Infusion Therapy

What’s Next For ICER: An Interview With New President Sarah Emond

The Institute for Clinical and Economic Review’s (ICER’s) new president and CEO Sarah Emond took over the role from the organization’s longtime leader and founder Steve Pearson on Jan. 1, and in an interview at the J.P. Morgan Healthcare Conference in San Francisco, she discussed some of the pressing drug pricing issues on ICER’s radar for the year ahead.

Emond has had a lengthy career at ICER, having worked for the organization for 14 years — most recently as vice president and chief operating officer, helping to lead strategic operations. She said the leadership change was part of a long and planned transition and Pearson continues to work as an advisor.

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News Briefs: Elevance Health Will Acquire Paragon Healthcare

Elevance Health, Inc. has agreed to acquire infusion services provider Paragon Healthcare, Inc., the health insurer said Jan. 4. The companies did not disclose financial details of the deal, which is expected to close in the first half of 2024. Paragon Healthcare serves more than 35,000 people at more than 40 ambulatory infusion centers in eight states, as well as in the home setting, and it treats more than 300 conditions. Once the deal is finalized, Paragon Healthcare will operate as part of CarelonRx, which is the pharmacy segment within Elevance Health’s Carelon health services division. The deal follows Elevance Health’s acquisition of BioPlus, a specialty pharmacy subsidiary of CarepathRx, a portfolio company of Nautic Partners, which it closed in February 2023.

Hizentra (immune globulin subcutaneous [human] 20% liquid) is now available in a 10 g prefilled syringe, manufacturer CSL Behring disclosed Jan. 3. The agent is the first and only subcutaneous immune globulin treatment approved for the maintenance of chronic inflammatory demyelinating polyneuropathy in the U.S. It also is approved for primary immunodeficiency in people at least 2 years old. In addition to the new size, the drug also is available in 1 g, 2 g and 4 g prefilled syringes.

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Tofidence, the First Actemra Biosimilar, Brings Another Option to Treat Inflammatory Conditions

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.

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Newly Approved Tofidence, First Actemra Biosimilar, Expected to Have Some Impact for Payers, Rheumatologists

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.

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FDA Approves First Multiple Sclerosis Biosimilar, Sandoz’s Tyruko

The FDA recently approved the first biosimilar for the treatment of multiple sclerosis (MS): Tyruko (natalizumab-sztn) from Novartis Pharmaceutical Corp. subsidiary Sandoz Inc. The drug is entering a fairly crowded class, and payers have said they expect it 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.

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Leqembi Treatment Infrastructure: If Medicare Pays For It, They Will Come

Eisai Co., Ltd. and its partner Biogen, Inc. crossed over the biggest barrier in their quest to commercialize Leqembi (lecanemab) now that Medicare will cover the cost of the Alzheimer’s disease drug. The next hurdles for doctors and patients will be obtaining blood tests and PET scans for confirming amyloid pathology in the brain, genetic testing to assess APOE4 status, MRIs to monitor for amyloid-related imaging abnormalities (ARIA) and infusion centers to administer the medicine — facilities that exist, but not in the numbers and locations needed to serve all of the US patients eligible for treatment.

CMS said that it will cover the cost of Leqembi on July 6, the day that the FDA converted the amyloid protofibril-targeting antibody’s accelerated approval for the treatment of mild cognitive impairment or mild dementia associated with Alzheimer’s disease (AD) into full approval. Eisai and others believe that while uptake of Leqembi will be slow as the health care system catches up with the diagnostic, monitoring and infusion requirements associated with the therapy, Medicare coverage gives providers the confidence they need to offer those services.

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Option Care Looks to Offer Broader Home-Based Care Model Through Amedisys Purchase

On May 3, Option Care Health, Inc., the largest independent provider of home and alternate site infusion services in the U.S., revealed that it was acquiring Amedisys, Inc., which provides home health, hospice and high-acuity care, for $3.6 billion. While opinions on the deal differed, one industry expert contends that the transaction offers multiple long-term benefits within the ever-evolving health care space, especially the home setting.

The deal comes less than a week after Option Care unveiled its wholly owned subsidiary Naven Health, Inc., a nationwide home infusion nursing network and platform employing more than 1,500 nurses and serving all 50 states.

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New First-in-Class Therapy Should Help Ease Disease Burden for People With Follicular Lymphoma

The FDA recently approved a new first-in-class agent for follicular lymphoma, an important development for people with the condition, according to one oncologist. Payers and oncologists both agreed that the drug’s approval should help ease the disease burden somewhat for people suffering from the condition, according to a Zitter Insights survey.

On Dec. 22, the FDA gave accelerated approval to Roche Group member Genentech USA, Inc.’s Lunsumio (mosunetuzumab-axgb) for the treatment of adults with relapsed or refractory follicular lymphoma after at least two lines of systemic therapy. The drug is a first-in-class CD20xCD3 T-cell engaging bispecific antibody. Dosing for the agent — which can be done in an outpatient setting — is 1 mg via intravenous infusion on day one of cycle one, 2 mg on day eight of cycle one and 60 mg on day 15 of cycle one, each over a minimum of four hours. On day one of cycle two, dosing is 60 mg, and then in cycle three and following cycles, dosing is 30 mg on day one; administration can be reduced to two hours if cycle one infusions were tolerated. Dosing for eight cycles is recommended. If people have a partial response or stable disease after eight cycles, an additional nine cycles may be administered. The drug’s price for eight cycles is about $180,000.

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More Complex Specialty Drug Management, Pandemic Pressures and Inflation Reduction Act Were Some 2022 Trends

Both the specialty pharmacy market and the home infusion space continued to grow in 2022. Congress finally passed legislation that will allow Medicare to negotiate drug prices with manufacturers for the first time, and many of the impacted agents are expected to be specialty medications. As payers grappled with their drug costs, some implemented new utilization management strategies. And the COVID-19 pandemic, now approaching its fourth year, remained a disruptor in both the specialty pharmacy and home infusion markets. AIS Health, a division of MMIT, spoke with various industry experts on multiple 2022 issues impacting those industries.

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ICER Examines Cost Effectiveness, Clinical Effectiveness of Multiple Sclerosis Drugs

Three FDA-approved multiple sclerosis treatments and one MS drug that the FDA is currently reviewing are not cost effective, according to an analysis from the Institute for Clinical and Economic Review (ICER). Jon Campbell, Ph.D., ICER’s senior vice president for health economics and one of the report’s authors, also tells AIS Health that there was “insufficient evidence” to differentiate the clinical effectiveness of any of those four drugs, which are known as monoclonal antibodies.

The findings were part of a larger ICER draft evidence report published on Oct. 17 that examined the clinical effectiveness and cost effectiveness of oral and monoclonal antibody disease modifying therapies (DMTs) for relapsing-remitting MS. About 85% of the 1 million Americans with MS have the relapsing-remitting form.

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