The September 29th Deadline Is Slipping: What Pharma Teams Need to Know Now

The bumpy road to drug pricing reform continues as the US Most Favored Nation deadline of September 29th faces delays. Regulatory complexities, competing healthcare priorities like the Strategic API Reserve, and election year politics are all contributing factors that may push implementation into 2024 or beyond.

• MFN model would force Medicare to pay the lowest drug prices available in other economically comparable countries
• Americans currently pay nearly 250% more for medications than citizens in 32 other developed nations
• Pharma manufacturers argue pricing parity could disincentivize R&D and reduce availability of breakthrough treatments
• Regulatory delays announced as the proposal must pass through review and public comment periods
• New Strategic Active Pharmaceutical Ingredients Reserve initiative may be drawing legislative focus away from pricing reform
• 70% of API manufacturing occurs overseas, mainly in India and China
• Election year politics may prefer to defer enforcement while using the MFN narrative for campaign momentum
• International reference pricing likely to become more common in US payer negotiations
• Digital companions and patient support platforms that demonstrate improved outcomes will be crucial for showing value
• Commercial teams should prepare contingency plans rather than waiting for formal announcements

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PostScripts Rx is not intended to constitute medical advice, nor is it intended to influence prescribing decisions or any other medical or clinical decision-making. All medical and clinical judgment and decision-making, prescribing decisions, and all related considerations remain exclusively the responsibility of providers and patients.

Episode Transcript

Speaker 1 (00:00):
Hello and welcome to Postscripts, the podcast
exploring what happens after thefirst prescription.
We cover the latest innovationsin patient access support,
digital tools, hcp engagementand pharma marketing that we all
hope drive better outcomes forpatients.
This podcast is forinformational purposes only and
should not constitute anymedical advice for anyone or
influence clinicaldecision-making in any way.

(00:21):
Patients should always consulttheir healthcare professionals.
Welcome to the podcast.
My name is Brian Carr and I amthe Medisafe team, although any
opinions expressed here arethose of my own and not
necessarily those of Medisafe orits partners.
Some progressing news today thebumpy road to drug pricing
reform.
So what?
We're seeing?
Some delays in what we'recalling the US most favored

(00:42):
nation deadline of September29th.
You may recall that was thedate that many pharma marketers,
patient access leaders, policywatchers are kind of tracking
closely, because that's when theadministration had originally
targeted for enforcement of amost favored nation pricing
model that could really forceMedicare to pay the lowest price
available to comparable marketsin developed nations.

(01:02):
So that is a fundamental shiftin how drug pricing could be
regulated here in the US and itreally does hold the major
implications for everything fromthe payer negotiations to
innovation timelines.
But now we're hearing theindustry and deciders and policy
experts are really questioningwhether the administration can
even hit that September 29 day,which is about 30 days 30
business days we look at away orif political, supply chain

(01:24):
regulatory complexities arealready in place.
Perhaps lawsuits will force adelay.
So today we're diving intowhat's really going on behind
the scenes and what it means forthe life sciences and
commercial and access teams.
So what's at stake here?
The MFN model Most FavoredNation.
It was introduced as a pathwayfor Medicare to pay no more than
the lowest drug pricesavailable economically anywhere

(01:46):
else in other economicallycomparable countries.
So proponents say it's reallynecessary to curb those
skyrocketing drug costs.
By the way, americans paysometimes nearly 250 percent
more than citizens in 32 otherdeveloped nations, and that's
according to data from the HouseWays and Means Committee from
2020.
And that's according to datafrom the House Ways and Means
Committee from 2020.

(02:06):
So, on the other hand, pharmamanufacturers and medical
innovation advocates are arguingthat such pricing parity could
really disincentivize researchand development due to the
tighter price controls right,lead to reduced availability of
breakthrough treatments and itcould create logistical and
compliance challenges acrossdifferent Medicare channels.
Compliance challenges acrossdifferent Medicare channels.
So for brand and access teams.

