CurrentAllCare Health CCOPolicy N/A

Abaloparatide (TYMLOS) Coverage Criteria

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This policy governs prior authorization coverage for abaloparatide (TYMLOS) for FDA-approved indications, including a 24-month cumulative treatment limit for osteoporosis and plan-year authorization.

Policy Summary

PayerAllCare Health CCO

PolicyAbaloparatide (TYMLOS) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization for TYMLOS and document an FDA-approved indication and, for osteoporosis, less than 24 months of cumulative parathyroid therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

TYMLOSProduct affected

24 monthsCumulative osteoporosis treatment limit

Plan yearCoverage duration

FDA-approvedCovered indication scope

Coverage Criteria

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Abaloparatide coverage criteria

Covered for an FDA-approved indication subject to the osteoporosis treatment-duration requirement.

Coverage criteria: The requested use is an FDA-approved indication; and, for osteoporosis, the member has received less than 24 months of cumulative treatment with any parathyroid therapy.Less than 24 months cumulative treatment

The cumulative-treatment requirement applies to osteoporosis.

Sympazan initial and renewal therapy

Covered for all FDA-approved indications subject to prior authorization.

Initial therapy: The patient has Lennox-Gastaut syndrome; therapy is prescribed by or provided in consultation with the required specialist; and the patient has a contraindication to or is unable to use prerequisite therapy.

Renewal coverage is requested within the plan-year coverage period.Plan year

Standard plan-year authorization

Covered for all FDA-approved indications subject to prior authorization.

Standard authorization: The product is prescribed for an FDA-approved indication and meets applicable product-specific criteria.Plan year

Applies to Cotellic, Xalkori oral capsules, Tafinlar oral capsules, and Vizimpro.

Xalkori pellet criteria

Covered for all FDA-approved indications subject to formulation-specific criteria.

Xalkori oral pellets: The product is prescribed for an FDA-approved indication and, for NSCLC, ALCL, or IMT, the patient is unable to swallow the capsule formulation.Plan year

Tafinlar suspension criteria

Covered for all FDA-approved indications subject to formulation-specific criteria.

Tafinlar oral tablet for suspension: The product is prescribed for an FDA-approved indication and the patient is unable to swallow Tafinlar capsules.Plan year

Dalfampridine initial and renewal therapy

Covered for all FDA-approved indications subject to initial and renewal criteria.

Initial therapy: The patient has multiple sclerosis with symptoms of a walking disability, such as mild to moderate bilateral lower-extremity weakness or unilateral weakness plus lower-extremity or truncal ataxia, and therapy is prescribed by or provided in consultation with a neurologist.

Renewal: The patient demonstrates improvement in walking ability.Plan year

Rasonque oncology authorization

Covered for all FDA-approved indications subject to prescriber restrictions.

Oncology authorization: The product is prescribed for an FDA-approved indication by or in consultation with an oncologist.

RASONQUE

Coverage is subject to prior authorization.

RASONQUE criteria: The requested use is an FDA-approved indication; metastatic pancreatic adenocarcinoma requires prescribing by or in consultation with an oncologist.

NUBEQA

Coverage is subject to prior authorization.

NUBEQA criteria: The requested use is an FDA-approved indication; for NMCRPC or MCSPC, the patient has received bilateral orchiectomy, has castrate testosterone, or uses a GnRH analog concurrently.Castrate testosterone less than 50 ng/dL

Coverage duration is the plan year.

Dasatinib

Coverage is subject to prior authorization.

Dasatinib criteria: For previously treated Philadelphia chromosome-positive chronic myeloid leukemia, obtain mutational analysis before initiation and verify that dasatinib is appropriate under the NCCN guideline treatment recommendation table based on the BCR-ABL1 mutation profile.Plan year

INQOVI

Coverage is subject to prior authorization.

INQOVI criteria: The requested use is an FDA-approved indication.Plan year

Deferasirox initial and renewal therapy

Coverage is subject to prior authorization.

Initial therapy: For transfusion-related chronic iron overload, serum ferritin is consistently above 1000 mcg/L; or for NTDT, serum ferritin is consistently above 300 mcg/L with at least two values in the previous three months and LIC is at least 5 mg Fe/g liver dry weight. Therapy is prescribed by or in consultation with a hematologist or hematologist/oncologist, and the patient has tried or is contraindicated to generic deferasirox oral tablet or tablet for oral suspension.

Renewal therapy: For transfusion-related chronic iron overload, serum ferritin is consistently above 500 mcg/L; or for NTDT, serum ferritin is consistently above 300 mcg/L with at least two values in the previous three months or LIC is at least 3 mg Fe/g liver dry weight. Specialist involvement continues to apply.Plan year

OSENVELT

Coverage is subject to prior authorization.

OSENVELT criteria: The requested use is an FDA-approved indication.Plan year

Deutetrabenazine indications

Coverage is subject to prior authorization.

Huntington disease: Deutetrabenazine is prescribed by or in consultation with a neurologist or movement disorder specialist.

Tardive dyskinesia: Deutetrabenazine is prescribed by or in consultation with a neurologist and the patient has a history of using agents that cause tardive dyskinesia.

VALTOCO

Coverage is subject to prior authorization.

