Dostarlimab-gxly (Jemperli)

Number: 0993

Policy

Note: Requires Precertification:

Precertification of dostarlimab-gxly (Jemperli) is required of all Aetna participating providers and members in applicable plan designs. For precertification of dostarlimab-gxly (Jemperli), call (866) 752-7021 (Commercial), (866) 503-0857 (Medicare), or fax (866) 267-3277.

Note: Site of Care Utilization Management Policy applies.  For information on site of service for dostarlimab-gxly (Jemperli), see Utilization Management Policy on Site of Care for Specialty Drug Infusions

  1. Criteria for Initial Approval

    1. Endometrial cancer (EC)

      Aetna considers dostarlimab-gxly (Jemperli) medically necessary for treatment of mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen, when used as a single agent.

    2. Solid Tumors

      Aetna considers dostarlimab-gxly (Jemperli) medically necessary for treatment of mismatch repair deficient (dMMR) recurrent or advanced solid tumors that has progressed on or following prior treatment and for whom there are no satisfactory alternative treatment options, when used as a single agent.

    Aetna considers all other indications as experimental and investigational (for additional information, see Experimental and Investigational or Not Medically Necessary, and Background sections).

  2. Continuation of Therapy

    Aetna considers continuation of dostarlimab-gxly (Jemperli) therapy medically necessary in members requesting reauthorization for an indication listed in Section I when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Dosage and Administration

Dostarlimab-gxly (Jemperli) is available as 500 mg/10 mL (50 mg/mL) solution in a single-dose vial for intravenous infusion.

Endometrial Cancer and Solid Tumors

The recommended dosage of Jemperli is:

  • Dose 1 through Dose 4: 500 mg every 3 weeks
  • Subsequent dosing beginning 3 weeks after Dose 4 (Dose 5 onwards): 1,000 mg every 6 weeks

Source: GlaxoSmithKline, 2021a

Experimental and Investigational or Not Medically Necessary 

Aetna considers dostarlimab-gxly (Jemperli) unproven and not medically necessary for who have experienced disease progression while on PD-1 or PD-L1 inhibitor therapy.

Background

U.S. Food and Drug Administration (FDA)-Approved Indications 

  • Jemperli is indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced: 

    • Endometrial cancer (EC), as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen;
    • Solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

Dostarlimab-gxly is available as Jemperli (GlaxoSmithKline, 2021a) and is a programmed death receptor-1 (PD-1)-blocking lgG4 humanized monoclonal antibody. By binding PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor located on T cells, T-cell proliferation and cytokine production are inhibited (GlaxoSmithKline, 2021a).

Per the prescribing information, dostarlimab-gxly (Jemperli) carries the following warnings and precautions:

  • Immune-mediated adverse reactions, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis, and immune-mediated dermatologic adverse reactions;
  • Infusion-related reactions;
  • Complications of allogeneic HSCT after PD-1/L-1–blocking antibody;
  • Embryo-fetal toxicity.

The most common adverse reactions (≥20%) are fatigue/asthenia, nausea, diarrhea, anemia, and constipation (GlaxoSmithKline, 2021a).

Endometrial Cancer

In the U.S., endometrial cancer (EC) is the most frequent gynecological malignancy with its prevalence on the rise. An estimated 75% of endometrial cancers are diagnosed at the beginning stage and are usually curable with surgery. Nevertheless, there are limited treatment options beyond front-line standard therapy with a platinum-containing chemotherapeutic regimen for women with advanced and recurrent endometrial cancer. Additionally, an estimated 25% to 30% of advanced endometrial cancer patients have mismatch repair deficient (dMMR) tumors (FDA, 2021a).

On April 22, 2021, the U.S. Food and Drug Administration (FDA) approved Jemperli (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, indicated for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as confirmed by an FDA-approved test, that have progressed on or following prior treatment with a platinum-containing regimen (GlaxoSmithKline, 2021b). The FDA granted Priority Review designation and Breakthrough Therapy designation to Jemperli for the endometrial cancer indication using the Accelerated Approval pathway (FDA, 2021a). The approval was based on supporting data from the ongoing GARNET study.

In the GARNET study, a multi-center, multicohort, open-label, non-randomized Phase 1 trial, Oaknin and colleagues (2020) evaluated the efficacy and safety of Jemperli in patients with dMMR endometrial cancer. Of the 104 enrolled women patients, the efficacy population consisted of 71 patients with dMMR recurrent or advanced EC who progressed on or after treatment with a platinum-containing regimen. Patients received 500 mg of Jemperli intravenously every 3 weeks for 4 doses followed by 1000 mg every 6 weeks until disease progression, treatment discontinuation, or withdrawal. The primary endpoints included objective response rate (ORR) and duration of response (DOR). Confirmed response was noted in 30 patients (objective response rate, 42.3%; 95% CI, 30.6%-54.6%); 9 patients (12.7%) had a confirmed complete response, and 21 patients (29.6%) had a confirmed partial response. The median duration of response was not reached (median follow-up was 11.2 months).The safety profile for Jemperli in patients included the occurrence of anemia (3 of 104 [2.9%]), colitis (2 of 104 [1.9%]), and diarrhea (2 of 104 [1.9%]) being the most common grade 3 or higher treatment-related adverse events.

