ModifiedConnectiCarePolicy C16154-A

Drug and Biologic Coverage Criteria: Antineoplastic Drugs and Biologics

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Coverage determinations for antineoplastic drugs and biologics for ConnectiCare commercial members, including medical necessity, prior authorization, preferred-product and biosimilar requirements, documentation, continuation, dosing, and state-specific utilization-management provisions.

Policy Summary

PayerConnectiCare

PolicyAntineoplastic Drugs and Biologics

Policy CodePolicy C16154-A

Change TypeModified

Effective DateMar 4, 2026

Next Review DateJan 1, 2027

Key ActionSubmit a documented medically accepted indication, treatment history, clinical evidence, and any required preferred-product or biosimilar documentation with each prior authorization request.

SourceLink

POLICY UPDATE CHANGES

The revision history identifies a Q1 2026 revision to diagnosis and continuation-of-therapy content.

The revision history also records prior updates to required medical information, approval duration, place of administration, background, references, and available dosage forms.

85%Minimum adherence for continuation therapy

6 monthsStandard authorization duration

14 daysStarter-fill supply for many medications

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ModifiedConnectiCarePolicy C16154-A

Drug and Biologic Coverage Criteria: Antineoplastic Drugs and Biologics

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Policy Summary

PayerConnectiCare

PolicyAntineoplastic Drugs and Biologics

Policy CodePolicy C16154-A

Change TypeModified

Effective DateMar 4, 2026

Next Review DateJan 1, 2027

SourceLink

POLICY UPDATE CHANGES

The revision history identifies a Q1 2026 revision to diagnosis and continuation-of-therapy content.

The revision history also records prior updates to required medical information, approval duration, place of administration, background, references, and available dosage forms.

85%Minimum adherence for continuation therapy

6 monthsStandard authorization duration

14 daysStarter-fill supply for many medications

90 daysStarter-fill threshold

FDA contraindicationsExplicit therapy exclusion

Coverage Criteria

Initial Therapy and All-Indication Requirements

Covered when all applicable requirements below are met.

ALL of the following

A documented diagnosis for a medically accepted indication is present, and the requested drug is FDA-approved for the indication or its use is supported by one or more citations included or approved for inclusion in the American Hospital Formulary Service Drug Information, DRUGDEX Information System, National Comprehensive Cancer Network (NCCN) Categories 1 or 2A only, or an applicable pediatric consortium such as Children's Oncology Group, St. Jude Consortium, or Dana-Farber Cancer Institute.
If the therapy is supported by an NCCN Category 2B regimen, authorization may be granted on an exception basis following documented consultation with a ConnectiCare medical director or oncologist, where applicable.
Dose and dates of all previous therapies, with the resulting outcomes where applicable, are documented.
The proper succession of therapies has been considered and applicable therapies have been tried and failed, or are inappropriate because of serious side effects, contraindication, or disease progression. The succession must be consistent with the applicable compendia monograph, FDA label, or NCCN guideline. Where those sources identify a formulary or preferred product at therapeutic parity, the formulary or preferred product must be used first where state regulations allow.
Related laboratory work, test results, or clinical markers supporting the diagnosis and/or continuation of treatment are documented.
The reviewer has verified whether the product is included in the split-fill program and has adjusted the day supply based on clinical appropriateness and the authorization arrangement with the appropriate specialty pharmacy.
All applicable state regulations and requirements have been considered, including any required exception to standard criteria.

Preferred Biologic and Biosimilar Requirements

For a non-formulary or nonpreferred pharmacy-benefit request, the following preferred-product requirements apply unless otherwise specified by applicable state regulations or data demonstrate clinical superiority of the reference product.

ALL of the following

When a reference product has an FDA-approved biosimilar available, treatment with at least two associated biosimilar products must have been ineffective, resulted in serious side effects, or been contraindicated before the reference product is authorized, unless an applicable state regulation provides otherwise or clinical data demonstrate superiority of the reference product over the FDA-approved biosimilar products.
A majority of no more than three biosimilar products may be required for a pharmacy-benefit request for a nonpreferred reference product.
The record documents the preferred biologic product or biosimilar trial and its length, with specific clinical documentation of therapeutic failure whenever possible.
If applicable, the record describes the medical problem caused by the preferred biologic or biosimilar; vague, nondescriptive symptoms such as ‘stomachache’ are insufficient.

