Specialty Drugs

The Big Three PBMs — The Cigna Group’s Express Scripts, UnitedHealth Group’s Optum Rx and CVS Health Corp.’s Caremark — all delivered positive results during the third quarter of 2023, and in some ways helped offset underperformance for the firms’ health benefits businesses.

Wall Street analysts were generally positive about the performance of the firms’ PBM subsidiaries, but they had questions about the way each firm plans to manage the cost of glucagon-like peptide 1 (GLP-1) agonists for their clients.

As the PBM and specialty pharmacy worlds have become more integrated, PBMs now are providing more specialty management services than they previously did. Only 15% of respondents to a recent survey said they carve out specialty drugs from the PBM that is providing their pharmacy benefit management, while 26% said they were considering taking this step, according to the 2023 Pharmacy Benefit Manager Customer Satisfaction Report from Pharmaceutical Strategies Group (PSG), an EPIC company.

The 85% of respondents whose PBMs provide both specialty and traditional pharmacy benefit management ranked formulary management of specialty drugs and financial reporting in the pharmacy benefit as the services they were most satisfied with, while they were least satisfied with management of specialty agents in the medical benefit and offering competitive discounts on specialty medications.

The FDA recently approved the first biosimilar of Actemra (tocilizumab) from Genentech USA, Inc., a member of the Roche Group, for multiple indications. Both payers and rheumatologists responding to a Zitter Insights survey said they expected the new drug to have some impact on their management of and prescribing for rheumatoid arthritis (RA). However, the drug’s lack of an additional formulation may hurt its uptake, say industry sources.

On Sept. 29, the FDA approved Bio-Thera and Biogen Inc.’s Tofidence (tocilizumab-bavi) intravenous formulation for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to at least one disease-modifying antirheumatic drug (DMARD), people at least 2 years old with active polyarticular juvenile idiopathic arthritis and people at least 2 years old with active systemic juvenile idiopathic arthritis. Dosing of the intravenous infusion is based on the indication.

The specialty drug landscape continues to be a dynamic space, as new agents enter the market and existing ones gain FDA approval for additional indications. Global health care and specialty pharmacy solutions organization AscellaHealth recently released its quarterly breakdown of insights into treatments within the segment.

The Q3 2023 Specialty & Rare Pipeline Digest examines new approvals and launches of specialty drugs, including biosimilars, generics, and cell and gene therapies, as well as ones in the pipeline.

Oct. 3: The FDA granted interchangeability to Biogen Inc. and Samsung Bioepis Co., Ltd.’s Byooviz (ranibizumab-nuna) for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization (mCNV). The agency first approved the biosimilar of Lucentis (ranibizumab) from Roche Group member Genentech USA, Inc. on Sept. 17, 2021. The vascular endothelial growth factor (VEGF) is administered by intravitreal injection once a month. Dosing for mCNV is up to three months. Drugs.com lists the price of a single-dose 10 mg/mL for 0.05mL vial as more than $1,199.

Oct. 11: The FDA expanded the approval of Fresenius Kabi’s Idacio (adalimumab-aacf) for the treatment of adults with moderate-to-severe hidradenitis suppurativa. The agency first approved the biosimilar of AbbVie Inc.’s tumor necrosis factor (TNF) blocker Humira (adalimumab) on Dec. 13, 2022. Dosing starts with 160 mg via subcutaneous injection on day one or split over two consecutive days, then 80 mg on day 15, and then on day 29 and subsequent doses, 40 mg every week or 80 mg every other week. The price of two single-dose prefilled pens or two single-dose prefilled glass syringes is $6,576.

The FDA recently approved the first biosimilar of Actemra (tocilizumab) from Genentech USA, Inc., a member of the Roche Group, for multiple indications. Both payers and rheumatologists responding to a Zitter Insights survey said they expected the new drug to have some impact on their management of and prescribing for rheumatoid arthritis (RA).

On Sept. 29, the FDA approved Bio-Thera and Biogen Inc.’s Tofidence (tocilizumab-bavi) intravenous formulation for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to at least one disease-modifying antirheumatic drug, people at least 2 years old with active polyarticular juvenile idiopathic arthritis and people at least 2 years old with active systemic juvenile idiopathic arthritis. Dosing of the intravenous infusion is based on the indication.

The first biosimilar for the treatment of multiple sclerosis recently received FDA approval, and when it launches, Tyruko (natalizumab-sztn) from Polypharma Biologics and Sandoz Inc. will enter a competitive therapeutic class that is a high priority for management. Payers have said they expect the new treatment to have a moderate impact on their management of the other agents available to treat the condition.

On Aug. 24, the FDA approved Tyruko for the treatment of two indications: (1) adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, and (2) adults with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn’s therapies and tumor necrosis factor (TNF) inhibitors.

A U.S. district court judge recently struck down a federal rule allowing health plans to not count copayment assistance against members’ out-of-pocket costs. The move clears the way for plans to have to discontinue use of copay offset programs such as copayment accumulators, which have been popular tools to keep their costs down and often impact specialty therapies. But as a result of the ruling, industry experts say that patient adherence likely will improve.

U.S. District Judge John D. Bates of the U.S. District Court for the District of Columbia issued the ruling on Sept. 29.

To help patients pay for costly specialty drugs, pharma manufacturers offer assistance that can help cover their out-of-pocket costs. Companies claim that the assistance helps improve patient adherence to medications that often treat rare and deadly conditions. But critics of them say such programs incentivize drugmakers to raise prices of these agents.

Boehringer Ingelheim’s adalimumab-adbm interchangeable biosimilar is now available at an 81% discount to the price of its reference drug, AbbVie Inc.’s Humira (adalimumab), the manufacturer said Oct. 2. In early July, the company launched a branded version of the agent, Cyltezo, at a 5% discount. Both are citrate-free formulations available in various strengths for multiple inflammatory conditions.

Takeda Pharmaceuticals U.S.A., Inc. will voluntarily withdraw Exkivity (mobocertinib) after the Phase III EXCLAIM-2 confirmatory trial did not meet its primary endpoint, the company disclosed Oct. 2. The FDA gave the kinase inhibitor accelerated approval on Sept. 15, 2021, for the treatment of adults with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The company says it made the decision in consultation with the FDA and is working with the agency on withdrawal timing. It also is working with other regulatory agencies to withdraw the drug globally. In the meantime, Takeda says it is working to make sure that people receiving Exkivity can maintain access to the medication.

The specialty drug landscape continues to be a dynamic space, as new agents enter the market and existing ones gain FDA approval for additional indications. Global health care and specialty pharmacy solutions organization AscellaHealth recently released its quarterly breakdown of insights into treatments within the segment.

The Q3 2023 Specialty & Rare Pipeline Digest examines new approvals and launches of specialty drugs, including biosimilars, generics, and cell and gene therapies, as well as ones in the pipeline.

Among the highlighted agents in the recently released report were Alzheimer’s disease drug Leqembi (lecanemab-irmb) from Eisai Inc. and Biogen, myasthenia gravis therapy Rystiggo (rozanolixizumab-noli) from UCB, Inc. and Pfizer Inc.’s alopecia areata medication Litfulo (ritlecitinib).