I recently had the opportunity to present recommendations for a Patient Support Program to a biotech’s executive leadership team. For US patients, the barriers to starting and staying on therapy, even a life-saving one, are most likely to be financial. Just because you have (employer-sponsored) insurance does not mean you will have coverage. You already know the drill. “Covered” is NOT the same as “no cost.”
insured ≠ covered ≠ affordable
I’ve done this launch readiness review (LRR) dance a dozen times now, but I was always in-house on the manufacturer side until late last year. Sometimes I wonder if the folks who comprise these Executive Committees have ever had a day of bad luck in their lives. As I re-read that last sentence, I pause. Its words don’t precisely convey what I meant, but its sentiment might.
You can never know another person’s struggles.
You may be presenting to a room filled with millionaires, but you have no idea who they really are or what their family’s story before the C-suite looked like. But then again, sometimes someone asks a question that leaves me scratching my head, much like the fabled story of a former US President who was “amazed” by a supermarket scanner. Speaking of supermarkets, years ago, I participated in a brand planning team exercise where colleagues had to share brand names that were universally recognized and whose products are widely accessible. Coca-Cola is both; Chanel is not. A VP seated at our team table picked Trader Joe’s. I rolled my eyes.
Always good natured, he teased me, “C’mon, how can you not like Trader Joe’s?!? I know you shop there. Great value, excellent price point.”
And then I said (admittedly, with a bit of bite), “Have you ever seen anyone use their EBT card at TJ’s?”
He dropped his voice, and asked, sincerely, “What’s an EBT card?”
A personal challenge for me, not just in business but also in life, is communicating a provocative message without sounding (ahem, being) obnoxious or, worse, self-righteous. I’m as bougie as anybody else working in Pharma. And especially now, as I find my footing as a consultant, I continue to wrestle with crafting a message that a client likes enough to listen and act upon AND that is an honest assessment of a patient challenge and recommended solution. I don’t always (or often) say the things clients want to hear. Manufacturer-sponsored Patient Support Programs try to solve for patient barriers to care. Most executive leadership teams in Pharma don’t understand financial hardship.
They don’t. Online pharma forums offer plenty of examples of senior leadership who participated (on-camera) in Zoom meetings from poolside patios or their ski condos. At the same time, their teams took pay cuts (or layoffs) on the chin during COVID. Tone-deaf? Absolutely. Cruel? Yes, but maybe not intentionally so. But if you can’t relate to your own teams, how will you relate to your patients? If you grew up with a kitchen refrigerator that made ice (or better yet, gave you a choice between cubes and crushed), understanding how to stretch groceries between EBT card refills was probably not a life skill your parents shared with you.
The most common patient access challenge in the US? How will the patient pay for their therapy.
And the flip side to that coin may very well be: how much is a patient willing to pay?
To be clear: US drug prices are not about patient willingness to pay or affordability. They are about stewardship of a company’s resources, fiduciary responsibility to shareholders, and what the market will bear. They are about margins.
And notably, while intertwined, drug prices and patient costs are not synonymous.
I’m not able to hammer down a stake and say, “Here you go, X dollar amount is what patients are willing to pay for your medicine, Ladies (plur.?) and Gentlemen of the Executive Committee. Reverse engineer your pricing strategy, payer engagement, and value proposition from there.”
What I try to do is explain how to think about a patient’s decision-making process. Dollars drive decisions. For someone in my role, following the dollars gives me a bread crumb trail or (dashed) outline of the “life of a script.” I try to identify product analogs and examine claims data for those analogs. I look at out-of-pocket costs and prescription abandonment rates. I try to find the tipping point where patients abandon their prescriptions.
Hint: for commercially insured patients, it’s probably somewhere around $47 per month for a Specialty drug for a chronic, but not life-threatening condition. If you’re working on a pediatric product, double that number. When you see an extremely generous copay card program, the manufacturer is solving for competition or market share, not patient willingness to pay.
But the claims data can only tell me about the behavior of those patients who did indeed get their prescription filled. Getting the data for all prescriptions written (those filled and unfilled) is a little bit trickier for Pharma manufacturers. Your pharmacy partners should have it. Pharmacies might want to end primary nonadherence even more than you do. More specifically, they should have data on the number of total prescriptions received from HCPs via e-prescription (sidebar: this is an old journal article on primary nonadherence, but there’s a reason why it still gets cited today). Still, they may not have solid numbers on why patients did not get those prescriptions filled. Data on nonadherence for products covered under medical benefits (notably those products administered in a hospital infusion center or ambulatory clinic) is trickier for a host of reasons I’ll examine in a future blog post.