Continuation Therapy

Continuation therapy is covered when all applicable continuation requirements are met.

ALL of the following

ONE of the following
- Adherence to therapy is at least 85% of the time, as verified by the prescriber or the member’s medication fill history.
- Adherence is below 85% because of surgery, treatment of an infection, or mitigation of an adverse event that caused temporary discontinuation.
There is documented clinically significant improvement in the disease state, stability on the medication, or lack of disease progression.
The prescriber attests, or clinical review finds, no evidence of intolerable adverse effects or unacceptable toxicity.

Advanced or Metastatic Cancer Anti-Step Criteria

For plans subject to the cited Mississippi provision, a plan covering advanced or metastatic cancer and associated conditions may not impose the following anti-step requirements before covering an FDA-approved prescription drug.

Applicable conditions

The drug is consistent with best practices for treatment of advanced or metastatic cancer or an associated condition.
The drug is supported by peer-reviewed, evidence-based literature.
The drug is approved by the United States Food and Drug Administration.
The enrollee is not required to successfully respond to a different drug before coverage of the FDA-approved drug.
The enrollee is not required to prove a history of failure of a different drug before coverage of the FDA-approved drug.

Experimental Use and Contraindications

The following uses and circumstances are excluded from coverage under this policy.

ALL of the following exclusions apply

All other uses of antineoplastic agents, meaning uses not otherwise supported by the applicable FDA label, compendia, or policy criteria, are considered experimental or investigational and follow the applicable off-label policy.
Any FDA-labeled contraindication to the requested therapy is an exclusion to therapy and is not covered.

Nothing in this section requires a health carrier to cover: (1) a prescription drug to treat an autoimmune disorder, multiple sclerosis, or cancer when the policy completely excludes that prescription drug from covered benefits; (2) a brand-name drug when an equivalent generic drug is available; or (3) a prescription drug that was certified through prospective or concurrent review by the covered person’s previous health carrier or under a previous employer’s fully insured health plan administered by a third-party administrator that provided coverage to the covered person.

APPENDIX. For Mississippi, prior authorization approvals and chronic-condition provisions are subject to the state-specific requirements described below.

Connecticut provision: Nothing in this section requires coverage of a brand-name drug when an equivalent generic drug is available, subject to the terms of the applicable policy and state law.

All FDA-labeled contraindications are exclusions to therapy. See the individual drug monograph for contraindications before authorization or continuation of treatment.

All other uses of antineoplastic agents are considered experimental or investigational and follow the applicable off-label policy.

Mississippi-specific exclusions and authorization provisions: A prior authorization approval is valid for the lesser of six months after the health care professional or provider receives approval, the length of treatment determined by the patient’s health care professional, or renewal of the policy or plan. The approval remains effective despite changes, including dosage changes, and the insurer and enrollee or health care professional may agree to extend the approval. Dosage increases must be based on established evidentiary standards, and safety edits are permitted. These provisions do not apply to benzodiazepines or Schedule II narcotic drugs, such as opioids.

For a recurring health care service or maintenance medication for a chronic or long-term condition, including chemotherapy for cancer, a required prior authorization remains valid for the lesser of 12 months from receipt of approval or the length of treatment determined by the patient’s health care professional. The insurer and enrollee or health care professional may agree to a longer period. This provision also does not apply to benzodiazepines or Schedule II narcotic drugs, such as opioids.

Nothing in these provisions requires a policy or plan to cover care, treatment, or services for a health condition that the policy or plan otherwise completely excludes from covered benefits, regardless of whether the care, treatment, or services are medically necessary.

Mississippi House Bill 1143 defines ‘associated conditions’ as symptoms or side effects associated with advanced or metastatic cancer or its treatment that, in the judgment of the health care practitioner, further jeopardize the patient’s health if left untreated. ‘Advanced, metastatic cancer’ means cancer that has spread from the primary or original site to nearby tissues, lymph nodes, or other areas or parts of the body. A health benefit plan that covers advanced, metastatic cancer and associated conditions may not require failure of, or a successful response to, a different drug before covering an FDA-approved prescription drug, provided the drug meets the applicable best-practice, peer-reviewed evidence, and FDA-approval requirements.

