High Importance: Must Read!!! Less Costly Alternative to Compounded Medications…Is there such a thing?

Less Costly Alternative to Compounded Medications…Is there such a thing? by myMatrixx | Posted in: News and tagged alternative compound medicine, brand names, compound, compounded medications, compounds, FDA, medications, prescription ingredients Michael Nguyen, Pharm.D., C.Ph., Director of Clinical Pharmacy I’ve lost count how many times a claim manager asks if there is a less costly alternative to the compounded medication being requested. Each one of these requests is for a compounded topical pain cream and the submitted cost is often in the thousands. The answer to this question is not straightforward because we have to define what “alternative” typically means. In the most ideal case, an alternative to a drug such as Nexium would be omeprazole. Both drugs are a part of the same class of FDA approved medications with clinical trial data showing similar efficacy and safety. The main difference between these drugs is that Nexium is a brand-name, fandangle, more expensive version of omeprazole. In the case of compounded medications, the comparison is between apples and oranges. Compounds that are frequently created to treat pain are not FDA approved; therefore, an “alternative” would be any FDA approved drug that is indicated for the symptoms being targeted by the compound. Since these compounds are not FDA approved, their consideration for use must be based on therapeutic failure of FDA approved alternatives. Additionally, since the compounds are intended for topical use, the first criterion for medical necessity is intolerance to oral medications. If a patient has not been prescribed oral pain medications, topical compounds should not be used. If a patient is concurrently taking oral medications, the medical necessity of a compounded topical medication should be questioned. Some physicians may state that they anticipate the compound will reduce the need for oral medications. If the patient is currently taking high doses of opioids, this may be a reasonable approach. Three things need to be considered as conditions for authorization of compounded medications: 1. The prescriber and the payer should be in agreement that the compound should not be continued if a reduction or elimination of opioid use does not indeed occur. 2. The number of active ingredients should be limited. Prescribers may not understand that the price of the compound is partly based on the cost of the individual ingredients. A compound with five active ingredients will cost substantially more than one with two active ingredients. Many of these compound formulations are pitched by the pharmacy to the prescriber and therefore it is in the pharmacy’s financial interest to recommend a compound with many active ingredients. If the compound ends up “working” for the patient, it is often hard for the doctor or pharmacist to determine which active ingredient is responsible for the therapeutic effect. For this reason, the formulation of the compound should be empirically derived. 3. Since the compound is being trialed, the starting quantity should be limited as well. If a compound is going to work, the effects should be immediately felt. For this reason, dispensing anything more than 1 to 2 ounces initially would create a huge potential for waste. Many of our clients are surprised to learn that despite the lack of FDA oversight and approval, compounds are allowed to be used. When compounding is used correctly it fills a need that is not being met, provides something that is not commercially available but medically necessary, and ensures that the true intention of compounding is being preserved. In conclusion, when compounding is in the interest of the patient’s wellbeing, collaboration is worth the effort. -

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