Solid Tumors

On August 17, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The approval was based on supporting data from the non-randomized, multicenter, open-label, multi-cohort GARNET study (FDA, 2021b).

In the GARNET study, the efficacy population comprised 209 patients with dMMR recurrent or advanced solid tumors who progressed following systemic therapy and had no satisfactory alternative treatment. Patients received Jemperli 500mg intravenously every 3 weeks for 4 doses followed by 1,000 mg intravenously every 6 weeks until disease progression or unacceptable toxicity. Primary efficacy endpoints included overall response rate (ORR) and duration of response (DOR). The results were as follows:41.6% (95% CI: 34.9, 48.6) for ORR, 9.1% for complete response rate, 32.5% for partial response rate, and 34.7 months (range 2.6, 35.8+) median DOR with 95.4% of patients with duration ≥ 6 months. The most common adverse reactions (≥20%) in these patients included fatigue/asthenia, anemia, diarrhea, and nausea. Commonly occurring Grade 3 or 4 reactions (≥2%) included anemia, fatigue/asthenia, increased transaminases, sepsis, and acute kidney injury (FDA, 2021b).

Table: CPT Codes / HCPCS Codes / ICD-10 Codes
Code Code Description

Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+" :

Other CPT codes related to the CPB:

96413 - 96417 Chemotherapy administration

HCPCS codes covered if selection criteria are met:

Dostarlimab-gxly (Jemperli) - No specific code:

ICD-10 codes covered if selection criteria are met:

C11.0 - C11.9 Malignant neoplasm of nasopharynx [mismatch repair deficient (dMMR) recurrent or advanced]
C12 Malignant neoplasm of pyriform sinus [mismatch repair deficient (dMMR) recurrent or advanced]
C13.0 - C13.9 Malignant neoplasm of hypopharynx [mismatch repair deficient (dMMR) recurrent or advanced]
C14.0 - C14.8 Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx [mismatch repair deficient (dMMR) recurrent or advanced]
C15.3 - C15.9 Malignant neoplasm of esophagus [mismatch repair deficient (dMMR) recurrent or advanced]
C16.0 - C16.9 Malignant neoplasm of stomach [mismatch repair deficient (dMMR) recurrent or advanced]
C17.0 - C17.9 Malignant neoplasm of small intestine [mismatch repair deficient (dMMR) recurrent or advanced]
C18.0 - C18.9 Malignant neoplasm of colon [mismatch repair deficient (dMMR) recurrent or advanced]
C19 - C21.8 Malignant neoplasm of rectosigmoid junction, rectum, anus and anal canal [mismatch repair deficient (dMMR) recurrent or advanced]
C22.0 Liver cell carcinoma [mismatch repair deficient (dMMR) recurrent or advanced]
C22.1 Intrahepatic bile duct carcinoma [mismatch repair deficient (dMMR) recurrent or advanced]
C23 - C24.9 Malignant neoplasm of gall bladder and other and unspecified parts of biliary tract [mismatch repair deficient (dMMR) recurrent or advanced]
C25.0 - C25.9 Malignant neoplasm of pancreas [mismatch repair deficient (dMMR) recurrent or advanced]
C26.0 - C26.9 Malignant neoplasm of other and ill-defined digestive organs [mismatch repair deficient (dMMR) recurrent or advanced]
C30.0 - C30.1 Malignant neoplasm of nasal cavity and middle ear [mismatch repair deficient (dMMR) recurrent or advanced]
C31.0 - C31.9 Malignant neoplasm of accessory sinuses (paranasal) [mismatch repair deficient (dMMR) recurrent or advanced]
C33 Malignant neoplasm of trachea [mismatch repair deficient (dMMR) recurrent or advanced]
C34.00 - C34.92 Malignant neoplasm of bronchus and lung [mismatch repair deficient (dMMR) recurrent or advanced]
C37 Malignant neoplasm of thymus [mismatch repair deficient (dMMR) recurrent or advanced]
C38.0 - C38.8 Malignant neoplasm of heart, mediastinum and pleura [mismatch repair deficient (dMMR) recurrent or advanced]
C39.0 - C39.9 Malignant neoplasm of other and ill-defined sites in the respiratory system and intrathoracic organs [mismatch repair deficient (dMMR) recurrent or advanced]
C40.00 - C40.92 Malignant neoplasm of bone and articular cartilage of limbs [mismatch repair deficient (dMMR) recurrent or advanced]
C41.0 - C41.9 Malignant neoplasm of bone and articular cartilage of other and unspecified sites [mismatch repair deficient (dMMR) recurrent or advanced]
C43.0 - C43.9 Malignant melanoma of skin [mismatch repair deficient (dMMR) recurrent or advanced]
C44.00 - C44.201 Other and unspecified malignant neoplasm of skin [mismatch repair deficient (dMMR) recurrent or advanced]
C46.1 Kaposi's sarcoma of soft tissue [mismatch repair deficient (dMMR) recurrent or advanced]
C47.0 - C47.9 Malignant neoplasm of peripheral nerves and autonomic nervous system [mismatch repair deficient (dMMR) recurrent or advanced]
C48.0 - C48.8 Malignant neoplasm of retroperitoneum and peritoneum [mismatch repair deficient (dMMR) recurrent or advanced]
C49.0 - C49.9 Malignant neoplasm of other connective and soft tissue [mismatch repair deficient (dMMR) recurrent or advanced]
C50.011 - C50.929 Malignant neoplasm of female and male breast [mismatch repair deficient (dMMR) recurrent or advanced]
C51.0 - C51.9 Malignant neoplasm of vulva [mismatch repair deficient (dMMR) recurrent or advanced]
C52 Malignant neoplasm of vagina [mismatch repair deficient (dMMR) recurrent or advanced]
C53.0 - C53.9 Malignant neoplasm of cervix uteri [mismatch repair deficient (dMMR) recurrent or advanced]
C54.0 - C54.9 Malignant neoplasm of corpus uteri [mismatch repair deficient (dMMR) recurrent or advanced]
C55 Malignant neoplasm of uterus, part unspecified [mismatch repair deficient (dMMR) recurrent or advanced]
C56.1 - C56.9 Malignant neoplasm of ovary [mismatch repair deficient (dMMR) recurrent or advanced]
C57.00 - C57.02 Malignant neoplasm of fallopian tube [mismatch repair deficient (dMMR) recurrent or advanced]
C58 Malignant neoplasm of placenta [mismatch repair deficient (dMMR) recurrent or advanced]
C60.0 - C60.9 Malignant neoplasm of penis [mismatch repair deficient (dMMR) recurrent or advanced]
C61 Malignant neoplasm of prostate [mismatch repair deficient (dMMR) recurrent or advanced]
C62.00 - C62.92 Malignant neoplasm of testis [mismatch repair deficient (dMMR) recurrent or advanced]
C63.00 - C63.9 Malignant neoplasm of other and unspecified male genital organs [mismatch repair deficient (dMMR) recurrent or advanced]
C64.1 - C68.9 Malignant neoplasm of kidney and other and unspecified urinary organs [mismatch repair deficient (dMMR) recurrent or advanced]
C69.00 - C69.92 Malignant neoplasm of eye and adnexa [mismatch repair deficient (dMMR) recurrent or advanced]
C70.0 - C70.9 Malignant neoplasm of meninges [mismatch repair deficient (dMMR) recurrent or advanced]
C71.0 - C71.9 Malignant neoplasm of brain [mismatch repair deficient (dMMR) recurrent or advanced]
C72.0 - C72.9 Malignant neoplasm of spinal cord, cranial nerves and other parts of central nervous system [mismatch repair deficient (dMMR) recurrent or advanced]
C73 Malignant neoplasm of thyroid gland [mismatch repair deficient (dMMR) recurrent or advanced]
C7A.1 - C7A.8 Malignant poorly differentiated neuroendocrine tumors [mismatch repair deficient (dMMR) recurrent or advanced]
C80.0 - C80.1 Malignant neoplasm without specification of site [mismatch repair deficient (dMMR) recurrent or advanced]
D00.00 - D09.9 Carcinoma in situ [mismatch repair deficient (dMMR) recurrent or advanced]

The above policy is based on the following references:

  1. GlaxoSmithKline. Jemperli (dostarlimab-gxly) injection, for intravenous use. Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline; revised August 2021a.
  2. GlaxoSmithKline PLC. FDA grants accelerated approval for GSK’s Jemperli (dostarlimab-gxly) for women with recurrent or advanced dMMR endometrial cancer. Press Release. London, UK: GlaxoSmithKline; April 22, 2021b.
  3. GlaxoSmithKline PLC. GSK received FDA accelerated approval for Jemperli (dosarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors. Press Release. London, UK: GlaxoSmithKline; August 17, 2021c.
  4. Oaknin A, Tinker AV, Gilbert L, et al. Clinical activity and safety of the anti-programmed death 1 monoclonal antibody dostarlimab for patients with recurrent or advanced mismatch repair-deficient endometrial cancer: A nonrandomized phase 1 clinical trial. JAMA Oncol. 2020;6(11):1766-1772.
  5. U.S Food and Drug Administration (FDA). FDA approves immunotherapy for endometrial cancer with specific biomarker. FDA News Release. Silver Spring, MD: FDA; April 22, 2021a.
  6. U.S. Food and Drug Administration (FDA). FDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors. Silver Spring, MD: FDA; August 17, 2021b.