Epilepsy criterion: For epilepsy in a patient age 12 years or older, the patient has tried the prerequisite therapy identified in the criteria.Age 12 years or older

The prerequisite therapy is not specified in the available text.

Diclofenac topical solution

Coverage is subject to prior authorization.

Knee osteoarthritis criterion: For knee osteoarthritis, the patient has tried or is contraindicated to a formulary version of the prerequisite therapy identified in the criteria.Plan year

Diclofenac knee osteoarthritis

Coverage criteria for diclofenac sodium topical solution in a metered-dose pump.

Formulary prerequisite: For osteoarthritis of the knee, the patient has tried or is contraindicated to a formulary version.

Dihydroergotamine acute migraine

Coverage criteria for dihydroergotamine nasal for acute migraine treatment.

Acute migraine requirements

Medication restriction: The patient has no concurrent use of specified medications.
Preferred-agent history: The patient has tried or is contraindicated to both a triptan, such as sumatriptan or rizatriptan, and a CGRP inhibitor, such as Nurtec ODT or Ubrelvy.

Dronabinol chemotherapy-related nausea

Coverage criteria for dronabinol capsules for nausea and vomiting associated with cancer chemotherapy.

Chemotherapy-associated nausea and vomiting: The patient has tried or is contraindicated to one specified therapy.

The therapy is not identified in the available text.

Criteria pending CMS review

Coverage criteria are not finalized in this window.

Review status: Prior authorization criteria are pending CMS review.

Applies to droxidopa and dupilumab products.

Vyalev initial and renewal therapy

Vyalev Parkinson's disease initial and renewal criteria.

Initial therapy

Prescriber: Therapy is prescribed by or in consultation with a neurologist.
Treatment eligibility
- The patient is unable to swallow extended-release tablets.
- The patient meets the source-listed oral carbidopa/levodopa regimen condition.
  The source text is truncated after this condition.

Renewal therapy: The patient demonstrates improvement in motor symptoms while on therapy.Plan year

Fruzaqla

Covered for all FDA-approved indications.

Fruzaqla coverage: The requested use is an FDA-approved indication.Plan year

Lytgobi

Covered for all FDA-approved indications.

Lytgobi coverage: The requested use is an FDA-approved indication. For intrahepatic cholangiocarcinoma, complete a comprehensive ophthalmological examination, including optical coherence tomography, before initiation and at recommended scheduled intervals.Plan year

Emgality

Criteria pending CMS review.

Review status: Exclusion, prescriber, off-label-use, Part B, and prerequisite-therapy criteria are pending CMS review.

Ztalmy

Covered for all FDA-approved indications.

Ztalmy coverage: The requested use is an FDA-approved indication.Plan year

Gefitinib

Covered for all FDA-approved indications.

Gefitinib coverage: The requested use is an FDA-approved indication; for metastatic NSCLC with an EGFR mutation, the patient is not receiving concurrent therapy with the agent or regimen specified in the policy.Plan year

Exxua

Criteria pending CMS review.

Review status: Exclusion, prescriber, off-label-use, Part B, and prerequisite-therapy criteria are pending CMS review.

Xospata

Covered for all FDA-approved indications.

Xospata coverage: The requested use is an FDA-approved indication.Plan year

Daurismo

Covered for all FDA-approved indications.

Daurismo coverage: The requested use is an FDA-approved indication.Plan year

Glatiramer and Glatopa

Covered for all FDA-approved indications.

Glatiramer coverage: The requested use is an FDA-approved indication.Plan year

Glatiramer products

Coverage is based on all FDA-approved indications.

Glatiramer products: The requested glatiramer or Glatopa product is used for an FDA-approved indication.Plan year

GLP1-dulaglutide

Coverage is based on all medically accepted indications.

Dulaglutide: Trulicity is used for a medically accepted indication.Plan year

GLP1-semaglutide

Coverage is based on all medically accepted indications.

Semaglutide: Ozempic oral, Ozempic subcutaneous, or Rybelsus is used for a medically accepted indication.Plan year

GLP1-tirzepatide

Coverage is based on all medically accepted indications.

Tirzepatide: Mounjaro is used for a medically accepted indication.Plan year

Guselkumab

Criteria are pending CMS review.

Review status: Exclusion, prescriber, off-label-use, Part B, and prerequisite-therapy criteria for guselkumab products are pending CMS review.

High-risk butalbital products

For patients 65 years of age or older, appropriate high-risk medication use criteria apply.

High-risk butalbital products: The patient is 65 years of age or older; the prescriber acknowledges or is aware that the drug is appropriate for use as a high-risk medication; and the requested use is an FDA-approved indication.65 years or older

Coverage duration is the plan year.

High-risk dipyridamole

For patients 65 years of age or older, appropriate high-risk medication use criteria apply.

Dipyridamole: The patient is 65 years of age or older; the prescriber acknowledges or is aware of appropriate use; and the requested use is an FDA-approved indication.65 years or older

Hospice patients are approved without additional criteria; coverage duration is the plan year.

High-risk estradiol-norethindrone

For patients 65 years of age or older, appropriate high-risk medication use criteria apply.

Estradiol-norethindrone products: The patient is 65 years of age or older and the prescriber acknowledges or is aware that the drug is appropriate.65 years or older

Vulvar/vaginal atrophy, osteoporosis, and vasomotor symptoms of menopause are approved without additional criteria; coverage duration is the plan year.