Nothing in the Mississippi provision requires coverage of care, treatment, or services for a health condition that the policy or plan completely excludes from covered benefits, regardless of medical necessity.

Initial Therapy Criteria

Initial Oncology Therapy

Initial therapy requires a medically accepted indication and the applicable documentation, sequencing, specialist, age, and dosing requirements.

Indication: The diagnosis and requested use are supported by FDA approval, AHFS, DRUGEX, NCCN Category 1 or 2A, or an eligible pediatric oncology consortium.NCCN Category 1 or 2A

NCCN Category 2B may be considered as an exception after documented medical director or oncologist consultation.

Prior therapy and clinical evidence: The request documents prior therapy doses, dates, outcomes, appropriate succession or failures, and related laboratory or clinical-marker evidence.

Prescriber, age, and regimen: The drug is prescribed by or in conjunction with an oncologist, hematologist, or other appropriate cancer specialist, follows FDA-, NCCN-, NCI-, or AHFS-supported dosing and schedules, and is prescribed within FDA- or compendia-supported age parameters.

Continuation of Therapy

Continuation of Oncology Therapy

Continuation of therapy requires all criteria below.

Adherence is at least 85%, or a lower rate is explained by surgery, infection treatment, or adverse-event mitigation causing temporary discontinuation.>= 85% unless an allowed temporary interruption applies

Response or stability: The disease has clinically significant improvement, remained stable, or has not progressed on therapy.

Tolerability: There is no intolerable adverse effect or unacceptable toxicity.

Preferred Product Sequencing

Step	Requirement	Exceptions or supporting conditions
1	Use the formulary or preferred product first when it has therapeutic parity with the requested agent and state regulations allow.	For a nonformulary or nonpreferred reference product with an available biosimilar, document failure, serious side effects, or contraindication to a majority of available biosimilars (not more than three). For a physician-administered reference medication, at least two associated biosimilars must have been ineffective, caused serious side effects, or been contraindicated, unless applicable state regulations or documented clinical superiority support an exception.

Supply and Dispensing Limits

Applicable split-fill products

Fills 1 through 6One 14- or 15-day supply for each fill

Fill 7A 28- or 30-day supply

Fill 7 determinationThe supply is based on package size

Selected Starter Fill Program drugs

14-day productsAfinitor, Afinitor Disperz, Balversa, Erivedge, and Pemazyre

15-day productsThe other listed Starter Fill Program drugs, including Akeega, Augtyro, Bosulif, Brukinsa, Cabometyx, Calquence, Daurismo, Exkivity, Fruzaqla, Gavreto, Gleevec, Inlyta, Iressa, Iwilfin, Jaypirca, Lorbrena, Lumakras, Lysodren, Nerlynx, Nexavar, Odomzo, Ogsiveo, Orserdu, Retevmo, Rozlytrek, Rubraca, Sprycel, Tagrisso, Talzenna, Tarceva, Targretin, Tazverik, Tibsovo, Truqap, Turalio, Vanflyta, Vitrakvi, Vizimpro, Votrient, Welireg, Xalkori, Xtandi, Yonsa, Zejula, Zolinza, Zykadia, and Zytiga

Program and Medication Identifiers

Starter Fill Program GPI identifiersmixed

215325300003**	Afinitor (everolimus) GPI
215325300073**	Afinitor Disperz (everolimus) GPI
214099021203**	Akeega (niraparib/abiraterone acetate) GPI
215338650001**	Augtyro (repotrectinib) GPI
214900090003**	Starter-fill GPI pattern shown for multiple listed oncology drugs
213700303003**	Daurismo (glasdegib) GPI
215322250003**	Balversa (erdafitinib) GPI
215340120003**	Bosulif (bosutinib) GPI
215321950001**	Brukinsa (zanubrutinib) GPI
215330101003**	Cabometyx (cabozantinib) GPI

1–10 of 52

1/6

Physician Administered Medication Listmixed

Various

Physician Administered Medication List

Starter-fill dispensing

Applies toNew utilizers of medications included in the Starter Fill Program

Supply per fillGenerally 14 days; selected drugs specify 15 days per fill

Restriction endsWhen the member reaches a cumulative 90-day supply

Adherence monitoring

Monitoring periodRolling 6-month periods

Cumulative targetA 90-day supply

If adherence falls below the threshold

Authorization, Documentation, and Denial Risks

Documentation Required

Medical Necessity and Treatment Sequencing

Before requesting coverage, submit documentation establishing medical necessity and the required treatment sequence. Show that the requested therapy is supported by an FDA-approved indication or by an accepted compendium or consortium source, and document required prior therapy trials or clinically supported reasons for not using them.

