Why new drugs are not sexy yet?

When a new medication is available, there is often a lot of excitement and hype about how a new option may bring hope to a medical condition. The new medication may offer breakthrough in improving important clinical outcomes (e.g. improving survival, preventing disease complications and significantly offering better quality of life for patients).  But before we jump on the bandwagon to start prescribing a new medication, here are few considerations the sales rep may not be quick to highlight or share.

  1. Great efficacy does not mean great effectiveness yet. Often a new medication is approved based on information derived from clinical efficacy data – that is data obtained from phase 3 clinical trials, demonstrating the medication works well for a particular indication.  Patients studied under this control environment are closely monitored and followed up.  But in real practice, the medication may not produce the same clinical response.
  2. Safety Profile is not well established yet. Data collected in clinical trials are often focused on understanding the clinical response of the medication in a particular condition / indication.  For example, a new medication for diabetes will look at how it lowers the blood sugar. But the study may not be set up to assess if it is safe in various conditions (e.g patients with renal insufficiency or complex comorbidities). While adverse events must be reported and collected in any clinical studies, they are only secondary data and insufficient to establish a complete safety profile.
  3. No drug interaction detected doesn’t mean no drug interaction.  We often rely on computerized system to detect any significant drug interactions when prescribing a new medication. This may not be reliable for a new medication. One reason is that the information for new medication may not be updated timely in the drug interaction database. Another reason is that there is a lack of experience with using the new medication with combination of other medications. The lack of experience means there isn’t much reported. But this doesn’t mean there is no drug interaction to be concerned with. It just means it isn’t well understood and well known yet.
  4. Provincial drug coverage may not be available yet. While the drug cost is expected to be higher for any new medications, many clinicians may not realize that a new drug approved doesn’t translate into a new drug listed for coverage by provincial drug plan immediately.  It may take months before it is available for coverage as many provincial payors will review data to determine if the new medication is more cost effective than the current options in the formulary.
  5. Your patient may be the guinea pig for Post marketing Surveillance Program. If you decide to start your patient on a new medication, keep in mind that your patient may be the guinea pig for collecting more data on clinical effectiveness, adverse drug reactions and other related information. Your patient may be paying out of pocket for a very expensive new medication but he or she may be paying for the price that information for the new medication may not be well known, or may be the first to report an adverse reaction that is otherwise not reported or known at the time.

While having new options are always great for clinicians and patients, it is important to keep in mind some of the limitations of the new medications coming into the market.  A well established medication has many years of experience of use. It means we have a lot of data on how it is used in different scenarios (e.g. special populations, potential drug interactions) and have more confidence on its safety too.  New medication just does not have the time to build up this “real life experience” yet. So old drugs may still offer great value at great cost with long term safety data – these are important considerations to keep in mind.

Thank you for reading my post!

 

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drugopinions

My name is Cynthia Leung and I am a practicing pharmacist in Kingston Ontario, Canada. This blog is for me to share my ideas, opinions and perspectives on how medications are used in our health care system. Note that these posts are my own opinions and do not represent the opinions of my current or former employers and / or organizations that I may belong to. Any possible case scenarios described in my posts would be modified to maintain patient confidentiality. This blog is not a platform for professional advise for patients or health care providers and the content is not meant to support any clinical decisions or replace professional opinions. Also the images are either taken or created by the author, or adapted with permission. I hope you will enjoy reading my posts!

2 thoughts on “Why new drugs are not sexy yet?”

  1. Every drug safety person i know, and I know a lot of them, suggests waiting for 5 years after a drug has been approved before using it, except obviously, in an emergency. By that time the safety profile has been established. (Vioxx had been on the market just over 4 years when the heart issues emerged.)

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