High-risk estrogen-medroxyprogesterone

For patients 65 years of age or older, appropriate high-risk medication use criteria apply.

Estrogen-medroxyprogesterone products: The patient is 65 years of age or older; the prescriber acknowledges or is aware that the drug is appropriate; and the requested use is an FDA-approved indication.65 years or older

Coverage duration is the plan year.

High-risk medication coverage

For patients age 65 years and older, coverage requires the applicable drug-specific criteria. Prior authorization is not required for ages 0–64 under the stated age restriction.

Age-based review: The patient is 65 years of age or older.65 years or older

Applicable pathway: The requested medication meets its applicable prescriber acknowledgment, prerequisite-therapy, or hospice criteria.

Glyburide and glyburide-metformin

For glyburide or glyburide-metformin used for type 2 diabetes mellitus, coverage requires one of the following.

Indication: The requested medication is used for type 2 diabetes mellitus.

Alternative therapy or acknowledgment

The patient has tried or is contraindicated to glimepiride or glipizide.
The prescriber acknowledges or is aware of the applicable high-risk medication concern.

Phenobarbital

For newly prescribed phenobarbital for epilepsy or seizures, coverage requires one of the following.

Indication: The patient has epilepsy or seizures and is newly prescribed phenobarbital.

Anticonvulsant failure or acknowledgment

The patient has not responded to at least one anticonvulsant.At least 1 anticonvulsant
The prescriber acknowledges or is aware of the applicable high-risk medication concern.

Promethazine

For promethazine, the criteria depend on the indication.

Pruritus, urticaria, or allergy

The patient has tried or is contraindicated to a non-sedating antihistamine such as levocetirizine.
The prescriber acknowledges or is aware that promethazine is high risk for patients age 65 years and older.

Nausea and vomiting: The prescriber acknowledges or is aware that promethazine is high risk for patients age 65 years and older.

Hospice use: A physician attests that the medication treats a diagnosis unrelated to the terminal illness or related condition.

Hospice patients are approved without trial of formulary alternatives or prescriber acknowledgment when this attestation is provided.

Other listed high-risk medications

For the listed medications without additional drug-specific clinical criteria, coverage is available for all FDA-approved indications subject to the applicable high-risk medication requirement.

FDA-approved indication: The requested use is an FDA-approved indication.

Age or hospice pathway

For a patient age 65 years or older, the prescriber acknowledges or is aware of the applicable high-risk medication concern.65 years or older
The patient qualifies for the stated hospice exception.

For osteoporosis, coverage is excluded when the member has received a total of 24 months of cumulative treatment with any parathyroid therapy.

Corticotropin (Cortrophin Gel Injection) criteria are pending CMS review. Exclusion, prescriber, off-label use, Part B, and prerequisite-therapy criteria have not been finalized in this policy segment.

For the metastatic non-small cell lung cancer (NSCLC) criterion, Vizimpro must not be used concurrently with an EGFR tyrosine kinase inhibitor.

For Emgality and Exxua, exclusion criteria are marked as pending CMS review. No definitive exclusion criteria are provided in this policy segment.

For gefitinib used for metastatic EGFR-mutated NSCLC, coverage excludes concurrent therapy with an unspecified agent or regimen. The source wording does not identify the concurrent agent or regimen.

Clinical Thresholds and Coding Details

Castrate testosterone threshold

Threshold< 50 ng/dL

Applies toCastrate level of testosterone for NMCRPC or MCSPC

Alternative qualifying criteriaBilateral orchiectomy or concurrent use with a GnRH analog

Initial transfusion-related serum ferritin

ThresholdConsistently > 1000 mcg/L

Applies toInitial chronic iron overload due to blood transfusions

Laboratory requirementSerum ferritin level must be consistently above the threshold

Initial NTDT serum ferritin

ThresholdConsistently > 300 mcg/L

Applies toInitial chronic iron overload in non-transfusion-dependent thalassemia (NTDT)

Sampling requirementAt least two lab values in the previous three months

Initial NTDT liver iron concentration

Threshold>= 5 mg Fe/g of liver dry weight

Applies toInitial chronic iron overload in non-transfusion-dependent thalassemia (NTDT)

MeasurementLiver iron concentration (LIC)

Renewal transfusion-related serum ferritin

ThresholdConsistently > 500 mcg/L

Applies toRenewal chronic iron overload due to blood transfusions

Laboratory requirementSerum ferritin level must be consistently above the threshold

Renewal NTDT serum ferritin

ThresholdConsistently > 300 mcg/L

Applies toRenewal chronic iron overload in non-transfusion-dependent thalassemia (NTDT)

Sampling requirementAt least two lab values in the previous three months

Renewal NTDT liver iron concentration

Threshold>= 3 mg Fe/g of liver dry weight

Applies toRenewal chronic iron overload in non-transfusion-dependent thalassemia (NTDT)

MeasurementLiver iron concentration (LIC); the renewal criterion states this threshold as an alternative to the serum ferritin criterion

High-risk medication age threshold

Age threshold65 years of age or older

Review requirementAppropriate high-risk medication use review applies

Prescriber actionPrescriber acknowledgment or awareness of appropriate use is required

Age restriction

Age restriction65 years of age or older

Age 0–64 yearsPrior authorization is not required under the stated age restriction

Older-adult requirementPatients age 65 years and older must meet the applicable drug-specific criteria

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required: TYMLOS

Prior authorization is required before TYMLOS is covered.