Now that I have my breadcrumb trail mapped out, I need to create the “street view.” Before I start tinkering with icons and commit any SmartArt to .ppt, I ask the Manufacturer questions. Lots of questions. Hundreds. I started writing examples for this post, and before I knew it, I had over 500 words’ worth of questions (if you’d like the list, email me). They generally fall into one of the five categories below:
- Patient Understanding of Their Disease
- Patient Experience on Your Therapy
- Patient Experience on Treatment (all therapies) for Their Disease(s)
- Patient Experience with Treatment Costs (in its entirety; not just your therapy)
- Is this medicine for them or their child?
- How do you know the above? Did you actually speak to any patients?
- Clinical trial interviews? Unlikely, as the primary focus of clinical trial design is determining clinical efficacy, not qualitatively measuring patient experience or behaviors related to the disease state. Some manufacturers are engaging patients earlier in clinical trial design. Please consult with your Compliance and Legal officers before allowing Commercial employees to engage in any way with clinical trial patients, past or present. If the therapy is already approved and on the market (and your business analytics teams is well-supported), there are real, actionable patient insights thanks to AI and real-world evidence.
- Market research? Who on your team or which vendor can talk me through the methodology?
- Patient ad boards? Can I see/listen to the tapes? So much gets lost in even the best transcriptions.
- Academic, peer-reviewed literature? Talk nerdy to me. Not for nothing; I personally start here because it helps me form the right follow-up questions for 1-6. 90-minutes on PubMed is gold.
Who are your patients? How well do think you know them?
Describe them.
- Busy soccer mom, high deductible HSA, doesn’t hesitate to get a funny mole or freckle checked by her primary care provider. Works through a bottle of Kim Crawford a week, runs 2.5 miles every morning. Had a career outside the home until the twins came along, doesn’t have time to be sick, and has not listened to a voicemail since 2017.
- Or a younger woman, maybe aged out of her parent’s health plan, had her annual GYN appointment at Planned Parenthood, and never in a million years thought that she’d leave that office visit with anything except a new prescription for birth control. She’s calling girlfriends for support. She’s too embarrassed to talk about anything GYN-related with her partner or even her mom. She’ll figure out what to do after the biopsy is over.
- 80-year old grandpa, a heart attack survivor, on Medicare and has fantastic supplemental coverage thanks to his past employer’s retirement package. Instead of ordering from Canada, he drops down to taking his meds five days out of seven beginning in August to avoid the donut hole, more so due to principle than income. He likes feeling that he’s beating the system. And his blood thinner makes him feel a little dizzy, anyway.
I chose these three patient “personae” because, well, most Pharma execs can relate to them. They are their wife, their daughter, their Dad. Frankly, while the patient financial need may not be as high, and the revenue impact is significant, it’s easier to pitch a more generous patient support program for these patients because the manufacturers’ leadership understands them.
Example (for the soccer mom): Copay assistance for commercially insured patients with a Pay As Low As (PALA) of $15 per monthly fill; the drug manufacturer will pay down their deductible (i.e., wholesale acquisition cost/WAC) up to an annual max of $2400.
- Yes! We are on board; this is the right thing to do for our patients. Subtext: we know these patients; we understand them.
Presenting a recommendation for the programs that support low-income patients is a much more difficult task, even when the financial impact to the company is low. I go into these LRR meetings “loaded for bear and praying for squirrel.”
Example: Free goods program for patients without insurance (or whose health plan has denied coverage) and have an annual household income equal to or less than 400% Federal Poverty Level (FPL), which in 2021 is ~$106K for a family of four, regardless of where they live in the lower 48.
- Well, shouldn’t the patient have to pay something, at least the shipping costs? Subtext: we want to make it harder for these patients to be on therapy. The patient needs to demonstrate that they’ll actually take our medicine because we don’t think applying to the program, submitting household financial documents, and providing insurance paperwork signed by your doctor is enough proof.
- Why should we give (at the Cost of Goods/ CoGs, which is often a small fraction of WAC) our medicine for free? Aren’t we really just subsidizing their poor life decisions? No one made them choose to work for a company with a crummy health benefit. Wait a minute, doesn’t everyone have insurance now? Subtext: we don’t trust the working poor.
- If we have a free goods program, won’t the payers take their time putting us on a formulary, or worse, deny coverage as long as they can? Yup. And that’s a payer and contracting challenge, not necessarily an output of who your patients are, particularly as you look at program income criteria.
- They’re not getting care from a 340b, are they? Not enough time or space to tackle this one on this blog :-P.
An observation: Chief Financial Officers (CFOs) never express concern about free goods programs for low-income patients. I chalked it up to coincidence the first few times, but now with almost a dozen experiences, I can say it’s a pattern. They may not know the patients, but they know the market, and they understand the dollars. They’ll drill down on the vendors administering these programs, but they never object to the program business rules. But, interestingly, their peers (SVPs and higher) sometimes have extreme opinions on free goods programs. And it only recently clicked for me: many of these leaders don’t trust these patients. They don’t know them.
