Counting Down: 47 Days Until Pharma's Pricing Reckoning

The clock is ticking for pharmaceutical companies as the September 29 deadline for most favored nation pricing plans looms just 47 days away. This sweeping policy shift represents one of the most significant pricing reforms in recent history, with profound implications for everyone from brand marketers to patient access teams.

Five major developments are converging to reshape the pharmaceutical landscape. First, government price negotiations are accelerating, targeting high-cost drugs without generic competition much earlier than originally projected. The Congressional Budget Office estimates these negotiations could save Medicare over $100 billion in the next decade. Second, the July 27 US-EU drug pricing deal introduces shared reference pricing models that could fundamentally alter global launch sequences and reimbursement ceilings. Third, new domestic manufacturing incentives offer substantial benefits for companies shifting production to the United States, including tax credits and expedited regulatory reviews, though potential tariff increases on imported medications could create new affordability challenges.

The fourth development involves comprehensive PBM reform that mandates transparent rebate reporting and price disclosure at the point of care. This increased transparency creates opportunities for patient service teams to better understand cost barriers in real-time and develop targeted interventions. Finally, recent adjustments following a Supreme Court ruling on Medicare Part B reimbursement could lead hospitals serving low-income populations to remove expensive therapies from their formularies, creating unpredictable access obstacles for specialty treatments.

As these changes converge, the healthcare system stands at a critical crossroads of affordability, innovation, and access. Forward-thinking pharmaceutical teams that integrate pricing, access, digital, and commercial strategies will be best positioned to navigate this new terrain. Digital health solutions that monitor treatment irregularities, enable proactive patient support, and leverage predictive analytics will become increasingly valuable tools for identifying and addressing barriers before they lead to treatment abandonment. How will your organization respond to these unprecedented changes? Subscribe to Post-Rifle for ongoing insights at the intersection of pharma, technology, and patient impact.

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):
Welcome to Post-Rifle , the podcast exploring what
happened after the firstprescription.
We cover the latest innovationsin patient access support,
digital tools, hcpa managementand pharma marketing that we
hope drive better outcomes forpatients.
This podcast is forinformational purposes only and
does not constitute any medicaladvice or should influence any
clinical decision-making.
Patients should always consulttheir healthcare professionals.

(00:23):
Welcome to the podcast.
My name is Brian Carr from theMedisave team, although my
opinions expressed here are myown and not necessarily those of
Medisave or its partners.
What we're talking about today,very quickly, is what pharma
needs to know before theSeptember 29 deadline set by the
US administration for pharmacompanies to deliver most
favorite nation pricing plansfor the American consumer.

(00:45):
That's about 47 days away andit's 31 or so if you're counting
business days.
So this is a sweeping policyshift that could expect to
impact pricing in ways that wereally haven't seen before, and
it's all prompted by the recentlegislative, legal trade
developments and this datereally kind of signifies how
long it's been mandated pricingreforms with potentially pretty

(01:06):
broad implications for pharmabrand marketers, patient access
teams, h&ps, manufacturers andeven innovation departments.
And today, very quickly, we'regoing to break down five major
developments that we see areshaping the landscape ahead of
this change and examine some ofthe emerging data, some
high-level implications andreally a central next step.

(01:26):
Keep an eye on what's going onhere If you're in pharma,
commercialization, patientservices or in addiction.
This is a quick strategicbriefing based on what we know
so far.
One government pricenegotiations are kicking off in
its accelerated timeline withpotentially big impact.
You know there's been longdebates on federal negotiations
on drug pricing and they'rereally officially set to begin

(01:46):
with 10 drugs impacted as earlyas September 29.
This kind of accelerated someof the original timelines
projected for 2026 or later,signaling the start of
longer-term price controls underthis expanded Medicare drug
negotiation authority.
Here's what we know as of today.
In August, a couple days ago,cnn reported that the first wave

(02:08):
of this is going to targethigh-cost drugs that do not have
generic competition, sohigh-value portfolio products
could be impacted for manybrands.
The Congressional Budget Officehas estimated, by the way, that
the federal government couldsave over $100 billion in
Medicare-related drug costs overthe next decade through these
negotiations alone.
So for pharma marketers andaccess teams, the signals it

(02:31):
really just only needs torevisit pricing strategies
perhaps, and patient co-pay,pathway messaging for certain
effective therapies, digitalsolutions that can enhance
market share, protect marketshare and connectivity with
patients, particularly in theprimary care and chronic disease
categories.
What's also happening, thesecond thing that you really all
keep an eye out for, is the USEU drug pricing deal.

