Market Access: A Primer
Your drug just got approved! Now who’s going to pay for it, prescribe it, and use it?
TLDR
Your new drug just got approved. That’s great! Now who’s going to cover it, pay for it, prescribe it, administer it, and use it? That’s market access.1
Your drug got approved… (yippee!)
The FDA just gave your drug accelerated approval. This is a BIG DEAL. It’s a one-time gene therapy for cardiovascular disease that lowers LDL-C.
You’re pricing it at $100K. That’s a steal! Life is swell.
… But now payers are asking tough questions
Payers: “Yeah, that’s great and everything. We get it, high LDL-C = bad. But … why can’t I just give someone generic statins or a PCSK9? Those are a lot cheaper. Can you prove your drug is good value for money?”
You: “Oh, er, right. Good questions. We’ve run analyses predicting fewer heart attacks and strokes with our drug vs. existing treatments. And initially we’ll just be focused on the highest-risk patients. Are you interested in a value-based contract? If patients have a heart attack or stroke we’ll give you some money back …”
[And on and on until an agreement can / cannot be reached]
… And so are providers
Physicians: “That sounds promising, but who should get it? Most of my patients do fine on statins or PCSK9s. How do I explain gene therapy to them? And how much time will I spend on the phone with payers getting this approved?”
Hospitals: “That sounds great! We could open a Center of Excellence for your drug. But … gosh this will be a lot of effort. We’ll have to train staff and figure out billing. Are you sure payers will cover this?”
You: “Oh, er, right. Good questions. We’re putting together training and education materials. We’re also talking with payers to make sure coverage and reimbursement are as predictable as possible …”
[And on and on until providers make go / no-go decisions]
… And so are patients
Patients: “What the H is ‘gene therapy’? Will this change my DNA? I’m already on Repatha and my doctor says it’s fine. How many hours will I spend on the phone with insurance to get it?”
You: “Oh, er, right. Good questions. The clinical trial data are very promising. And no, it doesn’t change your DNA because [Science]. Many patients also miss Repatha doses, which can be very bad. Did we mention we’ll help you check your insurance coverage …”
[And on and on until patients make a go / no-go decision]
So what’s next for market access?
So… it gets complicated fast - and that’s just one example!
But it doesn’t stop there. Many new and interesting things are coming down the pike in market access - a few that are noteworthy:
US market dynamics
The Inflation Reduction Act (IRA) and Most Favored Nations (MFN) are really shaking things up. The IRA allows CMS to negotiate some drug prices in Medicare for the first time, and MFN is starting to link US drug prices to those in other countries.
Those are big changes in a short period of time. Folks are re-thinking their clinical pipelines and pricing / access strategies accordingly.
Regulatory and access diverging
The arc of the universe seems to be bending toward quicker / more flexible regulatory pathways. But allowing for fewer clinical trials, surrogate endpoints, and quicker approvals also means the evidence base may be thinner when a drug gets to market.
This will shift more of the onus onto payers, physicians, hospitals, and patients to decide whether a drug is “worth it”.
Artificial intelligence!
If you’ve been following along, you’ll notice a lot of market access is managing uncertainty. How well does a drug work? For whom? How valuable is that?
But what if AI vastly improves predictions and reduces uncertainty? Some of the ‘rules’ we’ve put in place to manage uncertainty (prior auths, formularies, value-based contracts) might start to look very different!
Disclaimer: This is a fictional example with made-up facts. I’m simplifying a lot and taking a US pharma perspective. Devices, diagnostics, and ex-US markets can look very different.