(02:26):
The impact could reallydramatically reshape launch
pricing strategies and cadenceson which countries launch first
some of the payer contracts andlong-term forecasting models,
some of which will be for launchbrands that are coming out and
others may already be forecaststhat were in place and are
embedded for newly launchedbrands.
You know so what's holding allthis up.
We are seeing some regulatorydelays that were announced

(02:47):
yesterday.
According to Fierce Pharma, theWhite House proposal has to
pass through some regulatoryreview and public comment
periods, so that's going tostill be weeks away from it
formally being produced, rightand publicized.
So officials did cite legalcomplexity in linking the US
pricing to internationalbenchmarks, although, we should
note, this is already in placein Europe.

(03:07):
So European nations look at theother European nations around
them when they determine theirprices.
But it is noting that eachtherapy's price is negotiated
differently from country tocountry.
This makes an apples to applescomparison difficult could be
fraught with exceptions, right.
So, additionally, theadministration is really trying
to balance this reform alongsidesome other major health care

(03:27):
priorities, such as theStrategic Active Pharmaceutical
Ingredients Reserve.
So this was interesting thatwas announced this week, thing
that was announced this week.
This is the initiative which isaiming to unsure some of those
key active pharmaceuticalingredients and bolster the US
supply chain.
The challenge there is, youknow, that could be drawing some
legislative focus away frompricing due to the headline risk

(03:49):
around shortages in nationalsecurity.
So here's a little bit more onthose APIs.
On August 26th, which was, yeah,there was a fact sheet that
outlined a new executive order.
This wasn't August 26th, whichwas, yeah, there was a fact
sheet that outlined a newexecutive order.
This wasn't August 26th, but itmeant to secure the US
pharmaceutical chain.
But what they called iscreating a strategic stockpile
of the active pharmaceuticalingredients.
What happens is right now,about 70% of those API

(04:11):
manufacturing really does occuroverseas, mainly in India and
China, and that's according tothe FDA occur overseas, mainly
in India and China, and that'saccording to the FDA.
So when you see, supplyconstraints could really
increase the global drug pricesand really complicated any data
or pricing models that aresupposed to be used in the most
favored nation formulas.
So that means pricing reformcould be difficult to push
amidst some of the ongoingshortages or fears of foreign

(04:34):
dependence on ingredients thataren't produced here in the US.
So from an optics standpoint itmay be more feasible for
policymakers to show progressthrough a more resilient supply
chain rather than tackling oneof those most contentious issues
American health care the drugprices.
So another challenge to themeeting that September 29
deadline is the election yearcalculus.
Granted, it's a popular pricing, pricing on drugs is a popular

(04:58):
campaign talking point.
But really implementing such asweeping policy, and especially
one that can reduce access aswell to certain drugs, or slow
innovation, could have somepolitical blowback right.
So you could imagine somecommunities or rural areas or
some poverty areas might not begetting the drugs or the
treatments that otherwise otherswill be getting because they

(05:19):
could be more expensive to getthose medications right.
So lawmakers on both sides mayprefer to defer that enforcement
of that and use that whole mostfavored nation pricing
narrative for momentum as theycontinue in 2026 with their
debates and campaign trails,rather than actually make a
policy out of it.
So we'll see.
It could be a volatile electionyear next year with the

(05:39):
midterms.
Anyway, this has implicationsfor pharma commercial teams.
So what does it all mean forthe access teams, the marketers,
innovation leaders?
Well, the threat of mostfavored nation pricing, even if
delayed, can't be ignored.
It is driving higher scrutinyamong payers, providers and
teams Really should prepare tobe ready with clear value props,
cost-effective models and somekey adjustments.

