If you prescribe medications electronically through your electronic health record (EHR), you have almost certainly encountered a “formulary alert” from a patient’s pharmacy benefit plan warning you that you must select a “lower tier” drug before the drug you are trying to prescribe will be covered by the patient’s insurance. Pharmacy benefit plan algorithms may make sense to support antibiotic stewardship or the management of conditions like acne for which there are progressively more potentially risky systemic treatments based on failed response to topical therapy. However, a pharmacy benefit plan requirement for a lower tier drug makes no sense if there are no lower tier drugs! As an example, I first got the notification pictured more than a decade ago, informing me to employ collagenase only if a “tier 1 – 3 drug” was not appropriate. I was never able to find out what a tier 1-3 drug would be for wound debridement.
The good news is that there are at last more drugs (and biologics) in development for patients with chronic wounds. The bad news is that patient access to these new drugs might be restricted due to nonsensical pharmacy benefit plans. Dr. Jay Shah, President of the Texas Medical Association (TMA) has provided this guest blog about what the TMA is doing to monitor the issue of pharmacy benefit plan limitations on drug access. Thank you, Dr. Shah!
Caroline
Dr. Fife,
As President of the Texas Medical Association (TMA), I want to raise awareness of an issue pertaining to drug access. Right now, there are few FDA approved drugs specific to wound care (e.g., Santyl, Regranex). However, wound care practitioners see a variety of dermatological and vasculitic conditions (e.g., Pyoderma gangrenosum, psoriasis, vasculitis, etc.). For some of these dermatological conditions, drugs are available that are specifically approved by the FDA for that condition. For others, all the treatments are “off label” since there is no drug specifically approved for the disease. The FDA recognizes approved drugs may be prescribed off label (meaning, for a condition that is not one of the drugs’ official indications) when medically appropriate – this is a very common and completely accepted medical practice.
Here’s the problem practitioners are starting to notice about some pharmacy benefit plans:
- When there is a drug specifically approved by the FDA for a condition, many pharmacy drug plans require that a (cheaper) off-label drug be tried first before the approved drug can be used.
- However, when there is no drug specifically approved by the FDA for a condition, some benefit plans (and some pharmacists!) will deny the use of an off-label drug!
As new drugs are approved by the FDA for wound-related conditions, the issue of drug access due to poorly crafted pharmacy benefit plans will continue to grow.
I have also listed a few sources below that may be helpful. As a wound care practitioner myself, I appreciate you bringing this to the attention of others in the field.
Sincerely,
Jayesh Shah, MD, MHA
President, Texas Medical Association
Sources:
- Understanding Unapproved Use of Approved Drugs “Off Label”
- Examining the prior authorization process, patient outcomes, and the impact of a pharmacy intervention: A single-center review
- Medicare Prescription Drug Exceptions
- BENEFITS RELATED TO PRESCRIPTION DRUGS AND DEVICES AND RELATED SERVICES
The post TMA Raises Awareness About Drug Access Limitations by Pharmacy Benefit Plans – Guest Blog by Dr. Jay Shah appeared first on Caroline Fife M.D..