Black person in the water holds a life saver with pills for CF on it

What Are Patient Support Programs?

If you are prescribed a high-cost drug, chances are, you have had experience with patient support programs. Patient support programs, or PSPs, are programs funded by the manufacturer of a drug and administered by a third-party. The intent of most of these programs is to gather real world evidence on the effectiveness and safety of a medicine, and support the patient directly whether it be for compliance or financial assistance.

PSPs and CF

For people with cystic fibrosis (CF), the most common encounter with PSPs are through the high-cost CFTR modulator treatments such as Orkambi, Kalydeco, and Trikafta. Because these drugs are more expensive than an average drug, the manufacturer wants to ensure that the distribution and dispensing of the medication is uniform to prevent drug wastage.

What is the purpose of PSPs?

While the name PSPs indicates that the sole purpose of PSPs is to support the patient, that is not entirely true. Most PSPs also collect patient-level data – for example, how often you fill drug, whether you are tolerating drug, whether you discontinued drug – which provides the manufacturer with additional real world evidence about the therapy.  In terms of patient support initiatives, most PSPs can:

  • Help you remember to take your medication (ie- call you to check compliance)
  • Set up your medication for auto-fill, so that you don’t have to call the pharmacy to request a refill whenever you are out of medications
  • For drugs that require infusion (administration by intravenous route), some PSPs offer in-home nursing support to administer the medication
  • Offer some sort of financial assistance for the drug. For example, if your private insurance covers 80% of drug, some PSPs may help cover the remaining 20%
  • Arrange for delivery of your medication – most PSPs offer delivery services at no-charge of the patient

Do I have to enroll in a PSP?

Some people may choose not to enroll in a PSP. They may not want their patient-level data tracked – that is a completely justified and reasonable reason. Some point out that only their doctor should have access to their clinical data. You should never be forced to register in a PSP, nor should enrollment into a PSP be a requirement for you to access drug. Most countries have laws surrounding that. Always do what is best for you and what makes you feel comfortable.

What will my data be used for?

Typically with real world evidence generation, your name is not disclosed, but other identifiers may be used. For example, your age, weight, FEV values, geographic region may all be used to gather more data. This data can help infer future decision making on the drug and is not meant to replace clinical trials.

Are you enrolled into a PSP for a CF treatment? What has your experience been so far? Share your thoughts below!

By providing your email address, you are agreeing to our privacy policy. We never sell or share your email address.

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The Cystic-Fibrosis.com team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

Join the conversation

or create an account to comment.
poll graphic

Community Poll

GIVEAWAY: Did you enter to win a CF coloring book?