(06:01):
So integrated pricing models,so that international reference
pricing technique is probablygoing to become more common in
payer contract negotiations inthe US One of the underwritten
things on the EU.
Back to tariffs here.
With the EU tariff agreementthat was reached in, that was
the first time ever the US willactually allow international

(06:22):
reference pricing techniques toaffect the price of US
medications.
This is something historicallythe US had always rejected out
of hand, but with that new tradeagreement was written in that
we would accept pricingtechniques used in other
countries.
So it's real Data quality.
You know we could have the needto really validate methodology
and comparators of economicmodels in the formulary

(06:43):
submissions.
If medications are exactlysimilar, why wouldn't they be
priced the same?
But if there's some difference,well okay, if there's a
difference, can you quantifythat difference enough to
justify a higher price that isbeing paid worldwide?
Now, patient adherence andsupport these platforms like
Medisafe, full disclosure as youknow, I work at Medisafe but
even platforms that have thisdigital companions and real
world applications, adherencethat is demonstrated, that can

(07:06):
improve outcomes, show health,economic value.
You know, when pharma brandscan actually show success in
that digital environment, it'sgoing to.
They're going to needtransparency and partnership
with health economics teams andsome of these proactive patient
engagement solutions that reallywill reinforce the value of the
therapy right and the extravalue add if you have got a

(07:26):
dedicated digital supportplatform and team helping with
you and your support of thatmedication.
So you can imagine if ascenario where two medications
may be equally priced or in themarket and what's also going to
happen here is transparency onpricing is going to be done at
the HCP level.
So doctors may be able tochoose between two different
medications, but they seeperhaps more efficacy, more

(07:47):
value in one where the patientsseem to be more adherent.
Why?
Because they're using a digitalcompanion, or they have more
brand loyalty, because theydon't want to switch off it,
because they already talkedthere, whether it's a nurse
navigator, or they see plenty ofgreat content that is effective
for them in managing theirtreatment.
They don't want to leave acertain brand.
So when we, you know, in themarketing terms, we'll talk
brand loyalty In the financialoffice, they'll call that, you

(08:09):
know, preserving market share.
So what could happen next,although the September.
Mfn deadline reportedly issliding, something we predicted
here at the podcast.
That doesn't mean teams canjust take their foot off the gas
.
Several possible scenarios canbe in play.
I would imagine there's delay,but not abandonment.
Policy gets pushed to Q4 early2026, post-election, even during

(08:31):
the election year, and evenpost-election You're probably
going to see some pilot rollouts.
The administration might testMFN pricing in limited markets
to really gather the impact data.
You do see where pharmacompanies have come to the fore,
some of them promising to build$50 billion in injection into
the US economy, includingbuilding the new production
plants in the Virginia area.
So you know they may see ascenario where some prices from

(08:53):
certain pharma companyportfolios are affected
differently in a positive waybecause they are already
integrating and making someinroads and producing some
things in the US that they hadnot considered before.
You're probably going to seesome legislative linking so the
MFN provisions at any time couldbe tied to other larger bills
that are being negotiated,especially on supply chain

(09:14):
security preparedness.
You know, in any scenariocommercial and patient access
teams should be ready to updatetheir scenario plans and really
remain close in dialogue withthe market access and public
affairs partners and what'shappening in the news, things we
discuss here every day too, onthe podcast.
So hey, in conclusion, you knowflexibility is going to become
a pretty new superpower for ourteams and our verticals.

(09:36):
You know, in summary, here youlook at the administration's
status.
It's really right now lookingat delays, but the ambition is
not going to go away.
It's still going to be veryactive.
Can't be in a place where youare going to afford to wait for
formal announcements.
At least have some contingencyplans in place to preserve that
market share and brand loyalty,I would argue, through digital
solutions that really connectwith patients on a real evidence

(09:56):
basis and a real world basis.
So all right, anyway, thanksfor joining us here at
Postscripts.
If you have found aconversation valuable, please
follow or subscribe for moreinsights.
At the intersection of pharma,tech and patient impact, we do
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We also do a quick five to10-minute synopsis every morning
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the drug pricing model and theadministration's activities

(10:17):
around pharma and pharma pricing.
All right, folks, have a greatday and thanks so much.