Peek behind the paper: the consequences of rising out-of-pocket drugs costs for MS patients

Lead and senior authors Alvaro San-Juan-Rodriguez and Inmaculada Hernandez (both from the University of Pittsburgh; PA, USA) peek behind their study paper concerning Medicare and patient spending on multiple sclerosis (MS) disease-modifying therapies.

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In 2019, we reported on some important research investigating patients’ out-of-pocket, multiple sclerosis (MS) drug coverage payments, which revealed that under Medicare Part D, MS patients have faced a seven-fold increase in personal costs for drugs over the last decade.

Now, take the opportunity to revisit this and evaluate how far the field has come in this interview with lead and senior authors Alvaro San-Juan-Rodriguez and Inmaculada Hernandez (both from the University of Pittsburgh; PA, USA).


Please could you introduce yourselves and your institution(s)?

Inmaculada Hernandez: I am an Assistant Professor of Pharmacy and Therapeutics, as well as the Associate Director of the Center for Pharmaceutical Policy and Prescribing (CP3), at the University of Pittsburgh.

Alvaro San-Juan-Rodriguez: I am a Pharmacoeconomics and Outcomes Research Fellow at the University of Pittsburgh.

The University of Pittsburgh is one of the top institutions according to National Institutes of Health (MD, USA) funding—holding the third position in 2018 with 477 awards—and one of the more prolific biomedical research hubs in the USA. The CP3 fosters multidisciplinary collaboration to improve the quality, safety, efficacy and access of medications. The Center’s focus is on informing the regulation and coverage of pharmaceuticals, and improving patient and prescriber decision making on prescription drugs.


What prompted you to conduct this research?

In recent years, MS drugs have been well-known for presenting large price increases. However, the impact of these high and ever-rising drug prices on both Medicare Part D and patient out-of-pocket spending was unclear. Therefore, we undertook this study in order to shed some light on this crucial aspect of patients’ access to their essential, disease-modifying therapies.


What is Medicare Part D?

Medicare Part D is a public health insurance coverage program in the USA covering prescription drugs for individuals over 65 years. Medicare Part D is the largest purchaser of drugs in the USA and is mostly financed by taxpayers’ money. 


What is the importance of this kind of cohort analysis of market trend prices, for example, with regards to influencing policies?

By performing a cohort analysis of market trend prices, we have been able to demonstrate that Medicare spending on disease-modifying MS pharmacotherapies increased more than 10-fold over 2006—2016. Over this same period, patients’ self-funded spending on these therapies increased 7-fold too. This latter increase in patients’ out-of-pocket spending is particularly worrisome because it may jeopardize patients’ access to essential medications: Medicare Part D beneficiaries are aged 65 or older, making them a particularly vulnerable population to be in receipt of inconsistent therapy administration.

“…large increases in out-of-pocket spending may result in patients’ reduced access to [disease-modifying therapies] and, ultimately, poorer health outcomes for patients.”

Our study is therefore an important contribution to the current body of work assessing market trends and patient access to disease-modifying therapies; it demonstrates to taxpayers and policymakers that rising MS drugs prices have resulted in large increases in both Medicare and patient out-of-pocket spending. We hope our results will lead to reformed policies that ensure affordable drug prices and sustained patient access.


How may rising out-of-pocket drug costs for patients negatively impact on their access to essential, disease-modifying therapies?

MS disease-modifying therapies offer important benefits to patients, particularly those with relapsing–remitting MS (85–90% of MS cases are of the relapsing–remitting form at onset). These include decreased flare-up rates – which can involve a variety of disabling neurological symptoms such as vision loss, pain, fatigue and muscle weakness – and a slower accumulation of brain lesions. Patients with MS require lifelong administration of treatment for their disease management. Therefore, large increases in out-of-pocket spending may result in patients’ reduced access to them and, ultimately, poorer health outcomes for patients.


What do you hope some of the implications of your research may be, for example, suppressing critiques’ assumption that rebates and coupons etc. buffer the impacts of rising drug costs?

Critics have argued that since some of the costs of drugs are canceled out by manufacturer rebates and other discounts, rising list prices may not be translating into increased Medicare Part D spending. However, discounts are not passed on to Medicare Part D beneficiaries – discount coupons for Medicare beneficiaries are not allowed by federal law – and thus, our finding concerning the sharp increase in out-of-pocket spending remains unchanged.

“…our paper will serve as a call to action to address the pressing issue of high and rising drug prices in the USA, thereby maintaining the affordability and access to specialty medications, and the best possible outcomes for patients.”

We hope that by demonstrating this, our paper will serve as a call to action to address the pressing issue of high and rising drug prices in the USA, thereby maintaining the affordability and access to specialty medications, and the best possible outcomes for patients.


Do you have future studies planned concerning trends in market prices, for example, for other indications?

We will continue to evaluate trends in prices of high-cost therapies used for the treatment of relatively prevalent diseases; the impacts of these on society in general—and on the budgets of patients and health care systems in particular—has the potential to be of great magnitude.


Disclosures:

Inmaculada Hernandez reports personal fees from Pfizer outside the submitted work. Alvaro San-Juan-Rodriguez reports no disclosures relevant to this work. 

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