Specialty Medication Dose Creep: What It Is and How to Avoid It

Top 3 Things You’ll Learn

  1. Top drug class driving specialty spend for self-funded employee benefits plans
  2. How inappropriate dosing and dose creep is driving specialty medication costs
  3. Why employer-aligned clinical oversight is needed to prevent wasteful spending

As more high-cost specialty prescription drugs come to market, self-funded employers will continue to be challenged by managing specialty medications on their benefits programs. On the surface, the question is whether a specialty medication meets clinical criteria. However, the real issue requires a deeper inspection to see if the specialty medication:

  • Is being dosed correctly?
  • Is having its dose increased at an appropriate rate?
  • Is exhibiting a proper dosing frequency?

Dose creep in pharmacy benefits is a relatively unknown concept – and the reason makes sense. Exposing it conflicts with the traditional PBM business model, revealing the hidden secrets that they don’t want employers to understand in how they “manage” specialty drug costs. In basic terms, dose creep is defined as the process of increasing a medication’s dose or frequency beyond what is considered the standard of care for most of that medication’s patient population.

Often while clinically appropriate for a given indication, many medications may be used inappropriately through excessive dosing and excessive frequency of use, leading to unanticipated plan costs. Therefore, a robust independent PA process should be more than a one-time review process. 

Why Dose Creep Occurs

Specialty medications prescribed as anti-inflammatories continually rank as one of the leading therapy classes driving specialty spend for employers. High spend in this drug class is influenced primarily by treatments for Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis, Ulcerative Colitis, Crohn’s Disease, and Atopic Dermatitis. Common brand name medications include several household names, thanks to direct-to-consumer manufacturer advertisements: Humira®, Stelara®, Xeljanz®, Dupixent®, Otezla®, Cosentyx®, Tremfya®, Skyrizi®.

The high utilization of these brand name anti-inflammatory drugs is due, in part, to easy access to specialists who write prescriptions for high-cost specialty drugs – medications that are subject to dose creep and driving up plan costs along the way. Many times, these expensive anti-inflammatory medications get approved during the PBM prior authorization processes based on clinical rationale alone – without any additional review to validate increased quantities dispensed or frequency of dosing. This is because most PBMs have valid clinical criteria that upholds the drug’s medical necessity, but these criteria do not validate increased dosage or frequency of specialty medications.

Why not? The answer lies in the PBM business model itself. It is not in the PBM’s best interest to prevent dose creep because their revenue stream is aligned financially with both the pharmacy and drug manufacturer rebate contract. As a result, employers often find themselves on the losing end economically, unaware that they are overspending unnecessarily on prescription drugs.

How to Avoid Dose Creep

While a medication may be deemed clinically appropriate for the indication, medications may be used inappropriately through excessive dosing and excessive frequency of use, ie., dose creep. The employer’s pharmacy benefit plan design should focus on instituting appropriate cost controls of specialty drug spend, including tailored utilization management (UM) protocols, prior authorization (PA) guidelines that review drug dosing, and a UM review process that is independent of the PBM and leads to an established cadence of reviews. These additional independent review strategies also can help manage dose creep and related costs effectively:

  • A prospective review process could limit a PA to a certain dollar threshold and day supply. When that threshold is surpassed because of higher or more frequent dosing, another review by PBM-agnostic clinical pharmacists or physicians can validate the increase.
  • A retrospective review by PBM-agnostic clinical pharmacists or physicians – through a program like RxBenefits’ Complex Condition Intervention – could assist the employer in establishing protocols to address previously approved medication and authorization allowances for excessive dosing or frequency that may or may not remain clinically viable.

Another strategy to help further lower costs for appropriately prescribed medications is a manufacturer copay assistance program (MCAP), which can be implemented (if eligibility requirements are met) under the employer’s plan design. MCAP works by shifting additional cost share to members with manufacturer dollars being used to cover the full member’s out of pocket amount.

Where to Start

Understanding the drug classes that are most frequently used by a plan is an important first step in identifying any wasteful spending that is driving cost and increasing trend. If you are not sure whether your clients’ pharmacy benefits plans contain medications subject to post-authorization misuse, consider enlisting a pharmacy benefit optimizer (PBO) to help. Unlike a PBM, the PBO model aligns clinical oversight and cost management strategies with the employer to ensure only the most appropriate medications are being used at the lowest possible cost. This way, employers can prevent or eliminate unnecessary spending on medications so that they have funds to cover the essential medications.

Read our free PBO Clinical Strategies Playbook to learn more about how RxBenefits’ Rx utilization management strategies help employers eliminate waste and optimize therapy while improving the benefit value for members.

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