L.5.01.482

Vyvanse (lisdexamfetamine)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Lisdexamfetamine, a CNS stimulant, is a prodrug of dextroamphetamine and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and for the treatment of moderate to severe binge eating disorder (BED) in adults.

Quantity Limit

POLICY

Prior authorization is required.

The use of samples or vouchers/coupons by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. 

Vyvanse (lisdexamfetamine) chewable tablets are not covered on any BCBSMS Formulary.

Vyvanse (lisdexamfetamine) capsules may be considered medically necessary when ALL of the following criteria are met:

1. ONE of the following:

   1. The individual has a documented diagnosis of attention deficit hyperactivity disorder (ADHD) and ALL of the following:

      1. The individual is 6 to 18 years of age; AND

      2. ONE of the following:

         1. The individual has tried and had an inadequate response (see Policy Guidelines) or had a documented intolerance to at least two formulary generic extended-release stimulant agents approved for the treatment of ADHD. Medication trials must contain different active ingredients (i.e., amphetamine-based, methylphenidate-based, dexmethylphenidate-based, etc.); OR

         2. The individual has an FDA labeled contraindication or hypersensitivity to ALL formulary generic stimulant agents; OR

   2. The individual has a documented diagnosis of moderate to severe binge eating disorder (BED)* and ALL of the following:

      1. The individual is 18 to 65 years of age;

      2. Clinical documentation has been submitted to support ALL of the following:

         1. Binge eating episodes occur, on average, at least four times a week for 3 months;

         2. Description of binge eating episodes includes at least THREE of the following:

            1. Eating more rapidly than normal;

            2. Eating until feeling uncomfortably full;

            3. Eating large amounts of food when not feeling physically hungry;

            4. Eating alone because of embarrassment by the amount of food consumed; OR

            5. Feeling disgusted with oneself, depressed, or guilty after overeating;

         3. Binge eating episodes are NOT associated with regular use of inappropriate compensatory behavior (e.g., purging, fasting, excessive exercise); AND

         4. Binge eating episodes do NOT occur exclusively during the course of anorexia nervosa or bulimia nervosa;

      3. The individual is being treated by a psychiatrist or psychiatric nurse practitioner;

      4. The individual does not have serious cardiac disease (e.g., structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease);

      5. The requested agent is not being used for weight loss or to treat obesity;

      6. The individual has a BMI of 25 to 45;

      7. Documentation and outcomes are submitted of any non-pharmacologic therapies (cognitive behavioral therapy and/or interpersonal therapy with a clinician at least once a week) completed within the past 6 months for the treatment of BED; AND

      8. Documentation and outcomes are submitted of any pharmacologic therapies(i.e., zonisamide, topiramate, venlafaxine, citalopram, sertraline, fluvoxamine, etc.)tried within the past 6 months for the treatment of BED;

2. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage; AND

3. The individual does not have any contraindication(s) to therapy with the requested agent.

*Non-formulary lisdexamfetamine will be reviewed for medical necessity when requested for the treatment of binge eating disorder.

Length of Approval: 6 months (binge eating disorder)

Renewal Criteria

Vyvanse (lisdexamfetamine) capsules may be considered medically necessary for renewal for treatment of moderate to severe binge eating disorder when ALL of the following are met:

1. The individual has documented clinical improvement;

2. The individual has been adherent to the requested medication and cognitive behavioral therapy or interpersonal therapy, as appropriate;

3. The individual does not have any contraindication(s) to therapy with the requested agent; AND

4. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage

Length of Approval: 6 months

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

Structural Steel Self-Insured Group: Effective 06/16/2025, Vyvanse and generic lisdexamfetamine dimesylate (cap and chew) are covered without Prior Authorization or Quantity Limit. (FID#: 89805 Formulary Name: BCBSMS COMM-CUSTOM STEEL) 

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medication failure is defined as disease progression despite maximally tolerated dose (>3 months use) as appropriate for disease state being treated. Experience of common side effects of medication will not be considered medication failure for the purpose of this review.

BCBSMS determines patient medication trial 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. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

1. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

2. appropriate with regard to standards of good medical practice; and

3. not solely for the convenience of the Member, his or her Provider; and

4. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

01/01/2014: New policy added.

07/23/2015: Code Reference section updated for ICD-10.

10/27/2015: Policy section updated to state: Previous use of samples or vouchers/coupons will not be considered for authorization.

02/02/2016: Approved by Pharmacy & Therapeutics (P&T) Committee. Investigative definition updated in policy guidelines section.

04/01/2016: Policy description updated to add binge eating disorder as an indication for Vyvanse. Policy statement revised to state that Vyvanse will be approved for ADHD and narcolepsy when certain criteria are met. Added policy statement that Vyvanse will be approved for binge eating disorder when certain criteria are met.

05/31/2016: Policy number L.5.01.482 added.

02/07/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

02/06/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

02/05/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added drug name to the top of the policy. Policy description updated regarding indications for Vyvanse. Policy statements renumbered. Sources section updated. Effective 01/01/2019.

11/01/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated. Policy section updated to add the following statements: 1) Prior authorization is required. 2) The use of samples or vouchers/coupons by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Medically necessary policy statement criteria for ADHD updated to list examples of active ingredients for medication trials. Policy statements updated to change "patient" to "member." Added renewal criteria. Policy Exceptions updated. Policy Guidelines updated to define medication failure and medically necessary. Sources updated.

01/05/2021: Policy section updated to remove "narcolepsy" from the following statement: The member has tried at least two formulary generic extended-release stimulant agents approved for the treatment of ADHD. It previously stated, "The member has tried at least two formulary generic extended-release stimulant agents approved for the treatment of ADHD or narcolepsy."

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

06/16/2025: Added Self-Insured Group exception.

07/01/2025: Effective 09/01/2025 - Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description extensively revised. Revised indication for lisdexamfetamine and updated the quantity limits table. Policy statement revised to state that the use of samples or vouchers/coupons by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Added statement that Vyvanse (lisdexamfetamine) chewable tablets are not covered on any BCBSMS Formulary. Revised medically necessary criteria for ADHD and moderate to severe binge eating disorder. Added criteria for dose requirements and contraindications to therapy. Added statement that Non-formulary lisdexamfetamine will be reviewed for medical necessity when requested for the treatment of binge eating disorder. Length of approval updated. Revised renewal criteria. Policy Guidelines updated. Sources updated. Policy update effective 09/01/2025.

SOURCE(S)

Vyvanse prescribing information. Takeda Pharmaceuticals America, Inc. October 2023. Last accessed January 2025.

CODE REFERENCE

None