The Food and Drug Administration (FDA) approves drugs for the safety and efficacy of our population. There are so many new drugs produced and reviewed each year that the FDA struggles to keep up with the demand. Pharmacy Benefit Managers (PBM) do not approve the production of new drugs but they do have teams of clinical experts to keep track of the new to market drugs and alert their customers of upcoming impact. They also have the ability to warn customers of the effectiveness of the drugs. The issue is that on occasion a PBM may not be interested in alerting the plan to new drugs that may fuel their profitability through rebates or fees from the manufacturer.
Non-essential drugs or drugs that do not have a material impact over another less expensive drug, are a re-branding of one or more generic drugs into a branded/patented drug for financial gain by the manufacturer. Even though they provide no clinical advantage, they come to the market at a detrimental cost to the plan.
There are two types of non-essential drugs.
Combination Drugs are just a rehash of two current generic drugs into one tablet or capsule. This allows the manufacturer to create a new drug entity which can be patented and protected from a generic alternative. These “new” drugs are much higher in cost, and will often have slight modifications in drug strength, but provide little to no clinical advantage over less-expensive and existing alternatives.
Another non-essential drug category is manipulation of the drug release system. Manufacturers take an existing generic drug and overcomplicate the delivery system to develop a brand/patented drug. An example is a sustained release drug , (aka Extended Release, XR, Sustained Release, Slow Release, Delay Release) on a drug that does not need one. This allows the patient to move from taking a drug from twice a day to once a day. Nice feature but at what cost? $1,000 a month? The seems to be an excessive price for the convenience.
It would seem that drug manufacturers coming up with improved ways to combine medications, working with ingredients, and explore ways to improve prescription drug use, would be very convenient for the member, it is—in reality—a very expensive cost for the payor. In order to retain market share of a product, manufacturers and pharmaceutical companies will develop these non-essential drugs in order to gain a new patent. Some Pharmacy Benefit Managers (PBM’s) will receive rebates from the manufacturer for keeping these drugs on their formulary. Because the PBM receives rebates or manufacturer fees, they have a financial stake in keeping these drugs on the formulary. In addition, some PBM’s specifically prohibit the blocking of these drugs when identified by the consultant to prohibit their dispensing.
Let’s take look at non-essential drugs that are used by hundreds of thousands of people every day. The first example is Duexis. Duexis is combination medication that combines Ibuprofen (inflammation) and Famotidine (ulcers). The FDA approved this medication in April 2011 and costs $830.
Duexis 800-26.6mg, 30 tablets - $830
Ibuprofen (OTC), 120 tablets - $6.00
Famotidine 20mg. #30 - $2.00
Rayos DR is 5mg of prednisone in a delayed release dosage. The cost is about $2,000 versus prednisone 10mg which costs $8 per #30 tablets. Rayos DR is commonly used to treat inflammation of the skin, joints, lungs, and other organs.
Rayos DR 5mg - $2000
Prednisone 10mg #30 - $8
Treximet is another common drug that hundreds of thousands of migraine suffers are prescribed. As a migraine-headache treatment, it combines naproxen 500mg and Sumatriptan 80mg (imitrex) into one tablet.
Treximet 9 tablets- $259
Sumatriptan 100mg. 9 tablets- $12
Naproxen (OTC) 220mg. 18 tablets- $1
Lastly, Solodyn is a drug used to treat acne in people 12 and older. The prescription is minocycline 105mg. sustained release and was FDA approved in 2006.
Solodyn 90mg. - $1281
Minocycline Generic 100mg. - $25
These are just some examples of non-essential drugs that are commonly used. Many of these drugs were approved over 10 years ago, showing that this has been going on in the pharmaceutical industry for at least a decade. Utilization of these drugs is uninhibited unless the plan is aware of the costs or the PBM provides an ethical recommendation.
How can you protect and defend yourself from these non-essential drugs? Your best defense is working with a consultant that protects your interests, understands the industry, and has the knowledge and expertise in the market. Unbiased recommendations and the ability to understand successful programs in the marketplace serve the customer and the member from high cost non-essential drugs.