We’re in that last work week before everyone dashes off. My own clients have headed for the hills (Short Hills?) and I’ve been baking and wrapping this week. It makes me appreciate the usual day to day of policy and reimbursement more than I would have thought.
Next week I’ll pull out the vision boards and planners and see what I want to aim for in 2024 but it is funny how you really can’t plan for much. Like-march-in rights taken seriously-ish. Or obesity drugs being front and center Every. Single. Day. Or CMS telling plans to be nice to pharmacists.
Other things that got my attention this year –
Patience for patients. The listening sessions on the Inflation Reduction Act drugs were painful. Three minutes each, hard stop for patients who aren’t used to public speaking. And to cut off those with a disability who had trouble communicating felt cruel. It renewed my appreciation for patient advocacy groups that can pull things together. Minor rant ahead. Yes, those are often funded by pharmaceutical companies. So what. It isn’t like they have magic strings they can pull and get people to say what they want. But they do have a checkbook.
Accumulated sadness. A win and then a loss for copay accumulators. On one hand, I get the first lawsuit but then, after losing, the Administration says they won’t enforce it? It felt like an elementary school playground comeback.
Pharmacy benefit maneuvers. I thought this would be the year we saw some pharmacy benefit manager reform. Welp, guess not. But we are seeing the realization that something is afoot and moving their fees structures. My favorite 2023 surprise was the smaller PBMs getting together and saying “Not It.”
You Must Love Me. We started this year knowing that Humira was (finally) going to have biosimilars and some of them would be interchangeable. Knock that blockbuster down a peg or two. Unless you like discounts and rebates and the stronghold of Abbvie. Market share held pretty well given the onslaught of competition. The other biosimilar headscratcher was the Medicare Part D proposal to add substitutions of biosimilar biologics products other than interchangeable biological products to the type of formulary changes that apply to all enrollees (including those already taking the reference product prior to the effective date of the change) following a 30-day notice. I mean there is a reason the interchangeable designation exists. The Center for Medicare & Medicaid Services and the Food and Drug Administration (FDA) are both in the Department of Health and Human Services , get it together.
ICER continues to be ICER. It isn’t that it is bad just not helpful? I think they want to be, but we don’t have a national quality adjusted life year (QALY) we agree on (or that there should be one) and prices are never just prices. We live in a matrix of discounts and rebates that make things like Average Manufacturer Price (AMP) and Wholesale Acquisition Price (WAC) a starting not an ending point. There is a gap in clinical comparison and ICER could own it. Making noise might have served them in the past to get them on the national stage but, now that they are there, I am hoping we can see a less clickbait approach.
More zoom and doom. The prescription drug affordability board work at the state-level is so much damn work to get anywhere close to savings. Why? Because it is HARD to figure out what drugs to pick and what to price them at and do so in a way that is fair and transparent and saves money. My favorite moment was when I was on a call with a pharma government pricing person about upper payment limits and they had the sudden realization – wait, what if 50 states did this and all differently. Yup.
Medicaid considers Jenga: My gosh. On top of best price being able to be negative (take my drug, take my money, please) starting in 2024, CMS proposed regulation that would allow multiple discounts to be stacked. At what point do manufacturers reconsider participating in government programs?
340B is bananas. B-A-N-A-N-A-S. We are still waiting to hear if manufacturers are allowed to limit their 340B discounts to one contract pharmacy (Supreme Court 2024?) but, in the meantime, it is hard to see if it really made much of a difference. FOIA master Adam Fein released the latest 340B numbers and, well, it seems to make less than $1b of difference. The program keeps growing and growing and it is unclear (murky at best) that the discounts really get to patients. Look, I know no one feels bad for pharma companies but between the Medicaid changes, 340B growth, inflation penalties, 9 year negotiation window for small molecule drugs – that’s a lot of financial pressure.
Implementation rabbit hole. The sheer amount of TIME it takes to move the Inflation Reduction Act forward is gob smacking. There are multiple 50 person+ phone calls each week on the data field needed for implementation of the maximum fair price. Calls where plans say “not it” and everyone else tries to figure a way around it. A few words allowing the program to work like the coverage gap discount program and BAM. Tens of thousands of hours (hundreds of thousands?) saved. I am in constant awe of how a single bill sucks up resources. It is so much work to put this into place.
But someone has to do it and I’m not sad that I get to. I’ve never enjoyed being a clock watcher so the unpredictability (and weirdly joy and rush) of a 4:15 pm rule coming out keeps it interesting. That being said, I’m okay with the next two weeks slowing down and tuning out just a little bit. You never know what 2024 will bring – this year I got Apteka. Next year…?
Happy New Year.