Radar on Specialty Pharmacy

The FDA recently approved the fifth and sixth gene therapies, with four of those decisions coming in the second half of 2022. While payer respondents to a Zitter Insights survey have expressed interest in hemophilia B treatment Hemgenix (etranacogene dezaparvovec-drlb), its price may prove to be an obstacle to coverage.

On Nov. 22, the FDA approved uniQure N.V.’s Hemgenix for the treatment of people at least 18 years old with hemophilia B who currently use factor IX prophylaxis therapy or have current or historical life-threatening hemorrhage or have repeated serious spontaneous bleeding episodes. CSL Behring LLC, a CSL business, will market the gene therapy. The agency gave the first-in-class adeno-associated virus A5-based gene therapy — which previously was known as EtranaDez — priority review and orphan and breakthrough therapy designations.

Paying for specialty drugs continues to be a top concern for U.S. payers, and employers are utilizing various strategies to try to get a handle on their costs. Some relief should come, at least for Medicare, with the Inflation Reduction Act, which will start to have an impact this year as CMS names its top medications for negotiations on Sept. 1. AIS Health, a division of MMIT, spoke with multiple industry experts about what they’re expecting to see in 2023.

AIS Health: What are some specialty pharmacy issues to keep an eye on in 2023, and why?

Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates: Increasing acceptance of biosimilars by prescribers and patients may give payers confidence to implement coverage mandates and benefit designs that advantage their use.

One of the biggest events in the specialty pharmacy market is happening this year: the availability of biosimilars to AbbVie Inc.’s top-selling Humira (adalimumab). With its Jan. 31 launch, Amgen Inc.’s Amjevita (adalimumab-atto) was the first entrant, and others are expected this summer. But biosimilars of other top biologics also are coming down the pike. AIS Health, a division of MMIT, spoke with a variety of industry experts about what they’re watching in this space in 2023.

AIS Health: What kind of impact will be seen from the Humira biosimilars?

Nicole Kjesbo, Pharm.D., director of clinical program development for Prime Therapeutics LLC: Ideally, we’ll see price competition due to multiple biosimilars of Humira launching in 2023.

While the launches of biosimilars of AbbVie Inc.’s best-selling drug Humira (adalimumab) are arguably the top entrants expected on the U.S. marketplace in 2023, numerous other specialty agents are expected to join them. AIS Health, a division of MMIT, spoke with multiple industry experts on what they’re keeping an eye on in the late-stage pipeline.

AIS Health: Are there any big specialty drugs expected to see patent expiration — and potentially generic or biosimilar competition — in 2023?

Nicole Kjesbo, Pharm.D., director of clinical program development for Prime Therapeutics LLC: Generics are expected to launch in 2023 for [AstraZeneca’s] Iressa (gefitinib), [Jazz Pharmaceuticals plc’s] Xyrem (sodium oxybate), [Novartis Pharmaceuticals Corp.’s] Sandostatin LAR (octreotide acetate) and Thalomid (thalidomide) [from Bristol Myers Squibb unit Celgene Corp.]. Stelara [(ustekinumab) from Johnson & Johnson unit Janssen Biotech, Inc.] (IV/SC) and IV Actemra [[(tocilizumab) from Genentech USA, Inc., a member of the Roche Group] lose their exclusivity in 2023.

Jan. 19: The FDA expanded the label of BeiGene, Ltd.’s Brukinsa (zanubrutinib) to include the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. The agency initially approved the Bruton’s tyrosine kinase (BTK) inhibitor on Nov. 14, 2019. The agency granted the application orphan drug designation, and its review used the Assessment Aid. The recommended dose of the capsule is 160 mg twice daily or 320 mg once daily. Drugs.com lists the price of 120 80 mg capsules as more than $15,264.

Jan. 19: The FDA granted accelerated approval to Seagen Inc.’s Tukysa (tucatinib) in combination with trastuzumab for the treatment of adults with RAS wild-type, human epidermal growth factor receptor 2 (HER2)-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. The company says the tyrosine kinase inhibitor is the first FDA-approved treatment in HER2-positive metastatic colorectal cancer. The agency first approved the drug on April 17, 2020. The newest indication had priority review and breakthrough therapy designation. Dosing for the tablet is 300 mg twice daily. Drugs.com lists the price of 60 150 mg tablets as more than $12,389.