health economics researchers and patient advocates to discuss the connection between value assessment research and the practical applications that support and strengthen the decision-making process in the U.S. healthcare system. (PhRMA Foundation)
I was invited to provide opening remarks on why value assessments are important from a patient perspective. What is a value assessment? The Institute for Patient Access (IfPA) explains this in easy to understand layman terms in their Fast Facts:The Institute for Clinical and Economic Review:
A value assessment can help governments andother payers prioritize which expenses havethe greatest return on investment, or the mostvalue.Representing a balance of benefits andcosts to patients and society over time, a valueassessment can help inform decisions about howto spend limited health care dollars.But forpatients, especially those with rare conditions,value assessments can be used to restrict access to
I would like to share my remarks on an important and much needed conversation on improving how frameworks and metrics are developed in creating value assessments.
Thank you to the PhRMA Foundation and the
National Health Council for inviting me to speak about a topic that is very
important to myself and millions of Americans who rely on several modalities of
treatment to manage their chronic conditions. During my advocacy work, I have
learned a great deal about how therapies, devices and treatments are assessed and
the impact those decisions have on how those therapies are covered and
reimbursed.
As someone who lives with multiple chronic pain and mental
health conditions, I spend a lot of time in the doctor’s office and
subsequently, the pharmacy. Many times, I have had to pay high copays for a
specific drug, appeal a decision to have a medical device covered or pay out of
pocket because my insurer would not cover a specific treatment. Back then, I
was not aware of what influenced insurers to make those decisions. I just knew
that there were going to be hurdles and obstacles to overcome to gain access to
those treatments. Over this past year and a half, I have learned quite a lot
about what goes into assessing the value of therapies.
Value assessments have a tremendous impact on the patient
and physician relationship. The frameworks used by organizations, such as the
Institute for Clinical and Economic Review or ICER do not adequately incorporate
the patient’s input or the full value and benefits of medical innovation. Methodologies
used to measure value, such as the quality-adjusted life-year or QALY, rarely
evolve enough to truly provide the strongest view of a therapy’s value.
Many therapy value analyses take place around the time of
marketing approval. Nonetheless, applicable research pertaining to the
treatment, the disease it addresses, and other therapies are still emerging.
Also, this collection of facts over time gives the clearest interpretation of
the value of a treatment.
QALY can also discriminate against people with disabilities
and serious chronic conditions. To measure the extent to which a treatment
extends life and improves health, a QALY analysis uses a weight factor known as
a disability weight that reflects the severity of the disease on a scale from 0
(perfect health) to 1 (equivalent to death).
These disability weights reduces the value of
life-sustaining properties of a medication if it is also not possible to return
a patient to full health. For someone like myself, a drug may not seem valuable
to cover due to my diagnosis of chronic migraine which, on the Migraine
Disability Assessment Test, my score would reflect a level of moderate to
severe disability.
How does this affect patients? The Institute for Patient
Access explains this perfectly. The value-based standard cost for ICER is the
amount that health insurance companies are expected to spend on a particular
drug, device or study. Health insurers can then choose to use the ICER metric
for price negations and policy decisions, particularly if the price point
supports limitations and conditions that can help the company to reduce costs.
This is what CVS Caremark does, for example. The pharmacy
benefit manager permits the health insurers to exclude medications
that exceed a threshold set by ICER from coverage. This proposal can restrict
access to prescribed medicine by patients if they undergo an appeal or
complaint procedure. And even then, there is no guarantee of acceptance.
ICER has begun accepting written feedback from patients,
healthcare providers and patient advocacy groups during an “Open Input” period.
This duration is three weeks after the announcement of a topic. During this
time, stakeholders are invited to submit appropriate comments about the
forthcoming review. Written comments can also be submitted during the Draft
Scope Document, Draft Evidence Report and Draft Voting Questions phases of the
review. Oral comments are also welcomed during the public meeting. This is
where patient-relevant and patient-centered outcomes are considered, for
example, that were not adequately captured in the clinical trial data. However,
for patient testimony, we were allotted 5 spots during the public meeting on
CGRPs. One patient could not attend at the last minute due to a family medical
emergency. ICER did not allow us to replace her spot with another patient, but
instead gave the time to industry.
