Specialty Drugs

Sept. 8: The FDA approved BioLineRx Ltd.’s Aphexda (motixafortide) in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in people with multiple myeloma. The agency gave the agent orphan drug designation. Dosing for Aphexda is 1.25 mg/kg based on actual body weight via subcutaneous injection after filgrastim has been administered daily for four days and 10 to 14 hours prior to the start of apheresis. The drug’s price is $5,900 per vial, and the company has said that it expects most patients will need two vials.

Sept. 8: The FDA expanded the label of Sandoz Inc.’s Hyrimoz (adalimumab-adaz) to include the treatment of adults with non-infectious intermediate and posterior uveitis and panuveitis. The agency first approved the biosimilar of AbbVie Inc.’s TNF inhibitor Humira (adalimumab) on Oct. 30, 2018. Dosing starts with 80 mg via subcutaneous injection, followed by 40 mg every other week starting one week after the initial dose. The agent is available in a low-concentration, citrate-free version of its reference drug. The product launched in July with two wholesale acquisition costs: a branded version with a WAC of $6,576 and an unbranded one for $1,315 for a carton of two syringes or autoinjectors.

Findings from a study jointly conducted by AllianceRx Walgreens Pharmacy and Walgreen Co. reveal the importance of adherence to non-infused biologics for the treatment of rheumatoid arthritis (RA). Specifically, researchers found a connection between adherence and lower medical costs, rates of hospitalization and length of stay (LOS).

Researchers presented the findings on Sept. 20 at the National Association of Specialty Pharmacy (NASP) Annual Meeting & Expo, which was held Sept. 18-21.

The study used data from 2019-2020 in the MarketScan Commercial Claims and Encounters databases for patients with commercial coverage, and Supplemental or Coordination of Benefits databases for Medicare beneficiaries. It also used the reporting metric of proportion of days covered (PDC) from the Pharmacy Quality Alliance (PQA), an independent non-profit organization focused on improving safety, adherence and appropriate use of medications.

On Sept. 29, a U.S. District Court ruled in favor of patient advocates who challenged a regulation that allowed most individual and group market health plans to use copay accumulator programs. So far, it isn’t clear how CMS will respond to the ruling, likely leaving health plans and PBMs waiting eagerly for guidance from the agency. But one thing is certain: Health insurers aren’t happy about the decision.

Insurers created copay accumulator programs in response to the drug manufacturer practice of offering copay assistance programs — including coupons and copay cards — to defray high out-of-pocket costs patients might face for branded drugs. When copay accumulator programs are applied, health plan enrollees are not allowed to count any direct-to-consumer discounts toward their deductibles or out-of-pocket maximums.

CVS Health is getting into the biosimilars business, the company said in late August, and will officially enter the market on Jan. 1 in partnership with a Humira biosimilar. CVS stressed the importance of driving use of biosimilars and ensuring their supply, which sources say is a positive development. But one industry source questions whether the new company raises potential conflict-of-interest issues.

On Aug. 23, CVS revealed that it had launched the wholly owned subsidiary Cordavis to commercialize and/or co-produce biosimilars in collaboration with drug manufacturers. “Through Cordavis, CVS Health intends to develop a portfolio of products that it expects will facilitate broader access to biosimilars in the U.S. — creating more competition that drives down prices — while encouraging investment in future products,” said the company in a press release.

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.

Following the launch of almost 10 biosimilars of AbbVie Inc.’s Humira (adalimumab) this year, 2025 will be another big year for the U.S. biosimilar market, when no less than three versions of Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson are set to become available. Having the experience of assessing multiple competitors with varying attributes could help payers as they prepare for the launches, say industry experts.

Stelara is a human interleukin-12 (IL-12) and -23 (IL-23) antagonist indicated for the treatment of adults with moderately to severely active Crohn’s disease, adults with moderately to severely active ulcerative colitis, people at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and people at least 6 years old with active psoriatic arthritis.

The FDA recently granted another approval to Taiho Pharmaceutical Co., Ltd. Division Taiho Oncology, Inc.’s Lonsurf (trifluridine/tipiracil) in combination with another agent for a type of colorectal cancer. The decision provides another treatment option for a condition that respondents to a Zitter Insights survey regard as in need of more effective therapies.

On Aug. 2, the FDA approved Lonsurf as a single agent or in combination with bevacizumab for the treatment of adults with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) drug and, if Rat sarcoma (RAS) wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. Bevacizumab originally was available as Avastin from Genentech USA, Inc., a member of the Roche Group, but now four biosimilars of it are also on the market: Celltrion USA, Inc.’s Vegzelma (bevacizumab-adcd), Amneal Pharmaceuticals, Inc.’s Alymsys (bevacizumab-maly), Pfizer Inc.’s Zirabev (bevacizumab-bvzr) and Amgen Inc.’s Mvasi (bevacizumab-awwb).

As more and more high-cost therapies, including cell and gene therapies (CGTs), enter the U.S. market, commercial health plans have multiple tools at their disposal to manage these agents. Medicaid plans, however, are limited in what they can do. But a multistate value-based contracting (VBC) tool offered by Magellan Rx Management and its parent company, Prime Therapeutics LLC, is helping Medicaid programs access CGTs and ensuring that the agents’ costs are linked to patient outcomes.

A new Medicaid Pharmacy Insights report, titled The State of Value-Based Contracting: Reinventing the Current Drug Payment Model in Medicaid, notes that Medicaid is usually the largest expenditure in state budgets. States need to be able to offer costly CGTs while also managing their budgets. But various barriers to offering value-based contracts — including a lack of resources to negotiate them, as well as collect data and measure outcomes — have limited adoption of these agreements.

The Center for Medicare Advocacy and the Community Legal Services clinic at the University of the Pacific, McGeorge School of Law filed a class action lawsuit (Case 2:23-cv-01932-DB) against HHS on Sept. 8 on behalf of Medicare beneficiaries who have lost coverage of certain Medicare Part B drugs. Plaintiffs were receiving the Janssen Pharmaceutical Companies of Johnson & Johnson’s Stelara (ustekinumab) in an outpatient clinic, where the agent was administered by health care professionals and covered under Part B as an agent provided “incident to” a physician’s service due to disabilities that prevent them from self-administration. In October 2021, HHS denied coverage of Stelara under Part B because it had determined that the drug is “usually self-administered by the patient.” HHS did not notify patients about the change, and it did not require providers to issue a notice. One plaintiff had four injections of more than $40,000 each, while another had two injections of about $58,000 each, before they realized that they were responsible for the full cost of the drug. Plaintiffs are seeking “timely, adequate notice” be required when a Part B drug that has been furnished incident to a practitioner’s service is added to the self-administered drug (SAD) list, as well as a modification to Medicare allowing beneficiaries who cannot self-administer a medically necessary drug due to a disability to be able to receive Medicare-covered medications administered by a health care professional, among other requests.

CVS Health is getting into the biosimilars business, the company said in late August, and will officially enter the market on Jan. 1 in partnership with a Humira biosimilar. CVS stressed the importance of driving use of biosimilars and ensuring their supply, which sources say is a positive development. But one industry source questions whether the new company raises potential conflict-of-interest issues.

On Aug. 23, CVS revealed that it had launched the wholly owned subsidiary Cordavis to commercialize and/or co-produce biosimilars in collaboration with drug manufacturers. “Through Cordavis, CVS Health intends to develop a portfolio of products that it expects will facilitate broader access to biosimilars in the U.S. — creating more competition that drives down prices — while encouraging investment in future products,” said the company in a press release.