Document the diagnosis and medically accepted indication.
Document the dose and dates of previous therapies, outcomes, and any failure, serious adverse effects, contraindication, or disease progression.
Support the treatment sequence with the applicable FDA label, compendia monograph, or NCCN guideline.

Prior Authorization

Authorization Duration and Prescriber

Initial and continuation authorizations are generally limited to 6 months or the maximum duration supported by the FDA label, NCCN guideline, or consortium, whichever is shorter. The medication must be prescribed by or in conjunction with an oncologist, hematologist, or other specialist treating cancer.

Policy Background

This policy addresses coverage for antineoplastic drugs and biologics, including oral targeted therapies, cytotoxic chemotherapy, immunotherapies, hormonal and endocrine oncology therapies, supportive oncology agents, and biosimilar biological products. Coverage is based on a medically accepted indication supported by FDA labeling, specified drug compendia, NCCN Category 1 or 2A recommendations, or qualifying pediatric oncology consortium sources. The policy also establishes requirements for treatment sequencing, preferred products and biosimilars, specialist prescribing, dosing, continuation of therapy, and applicable utilization-management provisions.

Key Definitions

Associated conditions

Associated conditionsSymptoms or side effects associated with advanced, metastatic cancer or its treatment

Clinical judgmentThe health care practitioner determines that the symptoms or side effects further jeopardize the patient's health if left untreated

Relationship to cancerThe condition may be associated with the cancer itself or with its treatment

Advanced, metastatic cancer

Advanced, metastatic cancerCancer that has spread from the primary or original site

Spread toNearby tissues, lymph nodes, or other areas or parts of the body

Administration Setting

Note

No site-of-care restriction specified

The policy specifies no site-of-care restriction. Place of administration is listed as N/A.

Biosimilar Preferences

Billing Rule

Use the preferred biosimilar when applicable

Biosimilars are preferred for nonformulary or nonpreferred pharmacy requests and physician-administered drugs when applicable state regulations allow and there is no demonstrated clinical superiority of the reference product. A reference product generally requires failure, serious side effects, or contraindication to the required biosimilar products.

Note

Consider biosimilar preference

The policy describes potential preference for biosimilars when value can be added without compromising member satisfaction and safety. It does not identify a specific mandatory biosimilar substitution.

Policy Summary

PayerConnectiCare

PolicyAntineoplastic Drugs and Biologics

Policy CodePolicy C16154-A

Change TypeModified

Effective DateMar 4, 2026

Next Review DateJan 1, 2027

SourceLink

On This Page

A serious side effect or contraindication may include an allergic or adverse reaction to a specific inactive ingredient, or documented therapeutic success with a nonpreferred product and therapeutic failure with the preferred product supported by a patient diary or medical-chart notes.

The requested duration complies with the applicable authorization limit: initial authorization is 6 months or the maximum duration under the FDA label, NCCN guideline, or applicable consortium, whichever is shorter; continuation authorization follows the same limit.

The medication is prescribed by, or in conjunction with, an oncologist, hematologist, or other specialist treating cancer.

The prescription is within FDA- or compendia-supported labeled age minimums and maximums, and the dosing regimen or schedule is supported by the FDA label, NCCN, NCI, or AHFS.

Starter-Fill Dispensing

For newly initiated use of medications included in the Starter Fill Program:

Starter-fill conditions: Dispense the medication in the program-specific short supply until the member reaches a cumulative 90-day supply, and monitor whether the member fills a cumulative 90-day supply in rolling 6-month periods.Generally 14 days per fill; certain listed drugs specify 15 days per fill

The medication must be appropriate for dispensing in a 14-day supply and must not require manufacturer packaging such as dispense in original bottle.