Product: TYMLOS
Coverage is limited to a plan year.
Members may not exceed 24 months of cumulative treatment with any parathyroid hormone analog.

Prior Authorization

SYMPAZAN Authorization

Prior authorization is required for SYMPAZAN. For initial therapy, the member must have Lennox-Gastaut syndrome and the drug must be prescribed by or in consultation with an appropriate specialist.

Initial and renewal coverage is limited to a plan year.
A prerequisite therapy requirement applies.

Prior Authorization

Plan-Year Authorization

The listed products require plan-year authorization when prior authorization applies.

Products: COTELLIC, XALKORI oral capsule, TAFINLAR oral capsule, TAFINLAR oral tablet for suspension.
Coverage duration: plan year.

Prior Authorization

XALKORI Pellets Authorization

Prior authorization is required for XALKORI oral pellets.

Applies to XALKORI oral pellets 150 mg, 20 mg, and 50 mg.
Coverage is limited to a plan year.

Prior Authorization

Neurologist Involvement

Dalfampridine requires initial prescribing by or consultation with a neurologist.

Applies to multiple sclerosis.
Initial and renewal coverage is limited to a plan year.

Prior Authorization

RASONQUE Oncology Authorization

RASONQUE requires authorization for metastatic pancreatic adenocarcinoma when prescribed by or in consultation with an oncologist.

The prescriber restriction applies to the covered indication.

Prior Authorization

NUBEQA Prostate Cancer Authorization

NUBEQA requires prior authorization for eligible prostate cancer indications.

Applies to nonmetastatic castration-resistant or metastatic castration-sensitive prostate cancer.
Documentation must show bilateral orchiectomy, castrate testosterone, or concurrent GnRH analog use.
Coverage is limited to a plan year.

Prior Authorization

Dasatinib Authorization

Dasatinib requires plan-year authorization for covered indications.

Applies to the listed dasatinib oral tablet strengths.

Prior Authorization

INQOVI Authorization

INQOVI requires plan-year authorization for covered indications.

Coverage duration: plan year.

Unsupported block type: prior_auth

Prior Authorization

OSENVELT Authorization

OSENVELT requires plan-year authorization for covered indications.

Coverage duration: plan year.

Prior Authorization

Deutetrabenazine Authorization

Deutetrabenazine requires authorization for the applicable neurologic indications.

For Huntington disease, prescribing must be by or in consultation with a neurologist or movement-disorder specialist.
For tardive dyskinesia, prescribing must be by or in consultation with a neurologist.
Coverage is limited to a plan year.

Prior Authorization

VALTOCO Authorization

VALTOCO requires plan-year authorization for epilepsy indications.

For members age 12 years or older, documentation of a trial of or contraindication to required therapy is needed.
A prerequisite therapy requirement applies.

Prior Authorization

Dihydroergotamine Acute Migraine Criteria

Dihydroergotamine nasal requires authorization for acute migraine treatment.

No concurrent use of specified interacting medications.
The member must have tried or have a contraindication to both a preferred triptan and a preferred CGRP inhibitor, such as Nurtec ODT or Ubrelvy.
Coverage is limited to a plan year.

Prior Authorization

Dronabinol Chemotherapy-Related Nausea Criteria

Dronabinol requires authorization for nausea and vomiting associated with cancer chemotherapy.

The member must have tried or have a contraindication to one required alternative.
Coverage is limited to a plan year.

Note

Pending CMS Review

Droxidopa and DUPIXENT have prior authorization criteria pending CMS review.

The criteria, prescriber requirements, and prerequisite requirements are pending CMS review.

Prior Authorization

VYALEV Prior Authorization

VYALEV requires prior authorization for Parkinson disease therapy.

Initial therapy must be prescribed by or in consultation with a neurologist.
Initial and renewal coverage is limited to a plan year.
Initial therapy requires inability to swallow extended-release tablets or inability to use an oral carbidopa/levodopa regimen; renewal requires improvement in motor symptoms.

Prior Authorization

FRUZAQLA Prior Authorization

FRUZAQLA requires plan-year prior authorization for covered indications.

Coverage duration: plan year.

Prior Authorization

LYTGOBI Prior Authorization

LYTGOBI requires plan-year prior authorization for intrahepatic cholangiocarcinoma.

A comprehensive ophthalmological examination, including optical coherence tomography, is required before initiation and at recommended intervals.

Note

EMGALITY Pending CMS Criteria

EMGALITY criteria are pending CMS review.

Prior authorization criteria and prerequisite requirements remain pending CMS review.

Prior Authorization

ZTALMY Prior Authorization

ZTALMY requires plan-year prior authorization for covered indications.

Coverage duration: plan year.

Prior Authorization

Gefitinib Prior Authorization

Gefitinib requires plan-year prior authorization for metastatic NSCLC with an EGFR mutation.

The member must not be receiving concurrent therapy with the restricted agent.

Note

EXXUA Pending CMS Criteria

EXXUA criteria are pending CMS review.

Prior authorization criteria and prerequisite requirements remain pending CMS review.

Prior Authorization

XOSPATA Prior Authorization

XOSPATA requires plan-year prior authorization for covered indications.

