BC of Michigan Adds — and Drops — Step Edits for Darzalex Faspro

Just as quickly as it was announced, Blue Cross Blue Shield of Michigan dropped a step therapy requirement for the oncology drug Darzalex (hyaluronidase-fihj) Faspro. Through a provider alert posted on Feb. 6, 2025, the insurer indicated that beginning May 1, 2025, patients with Medicare Plus Blue and BCN Advantage would have to try and fail Darzalex (hyaluronidase) before an oncologist could use Darzalex Faspro.

But on Feb. 19, 2025, Blue Cross Blue Shield of Michigan indicated the change was put on hold. The insurer would not comment on what happened or why. “Blue Cross Blue Shield of Michigan consistently reviews our coverage process to ensure our members obtain access to high-quality, safe, affordable, and appropriate medications. BCBSM is currently evaluating any potential updates to the coverage process for Darzalex Faspro, and there are no changes at this time,” a spokesperson told Formulary Watch by email.

Darzalex and Darzalex Faspro are therapies developed by Johnson & Johnson. Both are indicated for eight indications in multiple myeloma, three of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible. Multiple myeloma is a cancer that forms in plasma cells in bone marrow. About 36,110 new cases will be diagnosed this year, and about 12,030 patients with multiple myeloma will die, according to the American Cancer Society.

First approved by the FDA in May 2020, Darzalex Faspro is co-formulated with recombinant human hyaluronidase PH20, which is Halozyme’s ENHANZE drug delivery technology. Halozyme’s technology allows biologics to be administered subcutaneously instead of through an IV. This reduces administration time and infusion-related reactions. Darzalex Faspro can be administered in three to five minutes. Darzalex IV’s first administration can be as long as seven hours, but is about three hours for the third and subsequent doses.

The list price for the IV Darzalex is $10,859 per dose and $10,572 per dose for Darzalex Faspro. A J&J spokesperson said the dosing frequency of both therapies tapers over time and varies based on the regimen, which impacts annual cost. Darzalex and Darzalex Faspro sales account for 13% of J&J’s revenue, and in 2024 J&J recorded sales of $11.6 billion, up almost 20%, according to a recent filing with the Securities and Exchange Commission.

J&J also would not comment on the specifics of the Blue Cross decision, but the spokesperson said Darzalex and Darzalex Faspro are covered by Medicare as well as the leading Medicare Advantage and commercial insurance plans.

Formulary Watch first saw providers discussing the proposed change in coverage on LinkedIn. Ming-Hei Tai, Pharm.D., a clinical pharmacy specialist at Karmanos Cancer Institutes in Flint, Mich., told Formulary Watch that provider pressure helped to change the insurer’s policy.

In posts on LinkedIn, Tai said the efficacy of Darzalex and Darzalex Faspro were similar, but the subcutaneous version was safer for patients. “When daratumumab was only available as an IV formulation, about half of patients would have an infusion-related reaction, most often during the first dose, and patients had to receive 8-hour infusions due to this risk,” he wrote in one post. “A small number of patients had to receive the first dose in the hospital. Fewer than 10% of patients on daratumumab hyaluronidase have a reaction, and most reactions occur in the first 3 hours of the first dose.”