Restriction periodThe applicable supply limit applies until the cumulative 90-day supply is reached

The member is limited to a 14-day supply until the 90-day cumulative supply is met

Prescriber must meet the applicable oncology-specialist requirement.
Use FDA-labeled, NCCN-, NCI-, or AHFS-supported dosing regimens and schedules.
Observe applicable labeled age restrictions.

Billing Rule

Review Split-Fill Requirements

Determine whether the requested product is included in the split-fill program and coordinate the authorization with the appropriate specialty pharmacy. Adjust the authorized day supply to clinical appropriateness and the package configuration.

Fills 1–6: one 14- or 15-day supply per fill.
Fill 7: a 28- or 30-day supply based on package size.

Step Therapy

Preferred-Product Sequencing

When an FDA label, compendium monograph, or NCCN guideline identifies a formulary or preferred product at therapeutic parity with the requested agent, use the preferred product first where state regulations allow. Document the applicable exception when the preferred product is not appropriate.

Address preferred-product sequencing in the request.
For a nonpreferred reference product with available biosimilars, document the required biosimilar trial and failure, serious side effect, contraindication, or applicable clinical-superiority evidence.

Prior Authorization

Mississippi Prior Authorization Approval Duration

Under the quoted Mississippi provision, a prior authorization approval is valid for the lesser of 6 months after the provider receives approval, the treatment length determined by the health care professional, or policy renewal. The period remains effective despite dosage changes, subject to evidentiary standards and safety edits; the parties may agree to a longer period.

The provision does not apply to benzodiazepines or Schedule II narcotic drugs such as opioids.
Coverage may still be excluded when the benefit document completely excludes the condition or service.

Prior Authorization

Mississippi Chronic-Condition Authorization Duration

For a recurring health care service or maintenance medication for a chronic or long-term condition, including cancer chemotherapy, the quoted Mississippi provision keeps approval valid for the lesser of 12 months from receipt of approval or the treatment length determined by the health care professional. A longer period may be agreed upon.

The provision does not apply to benzodiazepines or Schedule II narcotic drugs such as opioids.

Step Therapy

Cancer Anti-Step Requirement

For an FDA-approved drug used consistently with best practices for advanced or metastatic cancer or an associated condition and supported by peer-reviewed, evidence-based literature, the quoted provision prohibits requiring the enrollee to first fail to respond to another drug or prove a history of failure of another drug.

The requested use must be FDA approved.
The use must be supported by peer-reviewed, evidence-based literature.

Documentation Required

Diagnosis and Indication Support

Submit a documented diagnosis for a medically accepted indication. The indication must be FDA approved or supported by an accepted compendium or pediatric consortium source.

Accepted sources include AHFS Drug Information, DRUGDEX, NCCN Categories 1 or 2A, and qualifying pediatric consortium sources.
A Category 2B regimen may be authorized by exception with documented medical director or oncology consultation.

Documentation Required

Treatment History and Clinical Support

Provide a complete treatment history supporting the requested therapy. Include prior doses, dates, outcomes, therapeutic failures, serious side effects, contraindications, progression, and relevant laboratory work, test results, or clinical markers.

Describe the specific clinical problem caused by a preferred biologic or biosimilar; vague symptoms are insufficient.
Document the length of any preferred-product trial.

Documentation Required

Dose and Provider Documentation

When dosing depends on weight, body-surface area, or another member-specific measurement, include that measurement in the medical-necessity request. The data must support the requested dose.

Provide current member-specific measurements used in dose calculation.
Ensure the requested regimen is consistent with supported dosing schedules.

Documentation Required

Continuation Evidence

For continuation of therapy, document adherence of at least 85% based on prescriber verification or medication fill history, unless lower adherence resulted from surgery, infection treatment, or adverse-event mitigation causing temporary discontinuation. Also document clinically significant improvement, stability, or lack of progression and no intolerable adverse effects or unacceptable toxicity.

Provide adherence evidence or the qualifying reason for temporary interruption.
Document clinical benefit or stability.
Prescriber must attest to, or the reviewer must find, acceptable safety and tolerability.

Denial Risk

Unsupported Indication

Coverage may be denied when the submission does not establish a documented diagnosis for a medically accepted indication. FDA approval or qualifying compendial or consortium support must be identifiable in the request.