Does ICER use this valuable input in their analyses and
final findings? Not exactly, unfortunately. ICER acknowledges the issues but
changes its way of addressing them significantly. In general, physicians and
clinicians have noticed that ICER does not sufficiently integrate the
intangible benefits of good health. These include considerations related to
quality of life, such as being able to physically carry out an event and attend
a meeting, as well as having the mental well-being to interact with family and
friends, at work or in community activities.
Overall, the impact these value assessments have on
patients is extremely monumental in how we can live quality lives. When third
parties make medical decisions for patients and physicians, it creates access
barriers to treatments and therapies much needed to obtain better health, well-being,
decreased disability and higher quality of life. Impeding on the conversations
and decisions made between healthcare professionals and their patients limits access
to life-changing and possibly, life-saving treatments.
Last year, a groundbreaking treatment was FDA approved in
the prevention of migraine. For decades, people living with migraine were
taking off-label medications as preventives. These drugs, anti-CGRP (calcitonin
gene-related peptide) monoclonal antibodies was reviewed by ICER to evaluate
the cost effectiveness of this treatment. ICER’s findings drew a negative
impact on patient access to this life-changing medication.
Insurance companies usually use a negative ICER review to
justify their denial of a medication. ICER actually agreed with the pricing for
CGRP inhibitors and found it was cost-effective (which is rare) for chronic
migraine, but not episodic. But insurance companies are still throwing up
barriers and dismissing the ICER review. ICER also refused to take into
consideration the positive impact of innovative migraine treatments on the
nationwide opioid epidemic.
The relatively high price tag associated with these groundbreaking
drugs compared to oral preventatives allows insurers and pharmacy benefit
providers to limit patients to less effective, cheaper medications that have a
wider side effect profile. Policies are implemented such as fail first/step
therapy, prior authorization and non-medical switching which negatively impacts
the patient and prolongs access to the medication with the highest efficacy and
lowest side effect profile originally prescribed to them. These policies
implement prudent use of CGRP inhibitors by clinicians, thus reducing costs to
insurers.
The negative repercussions from ICER’s final report has
resulted in insurers limiting the prescription of CGRP inhibitors to headache
specialists with a certification in headache medicine from the United Council
for Neurologic Subspecialties. With around 520 UCNS certified specialists to
serve over 40 million Americans with migraine, that severely limits access to not
only seeing a headache specialist but being prescribed a medication that could
greatly reduce the frequency and severity of attacks.
For many people living with migraine, like myself, combined
therapies are the most significant approach in managing chronic migraine.
Taking both a botulinum neurotoxin and a CGRP inhibitor helps to reduce the
number of days spent in pain and lost to disability. However, since the
combination of both drugs were excluded during clinical trials many insurers
are not approving coverage of both therapies simultaneously due to their
associated costs, regardless of their efficacy in treating and preventing
migraine.
Patients are put in situations where they are rarely in
control of their own healthcare due to the interference of insurers by way of
value assessment frameworks that poorly balances their evaluations with a
comprehensive consideration of benefits to the patient. Patient input, updated
use of QALY’s to also address disabilities and chronic conditions and proper
representation on the voting panel to include clinical experts who are within
the medical specialty they are assessing.
Like Lindsay Videnieks of the Headache and Migraine Policy
Forum said, “by using a cookie-cutter approach in its assessment, ICER
diminishes the patient experience.” The patient experience is extremely
valuable and necessary, as is the physician and patient narrative. It is my
hope that through the engagement of patient advocacy groups and their reach on
platforms like social media, the inclusion of the patient voice will be a permanent
piece of future value assessments.
My name is Sistine Van Pelt
ReplyDeleteI suffer from migraines and I didn't start having them until I was 22 and I tried all the pills to but I finally got them to go away but I still get them from time to time and it does bring me down for four days but then I go see the doctor if I can't get rid of the migraine
Hi Sistine,
DeleteI’m sorry to hear that when you have an attack it puts you down for so long. It sounds like you’re able to get relief once you see your doctor. Do you get specific medications or treatments to abort the migraine that you’re not able to do at home?