Coverage Policies

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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 07/01/2015 Title: Ibrance (Palbociclib)
Revision Date: 07/01/2021 Document: BI484:00
CPT Code(s): None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Ibrance is used to treat advanced breast cancer and soft tissue sarcoma.

2)    Ibrance (Palbociclib) requires pre-authorization.

3)    Ibrance is a specialty medication and must be obtained through the contracted specialty pharmacy.


Medical Statement

Ibrance (Palbociclib) is considered medically necessary for members meeting the following criteria:

Breast Cancer

a)    Diagnosis of estrogen receptor (ER)-positive, HER2-negative advanced breast cancer in postmenopausal women; AND

b)    Used in combination with an aromatase inhibitor (e.g., anastrozole, letrozole, exemastane) and is a postmenopausal female; OR

c)    Used in combination with Faslodex (fulvestrant) and disease has progressed following endocrine therapy.

 

Soft Tissue Sarcoma

a)    Diagnosis of retroperitoneal well-differentiated/dedifferentiated liposarcoma;

b)    Prescribed by or in consultation with an oncologist;

c)    Age ≥ 18 years;

d)    Disease is unresectable;

e)    Prescribed as a single agent;

f)     Dose is within FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).*

 

*Prescribed regimen must be FDA-approved or recommended by NCCN

Approval duration: 6 months

Re-authorization Criteria

For re-authorization (12 months), must document patient has not shown evidence of progression of disease while on Ibrance therapy.


Limits

As a specialty drug, Ibrance is limited to no more than a 30 day supply per fill through the contracted specialty pharmacy.


Reference

1)    Ibrance Prescribing Information. Pfizer Labs. New York, NY. March 2017.

2)    Clinical Pharmacology. Accessed online February 14, 2019.

3)    NCCN Drug Compendia. Accessed online May 16, 2021.

 

Addendum:

1)    Effective 04/01/2019:  Clarified use in combination with aromatase inhibitors and with Faslodex; added reauthorization criteria.

2)    Effective 07/01/2021: Update to include criteria for soft tissue sarcoma.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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