Coverage duration: plan year.

Prior Authorization

DAURISMO Prior Authorization

DAURISMO requires plan-year prior authorization for covered indications.

Coverage duration: plan year.

Prior Authorization

Glatiramer Prior Authorization

Glatiramer products require plan-year prior authorization for covered indications.

Products include glatiramer and GLATOPA prefilled syringes.
Coverage duration: plan year.

Prior Authorization

Product-Specific Prior Authorization

Product-specific prior authorization applies to the listed products and is generally limited to a plan year.

Products include TRULICITY, OZEMPIC, RYBELSUS, MOUNJARO, and the listed high-risk medications.
Verify the product-specific criteria before submitting the request.

Note

Guselkumab Criteria Pending CMS Review

TREMFYA criteria are pending CMS review.

Prior authorization criteria and prerequisite requirements remain pending CMS review.

Prior Authorization

Age-Based High-Risk Drug Review

High-risk medication review applies to the listed products for members age 65 years and older.

PA is not required for members age 0–64 for these age-based criteria.
Prescriber acknowledgment may be required.
Hospice exceptions apply for specified products and indications.

Prior Authorization

Age-Based Prior Authorization

The listed high-risk medications require age-based prior authorization or review for members 65 years and older.

PA is not required for members age 0–64.
Coverage is generally limited to a plan year; ketorolac has a 30-day duration.

Step Therapy

Drug-Specific Prerequisite Therapy

Certain products require documentation of drug-specific prerequisite therapy before approval.

Glyburide and glyburide-metformin: trial of or contraindication to glimepiride or glipizide, or qualifying prescriber acknowledgment.
Phenobarbital: newly prescribed patients must have failed at least one anticonvulsant or meet the acknowledgment exception.
Promethazine: allergy treatment requires trial of or contraindication to a non-sedating antihistamine, unless the acknowledgment exception applies.

Denial Risk

Cumulative Treatment Limit

TYMLOS is subject to a cumulative treatment limit.

The member must not have received 24 months of cumulative treatment with any parathyroid hormone analog.

Denial Risk

No Concurrent EGFR Tyrosine Kinase Inhibitor

VIZIMPRO coverage requires that a member with metastatic NSCLC is not receiving concurrent EGFR tyrosine kinase inhibitor therapy.

Concurrent restricted therapy may result in denial.

Documentation Required

XALKORI Unable to Swallow Capsules

XALKORI oral pellets are intended for covered conditions when the member is unable to swallow capsules.

Applies to NSCLC, ALCL, and IMT.

Documentation Required

TAFINLAR Unable to Swallow Capsules

TAFINLAR oral suspension coverage requires documentation that the member is unable to swallow TAFINLAR capsules.

Coverage is limited to a plan year.

Documentation Required

Dasatinib Mutation Analysis and NCCN Appropriateness

Dasatinib requests require mutation analysis and confirmation that treatment is appropriate under the NCCN guideline table.

For previously treated Ph-positive CML, submit BCR-ABL1 mutation analysis before initiation.
Document appropriateness based on the mutation profile.

Documentation Required

Deferasirox Iron-Overload Laboratory Criteria

Deferasirox requests require laboratory documentation supporting iron overload.

Transfusion-related initial therapy: serum ferritin consistently above 1,000 mcg/L.
NTDT initial therapy: ferritin consistently above 300 mcg/L with at least two values in the prior three months and LIC at least 5 mg Fe/g liver dry weight.
Renewal thresholds differ: transfusion-related ferritin above 500 mcg/L; NTDT ferritin above 300 mcg/L or LIC at least 3 mg Fe/g.

Documentation Required

Deferasirox Renewal Documentation

Deferasirox renewal requests must include current iron-overload laboratory results meeting the renewal thresholds.

Submit ferritin and, when applicable, liver iron concentration results.
For NTDT renewal, document ferritin above 300 mcg/L or LIC at least 3 mg Fe/g liver dry weight.

Documentation Required

Deutetrabenazine Specialist Documentation

Deutetrabenazine requests require specialist documentation and indication-specific history.

Document neurologist or movement-disorder specialist involvement when required.
For tardive dyskinesia, document a history of using agents that cause tardive dyskinesia.

Documentation Required

LYTGOBI Ophthalmological Examination

LYTGOBI requests require an ophthalmological examination before treatment and during therapy.

The examination must be comprehensive and include optical coherence tomography.
Repeat examinations at the recommended scheduled intervals.

Documentation Required

VYALEV Initial-Treatment Documentation

VYALEV initial-treatment requests require documentation supporting the Parkinson disease criteria.

Document neurologist involvement.
Document inability to swallow extended-release tablets or inability to use an oral carbidopa/levodopa regimen.

Documentation Required

Prescriber Acknowledgment

The listed high-risk medication requests require prescriber acknowledgment of appropriate use for older adults.

Applies to butalbital products, dipyridamole, menopausal hormone products, glyburide products, ketorolac, phenobarbital, promethazine, scopolamine, diphenoxylate-atropine, indomethacin, and megestrol.
Document awareness that the drug is high risk for patients age 65 years and older.

Documentation Required

High-Risk Medication Acknowledgment

High-risk medication requests for older adults require acknowledgment unless an applicable hospice exception applies.

Applies to the listed products for members age 65 years and older.
Hospice patients may require physician attestation or may be approved without additional criteria depending on the product.