(02:55):
That was actually it happenedon July 27th as part of the new
trade agreement between the USand the EU, but what really
didn't get reported as much onis the pricing situation for
medication.
So it included the introductionof what they call shared
reference pricing models, whichis a somewhat fancy way of

(03:15):
saying you get to.
What Europe does already istake the paraphrasing here,
really, but they take theaverages of prices throughout
European countries as anindicator of what certain
countries should pay for theirpricing on medication.
So the US, as prior to July27th, did not do that and take
that into consideration, but thenew pricing deal that was

(03:37):
announced as part of the tariffssays the US will take that into
consideration starting afterJuly 27th.
So what this shared referencepricing could do is basically
enforce what is alreadyhappening in Europe, but
basically, prices are negotiatedbased on what other countries
are paying, and that's exactlywhat the US administration has
said they want as well.
So you know, we do see.

(03:57):
You know regulatoryharmonization could be generally
good for pipeline launches, butit could also mean this now the
?
U, the U?
S is going to allowinternational reference pricing
to enter that conversation onhow much they should be
reimbursing for for Medicare,and you know it's something we
previously have resisted, theprevious administration have
resisted in the US, right.

(04:18):
What they could do is drivedown reimbursement ceilings and
therefore influence the launchtrajectory of maybe new
therapies, even globally, right.
What you may have is newtherapies may launch in the US
first.
They may launch even moreincreasingly in other countries
first.
So pharma teams that areprobably already considering how
this could affect global launchsequencing, planning and even
engagement with payers and a lotof their forecasting models

(04:41):
some of them are already bakedand out there, you know, launch
brands or they're in theirsecond or third year.
They may need to revisit someof those models, especially
given the volatile currencydynamics that are happening in
between international marketsright now.
The third impact to keep an eyeon is the domestic manufacturing
incentives.
They really could alter supplychain strategy.

(05:02):
So you may have seen earlierthis month new legislation that
is being pushed offers taxincentives and what kind of
didn't get covered as much asexpedited FDA and EPA reviews
for pharma companies that wantto shift production overseas
into the US.
So there were three majorincentives it's up to a 25%

(05:23):
federal tax credit on domesticproduction costs they're doing
shorter validation timelines fornew US-based production
facilities, really expediting itand a priority FDA review for
supply security risk therapiesif everything's US-produced
right.
So its position is acost-saving and risk mitigation
strategy.

(05:44):
Patient support and accessleaders will need to understand
how potential shifts in themanufacturing location could
disrupt availability, especiallyduring transition.
For example, there's also areporting this week that tariffs
on international medicationscoming into the US could be
increased as much as 250 percent, particularly for meds that are
even generics right.

(06:04):
So that cost could actuallyenter the equation and, as we
all know, cost is one of thefactors of non-adherence with
medications.
So it could be a factor thatthe patient access and support
teams are going to want to keepin mind.
You know digital solutions likeMedisafe's companion that we're
all familiar with, obviouslycan help monitor the
irregularities and that could,you know, be triggered by

(06:24):
regional or fulfillment-basedissues.
You know when you can trigger,find out what about them before
they escalate.
Contact a patient In yoursupport programs.
Hey, we notice you haven'ttaken the meds.
Well, you may actually say,well, I'm kind of rationing them
.
I know I can't afford the newprice increase If I take fewer
meds.
I can, you know, space them outover the month.

(06:46):
You know we've all heard that,so that could be something that
is an impact there.
Fourth, you know you got tothink PBM reform could be
finally funded.
You may see a lot more directaccess to midstream data and
it's one of the least visiblebut most powerful developments
based on a funding bill thatpassed in late 2024.
Cnn had pointed out thatcongressional approval now pays
for the reform, will now pay forthe pharmacy benefit managers,

(07:07):
particularly requiringtransparent rebate reporting,
final price disclosure toprescribers and patients at
point of care.
Limitations on verticalintegration between the PBMs and
payers, and it could open newopportunities for patient
service teams to prescribers andpatients at point of care.
Limitations on verticalintegration between the PBMs and
payers.
And it could open newopportunities for patient
service teams to really betterunderstand these cost barriers
in real time and especially withtransparency, and really tailor
interventions dynamically,especially when they're laid

