Introduction and Overview 1
Evaluation of drug safety and efficacy is a core function of the U.S Food and Drug Administration (FDA). Each year the FDA grants approval to a variety of drug and biological products. Many of these products are considered unique or innovative drugs and will play a key role in the treatment of one or more disease states. Others, however, are very similar or related to previously approved existing drug products. For example, in 2015 the FDA approved 122 original new drug and biologics license applications. Of these approvals only 45 products (37 percent) were considered to be novel drug approvals. The remaining products will likely enter the prescription drug marketplace as direct competitors to existing drug products. Many of these non-novel drugs are created by making very slight modifications to ingredients contained within existing products. They generally offer little to no distinct clinical advantage over existing products and, unfortunately, routinely carry significantly inflated price tags. Consequently, MedTrak has identified these products as non-essential drug therapies.
Non-Essential Drugs 2, 3
The prevalence of non-essential drugs has increased significantly over the past several years. The majority of these drugs exist within the prescription drug marketplace for the sole purpose of retaining product earnings amongst pharmaceutical manufacturers, rather than providing unique and innovative medication therapies. In fact, the term “evergreening” has emerged as a method of describing this phenomenon within the pharmaceutical industry. According to the British Journal of Medicine, “evergreening” is a term that is applied to various strategies used by pharmaceutical companies to retain market share of a product after the 20 year period of exclusive manufacturing rights has expired. Examples of such strategies may include:
• A minimal and clinically insignificant change in the dose or potency of an existing drug product
• Development of a new salt form of an existing drug product
• Development of an extended-release formulation of an existing drug product
• Combining two existing generic ingredients into a “new” brand name drug product
Generally, MedTrak defines a non-essential drug as a new, high costing drug where slight modifications have been made to develop a product which offers little to no clinical advantage over existing, lower-costing alternatives. Table 1 provides examples of non-essential drug products and highlights the negative financial impact associated with their use:
|Non-Essential Drug (active ingredients)||Monthly Cost of Non-Essential Drug||Existing Aleternative(s)||Monthly Cost of Alternative(s)||Additional Monthly Cost Associated with Non-Essential Drug|
(ibuprofen and famotidine)
|$1,782.00||ibuprofen and famotidine||$17.10||$1,764.90|
(naproxen and esomeprazole)
|$1,782.00||naproxen and esomeprazole||$547.20||$1,234.80|
Naprozen and sumatriptan
|$874.40||naproxen and sumatriptan||$14.77||$859.63|
*Note: Pricing may vary based on medication strength and patient-specific dosing regimens. Values displayed are based on Average Wholesale Price.
MedTrak’s Cost Management Strategy: The Non-Essential Drug List
Non-essential drugs pose a significant risk to the financial well-being of prescription benefit plans and typically offer no clinical advantage or health benefit to consumers. Therefore, MedTrak’s Clinical Care Center has identified and maintains a list of non-essential drug products. Currently, 36 drug products are managed under the non-essential drug program. MedTrak’s team of clinical pharmacists continuously review new-to-market drug products in an effort to evaluate potential additions or changes to the program. Because these products have lower-costing and near-equivalent therapeutic alternatives, non-essential drugs are excluded from benefit coverage. Members who are prescribed a non-essential drug product will be directed to one or more covered, lower-costing alternatives. Exception requests require supportive clinical documentation from the member’s prescriber and will be considered on a case-by-case basis.
1. U.S. Food and Drug Administration Web site. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm430302.htm. Accessed February 12, 2016.
2. Alkhafaji AA, et al. Impact of evergreening on patients and health insurance: a meta analysis and reimbursement cost analysis of citalopram/escitalopram antidepressants. BMC Medicine. 2012 10:142.
3. Hemphill CS, Sampat BN. Evergreening, patent challenges, and effective market life in pharmaceuticals. Journal of Health Economics. 2012; 31:327-339.
4. Drug pricing information obtained from Medi-Span Master Drug Database. Accessed via Laker Software Pharmscreens February 12, 2016.
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