Medical Policy
Effective Date:06/01/2020 Title:Asparlas-Oncaspar
Revision Date: Document:BI642:00
CPT Code(s):J9118, J9266
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)    Asparlas (calaspargase pegol-mknl) and Oncaspar (pegaspargase) require prior authorization.

2)    Asparlas and Oncaspar are used to treat acute lymphoblastic leukemia (ALL).

3)    Both Asparlas and Oncaspar are considered specialty drugs.
Medical Statement

Asparlas (calaspargase pegol-mknl) and Oncaspar (pegaspargase) are considered medically necessary for members meeting the following criteria:

 

Acute Lymphoblastic Leukemia (ALL) (must meet all)

1)    Diagnosis of ALL;

2)    Prescribed by or in consultation with an oncologist or hematologist;

3)    Request meets one of the following (a, b, or c):*

a.    Requestis for Oncaspar: dose does not exceed 2,500 IU/m2 every 14 days (age <21 years) or 2,000 IU/m2 every 14 days (age > 21 years);

b.    Request is for Asparlas: dose does not exceed 2,500 IU/m2 every 21 days (age 1 month to 21 years);

c.    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label dose (prescriber must submit supporting evidence).

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

 

Extranodal NK/T-Cell Lymphoma (must meet all)

1)    Diagnosis of NK/T-cell lymphoma, nasal type;

2)    Prescribed by or in consultation with an oncologist or hematologist;

3)    Age >18 years;

4)    Prescribed as a component ofany of the following regimens (a, b, or c):

a.    Modified-SMILE (steroid [dexamethasone], methotrexate, ifosfamide, pegaspargase, etoposide);

b.    P-GEMOX (gemcitabine, pegaspargase, oxaliplatin);

c.    AspaMetDex (pegaspargase,  methotrexate,dexamethasone);

5)    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.
Limits
Intentially left empty
Reference

1)    Oncaspar Prescribing Information. Boston, MA: Servier Pharmaceuticals LLC; August 2019.

2)    Asparlas Prescribing Information. Boston, MA: Servier Pharmaceuticals LLC; September 2019.

3)    NCCN Drugs and Biologics Compendium. Accessed online 03-13-2020.
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.