Step Therapy

Type 2 Diabetes Alternative Therapy

For type 2 diabetes, glyburide and glyburide-metformin require an alternative-therapy review.

Document trial of or contraindication to glimepiride or glipizide.
Alternatively, submit qualifying prescriber acknowledgment that the drug is high risk for patients age 65 years and older.
Hospice exceptions apply.

Documentation Required

Phenobarbital Clinical History

New phenobarbital therapy for epilepsy or seizures requires a clinical history of prior anticonvulsant response or failure.

Document that the patient has not responded to at least one anticonvulsant, or provide qualifying prescriber acknowledgment.
Hospice exceptions apply.

Documentation Required

Promethazine Documentation

Promethazine requests require documentation appropriate to the indication and patient age.

For pruritus, urticaria, or allergy: document trial of or contraindication to a non-sedating antihistamine, or qualifying acknowledgment.
For nausea and vomiting: document prescriber acknowledgment of high-risk use in patients age 65 years and older.
Hospice patients require physician attestation that use treats a diagnosis unrelated to the terminal illness or related condition.

Documentation Required

Scopolamine Hospice Attestation

Scopolamine requests for hospice patients require a physician attestation regarding the diagnosis being treated.

Attest that the requested medication is used to treat a diagnosis unrelated to the terminal illness or related condition.
Hospice patients are approved without prescriber acknowledgment when the attestation requirement is met.

Note

Pending CMS Review

CORTROPHIN GEL, EMGALITY, EXXUA, and TREMFYA criteria are pending CMS review.

Exclusion, prescriber, indication, Part B, and prerequisite criteria remain pending CMS review as applicable.

Denial Risk

No Concurrent EGFR Tyrosine Kinase Inhibitor

VIZIMPRO requires documentation that the member is not receiving concurrent EGFR tyrosine kinase inhibitor therapy.

Applies to metastatic NSCLC.

Documentation Required

Dasatinib Mutation Analysis and NCCN Appropriateness

Dasatinib requires mutation analysis before initiation and NCCN-consistent treatment selection.

Applies to previously treated Ph-positive CML.
Base appropriateness on the BCR-ABL1 mutation profile and the NCCN treatment table.

Documentation Required

Deferasirox Iron-Overload Laboratory Criteria

Deferasirox requires iron-overload laboratory evidence before approval.

Initial and renewal ferritin and liver iron concentration thresholds apply according to transfusion status and NTDT status.

Step Therapy

Generic Deferasirox Prerequisite

Deferasirox requires a trial of or contraindication to generic deferasirox oral tablet or oral suspension.

A prerequisite therapy requirement applies.

Documentation Required

Deutetrabenazine Tardive Dyskinesia History

Deutetrabenazine for tardive dyskinesia requires a documented history of exposure to agents that cause tardive dyskinesia.

Specialist involvement requirements also apply.

Step Therapy

VALTOCO Epilepsy Step Therapy

VALTOCO for epilepsy in members age 12 years or older requires a trial of or contraindication to the required prior therapy.

A prerequisite therapy requirement applies.

Step Therapy

Diclofenac Topical Step Therapy

Diclofenac topical solution requires a trial of or contraindication to a formulary version for knee osteoarthritis.

A prerequisite therapy requirement applies.
Coverage is limited to a plan year.

Step Therapy

Formulary Version Prerequisite

Diclofenac topical solution requests must document use of the applicable formulary version before the nonformulary product is approved.

A trial of or contraindication to the formulary version is required for knee osteoarthritis.

Step Therapy

Triptan and CGRP Inhibitor Prerequisite

Dihydroergotamine nasal requires failure of or contraindication to both a triptan and an acute-migraine CGRP inhibitor.

Examples include sumatriptan or rizatriptan and Nurtec ODT or Ubrelvy.
No concurrent use of restricted medications.

Step Therapy

Chemotherapy Nausea Prerequisite

Dronabinol for chemotherapy-related nausea requires a trial of or contraindication to one required alternative.

Document the alternative therapy trial or contraindication.

Step Therapy

Sulfonylurea Step Therapy

Glyburide and glyburide-metformin require step therapy or qualifying acknowledgment for type 2 diabetes.

Trial of or contraindication to glimepiride or glipizide is required unless the acknowledgment exception applies.
Hospice exceptions apply.

Step Therapy

Anticonvulsant Step Therapy

New phenobarbital therapy requires failure or inadequate response to at least one anticonvulsant unless the acknowledgment exception applies.

Applies to epilepsy or seizures.
Hospice exceptions apply.

Step Therapy

Non-Sedating Antihistamine Step Therapy

Promethazine for pruritus, urticaria, or seasonal/perennial allergy requires a trial of or contraindication to a non-sedating antihistamine.

An example is levocetirizine.
A qualifying prescriber acknowledgment may satisfy the alternative pathway.

Documentation Required

Walking Disability and Response to Therapy

Dalfampridine initial therapy requires symptoms of a walking disability, and renewal requires demonstrated improvement in walking ability.

Examples include mild-to-moderate bilateral lower-extremity weakness or unilateral weakness with lower-extremity or truncal ataxia.
Neurologist involvement is required.

Prior Authorization

Lennox-Gastaut Syndrome Criteria

SYMPAZAN initial therapy requires Lennox-Gastaut syndrome criteria and specialist involvement.

