Radar on Specialty Pharmacy

News Briefs: Multiple Developments Around Biosimilar Humiras Occurred

Multiple developments around biosimilar versions of AbbVie Inc.’s Humira (adalimumab) have occurred. Teva Pharmaceuticals, a unit of Teva Pharmaceuticals Industries Ltd., and Alvotech launched Simlandi (adalimumab-ryvk) in the U.S., the companies disclosed on May 20. The FDA approved the interchangeable, high-concentration, citrate-free drug on Feb. 23 for nine of its reference drug’s indications.…Boehringer Ingelheim said on May 13 that it had signed an agreement with Quallent Pharmaceuticals, a private-label pharmaceutical distributor that is a wholly owned subsidiary of The Cigna Group, to offer both high- and low-concentration, citrate-free versions of adalimumab-adbm through a copay assistance program. The tumor necrosis factor (TNF) inhibitor’s interchangeable designation applies to the low-concentration version. Boehringer will continue to commercialize that agent and its branded version, Cyltezo, which has approval for nine of Humira’s indications.…Celltrion USA has made its high-concentration, citrate-free adalimumab-aaty available at a low wholesale acquisition cost that is an 85% discount to Humira’s WAC, the company revealed on May 9. Its branded version, Yuflyma, remains available at a 5% discount to Humira’s WAC. The agent is approved for eight of Humira’s indications.

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How Will Beqvez Fare in Challenging Market for Cell and Gene Therapies?

The FDA recently approved the second gene therapy for hemophilia B, Pfizer Inc.’s Beqvez (fidanacogene elaparvovec-dzkt). While the agent offers an additional treatment option with the potential for freedom from regular infusions of factor therapy, its price — which is equal to that of its competitor — may be too high for many payers, according to a Zitter Insights survey. Industry experts say that it may suffer from some of the challenges other cell and gene therapies have faced in gaining a foothold in the U.S. market.

On April 25, the FDA approved Beqvez for the treatment of adults with moderate to severe hemophilia B who use factor IX (FIX) prophylaxis therapy; have current or historical life-threatening hemorrhage; or have repeated, serious spontaneous bleeding episodes and do not have neutralizing antibodies to adeno-associated virus (AAV) serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test. The manufacturer launched a warranty program for the intravenous infusion based on durability of patient response to treatment.

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Cell and Gene Therapies Pose Multiple Challenges but No Easy Solutions

While health care payers are facing a variety of issues, paying for multimillion-dollar cell and gene therapies (CGTs) is one of the most pressing, as evidenced by sessions at two recent AHIP conferences. Multiple speakers discussed various approaches to the agents, as well as challenges payers need to tackle, but all acknowledged that a truly successful model has yet to be implemented.

Many CGTs are in the pipeline, impacting potentially millions of patients and prompting many questions around affordability and accessibility, stated Sean Dickson, senior vice president of pharmaceutical policy at AHIP, during a session in Baltimore titled “Cell and Gene Therapies: Regulatory Updates and Coverage Policies.” “Oncology is where it will get really interesting,” and these agents will have the greatest impact on Medicare payers.

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Home Infusion Providers Can Navigate Contracting Process With Various Strategies

While home infusion has been an option for patients for decades, the space continues to evolve. Within this landscape, providers must successfully execute the contracting process with PBMs and government and commercial insurers, navigating various pitfalls along the way.

Attorney Jesse Dresser, a partner in law firm Frier Levitt’s life sciences department who heads the firm’s pharmacy practice group and frequently helps pharmacies and pharmacy providers on issues with payers and PBMs, moderated a panel discussion titled “Strategies for Successful Payer and PBM Contracts in Home Infusion” at the National Home Infusion Association’s (NHIA) annual conference, held March 23 through 27 in Austin, Texas.

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News Briefs: Fresenius Kabi Launches First Actemra Biosimilar

Fresenius Kabi AG launched Tyenne (tocilizumab-aazg), the first biosimilar of Roche Group member Genentech USA, Inc.’s Actemra (tocilizumab) to become available in the U.S., the company revealed April 15. The FDA approved the interleukin-6 inhibitor on March 5 in both intravenous and subcutaneous formulations, making it the only Actemra biosimilar approved so far in both. On Sept. 29, 2023, the FDA approved Bio-Thera and Biogen Inc.’s Tofidence (tocilizumab-bavi) as an intravenous formulation only. Fresenius says Tyenne is available now in an intravenous formulation only. The agents are approved for several autoimmune conditions.

