Stelara (ustekinumab) is a biologic medication used to manage chronic inflammatory conditions, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. While effective in alleviating symptoms, its high cost often raises questions. This article explores the various factors that contribute to its expense.
The Extensive Path from Discovery to Approval
Developing a new biologic medication like Stelara requires substantial financial and time investments. The journey begins with preclinical research, involving laboratory studies to identify potential targets and compounds. This early stage can span three to six years and cost hundreds of millions of dollars.
Following successful preclinical work, a drug candidate progresses to multi-phase human clinical trials. These trials are expensive, involving patient recruitment and detailed data analysis. The majority of drug candidates fail at various stages of clinical development, with only about 12% of drugs that enter clinical trials eventually receiving approval.
The high failure rate means that the costs of unsuccessful drug development programs are ultimately absorbed into the prices of the few drugs that do make it to market. The overall cost to develop a new biologic drug and bring it to market can range from $800 million to $2.6 billion, typically taking 8 to 15 years. This extensive and rigorous evaluation process establishes the framework for regulatory approval.
Intellectual Property and Market Exclusivity
Intellectual property rights, primarily patents, play a significant role in enabling pharmaceutical companies to set high prices for medications like Stelara. Patents grant the innovator company exclusive rights to manufacture and sell the drug for a specific period. This exclusivity prevents immediate competition from other manufacturers.
Beyond composition patents, other patents exist, including those related to specific methods of treatment or manufacturing processes. This system of intellectual property protection allows companies to recover their substantial research and development costs and generate profit to fund future innovations. Stelara has generated significant revenue for its developer, with sales reaching billions annually, partly because patent protection prevented generic versions from entering the market for an extended period.
Complex Production of Biologic Medications
The manufacturing of biologic medications like Stelara is inherently more complex and costly than that of traditional small-molecule drugs. Unlike chemically synthesized small-molecule drugs, biologics are large, intricate molecules derived from living organisms, such as cells or tissues. This difference necessitates a highly specialized and controlled production environment.
The manufacturing process for biologics involves multiple intricate steps, including cell culture, fermentation, purification, and sterile filling. These processes demand highly specialized facilities, which can cost hundreds of millions of dollars to build—significantly more than facilities for small-molecule drugs. Operational costs are also substantially higher due to expensive raw materials and the need for highly skilled personnel. Extensive and stringent quality control measures are required throughout every stage of production to ensure the safety, purity, and potency of the biologic product, which further adds to the overall manufacturing expense.
Managing High Costs as a Patient
For patients prescribed Stelara, navigating its high cost often involves a combination of insurance coverage and financial assistance programs. Health insurance plays a primary role, but even with coverage, patients may face substantial out-of-pocket expenses due to high deductibles, co-pays, or specific formulary restrictions. These factors can leave individuals with significant financial burdens.
To address these challenges, pharmaceutical manufacturers often offer patient assistance programs. Janssen CarePath, for example, provides savings programs that can help eligible commercially insured patients reduce their out-of-pocket costs, sometimes to as little as $5 per dose. These programs aim to improve access for patients who meet specific eligibility criteria, though they typically do not apply to those with government-funded insurance like Medicare or Medicaid.
The emergence of biosimilars offers a potential for more affordable alternatives. Biosimilars are highly similar versions of approved biologics that enter the market after the original drug’s patents expire. While not identical to the reference product, biosimilars such as Wezlana (ustekinumab-auub) have received FDA approval, demonstrating no clinically meaningful differences in terms of safety and effectiveness. Several ustekinumab biosimilars are expected to launch in 2025, which could increase competition and potentially lower overall treatment costs.