Medical Policy

Effective Date:07/01/2022 Title:Enjaymo
Revision Date:06/01/2023 Document:BI700:00
CPT Code(s):C9094, J1302
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)    Enjaymo (sutimlimab) requires prior authorization.

2)    Enjaymo is indicated to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD).

3)    Enjaymo is a specialty drug covered under the medical benefit.

Medical Statement

Initial Approval Criteria A. Cold Agglutinin Disease (must meet all):

 

1. Diagnosis of primary cold agglutinin disease (CAD);

2. Prescribed by or in consultation with a hematologist or oncologist;

3. Age ≥ 18 years;

4. Secondary CAD has been ruled out (i.e., cold agglutinin syndrome secondary to infection, rheumatologic disease, or active hematologic malignancy);

5. Member meets all of the following (a, b, c, and d):

a. Active hemolysis as evidenced by elevated total bilirubin;

b. Polyspecific direct antiglobulin test (DAT) (i.e., Coombs test) is positive;

c. Monospecific DAT shows both of the following (i and ii):

i. C3d DAT: strongly positive;

ii. IgG DAT: negative or weakly positive;

d. Cold agglutinin titer ≥ 64 at 4 degrees Celsius;

6. Hemoglobin ≤ 10 g/dL;

 

7. Enjaymo is not prescribed concurrently with rituximab or rituximab-based regimens (i.e., rituximab with bendamustine or fludarabine);

8. Dose does not exceed one of the following (a or b):

a. For body weight 39 kg to < 75 kg: 6,500 mg (6 vials) on Day 0, Day 7, then every 2 weeks thereafter;

b. For body weight ≥ 75 kg: 7,500 m (7 vials) on Day 0, Day 7, then every 2 weeks thereafter.

 

Approval duration: 6 months

 

 

Continued Therapy

A. Cold Agglutinin Disease (must meet all):

1. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;

2. Member is responding positively to therapy as evidenced by one of the following since initiation of Enjaymo therapy (a and b):

a. Increase in hemoglobin > 1.5 g/dL or hemoglobin level > 12 g/dL;

b. Transfusion free or decreased number of transfusions/blood units;

3. If request is for a dose increase, new dose does not exceed one of the following (a or b):

a. For body weight 39 kg to < 75 kg: 6,500 mg (6 vials) every 2 weeks;

b. For body weight ≥ 75 kg: 7,500 mg (7 vials) every 2 weeks.

 

Approval duration: 12 months

 

 

 

Codes Used In This BI:

 

1)    C9094 – Inj, sutimlimab-jome, 10mg (code deleted & replaced by J1302 eff 10-1-22)

2)    J1302 - Inj, sutimlimab-jome, 10 mg

Limits
Intentially left empty
Reference

1. Enjaymo Prescribing Information. Waltham, MA: Bioverativ USA Inc (A Sanofi Company); February 2022. Available at https://www.enjaymohcp.com/. Accessed March 8, 2022.

2. FDA grants priority review of sutimlimab, potential first approved treatment of hemolysis in adult patients with Cold Agglutinin Disease. Sanofi Press Release. May 14, 2020. Available at https://www.sanofi.com/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/media-room/press-releases/2020/2020-05-14-07-00-00-2033186-en.pdf. Accessed March 23, 2021.

3. Positive results presented from pivotal Phase 3 trial of sutimlimab in people with cold agglutinin disease. Presented at the Late Breaking Abstracts Session of the 61st Annual Meeting of the American Society of Hematology in Orlando, FL. Sanofi Press Release. December 10, 2019. Press release available at https://www.sanofi.com/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/media-room/press-releases/2019/2019-12-10-13-30-00-1958469-en.pdf. Accessed March 23, 2021.

4. A study to assess the efficacy and safety of BIVV009 (sutimlimab) in participants with primary cold agglutinin disease who have a recent history of blood transfusion (Cardinal Study). NCT03347396. ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT03347396?term=NCT03347396&rank=1. Accessed March 23, 2021.

5. Ulrich J, D’Sa S, Schorgenhofer C et al. Inhibition of complement C1s improves severe hemolytic anemia in cold agglutinin disease: a first-in-human trial. Blood. February 28, 2019;133(9):893-901.

6. Hill QA, Stamps R, Massey E, et al. The diagnosis and management of primary autoimmune haemolytic anaemia. British Journal of Haematology. 2017;176:395-411. https://doi.org/10.1111/bjh.14478.

7. Bylsma LC, Ording AG, Rosenthal A, et al. Occurrence, thromboembolic risk, and mortality in Danish patients with cold agglutinin disease. Blood Adv. 2019 Oct 22;3(20):2980-2985. DOI:10.1182/bloodadvances.2019000476.

8. Berentsen S. How I manage patients with cold agglutinin disease. British Journal of Haematology. 2018;181:320-330.

9. Berentsen S, Ulvestad E, Langholm R, et al. Primary chronic cold agglutinin disease: a population based clinical study of 86 patients. Haematologica. 2006;91:460-466.

10. Röth A, Barcellini W, D`Sa S, et al. Sutimlimab in cold agglutinin disease. N Engl J Med. 2021;384(14):1323-1334. doi:10.1056/NEJMoa2027760.

 

 

Addendum:

1)    Effective 06-01-2023: Updated initial criteria to remove requirement for history of at least one blood transfusion in past 6 months and revised continuation criteria of required increase in hemoglobin level from 2 to 1.5 g/dL.

2)    Effective 10-01-2022: Code C9094 was deleted and replaced by J1302.

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.