Oncology

Feb. 3: The FDA expanded the patient population for Takeda’s Takhzyro (lanadelumab-flyo) to include the prevention of hereditary angioedema attacks in people at least 2 years old. The agency initially approved the plasma kallikrein inhibitor on Aug. 3, 2018. Dosing of the subcutaneous injectable in people at least 12 years old is 300 mg every two weeks. In people at least 6 and less than 12, dosing is 150 mg every two weeks, and for people 2 years old and younger than 6, dosing is 150 mg every four weeks. Drugs.com lists the price of one single-dose 300 mg/2 mL subcutaneous solution as more than $26,165.

Feb. 8: The FDA granted another indication to Regeneron Pharmaceuticals, Inc.’s Eylea (aflibercept) for the treatment of retinopathy of prematurity in preterm infants. The agency first approved the drug on Nov. 18, 2011. Dosing of the vascular endothelial growth factor (VEGF) inhibitor for the newest indication is 0.4 mg via intravitreal injection; treatment may be given bilaterally on the same day. Injections may be repeated with an interval of at least 10 days. Drugs.com lists the price of a 40 mg/ml intravitreal solution as more than $1,957.

The FDA recently approved the first gene therapy for bladder cancer, Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firadenovec-vncg). Almost three-quarters of oncologists surveyed by Zitter Insights expressed at least moderate interest in the agent, and payers said they likely will manage the drug to label.

On Dec. 16, the FDA approved Adstiladrin for the treatment of adults with high-risk, Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. The agency gave the novel adenovirus vector-based gene therapy priority review, breakthrough therapy and fast track designations. Dosing is once every three months into the bladder via a urinary catheter. The company said it expects the therapy to be available in the second half of 2023.

Cigna Corp.-owned Express Scripts removed 43 medications from its 2023 National Preferred Formulary, while the other two major PBMs — CVS Health Corp.’s Caremark and UnitedHealth Group’s Optum Rx — cut 23 and 19 drugs from their formularies in 2023, respectively. Since 2014, the three PBMs have dramatically increased the number of excluded drugs, but the growth rate of exclusions has slowed for the second year in a row.

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.

AstraZeneca will permanently withdraw Lumoxiti (moxetumomab pasudotox-tdfk) from the U.S. market, the company revealed recently. In a letter to health care providers, the company said it will direct its distributors to halt distribution of the agent in August 2023 and will request that those distributors return any Lumoxiti packs. The FDA approved the medication on Sept. 13, 2018, for the treatment of relapsed or refractory hairy cell leukemia in people who had received at least two prior systemic therapies including a purine nucleoside analog. The manufacturer said that the drug’s withdrawal is not related to its safety or efficacy and that the medicine has had “very low clinical uptake” since its approval, “due to the availability of other treatment options and possibly due to the specialized complexity of administration, toxicity prophylaxis and safety monitoring needs for patients.” The company advised providers not to start treatment of the drug. For patients already taking it, providers have “adequate time to complete six cycles of treatment.”

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.

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.

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.

A group of Blue Cross and Blue Shield-affiliated companies recently unveiled a new medication contracting organization focused on medical benefit drugs. The new company, known as Synergie Medication Collective, will be successful in improving the affordability of these treatments and patients’ access to them, an industry expert says, but it also will need to show that patients are seeing those savings.

Unveiled Jan. 5, the company says it “is focused on improving affordability and access to costly medical benefit drugs — ones that are injected or infused by a health care professional in a clinical setting — for nearly 100 million Americans.” It will focus not only on infusible treatments for conditions such as cancer but also on multimillion dollar gene therapies. The company says its goal is to “significantly reduce medical benefit drug costs by establishing a more efficient contracting model based upon its collective reach and engagement with pharmaceutical manufacturers and other industry stakeholders.” It plans to “bring to market several new product offerings” this year, among them “transformative value-based models.”

Dec. 12: The FDA gave accelerated approval to Mirati Therapeutics, Inc.’s Krazati (adagrasib) for the treatment of adults with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test (see below brief), who have received at least one systemic therapy. Dosing for the tablet is 600 mg twice daily. The drug is priced at $19,750 per month.

Dec. 12: The FDA approved two companion diagnostics for Krazati (see above brief): Agilent Technologies Inc.’s Agilent Resolution ctDx FIRST assay and Qiagen N.V.’s Qiagen therascreen KRAS RGQ PCR kit. A liquid biopsy next-generation sequencing assay, the Agilent test detects genomic alterations in circulating tumor DNA from plasma. The Qiagen test, first approved July 6, 2012, is a tissue-based assay.