Washington,
D.C.–Senate
Republicans, led by Senate Finance Committee Ranking Member Mike Crapo
(R-Idaho), urged government health officials against the implementation of a
drug-pricing model selected by the Department of Health and Human Services
(HHS) to complement the Administration’s prescription drug pricing
scheme.
In a letter
to HHS Secretary Xavier Becerra and Centers for Medicare and Medicaid Services
(CMS) Administrator Chiquita Brooks-LaSure, the senators note the Accelerating
Clinical Evidence Model has attracted concerns from a range of stakeholders,
including patient advocates and providers, given its potential to slash
reimbursement rates for drugs approved through the FDA’s Accelerated Approval
Program (AAP).
The senators
highlight key concerns with the model, as described in the Secretary’s report,
noting, among other issues, its potential to:
- Slash
reimbursement rates for drugs approved through the FDA’s Accelerated
Approval Program (AAP); -
Further
deter innovation and timely drug development by undermining the
accelerated approval pathway; -
Delay
patient access to life-saving therapies by discouraging drugmakers from
pursuing accelerated approval; -
Hindering
cancer care and therapeutic innovations for other conditions with
insufficient treatment options; -
Stray
from the CMS’s statutory mission and purpose by supplanting FDA
decision-making; and - Slash
reimbursement rates for frontline health care providers.
From the letter:
By bringing
groundbreaking therapies to patients years before these products could
otherwise reach the market, the FDA’s Accelerated Approval Program (AAP) has
saved countless lives while upholding strong safeguards and standards.
The
Accelerating Clinical Evidence Model recently announced by the Biden
Administration, unfortunately, risks undermining or even reversing this trend,
triggering access gaps for seniors, as well as imposing cuts on frontline
providers.
If proposed
and finalized as described, this profound policy shift would inevitably chill
incentives for leveraging the FDA’s game-changing expedited regulatory avenue,
which has served patients with life-threatening diseases for decades.
Later approvals and access delays would follow.
We all share
the goal of improving prescription drug access and affordability, but this
model represents a step in the opposite direction for seniors. We
strongly encourage you not to pursue it any further.
The letter is
signed by Senators Mike Crapo (R-Idaho), John Barrasso (R-Wyoming), Marsha
Blackburn (R-Tennessee), Ted Budd (R-North Carolina), Shelley Moore Capito
(R-West Virginia), Susan Collins (R-Maine), John Cornyn (R-Texas), Kevin Cramer
(R-North Dakota), Steve Daines (R-Montana), Cindy Hyde-Smith (R-Mississippi),
James Lankford (R-Oklahoma), Roger Marshall (R-Kansas), Jim Risch (R-Idaho),
Marco Rubio (R-Florida), Rick Scott (R-Florida), Tim Scott (R-South Carolina),
Thom Tillis (R-North Carolina), Roger Wicker (R-Mississippi).
Read the full
letter here
or below.
____________________________________
Dear Secretary
Becerra and Administrator Brooks-LaSure:
For far too
many seniors and Americans with disabilities, delays in access to high-quality
medical treatments can mean the difference between life and death. With
respect to physician-administered drugs and biologics, the Medicare program has
traditionally reflected this reality, applying the same general coverage and
reimbursement policies across all medications deemed safe and effective by the
Food and Drug Administration (FDA), regardless of their approval pathway.
By bringing groundbreaking therapies to patients years before these products
could otherwise reach the market, the FDA’s Accelerated Approval Program (AAP)
has saved countless lives while upholding strong safeguards and standards.
The
Accelerating Clinical Evidence Model recently announced by the Biden
Administration, unfortunately, risks undermining or even reversing this trend,
triggering access gaps for seniors, as well as imposing cuts on frontline
providers. As envisioned by the Secretary’s February 14 report,[1] this model would serve to erode the AAP by
slashing Medicare payment rates for medicines approved through the accelerated
approval pathway. If proposed and finalized as described, this profound
policy shift would inevitably chill incentives for leveraging the FDA’s
game-changing expedited regulatory avenue, which has served patients with
life-threatening diseases for decades. Later approvals and access delays
would follow. Even for drugs still opting for the accelerated approval
pathway, inadequate reimbursement for medical providers could force clinicians
to steer Medicare beneficiaries away from potentially life-saving treatments,
or to shift patients toward higher-cost sites of care. With these and
various other concerns in mind, we urge you not to move forward with testing
this misguided experimental initiative.
As of last
December, the FDA had approved a total of 290 treatments through the AAP,
enabling expedited availability for therapies targeting a wide range of
conditions, from cancer and HIV/AIDS to sickle cell disease. Numerous
studies have found that drugs opting for the accelerated approval pathway reach
patients an average of more than three years before they would have otherwise.[2]
As an analysis published last year illustrates in explicit terms, for even a
single product, the AAP can mean hundreds of thousands, if not millions, of
added or enhanced years of life for Americans.[3] Moreover, the FDA
has subjected AAP applicants to rigorous criteria and quality controls,
extending the pathway only for safe and effective medicines likely to meet an
unmet need for a serious health condition. As the agency has repeatedly affirmed,
“Drugs granted accelerated approval must meet the same statutory standards for
safety and effectiveness as those granted traditional approval.”[4]
The
Accelerating Clinical Evidence Model appears to call this paradigm into
question, treating drugs approved through the AAP as substandard and penalizing
frontline providers who choose to administer products that advance through this
pathway, regardless of clinical value. The deterrent effects on research
and development, on utilization of accelerated approval, and on prescribing of
innovative products could all prove dire for patients. To take one
crucial example, the test runs directly counter to the President’s Cancer
Moonshot, particularly given that an estimated 85 percent of drugs granted accelerated
approval between 2010 and 2020 were approved for oncology indications.[5]
Delays in access to breakthrough cancer technologies would pose painful
consequences for seniors from all walks of life.
In moving
forward with such a model, the Centers for Medicare and Medicaid Services (CMS)
would also stray from its statutory purpose and role and take on
responsibilities delegated by Congress to the FDA. The FDA, in turn,
would depart from its own Congressional directives and mission in consulting with
CMS on the test’s parameters, including, presumably, with respect to
reimbursement-related decisions. The model thus doubles down on a trend
initiated through CMS’s unprecedented and restrictive national coverage
determination for an entire class of potential Alzheimer’s disease therapies,
where the agency similarly supplanted the FDA as the de facto arbiter of drug
safety and effectiveness and bifurcated coverage based on a medication’s
approval pathway.[6]
While the
Secretary’s report cites the model as an incentive for timely completion of
confirmatory trials, Congress enacted a suite of policies last year to provide
the FDA with extensive authorities and tools aimed at achieving that
goal. For medicines treating diseases like Alzheimer’s and certain cancers,
such trials may still take years to complete, even if initiated as quickly as
possible. That reality, in fact, formed the basis for Congress’s creation
of the AAP in the first place. Punitive treatment of products that opt
for accelerated approval sends a precarious signal to patients, providers,
payers, and the public that CMS lacks confidence in this life-saving
pathway.
We all share
the goal of improving prescription drug access and affordability, but this
model represents a step in the opposite direction for seniors. We
strongly encourage you not to pursue it any further. If you have
questions, please contact Conor Sheehey of the Senate Finance Committee
staff. We look forward to reviewing your response.
Sincerely,