Include the diagnosis and the supporting indication source.
Do not rely on an unsupported or undocumented use.

Denial Risk

Insufficient Medical Necessity Documentation

Insufficient medical-necessity documentation can result in denial. Missing treatment sequencing, prior therapy history, doses or dates, outcomes, laboratory or clinical-marker support, or required split-fill information may prevent approval.

Explain why required therapies were tried, failed, contraindicated, or not appropriate.
Include relevant test results and clinical markers.
Address split-fill eligibility and day-supply setup when applicable.

Denial Risk

Preferred Biologic or Biosimilar Not Addressed

A non-formulary or nonpreferred biologic or reference product may be denied when the request does not address the preferred biologic or available biosimilars. Submit the required trial-and-failure, serious-side-effect, contraindication, or exception documentation.

For a reference product with available biosimilars, document trial and failure, serious side effects, or contraindication to a majority of available biosimilars, not more than three, unless state rules or clinical-superiority evidence provide otherwise.
For physician-administered reference medication, document ineffective treatment, serious side effects, or contraindication with at least two associated biosimilars when required.

Denial Risk

Continuation Criteria Not Met

Continuation authorization may be denied when the record does not establish the required adherence, clinical benefit or stability, and acceptable safety profile. The continuation request must address each criterion.

Adherence must generally be at least 85%, subject to the stated temporary-discontinuation exception.
Document improvement, stability, or lack of disease progression.
Address intolerable adverse effects and unacceptable toxicity.

Denial Risk

Documentation Does Not Support Determination

The payer may deny reimbursement or take other appropriate action when submitted documentation does not support the determination that the drug or service is medically necessary, noninvestigational, experimental-free, and within the member’s benefits. Additional records, test results, or provider credentials may be requested.

Maintain records supporting the initial determination.
Ensure documentation does not demonstrate inappropriate or excessive billing practices.

Denial Risk

Experimental or Off-Label Use

Uses of antineoplastic agents outside covered FDA-labeled, compendial, or otherwise supported indications are considered experimental or investigational and follow the applicable off-label policy. Confirm the requested use is within the policy’s supported indications before submitting.

Consult the individual drug monograph for covered or compendial uses.
Unsupported off-label uses may be denied.

Denial Risk

FDA Contraindication

All FDA-labeled contraindications are exclusions to therapy. Review the product prescribing information and document that no applicable contraindication is present before requesting coverage.

A contraindicated requested therapy may be denied.
Address relevant contraindications and safety considerations in the clinical submission.

Billing Rule

Improper Billing or Excluded Benefit

Codes in the policy are for reference and do not guarantee coverage or reimbursement. Claims may be rejected, or payment may be recovered, when the service is excluded by the benefit, the code is deleted or ineffective on the date of service, or billing reflects inappropriate or excessive practice.

Use codes effective on the date of service and follow industry-standard coding practices.
Verify benefit eligibility and exclusions in the member’s benefit document.
Listing a code does not establish coverage.

The original site of the cancer

Biosimilar

BiosimilarA highly similar version of a brand-name biological drug

Consistency requirementsThe product must meet strict controls for structural, pharmaceutical, and clinical consistency

Clinical differenceThe manufacturer must demonstrate no meaningful differences in safety or efficacy from the reference product

Associated conditions

Associated conditionsSymptoms or side effects associated with advanced, metastatic cancer or its treatment

Practitioner determinationThe health care practitioner judges that leaving the symptoms or side effects untreated would further jeopardize the patient's health

Covered contextThe definition applies in the context of advanced, metastatic cancer and its treatment

Advanced, metastatic cancer

Advanced, metastatic cancerCancer that has spread from the primary or original site of the cancer

Nearby spreadThe cancer may spread to nearby tissues or lymph nodes

Distant spreadThe cancer may spread to other areas or parts of the body

Starter Fill Program / Split Fill Program

ProgramA program for selected medications with a high incidence of adverse effects, frequent dose modifications, or poor tolerability

New utilizersNew utilizers receive a short initial supply

Cumulative restrictionDispensing is limited to a 14-day supply until the member receives a cumulative 90-day supply

Program goalsThe program is intended to reduce medication waste and improve member care and medication adherence