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US Specialty Drug Market Access

  • ID: 4421380
  • Report
  • Region: United States
  • 70 pages
  • Datamonitor Healthcare
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High-touch specialty drugs for complex, chronic, high-cost, or rare diseases are an increasingly significant component of the US pharmaceutical market. A sharp growth in regulatory approvals accompanied by high prices has driven rapid increases in expenditure on specialty therapies by both public and private payers. These factors, coupled with subsequent price rises and strong uptake of some specialty drugs, have prompted payers to adopt stringent cost- and utilization-management strategies in categories such as oncology, multiple sclerosis, rheumatoid arthritis, and hepatitis C.

The specialty drugs trend has also brought new players, such as specialty pharmacies, distributors, and drug hubs, into the pharmaceutical value chain to address unique challenges encountered in the distribution, administration, and reimbursement of specialty products. These challenges include restricted distribution channels that provide specialized services such as fulfillment of Risk Evaluation and Mitigation Strategies or patient support programs, as well as closed networks of specialty pharmacies to drive cost efficiencies, consistency of care, and optimal clinical outcomes. Some payers are also “carving out” specialty pharmacy benefits to focus attention on issues such as patient support, drug adherence, or the generation of outcomes data.

While payers are becoming more adept at managing the costs of specialty drugs reimbursed under medical benefits, a shift from medical to pharmacy coverage, or to integrated specialty drug coverage, may offer more clarity and options to control utilization and costs. In particular, these include prior authorization requirements, step edits, quantity restrictions, diagnostic tests, tiered formularies with high cost-sharing for specialty drugs, discounts, and rebates secured from manufacturers or pharmacists. Some payers also encourage the use of lower-cost sites of care for provider-administered specialty drugs. These strategies are increasingly likely to be supplemented with innovative cost-management techniques such as risk-sharing and performance-based pricing or reimbursement, with an emphasis on bundled services and outcomes.

The emerging US biosimilars market will present significant opportunities to lower the costs of premium-priced specialty biologics, even with relatively modest discounts against the originator brands. Patient-centric services will remain an important part of the equation, although manufacturer support programs to offset the often substantial cost-sharing for specialty drugs will continue to be viewed in some quarters as a pretext to circumvent formulary restrictions and maintain premium prices.
Note: Product cover images may vary from those shown
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  • The specialty drugs market in the US is experiencing rapid growth
  • There are numerous players in the specialty pharma value chain
  • Reimbursement of specialty drugs
  • Specialty drugs’ cost burden on patients
  • Value-based reimbursement and specialty drugs
  • Costs and complexity define specialty drugs
  • Trends in specialty drug expenditures and prices
  • Bibliography
  • Players in the specialty pharma value chain
  • Specialty pharmacies have evolved to fulfill the complex needs of specialty drug access
  • Hubs and support services are a key part of the specialty pharmacy value proposition
  • Pricing relationships throughout the specialty pharma value chain
  • Specialty pharmacies’ relationships with other healthcare stakeholders
  • Bibliography
  • Specialty drug reimbursement is undergoing a shift toward tighter control
  • Benefit design and utilization management for specialty drugs
  • Site-of-care issues are an important consideration with specialty drugs
  • Employers play a role in benefits design and cost-containment efforts
  • Federal programs
  • Pharmacy benefit managers have a key role in controlling access to specialty drugs
  • Bibliography
  • Specialty drugs are often associated with high out-of-pocket patient expenditure
  • Bibliography
  • Formulary exclusions will become more common for specialty drugs
  • There are limits to cost-sharing
  • The shift towards value-based reimbursement will be decisive
  • Payers look to biosimilars to curb specialty expenditure rises
  • Bibliography
List of Figures
Figure 1: Key characteristics of specialty pharmaceuticals
Figure 2: US Food and Drug Administration specialty and conventional drug approvals, 2005-15
Figure 3: Top therapeutic categories for specialty drug spending by selected US payers
Figure 4: Challenges for stakeholders involved with distribution, administration, and reimbursement of specialty drugs
Figure 5: US pharmaceutical supply chain: specialty drug product flow
Figure 6: Specialty pharmacy processes and capabilities
Figure 7: Market share of US specialty pharmacy revenues, 2014 and 2015
Figure 8: Financial relationships in the US specialty pharmaceutical value chain
Figure 9: Reimbursement basis for US drugs, by administration channel, 2015
Figure 10: Specialty drugs or therapeutic areas with preferred products and/or rebates
Figure 11: US health plans with pharmacy benefit for specialty drugs in selected diseases, 2011 and 2013
Figure 12: Key cost management tools for specialty drugs and extent of usage in 2015/16
Figure 13: US commercial payers’ site-of-service strategies
Figure 14: Covered US employees’ average co-payment and co-insurance rates, by pharmacy formulary tier
Figure 15: Future strategies to control specialty drug expenditure
Figure 16: Top specialty pharmacy goals for health insurance plans

List of Tables
Table 1: Specialty drug spending reported by Express Scripts and CVS Caremark (%), 2010-15
Table 2: Strategies used by employer-sponsored health insurance plans in the US to contain the costs of specialty drugs, 2015
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