I’d Like To Speak With An Attorney.

I have a high appetite for risk. Move away 2800 miles to go to a college I had never seen (except in catalogs), with the closest family living a 3-hour flight away? Why not? Drop out of that same college and couch surf while I desperately tried to crack into the newspaper business? If you don’t try, how would you know that you’re not the next Margaret Moth? Ok, maybe (definitely) I was not. I could give dozens of examples. Hopping on stage to dance with De La Soul, starting my own business in the middle of a global pandemic… I miss more shots than I make, but that doesn’t stop me from trying to reach the hoop. I love brainstorming, throwing spaghetti at the wall, seeing what sticks. I ask “Why?” a lot. Like, a-lot-a-lot.

There are a few areas, though, where begging forgiveness is not better than asking permission. Permission may not be the right word. Ask for advice.

Twenty-plus years ago, I was interning for a public television station, and I heard something that has become a bit of a professional keystone for me. We were working on a new series about evolution, and someone said,

“If there’s any controversy, make sure the conversation is about the science and not us.”

If you work in Biotech Patient Support, this is excellent advice. The controversial, lively scientific debate should be among clinicians on where your product fits into (becomes) the standard of care. The patient and their health care team should share the decision to treat. It is a sad truth that in the US, non-clinical decision points often drive prescriber decisions. But just because this happens does not mean Biotech and Pharma should encourage bad behavior.

If your team examines your patient journey and identifies patient barriers to care (examples: medication costs, lost income, anxiety over self-injection, transportation for frequent medical visits, childcare while a family member is hospitalized… sadly, this list is endless), have a chat with your colleagues in Legal, Compliance, Patient Advocacy, and Medical Affairs. Do it sooner rather than later, especially if your launch timeline is aggressive. You don’t want to invest resources (including your own time) in creating solutions that cannot be implemented or could endanger your company’s ability to serve patients in Federal health care programs.

I’ve observed a kind of Groundhog Day phenomenon lately with clients. I gently ask if Legal has had the opportunity to weigh in on the organization’s patient support philosophy. Interestingly, I hear, “No, we don’t want them to shut us down or cramp our thinking.” 

If there is trust in an organization, and if the patient is genuinely your organization’s true north, your colleagues sitting outside Commercial will do everything to help you. Really. Truly. 

Their expertise can and should inform your understanding of what is possible:

  • What does the Office of the Inspector General (OIG) say about pharmaceutical manufacturer financial assistance programs? Legal
  • How can your Commercial sales teams speak about medication costs? Compliance
  • Would a disease state education website be tone-deaf? Patient Advocacy
  • Does your patient support enrollment form inadvertently solicit clinical information that could be a reportable adverse event (AE)? Medical Affairs
  • Can you talk to patients currently in the clinical trial to see what they want and need? Everybody Above

In my experience working with Legal and Compliance officers at different manufacturers, I find, more often than not, that if they do say “No,” they often follow it with “But.” 

  • No, you can’t offer a copay card to cover that, but Patient Advocacy may be able to help.
  • No, the reps can’t tell HCPs that, but the Hub may be able to.
  • No, the patient community would find it very helpful, but we need to minimize its risk of being perceived as promotional when ours is the only approved therapy.
  • No, you don’t want to ask the HCPs to send the chart, but you can provide them checkboxes with the ICD-10 codes.
  • No. Ok, well, exactly what are you trying to accomplish?

While I have commercial launch experience, my consulting practice and expertise are focused on manufacturer-sponsored Patient Support Programs (PSPs). They’re our jam.

But, as much as I love what Galway Group and I do, I know that our work is not the only way manufacturers can help patients access the medications they need. By engaging counterparts in Legal, Compliance, and other functional areas early and often, we expand our understanding of how we can appropriately help patients. Patient Support doesn’t need to become a turf war. Frankly, there is enough work to go around.

Galway Group’s position is that we try to do right by patients, even if it means that we’ve talked a client out of hiring us.

Someday I’ll find or create the appropriate diagram, but in the interim, I thought this was prettier than a photo of the million post-it notes on one of my office walls.

Why do you think you need to build a Patient Support Services Program?

  • Our HCPs have told us that they hate Specialty Pharmacies.
  • We think there’s going to be a lot of confusion about coverage if the HCPs need to use a miscellaneous J-code for the first 6-9 months after approval.
  • These are otherwise healthy patients who may be intimidated by the thought of giving themselves a shot at home.
  • We’re having a tough time with the payers, and we’re worried that patients will get hit with high out-of-pocket costs even with insurance.
  • This is a lifesaving therapy, and we want to make sure patients have access to it even if their insurance won’t cover it.

There are probably over one hundred possible answers to the question, and not one of them is wrong. Take the time to talk to your teammates to make sure you develop the right solutions. Galway Group is happy to help facilitate those conversations.

We ask the right questions.

Kindly note that this article is general in nature and is not intended, and should not be interpreted as legal advice. Did you even read the post above?