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12 November 2019

The Impact of Value Assessments on Patients

Today, PhRMA Foundation and the National Health Council put together a conference to discuss value assessments and their impact on patients - The Next Generation of Value Assessment: Including the Patient Voice. This conference brought together leading
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 and
other payers prioritize which expenses have
the greatest return on investment, or the most
value.Representing a balance of benefits and
costs to patients and society over time, a value
assessment can help inform decisions about how
to spend limited health care dollars.But for
patients, 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.    


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