Radar on Specialty Pharmacy

Feb. 9: The FDA approved Aurobindo Pharma Limited’s deflazacort for the treatment of Duchenne muscular dystrophy (DMD) in people at least 5 years old. The corticosteroid is the first generic of PTC Therapeutics, Inc.’s Emflaza that the agency has approved. It has approval as a tablet for all of Emflaza’s dosage strengths: 6 mg, 18 mg, 30 mg and 36 mg. Emflaza also is available as an oral suspension. That agent is approved for the treatment of DMD in people at least 2 years old; it has exclusivity for the treatment of people ages 2 to 5 years old until June 2026. The recommended daily dosing is 0.9 mg/kg. Drugs.com lists the price of 30 18 mg tablets of Emflaza as more than $9,706.

Feb. 9: The FDA approved Takeda Pharmaceuticals U.S.A., Inc.’s Eohilia (budesonide) for the treatment of people at least 11 years old with eosinophilic esophagitis. The corticosteroid is the first and only FDA-approved oral treatment for the indication. Recommended dosing is 2 mg twice daily for 12 weeks; the agent is available in 2 mg/10 mL single-dose stick packs. Its monthly wholesale acquisition cost is $1,875.

Coherus BioSciences, Inc. launched its Udenyca Onbody, an on-body injector (OBI) presentation of Udenyca (pegfilgrastim-cbqv), the company said Feb. 21. The OBI is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in people with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Udenyca was first approved Nov. 2, 2018, and the leukocyte growth factor is one of six biosimilars of Amgen Inc.’s Neulasta (pegfilgrastim) that the agency has greenlighted. A health care provider must fill the OBI with the co-packaged syringe and apply it to the patient’s abdomen or back of the arm. About 27 hours after it is applied to the skin, the OBI will deliver a 6 mg/0.6 mL dose of Udenyca over about five minutes.

Catalyst Pharmaceuticals, Inc.’s Agamree (vamorolone) is now available in the U.S., the company said March 13. The FDA approved the first-in-class corticosteroid on Oct. 26 for the treatment of Duchenne muscular dystrophy in people at least 2 years old. The company is offering the comprehensive support program Catalyst Pathways Patient Assistance Program for Agamree for eligible patients. Drugs.com lists the price of 40 mg/mL oral suspension as more than $10,013.

An ongoing lawsuit over the use of copay accumulators is drawing to a close following the defendants’ and plaintiffs’ motions to dismiss their appeals. The ball is now in the federal government’s and state insurance commissioners’ courts to enforce a district court judge’s ruling, which states that manufacturer assistance must be counted toward patients’ out-of-pocket responsibility unless a brand-name drug has a medically appropriate generic equivalent.

Health plans and PBMs several years ago began implementing copay accumulators — and then a new iteration known as copay maximizers that declare certain drugs non-essential health benefits to avoid covering them per the Affordable Care Act (ACA) — to counter manufacturer copay assistance programs. Before these tools, that assistance would count toward beneficiaries’ annual out-of-pocket expenses. When those out-of-pocket maximums were reached, health plans would cover the remainder of members’ costs for the year. With accumulators and maximizers, patients can still use that assistance, but it does not help reduce those out-of-pocket costs.

While the FDA approved a large number of specialty drugs in 2023, payers shouldn’t let their attention wander in 2024. Multiple potential blockbusters are slated for decisions by the agency this year, as are several biosimilars and generic versions of specialty medications. Gene therapies will continue to garner headlines — and payer dollars. All of these trends and more point to an active year ahead within the specialty pharmacy space. AIS Health, a division of MMIT, spoke with some industry experts about what’s on board.

AIS Health: What are some specialty pharmacy issues to keep an eye on in 2024, and why?

Less than two years after Walgreens Boots Alliance Inc.’s purchase of Shields Health Solutions, the pharmacy giant is rumored to be seeking a sale of the health system-owned specialty pharmacy integrator, per a Jan. 23 Bloomberg article, which valued the company at around $4 billion. While returns from a sale could help the company shore up certain units, divesting itself of Shields at a time when specialty pharmacy continues to be a hot commodity may be a questionable approach, say industry experts.

A Walgreens spokesperson told AIS Health, a division of MMIT, that the company has no comment.