Bringing in a new drug to the market is a costly endeavor. Let’s put ourselves in the shoes of a drug manufacturer for a moment. There has to be a really high demand to start producing a new drug as it can cost 1 billion to 2 billion dollars to research and develop the drug before making it commercially available.

While keeping these numbers in mind, let's talk about a scenario where this may cause some issues. Porokeratosis is a disease that affects about 200,000 people in the United States. It is non-life threatening, but it brings the onset of small, scaly rings on the skin. Because of the effect it has on the skin’s appearance, many people seek treatment for it. What they are willing to pay for it, though, is rather limited.

Let’s say, out of the 200,000 of people affected with porokeratosis, 150,000 of them seek treatment with a provider. They go into the provider’s practice, get diagnosed, and are given a prescription. The medication that they were prescribed ends up costing $200. Let’s assume they are all willing to pay for that medication at that price. That means that there is a total of $30M in revenue. Assuming it costs $10M to make all of those prescriptions, move them through the supply chain of the pharmacy, and those patients refill their prescriptions 4 times each, the drug company ends up generating $100M. This still leaves them over $1 Billion upside down. This means that the numbers just do not make sense to pursue making an FDA commercially available and approved medication. 

What Constitutes A New Drug That Would Require These Kind of Costs in the United States?

If there is a demand for increasing the strength of a certain medication that is already on the market, or if it is desired to be delivered to the body in a different form, this would require a new drug application, which comes with a high price tag. That is why there must be sufficient demand for a new drug as it is very costly to make a new one, and it takes roughly 10-15 years before it can become commercially available. 

While the above information does play a part in reducing the patient’s ability to receive treatment for their condition, that doesn't mean the patient can not and should not receive treatment. 

Take our wart peel for example. A patient needs a topical medication to treat their warts. There is a compounded medication that we make that consists of 17% salicylic acid and 2% fluorouracil cream. This is not commercially available, and yet it has been a go-to for providers for decades. 

For another example, a patient may be prescribed three different topical medications to treat their condition. The application procedure for the three medications can be complex and time-consuming and the patient may find it difficult to stay compliant with the treatment process. The patient might have to apply the three creams throughout the day which can make it a bit of a nuisance. Here is one example of an application procedure a patient has to follow to treat their condition. 

• Drug A – apply, rub in thoroughly and let dry for 15 minutes (wash your hands afterwards to avoid transfer of the medication)
• Drug B – Apply, rub in thoroughly and let dry for 15 minutes (wash your hands afterwards to avoid transfer of the medication)
• Drug C – Apply and rub in thoroughly (wash your hands afterwards to avoid transfer of the medication)

How many patients are going to want to spend 30-40 minutes of their day just applying their topical medications and waiting for them to dry? Not many more than likely. This is where patients can benefit from having a compounded medication as it can combine all three of these medications, and mix them into one, easy to apply cream. This saves the patient a lot of time as it can take 5 minutes to apply the one cream, versus the 40 minutes it took for them to apply the 3 creams. Not only does this save the patient time, but it also helps them to stay compliant.

A patient may not be able to use a commercially available medication to treat their condition because it is only available in one form that may be difficult to apply to the area that is affected. Let's say a patient needs a medication that needs to be applied to their scalp, but the only one that is commercially available comes in an ointment, which may be difficult to apply. Fortunately, a compounded medication may not be limited to one form. It can be made in a solution, foam, or even a shampoo. All of these are better and more efficient alternatives to apply the medication to the scalp. 

We are only scratching the surface of the general reasons why compounds are prescribed for patients at times rather than commercially available medications. To learn more check out our other blog topics on compounding and also check out Medisca and PCCA.