Dr. Rubenstein on reimbursement aspects of new leuprolide formulation

Jonathan Rubenstein, MD

In March 2022, Accord BioPharma announced the US launch of a ready-to-inject subcutaneous depot formulation of leuprolide mesylate (Camcevi 42 mg).¹ In this interview, Jonathan Rubenstein, MD, discusses the FDA’s approval of Camcevi and also explains its unique reimbursement aspects. Rubenstein is compliance officer and medical director of coding and reimbursement, United Urology Group and Chesapeake Urology, Towson, Maryland.

Can you comment on the significance of the FDA’s approval of Camcevi in advanced prostate cancer?

RUBENSTEIN: Camcevi adds to the armamentarium of injectable luteinizing hormone-releasing hormone (LHRH) therapies for use in men with prostate cancer. There are a number of LHRH therapies currently on the market and this new product adds to the options that men have.

Like several other LHRH products on the market, Camcevi’s main component is leuprolide. However unlike the other leuprolide products on the market which are leuprolide acetate, Camcevi is leuprolide mesylate.While leuprolide acetate is available in 1-month, 3-month, 4-month, and 6-month formulations, Camcevi is only available in a 6-month formulation. The good part about Camcevi is that it does not need to be mixed but rather comes pre-mixed. To administer Camcevi, the product is removed from the refrigerator for 30 minutes, the needle is applied, and the produce is administered by a subcutaneous injection in the abdominal region.

What else is unique about Camcevi from a reimbursement standpoint?

RUBENSTEIN: The interesting part about Camcevi is that it has its own unique Healthcare Common Procedure Coding System (HCPCS) code J1952, whereas the other leuprolide products use J9218.When billing for any of the LHRH injectable products, CPT code 96402 is used for the work of the injection. When billing leuprolide acetate, you also bill HCPCS code J9218 per milligram, whether it’s 7.5 mg, 22.5 mg, 30 mg, or 45 mg. With Camcevi, you also bill J1952, again per 1mg.So for 42 mg of Camcevi, you would bill 42 units of J1952.

Is there anything else that practicing urologists should know about Camcevi, either from a treatment or reimbursement standpoint?

RUBENSTEIN: As far as we can tell, the efficacy is very similar. Again, the nice part about Camcevi is that it doesn’t need to be mixed. So again, it’s just another product in the armamentarium.

The one thing I do recommend is having people check with their insurers to make sure that Camcevi is approved on their formularies. Sometimes, new medications don’t get onto formularies immediately. I just think it’s important before providing it to make sure that the patient’s insurer will accept that medication for this indication. What I don’t want people to do is to get Camcevi, see the word “leuprolide” and pull the wrong J code. There are different reimbursements for these different products, and one can face denials if using the wrong HCPCS code. And also these products are not interchangeable, meaning having prior authorization for leuprolide acetate does not imply that is it OK to inject leuprolide mesylate.

Reference

1. Accord BioPharma announces U.S. launch for CAMCEVI (Leuprolide) injection emulsion for the treatment of advanced prostate cancer in adults. News release. Accord Biopharma. March 31, 2022. Accessed July 6, 2022. https://yhoo.it/3uFHv8s