The drug must be prescribed by or in consultation with an appropriate specialist.
A prerequisite therapy requirement applies.

Documentation Required

Dasatinib Clinical Documentation

Dasatinib clinical documentation must support the diagnosis, prior treatment status, mutation analysis, and NCCN-appropriate selection.

Applies to previously treated Ph-positive CML.
Submit BCR-ABL1 mutation results before initiation.

Documentation Required

Deferasirox Laboratory Documentation

Deferasirox requests require laboratory documentation of the applicable ferritin and liver iron concentration thresholds.

Submit at least two ferritin values in the prior three months when required for NTDT initial therapy.

Documentation Required

Deferasirox Renewal Documentation

Deferasirox renewal requests require updated laboratory documentation demonstrating continued eligibility.

Document the applicable renewal ferritin and/or liver iron concentration threshold.

Documentation Required

Deutetrabenazine Specialist Documentation

Deutetrabenazine requests require documentation from or consultation with the appropriate neurologic specialist.

A neurologist or movement-disorder specialist is required for Huntington disease.
A neurologist is required for tardive dyskinesia.

Documentation Required

LYTGOBI Ophthalmological Examination

LYTGOBI requires a comprehensive ophthalmological examination before initiation.

Include optical coherence tomography.
The examination must occur before treatment and at recommended scheduled intervals.

Prior Authorization

VYALEV Parkinson Disease Initial Criteria

VYALEV initial therapy requires documentation of Parkinson disease criteria and neurologist involvement.

Document inability to swallow extended-release tablets or inability to use an oral carbidopa/levodopa regimen.

Documentation Required

LYTGOBI Ophthalmological Monitoring

LYTGOBI requires ongoing ophthalmological monitoring during therapy.

Repeat comprehensive examinations, including OCT, at the recommended scheduled intervals.

Denial Risk

Gefitinib Concurrent-Therapy Restriction

Gefitinib coverage requires that metastatic EGFR-mutated NSCLC is not being treated concurrently with the restricted therapy.

Concurrent therapy may result in denial.

Note

EMGALITY and EXXUA Criteria Pending CMS Review

EMGALITY and EXXUA criteria are pending CMS review.

Prior authorization and prerequisite criteria remain pending CMS review.

Note

Guselkumab Pending CMS Review

TREMFYA (guselkumab) criteria are pending CMS review.

Prior authorization and prerequisite criteria remain pending CMS review.

Prior Authorization

High-Risk Medication Use in Older Adults

High-risk medication use in adults age 65 years and older requires appropriate-use review and, when applicable, prescriber acknowledgment.

PA is not required for members age 0–64 under these age-based criteria.
Hospice exceptions may remove additional criteria for specified products.

Denial Risk

Failure to Meet High-Risk Medication Criteria

Failure to meet the applicable high-risk medication criteria may result in denial.

For members age 65 years and older, submit required acknowledgment or alternative-therapy documentation.
Apply product-specific hospice exceptions when supported.

Step Therapy

Promethazine Alternative Therapy Requirement

Promethazine allergy indications require a non-sedating antihistamine trial or contraindication unless the acknowledgment pathway applies.

Example alternative: levocetirizine.
Nausea and vomiting indications require high-risk prescriber acknowledgment for members age 65 years and older.
Hospice patients require physician attestation regarding an unrelated diagnosis.

Step Therapy

Phenobarbital Prerequisite Requirement

Phenobarbital initiation requires prior anticonvulsant therapy failure or a qualifying prescriber acknowledgment.

Applies to newly prescribed epilepsy or seizure therapy.
Hospice exceptions apply.

Initial Therapy Criteria

Abaloparatide initial therapy

Prior authorization coverage criteria for abaloparatide.

Initial coverage: The requested use is an FDA-approved indication; for osteoporosis, the member has received less than 24 months of cumulative treatment with any parathyroid therapy.Less than 24 months cumulative treatment

Sympazan initial therapy

Initial coverage is subject to indication, specialist, and prerequisite-therapy criteria.

Sympazan initial therapy: The patient has Lennox-Gastaut syndrome; therapy is prescribed by or provided in consultation with the required specialist; and the patient has a contraindication to or is unable to use prerequisite therapy.

Dalfampridine initial therapy

Initial coverage is subject to neurologist involvement and clinical walking impairment.

Dalfampridine initial therapy: The patient has multiple sclerosis with symptoms of a walking disability and therapy is prescribed by or provided in consultation with a neurologist.

Examples include mild to moderate bilateral lower-extremity weakness or unilateral weakness plus lower-extremity or truncal ataxia.

Rasonque initial therapy

Initial coverage is subject to oncology specialist involvement.

Rasonque initial therapy: The product is prescribed for an FDA-approved indication by or in consultation with an oncologist.

Deferasirox initial therapy

Initial deferasirox therapy requires disease-specific laboratory criteria, specialist involvement, and generic prerequisite therapy.

Transfusion-related chronic iron overload: Serum ferritin is consistently above 1000 mcg/L.> 1000 mcg/L

NTDT chronic iron overload: Serum ferritin is consistently above 300 mcg/L with at least two lab values in the previous three months and LIC is at least 5 mg Fe/g liver dry weight.Ferritin > 300 mcg/L; LIC >= 5 mg Fe/g

Prescriber and prerequisite: Therapy is prescribed by or in consultation with a hematologist or hematologist/oncologist, and the patient has tried or is contraindicated to generic deferasirox oral tablet or tablet for oral suspension.

