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)    Jemperli (dostarlimab-gxly) requires prior authorization.

2)    Jemperli is a specialty drug covered under the medical benefit.

Jemperli (dostarlimab-gxly) is considered medically necessary for members meeting the following criteria:

Endometrial Carcinoma (initial approval)

1)    Diagnosis of endometrial carcinoma; AND

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

3)    Age > 18; AND

4)    Disease has both of the following characteristics (a and b):

a.    Recurrent or advanced

b.    dMMR (i.e., disease is indicative of MMR gene mutation or loss of expression) or microsatellite instability-high (MSI-H);

5)    Disease has progressed following prior treatment with a platinum-containing regimen (e.g., carboplatin/cisplatin); AND

6)    Member is not a candidate for curative surgery or radiation

7)    Request meets one of the following (a or b)*:

a.    Dose does not exceed 500mg every 3 weeks for dose 1 through 4, followed by 1,000mg 3 weeks after dose 4, then 1,000mg every 6 weeks; OR

b.    Dose 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.

            Initial Approval Duration: 6 months

Solid Tumor

1)    Diagnosis of solid tumor (e.g., breast cancer, colon cancer [including appendiceal adenocarcinoma], esophageal and esophagogastric junction cancers, gastric cancer, hepatobiliary cancer, ovarian/fallopian tube/primary peritoneal cancer, rectal cancer, small bowel adenocarcinoma, occult primary cancer, ampullary adenocarcinoma).; AND

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

3)    Age > 18; AND

4)    Disease has both of the following characteristics (a and b):

a.    Metastatic, recurrent or advanced;

b.    dMMR (i.e., disease is indicative of MMR gene mutation or loss of expression) or MSI-H; AND

5)    Disease has progressed following prior treatment with a platinum-containing regimen (e.g., carboplatin/cisplatin); AND

6)    Prescribed as a single agent

7)    Request meets one of the following (a or b)*:

a.    Dose does not exceed 500mg every 3 weeks for dose 1 through 4, followed by 1,000mg 3 weeks after dose 4, then 1,000mg every 6 weeks; OR

b.    Dose 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.

            Initial Approval Duration: 6 months

Reauthorization (12 months)

1)    Currently receiving medication via QualChoice benefit, or documentation supports that member is currently receiving Jemperli and has received this medication for at least 30 days; AND

2)    Member is responding positively to therapy; AND

3)    If request is for a dose increase, request meets one of the following (a or b)*:

a.    Dose does not exceed 1,000mg every 6 weeks;

b.    New dose 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.

Codes Used In This BI:

J9272 – Injection, dostarlimab-gxly, 10mg

1)    Jemperli Prescribing Information. Philadelphia, PA: GlaxoSmithKline LLC; April 2021.

2)    Dostarlimab-hxly In: National Comprehensive Cancer Network Drugs and Biologics Compendium.

Addendum:

Effective 08/01/2023: Updated endometrial cancer coverage criteria.

Effective 11/01/2023: Updated examples and characteristics of solid tumors included.