Radar on Specialty Pharmacy

New FDA Approvals: FDA Approves First Generic of Emflaza

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.

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News Briefs: Coherus Launches Udenyca Onbody

Coherus BioSciences, Inc. launched its Udenyca Onbody, an on-body injector (OBI) presentation of Udenyca (pegfilgrastim-cbqv), the company said Feb. 21. Approved Dec. 22, 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.

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AI Helps Streamline Some Health Care Tasks, Prompts Caution With Others

Recently it’s been difficult to underestimate artificial intelligence’s (AI) reach across health care entities such as specialty pharmacies, infusion providers and pharma companies. While AI has helped streamline many processes, its ultimate impact may be debatable at this point, and caution in certain areas is warranted, according to some industry experts.

“AI-enabled solutions have transformed the specialty pharmacy and home infusion industries,” contends Mesfin Tegenu, CEO and chairman of RxParadigm, Inc. He notes that AI’s subset of machine learning (ML) uses algorithms to find patterns and make predictions, leading to streamlined operations, better patient care and optimized resource allocations, all of which have the potential to result in cost savings.

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Is Sale of Specialty Pharmacy Accelerator Shields in Walgreens’ Best Interests?

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.

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FDA Warns on CAR-Ts, but Benefits Outweigh Risks for Now

A couple of months after the FDA revealed that it was investigating the risks of chimeric antigen receptor T cell (CAR-T) immunotherapies, the agency is seeking updated language in their labels warning about those risks. However, the fact that the FDA is allowing the therapies to remain on the market suggests that their overall benefits outweigh their potential risks, says one industry expert.

In late November, the FDA revealed that it was investigating the risks of CAR-T therapies following reports of T cell malignancies in people who had undergone treatment with the agents. Less than two months later, the agency issued safety labeling change notification letters to the six available B cell maturation antigen (BCMA)-directed or CD-19 directed autologous CAR-Ts, which cover a range of hematologic cancers:

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New FDA Approvals: FDA Broadens Keytruda Use in Cervical Cancer

Jan. 12: The FDA broadened the label of Merck & Co., Inc.’s Keytruda (pembrolizumab) to include, in combination with chemoradiotherapy, the treatment of people with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer. The agency initially approved the programmed death receptor-1 (PD-1) inhibitor on Sept. 4, 2014. The indication is the drug’s third in cervical cancer and 39th overall. The application was granted priority review. That review was conducted under Project Orbis in collaboration with the Australian Therapeutic Goods Administration and the Brazilian Health Regulatory Agency, and it used the Assessment Aid. Dosing is 200 mg every three weeks or 400 mg every six weeks via a 30-minute intravenous infusion. The agent’s price for every-three-weeks dosing is $11,115; for every-six-weeks dosing, it’s $22,230.

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News Briefs: CMS’s Cell and Gene Therapy Model Will First Focus on Sickle Cell Disease

CMS’s Cell and Gene Therapy Access Model’s first focus will be on therapies for sickle cell disease, the agency said Jan. 30. The administration unveiled the model almost one year ago as one of three new models for testing by CMS’s Innovation Center to lower the cost of drugs and increase access to new treatments. The model will implement outcomes-based agreements (OBAs) for cell and gene therapies to treat sickle cell disease beginning in 2025 “and may be expanded to other types of CGTs in the future.” The administration estimates that about half of people with sickle cell disease are enrolled in Medicaid, with health care services costing about $3 billion annually. Through the model, CMS will negotiate OBAs, and states can decide whether to enter into the arrangements. “CMS will negotiate financial and clinical outcome measures with drug manufacturers and then reconcile data, monitor results, and evaluate outcomes. The CGT Access Model will begin in January 2025, and states may choose to begin participation at a time of their choosing between January 2025 and January 2026.”

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Cell and Gene Therapies, Biosimilars, Medical Benefit Drugs Are Areas to Watch Moving Forward

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?

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Copay Accumulator Lawsuit Comes to an End; Will Ruling Be Enforced?

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.

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Industry Veteran Suggests Broader Genomics Use for Proactive Approach to Health Care

Tremendous strides have been made in personalized medicine over the past several years — not only in drugs but in the various biomarkers used to identify the right drug for the right patient at the right time. While many people may think of this approach as one mainly solely for cancer, the potential for personalized medicine to have a broader impact on health outcomes when it is used proactively has not fully been realized.

In September, InformedDNA — which provides genomic solutions to an array of health care stakeholders to improve outcomes — acquired gWell Health, a digital health, genomics and wellness company. As part of the deal, gWell founder and CEO Surya Singh, M.D., transitioned to CEO of InformedDNA. Singh has worked in various health care organizations in more than 20 years, including serving as corporate vice president and chief medical officer at CVS Health Specialty.

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