Diclofenac formulary prerequisite

Initial prior authorization criteria for diclofenac sodium topical solution.

Formulary prerequisite: For knee osteoarthritis, the patient has tried or is contraindicated to a formulary version.

Dihydroergotamine preferred agents

Initial prior authorization criteria for dihydroergotamine nasal.

Acute migraine prerequisite: There is no concurrent use of specified medications, and the patient has tried or is contraindicated to both a triptan and a CGRP inhibitor for acute migraine treatment.

Dronabinol prerequisite

Initial prior authorization criteria for dronabinol oral capsule.

Chemotherapy-associated nausea and vomiting: The patient has tried or is contraindicated to one specified therapy.

Droxidopa pending review

Initial prior authorization criteria for droxidopa.

Review status: Criteria are pending CMS review.

Dupilumab pending review

Initial prior authorization criteria for dupilumab products.

Review status: Criteria are pending CMS review.

Vyalev initial therapy

Vyalev Parkinson's disease initial therapy.

Prescriber requirement: Therapy is prescribed by or in consultation with a neurologist.

Treatment eligibility

The patient is unable to swallow extended-release tablets.
The patient meets the source-listed oral carbidopa/levodopa regimen condition.
The source text is truncated after this condition.

Lytgobi initial therapy

Lytgobi intrahepatic cholangiocarcinoma criteria.

Required monitoring: Complete a comprehensive ophthalmological examination, including optical coherence tomography, before initiation and at the recommended scheduled intervals.

Initial product coverage

Initial coverage is subject to the applicable product-specific criteria.

Product-specific criteria: The requested product satisfies the applicable indication and product-specific prior authorization criteria.Plan year where specified

No Part B prerequisite or prerequisite-therapy requirement is identified for these entries.

Guselkumab initial therapy

Initial criteria are pending CMS review.

Review status: The applicable exclusion, prescriber, off-label-use, Part B, and prerequisite-therapy criteria remain pending CMS review.

Initial phenobarbital therapy

Newly prescribed phenobarbital for epilepsy or seizures requires one of the following.

Initial criteria

The patient has not responded to at least one anticonvulsant.At least 1 anticonvulsant
The prescriber acknowledges or is aware of the applicable high-risk medication concern.

Initial glyburide therapy

Initial glyburide or glyburide-metformin therapy for type 2 diabetes requires one of the following.

Initial criteria

The patient has tried or is contraindicated to glimepiride or glipizide.
The prescriber acknowledges or is aware of the applicable high-risk medication concern.

Prerequisite and Step-Therapy Requirements

Medication or indication	Prerequisite therapy	Requirement
Sympazan — initial Lennox-Gastaut syndrome therapy	Prerequisite therapy	Document a contraindication to, or inability to use, the prerequisite therapy.

Medication or indication	Prerequisite therapy	Requirement
Deferasirox	Generic deferasirox oral tablet or tablet for oral suspension	Document a trial of, or contraindication to, generic deferasirox.

Medication or indication	Prerequisite therapy	Requirement
VALTOCO — epilepsy, age 12 years or older	Prerequisite therapy identified in the coverage criteria	Document a trial of the prerequisite therapy. The specific therapy and failure details are not identified in the available criteria.

Medication or indication	Prerequisite therapy	Requirement
Diclofenac sodium topical solution — knee osteoarthritis	Formulary version of the prerequisite therapy	Document a trial of, or contraindication to, the formulary version.

Medication or indication	Prerequisite therapy	Requirement
Diclofenac sodium topical solution in a metered-dose pump — knee osteoarthritis	Formulary version	Use or document a contraindication to a formulary version before requesting diclofenac topical solution.

Medication or indication	Prerequisite therapy	Requirement
Dihydroergotamine nasal — acute migraine treatment	Both a triptan and a CGRP inhibitor	Document a trial of, or contraindication to, both agents. Examples include sumatriptan or rizatriptan and Nurtec ODT or Ubrelvy.

Medication or indication	Prerequisite therapy	Requirement
Dronabinol oral capsule — chemotherapy-associated nausea and vomiting	One specified therapy	Document a trial of, or contraindication to, the specified therapy.

Medication or indication	Prerequisite therapy	Requirement
Glyburide, glyburide micronized, or glyburide-metformin — type 2 diabetes mellitus	Glimepiride or glipizide	Document a trial of, or contraindication to, glimepiride or glipizide. The policy also permits the applicable prescriber acknowledgment or awareness pathway.

Medication or indication	Prerequisite therapy	Requirement
Promethazine — pruritus, urticaria, or seasonal/perennial allergy	A non-sedating antihistamine, such as levocetirizine	Document a trial of, or contraindication to, the non-sedating antihistamine. The policy also permits prescriber acknowledgment of high-risk use for patients age 65 years and older.

Medication or indication	Prerequisite therapy	Requirement
Phenobarbital — newly prescribed for epilepsy or seizures	At least one anticonvulsant	Document nonresponse to at least one anticonvulsant. The policy also permits prescriber acknowledgment of the applicable high-risk medication concern.