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What is a vigilant drug list? A deep dive into pharmacy benefit programs

4 min read

According to Optum, high-cost drugs with little clinical benefit drive up prescription costs significantly, threatening the affordability of employer-provided coverage. A vigilant drug list is a key tool used by Pharmacy Benefit Managers (PBMs) to manage this challenge by excluding certain high-priced, low-value medications from coverage.

Quick Summary

A vigilant drug list identifies and excludes specific high-cost, low-value medications from insurance coverage. This strategy helps manage pharmacy benefits by directing patients toward more clinically and financially effective alternatives.

Key Points

  • Strategic Cost Control: A vigilant drug list is a proactive tool used by Pharmacy Benefit Managers (PBMs) to manage prescription costs by excluding high-cost, low-value medications.

  • Clinical Duplicates: A primary reason for exclusion is when a newer, expensive drug offers no clinical advantage over an existing, more affordable alternative or generic.

  • High-Cost Generics: These lists also target and exclude generic drugs that are priced significantly higher than other generics within the same therapeutic class.

  • Non-Essential Products: Exclusions often include costly, non-FDA-approved or otherwise unnecessary products like certain topical creams, patches, and wound dressings.

  • Impact on Patients: While it may limit medication options, the program aims to ensure patients have access to clinically sound and affordable therapeutic alternatives, potentially lowering their overall costs.

  • Forced Review: Vigilant drug programs can also exclude new drugs from the market until they undergo a formal review process to determine their clinical and economic value.

In This Article

A vigilant drug list is a component of a pharmacy benefits management strategy designed to improve medication quality and control costs for health plans and patients. The concept is primarily associated with programs offered by Pharmacy Benefit Managers (PBMs), such as Optum Rx. The goal is to identify and exclude high-cost prescription drugs that offer minimal or no additional clinical benefit over less expensive alternatives. By doing so, PBMs aim to reduce wasteful spending and promote the use of more clinically and economically valuable therapies. For health plan members, this means certain medications may not be covered, necessitating a conversation with their doctor about covered, clinically appropriate substitutes.

How a vigilant drug list works

At its core, a vigilant drug program uses market surveillance and advanced analytics to identify drugs that fit specific exclusion criteria. These programs are often modular and flexible, allowing health plans to choose which strategies to implement to maximize savings. Instead of simply managing a broad formulary, a vigilant list actively targets specific categories of products that drive up costs without improving patient outcomes.

Exclusion strategies for vigilant drug lists

PBMs use several specific strategies to populate a vigilant drug list:

  • New Drugs to Market Strategy: When a new drug is launched, it may be temporarily excluded from coverage until it can be formally reviewed by the PBM's Pharmacy & Therapeutics (P&T) Committee. This approach minimizes patient disruption and financial risk until the new drug's clinical and financial value is established.
  • Clinical Duplicates Strategy: This is one of the most common reasons for exclusion. It involves identifying and excluding newer, more expensive medications that have similar chemical compositions and offer no significant clinical advantage over existing, less costly alternatives, including generics. Examples include unique dosage forms, combination products, or alternative delivery devices.
  • High-Cost Generics Strategy: This targets generic drugs that are priced substantially higher than other generics within the same therapeutic class. Excluding these outliers helps to bring the overall cost of generic medications in line with market value.
  • Non-Essential Products Strategy: This strategy excludes select high-cost products that may not be approved by the FDA or are deemed unnecessary, such as certain patches, creams, and kits. These preparations often contain ingredients that are inexpensive when purchased individually, offering little clinical value over well-tested, FDA-approved agents.
  • Performance Drivers Strategy: This method focuses on excluding the drugs with the lowest clinical and economic value for their price point, directing utilization towards alternatives with higher overall value.

Implications for patients and prescribers

The implementation of a vigilant drug list has significant ramifications for patients and healthcare providers. For patients, it may mean that a newly prescribed medication is not covered by their insurance, requiring them to switch to a different, covered alternative. While this can sometimes be frustrating, the intent is to ensure they receive a medication that is both clinically effective and affordable. For prescribers, these lists require them to stay informed about formulary changes and potentially adjust their prescribing habits to align with the health plan's coverage policies. PBMs often offer alternative programs, such as prior authorization, for clients who prefer a less restrictive approach than outright exclusion.

Comparison of vigilant drug list exclusions and alternatives

The following table illustrates a hypothetical example of how a vigilant drug list exclusion might compare to its covered alternative, based on the types of products often targeted by these programs.

Feature Excluded Vigilant Drug (Example: High-Cost Wound Dressing) Covered Alternative (Example: Lower-Cost Wound Dressing)
Cost to Health Plan Up to $5,726 (AWP) As low as $12 (AWP)
Ingredient Composition Similar ingredients to OTC or lower-cost products Similar or identical active ingredients
Clinical Value Often minimal added value over alternatives Established clinical safety and effectiveness
Coverage Status Excluded Covered
FDA Approval Status May be non-essential or not FDA-approved Typically FDA-approved
Patient Impact Requires doctor to prescribe a different product, potential frustration Can lead to cost savings for patient, ensures access to proven therapy

The long-term impact on healthcare affordability

The rise of vigilant drug lists reflects a broader trend in the healthcare industry to control the escalating costs of prescription medications. By strategically removing wasteful spending on high-cost, low-value drugs, PBMs and health plans can potentially lower overall healthcare costs, which benefits both plan sponsors and patients. The vigilance program encourages a greater reliance on evidence-based medicine and pharmacoeconomics, ensuring that resources are allocated to treatments that provide the most significant health outcomes for the investment.

For more information on the economics of drug formularies, an authoritative resource can be found on the Optum Business insights website.

Conclusion

Ultimately, what is a vigilant drug list is best understood as a proactive, cost-saving measure employed by Pharmacy Benefit Managers. It is not an arbitrary list but a result of a careful analysis of a drug's clinical efficacy, cost-effectiveness, and overall value. While it may require patients and prescribers to adapt, its primary purpose is to curb healthcare spending and ensure that members have access to clinically sound and affordable therapeutic options. The program's evolution, with its various exclusion strategies, highlights the healthcare sector's ongoing efforts to balance innovation, affordability, and quality of care.

Frequently Asked Questions

A vigilant drug list is an exclusionary list created by Pharmacy Benefit Managers (PBMs) to remove coverage for high-cost medications that offer little to no additional clinical benefit over more affordable, existing alternatives.

These lists are created and managed by Pharmacy Benefit Managers (PBMs), such as Optum Rx, as part of their formulary management services for health plan clients and their members.

The list often includes newer, expensive brand-name medications with cheaper alternatives, high-cost generics, and non-essential products like certain topical creams, patches, and wound dressings.

A vigilant drug list can affect patients by requiring them to use a covered, clinically-appropriate alternative to a non-covered drug. While this may require a change in prescription, it can lead to lower out-of-pocket costs.

Some health plans offer alternative programs, like prior authorization, which may allow for coverage of an excluded medication if a compelling clinical need is demonstrated, though the default is often exclusion.

Not all PBMs use a program with this specific name. However, many PBMs employ similar formulary management strategies to control costs by prioritizing clinically and economically valuable drugs.

Patients can consult their health plan's specific formulary or contact their insurance provider or PBM directly. Their prescribing physician and pharmacist should also be aware of formulary coverage restrictions.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.