The rise of direct-to-patient (DtP) shipping seems to know no bounds. The opportunities afforded by DtP means processes can be streamline, and the patient’s needs are met. With DtP growing in popularity, could the day be on the horizon whereby the patient no longer needs to go a lab to participate in a trial?
While the advantages of DtP are seemingly numerous, there are a number of pitfalls and obstacles that need to be overcome. In CTA’s latest Industry Viewpoint, Jisong Seo speaks to Michael Sparozic, Lead Trial Supply Operations Manager at Sanofi. In this compelling interview, Sparozic outlines the pros and cons of DtP.
Jisong Seo: What is the biggest topic in pharma industry?
Michael Sparozic: DtP is the most interesting topic at the moment as more and more pharma companies are doing it or seriously looking into it now. DtP involves delivering medication straight to home not to the doctor’s office, so patients don’t need to travel. The whole process is a lot easier like this and people are more willing to sign up for a trial. Especially for paediatric trial, it makes a lot easier for patients to participate.
We are not making them to journey to a scary hospital or doctor’s office. We can bring that treatment to their home and patients will be in comfortable in a setting with their family members around. Also, if the kid is of school age, they don’t need to do it during school time anymore, as a nurse can to go to their home directly after school hours.
JS: Are there any challenges surrounding DtP? If so, what are they?
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Sparozic: Yes, there are difficulties. There has to be a balance between cost for taking medication to the patient directly and the cost for taking them to the doctor’s office. You should think carefully if you have a long-term extension regarding the cost. Traditionally, patients have to come to the doctor’s office every three months to get the medication, but with DtP, that’s no longer the case.
What’s going on now is a courier goes to the doctor’s office to pick up their medication and deliver it to the patient’s home, which costs a lot. I’m looking at using a central pharmacy that’s in progress now.
If leveraged correctly, using a central pharmacy can decrease cost. As you take away patients coming to the office, you are streamlining processes. However, when it comes to change, pharmaceutical industry is change averse so it will take time for the industry to adopt the use of a central pharmacy.
JS: Are there any regulations around DtP?
Sparozic: There is nothing in the U.S., but there are some restrictions outside of the U.S., but it varies country to country. When you start the clinical trial application, you have to start negotiations with regulatory authorities in each country, if you’re adopting DtP.
In the U.S., it’s commonly accepted and is slowly becoming the norm. In some parts of Europe, you can also do this but not everywhere so sponsors need to be careful.
JS: It can also reduce inaccuracy of forecasting problem?
Sparozic: You are right in that respect. If you have a trial in the U.S. for 40 sites, drugs might be used in some sites but not others, and the ones that aren’t being used may end up being wasted. However, with a central pharmacy, you can mitigate this problem.
Especially for rare diseases and short supply drugs, you can have better control. If you do DtP, as physicians need it, you can either send it to physician’s office or the patient’s house on an as needed basis.