(07:30):
with the support toolspredictive analytics, especially
from data platforms likeMedistate, for example, you know
, do predictive trends,sometimes using AI, where we
could see, you know, whatpatients may be at risk of
falling off treatment or basedon other trends we've seen in
their behavior right.
So it's really going to enhancethe need to have remote

(07:52):
reporting and real-time datareal-world data as well that can
really inform pharma decisionmakers and support teams and not
only enhance brand loyalty butalso protect brand market share
if pricing becomes one of themajor considerations.
Lastly, here, keep an eye on theSupreme Court decision, the
Medicare Part B reimbursement.
There was a 2022 ruling thatinitially limited how healthy

(08:15):
human services could reimbursehospitals for outpatient drugs.
What's happened is recentlyfollow-up adjustments were
announced that are feelingconcerned that hospital systems
might face further disparitiesin their Medicare Part B
reimbursement.
So what does this really mean?
Some hospitals that are servinglow-income populations,
especially in the 340B program,may drop some expensive

(08:36):
therapies or formularies.
You know, if the reimbursementis uncertain, this means patient
access obstacles could increaseunpredictably for specialty
therapies.
You know pharma brand leaders,especially in oncology or rare
diseases, should probably lookforward to looking, look ahead
to plan and identify support onthose effective patients with
strong navigator tools, hubsupport.
You know wraparound services aswell.

(08:58):
You know it includes tools likeMedisafe and others.
With dynamic notification fieldtracking, they can really help
ensure patients stay connectedand, if barriers come up, they
can talk to their support teamsabout them right away and they
won't need to drop off as much.
So a couple of strategictakeaways for the industry
stakeholders here.
You know, as we were watchingthis countdown, the pharma
industry is.

(09:18):
You know many of them arepreparing to integrate a policy
awareness into commercializationstrategy and execution.
Key actions for brand marketing, for example, could use the
moment to revamp payerstrategies, messaging framework
and value for both patients andHCPs, such as pricing shifts,
fluctuating co-pays, unexpectedsupply chain changes that could

(09:46):
come about with whether it'stariffs on medications coming in
from overseas or new productionfacilities being launched in
the US.
Innovation teams lots of eyesare going to be on how they
evaluate new US manufacturingincentives and integrate with
digital traceability andoperational scale-up plans and
ROI how digital can be broughtin by innovation teams and
really help return on investmentat a time when prices may be

(10:09):
squeezed right.
Hcp engagement teams it'sreally going to be incumbent on
them to educate prescribers inreal time and maybe at some of
the PBM changes that are comingand the visibility to coverage
using data-driven field commsand updates.
Right, you know the digitalhealth integrators.
Neil's going to be looking atenhanced ecosystem integrations

(10:29):
with tools, with Medisafe.
You already saw and we talkedabout it in a different podcast
on the transparency of healthrecords plans that the US
government is talking aboutenforcing.
That would really bridgeadherence gaps, visualize ref
refill trends and really trackengagement and surrounding cost
concerns digitally andtransparently.
All right, with many of thesechanges that are converging, the

(10:51):
healthcare system really is ata tipping point.
Some consider that because,when it comes to affordability,
innovation, access whether it'sgoing to be a global pricing
alignment, domestic productionor even PBM reforms each lever
really can affect the patientjourney and therefore commercial
and clinical success.
And the proactive teams, thosewho are working
cross-functionally with pricingaccess, digital commercial, are

(11:14):
really positioned to adapt andalso thrive in the new terrain
and using digital platform toolslike Medisafe and others are
here to support patientsthroughout the complexity.
They can combine thepersonalization, real-world data
and intelligence guidance.
It's going to be an interestingcouple of weeks here as we
approach the deadline and seewhat happens with the September

(11:34):
29 date.
I really do.
Thank you two for joining us onPostgres.
If you found this conversationvaluable, follow, subscribe for
more insights.
At the Unisection of PharmaTechnology and Patient Impact,
we typically do a daily podcastthat's five to 10 minutes most,
just to keep you updated on whatwe're hearing.
Until the next time, keeplooking forward, and the real
work begins after that script iswritten.
Thanks, folks.