Radar on Specialty Pharmacy
-
Stelara Formulations, White Bagging Bring Complexity to IRA Negotiated Drug List
As CMS engages in the initial round of Inflation Reduction Act (IRA)-mandated drug price negotiations with manufacturers, one of the agents on the list of Medicare Part D drugs to be negotiated has certain aspects that make it a not-so-straightforward candidate. Stelara (ustekinumab) from the Janssen Pharmaceutical Companies of Johnson & Johnson has particular qualities that could result in unintended consequences, asserts one industry expert.
Stelara is unique among the first drugs to be negotiated in that it is available in both subcutaneous and intravenous formulations. The human interleukin-12 and -23 antagonist is approved for subcutaneous use for the treatment of 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 with active psoriatic arthritis. It also is approved for the treatment of adults with moderately to severely active Crohn’s disease and adults with moderately to severely active ulcerative colitis, for whom treatment is initiated with a single intravenous dose, followed by subcutaneous maintenance dosing.
-
COA: New Part D Reimbursement Is Not ‘Reasonable and Relevant’
Specialty pharmacies and oncology practices dispensing costly specialty medications have long complained that Medicare Part D direct and indirect remuneration (DIR) fees are not appropriate for these drugs. Efforts to do away with these retroactive fees were finally successful, but revamped reimbursement has brought a new problem — underwater reimbursement — claims the Community Oncology Alliance (COA).
DIR includes rebates and price concessions that occur after the point of sale. According to CMS, total DIR “has been growing significantly in recent years.…In 2020, pharmacy price concessions accounted for about 4.8 percent of total Part D gross drug costs ($9.5 billion), up from 0.01 percent ($8.9 million) in 2010.”
-
Cardinal Health Report Highlights ‘Pivotal Year’ for Biosimilars
The FDA approved the first biosimilar in 2015, and since then, almost 50 more have been greenlighted. Last year saw the biggest influx of these competitors onto the U.S. market, and a recent Cardinal Health report, titled 2024 Biosimilars Report: Insights on a pivotal year of evolution and expansion, highlights this burgeoning market.
Since 2015, biosimilars have saved $23.6 billion, with $9.4 billion of that total coming in 2023 alone. Last year saw the long-awaited competition to the top-selling Humira (adalimumab) from AbbVie Inc., with nine biosimilars launching, two of them with interchangeable status, an important differentiator to providers. “As the top-selling drug in the world with annual sales of $20 billion in 2022, the potential monetary impact of increased market competition cannot be overstated,” says the report.
-
FDA Grants Full Approval to Game-Changing Regimen for Urothelial Cancer
Late last year, the FDA approved a new regimen for urothelial cancer that could transform the treatment of the condition, according to industry experts. However, the cost of the combination — which is estimated to be more than half a million dollars annually — could pose a barrier to its uptake.
On Dec. 15, 2023, the FDA approved Pfizer Inc. and Astellas Pharma Inc.’s Padcev (enfortumab vedotin-ejfv) in combination with Merck & Co., Inc.’s Keytruda (pembrolizumab) for the treatment of people with locally advanced or metastatic urothelial cancer (la/mUC). The agency gave accelerated approval to this combination for people with la/mUC who are not eligible for cisplatin-containing chemotherapy on April 3, 2023. The newest approval converts that accelerated approval to full and expands the labeled indication to include the treatment of people eligible for cisplatin chemotherapy. The application had priority review and breakthrough therapy designation.
-
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.
The Latest
Meet Our Reporters
Meet Our Reporters