Sandoz reached an agreement with Amgen Inc. resolving all patent litigation related to denosumab, Sandoz revealed April 30. The FDA approved Sandoz’s Jubbonti (denosumab-bbdz) and Wyost (denosumab-bbdz) on March 5 as biosimilar to and interchangeable with Amgen’s Prolia (denosumab) and Xgeva (denosumab) for all of their indications. They are the first FDA-approved denosumab biosimilars. The agreement will allow the agents to launch on May 31, 2025, or earlier “under certain circumstances if customary acceleration provisions are triggered.”

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Established TKI Gains New Indication to Treat Aggressive Cancer

After first gaining approval more than a decade ago, Takeda Pharmaceuticals U.S.A., Inc.’s Iclusig (ponatinib) recently gained approval for the frontline treatment of an aggressive blood cancer. One clinical trial found that people on the agent experienced complete remission more than twice as often as those on a comparator therapy. Industry sources point to the drug’s clinical efficacy as a significant development in the treatment of the disease.

On March 19, the FDA gave accelerated approval to Iclusig in combination with chemotherapy for the treatment of adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The newest application had priority review and orphan drug designation, and its review used the Real-Time Oncology Review and the Assessment Aid.

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One Repatha Presentation Will Be Discontinued Next Month, Another in 2025

Amgen Inc. will discontinue the Repatha (evolocumab) Pushtronex system, an on-body infusor, on June 30, the company said April 12. Certain patients, however, may need to remain on that system, and the manufacturer says it will maintain inventory of it to meet their needs.

In addition to the 420 mg/3.5 mL single-dose Pushtronex, Repatha is available as a 140 mg/mL single-dose SureClick autoinjector and a 140 mg/mL single-dose prefilled syringe. The company is urging users to transition to the SureClick because it plans to discontinue the prefilled syringe in mid-2025.

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Walgreens Will Launch New Specialty Pharmacy With ‘Significant’ Cell and Gene Therapy Offering

On April 24, Walgreens Boots Alliance Inc.’s Walgreens revealed that it will launch Walgreens Specialty Pharmacy on Aug. 1. The company is touting the new division, which will include AllianceRx Walgreens Pharmacy and four central specialty pharmacies, as being able to swiftly serve patients without being invested in a PBM. And that could mean enhanced opportunities for contracting with payers and manufacturers, according to one expert.

The new unit will also feature nearly 300 community-based specialty pharmacies across the U.S. and a new 18,000-foot Gene & Cell Services Pharmacy and Innovation Center in Pittsburgh. The division will have more than 1,500 specialty-trained pharmacists, 5,000 patient advocacy support staffers and 10 Specialty360 teams. It also has access to more than 240 limited distribution drugs, including 40 narrow networks and 12 exclusive limited distribution agents.

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New FDA Approvals: FDA Approves AstraZeneca’s Voydeya

March 29: The FDA approved Alexion, AstraZeneca Rare Disease’s, Voydeya (danicopan) as an add-on therapy to ravulizumab (currently available as the company’s Ultomiris) or eculizumab (currently available as the company’s Soliris) for the treatment of extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria. The agent is a first-in-class factor D inhibitor, and it has breakthrough therapy designation. Initial dosing for the tablet is 150 mg three times a day, which can be increased to 200 mg three times a day. Drugs.com lists the price of 180 50 mg-100 mg tablets as more than $4,359.

April 5: The FDA expanded the patient population of AstraZeneca’s Fasenra (benralizumab) to include the add-on maintenance treatment of people aged 6 to 11 with severe asthma with an eosinophilic phenotype. The agency first approved the interleukin-5 receptor alpha-directed cytolytic monoclonal antibody on Nov. 14, 2017. Dosing for the newest indication for pediatric patients weighing less than 35 kg is 10 mg via subcutaneous injection every four weeks for the first three doses and then once every eight weeks; for those at least 35 kg, dosing is 30 mg every four weeks, followed by once every eight weeks. The list price for one 30 mg/mL solution is $5,511.41.

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Payers Continue to Employ Array of Specialty Drug Management Strategies

Rebates continue to be a huge part of the specialty pharmacy space, with 93% of respondents to a recent survey receiving them for drugs in the pharmacy benefit. Meanwhile, 44% of respondents said their firm received rebates for medical benefit drugs, representing an increase from 39% in the prior year’s survey. Those are just some of the findings in the Trends in Specialty Drug Benefits Report from Pharmaceutical Strategies Group (PSG), an EPIC company.

The 11th annual survey, which reflects 2023 information, was fielded from Sept. 18 through Oct. 13, 2023. The primary source of respondents was PSG’s proprietary database of drug benefit decision makers, and they included people from employers, health plans (or third-party administrators or insurance companies) or union/Taft-Hartley plans. There were 185 benefits leaders from plan sponsors with an estimated 86.6 million lives.

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