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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: 06/01/2020 Title: Ayvakit
Revision Date: 07/01/2021 Document: BI654:00
CPT Code(s):
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)    Ayvakit (avapritinib) requires prior authorization.

2)    Ayvakit is used to treat gastrointestinal stromal tumors (GIST) and myeloid/lymphoid neoplasm (MLNE).

3)    Ayvakit is an oral specialty drug and must be obtained through a contracted specialty pharmacy.


Medical Statement

Ayvakit (avapritinib) is considered medically necessary for members 18 years of age and older who meet the following criteria:

 

Gastrointestinal Stromal Tumor (GIST)

 

1)    Diagnosis of unresectable or metastatic GIST AND

2)    Prescribed by or in consultation with an oncologist AND

3)    One of the following (a or b):

a.    Documentation of PDGFRA exon 18 D842V mutation:

b.    Member meets both of the following:

                                          i.    Documentation of PDGFRA exon 18 mutation other than D842V;

                                        ii.    Failure of imatinib, unless contraindicated or clinically significant adverse effects are experienced;

4)    Dose does not exceed 300mg (1 tablets) per day.

 

Myeloid/Lymphoid Neoplasm with Eosinophilia and Tyrosine Kinase Fusion Gene (must meet all)

 

1)    Diagnosis of myeloid/lymphoid neoplasm with eosinophilia (MLNE) and FIP1L1- PDGFRA rearrangement;

2)    Prescribed by or in consultation with an oncologist;

3)    Age ≥ 18 years;

4)    For Ayvakit request, medical justification supports inability to use avapritinib, if available, (e.g., contraindications to excipients);

5)    Member meets both of the following (a and b):

a.    Documentation of a PDGFRA D842V mutation;

b.    Failure of imatinib*, unless contraindicated or clinically significant adverse effects are experienced;

*Prior authorization may be required for imatinib

6)    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

 

Reauthorization is approved if documented that member is responding positively to drug and dose does not exceed 300mg per day.


Limits

As an oral specialty drug, Ayvakit is limited to a maximum 30-day supply per fill.


Reference

1)    Ayvakit Prescribing Information. Cambridge, MA: Bluespring Medicines Corporation; January 2020.

2)    NCCN Drugs & Biologics Compendium. Accessed online 05-17-21.

3)    Clinical Pharmacology. Accessed online 05-17-21.

4)    Heinrich M, Jones RL, Mehren M, et al. A hase 1 study of BLU-285 in patients with gastrointestinal stromal tumors (GIST) andotherrelapsed and refractory solid tumors (NAVIGATOR). (2019). Retrieved from https://clinicaltrials.gov/ct2/show/record/NCT02508532 (Identification No. NCT02508532)

Addendum:

1)    Effective 07-01-2021: Updated to include criteria for coverage of myeloiod/ymphoid neoplasm with eosinophilia and tyrosine kinase fusion gene.


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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