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CME / ABIM MOC / CE

How Are Higher Insulin Prices Affecting Diabetes Care?

  • Authors: News Author: Miriam E. Tucker; CME Author: Laurie Barclay, MD
  • CME / ABIM MOC / CE Released: 5/1/2020
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 5/1/2021
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Target Audience and Goal Statement

This article is intended for primary care clinicians, diabetologists/endocrinologists, cardiologists, nephrologists, nurses, pharmacists, and other members of the healthcare team for patients with diabetes.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  • Describe the national scope and associated trade-offs of financial hardship from medical bills among nonelderly persons with diabetes mellitus, according to an analysis of National Health Interview Survey data from 2013 to 2017
  • Determine the effects of Medicare Part D policy changes, particularly on higher prices for patients’ out-of-pocket costs for insulin from 2014 to 2019, according to an analysis of 2014 and 2019 Medicare formulary and pricing files
  • Outline implications for the healthcare team


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Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.


News Author

  • Miriam E. Tucker

    Freelance writer, Medscape

    Disclosures

    Disclosure: Miriam E. Tucker has disclosed no relevant financial relationships.

CME Author

  • Laurie Barclay, MD

    Freelance writer and reviewer, Medscape, LLC

    Disclosures

    Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

Editor/CE Reviewer

  • Esther Nyarko, PharmD

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Disclosure: Esther Nyarko, PharmD, has disclosed no relevant financial relationships.

CME Reviewer/Nurse Planner

  • Hazel Dennison, DNP, RN, FNP, CPHQ, CNE

    Associate Director, Accreditation and Compliance , Medscape, LLC

    Disclosures

    Disclosure: Hazel Dennison, DNP, RN, FNP, CPHQ, CNE, has disclosed no relevant financial relationships.

Medscape, LLC staff have disclosed that they have no relevant financial relationships.


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CME / ABIM MOC / CE

How Are Higher Insulin Prices Affecting Diabetes Care?

Authors: News Author: Miriam E. Tucker; CME Author: Laurie Barclay, MDFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME / ABIM MOC / CE Released: 5/1/2020

Valid for credit through: 5/1/2021

processing....

Clinical Context

Total and out-of-pocket spending among patients with diabetes mellitus appears to be increasing, posing a risk for financial hardship for these patients and a threat to medical and nonmedical needs. Using National Health Interview Survey data from 2013 to 2017, a study by Caraballo and colleagues assessed the national scope and associated trade-offs of financial hardship from medical bills among nonelderly persons with diabetes mellitus.

One-third of Medicare beneficiaries have diabetes, and 3.1 million require insulin, but one-quarter of persons taking insulin report reducing their use because of cost. After implementation of the Affordable Care Act, patients have paid a lower percentage of a drug’s price, but these savings can be offset by simultaneous price increases. A second study by Tseng and colleagues used 2014 and 2019 Medicare formulary and pricing files to determine how patients’ out-of-pocket costs for insulin would have decreased from 2014 to 2019 because of Part D policy changes and the opposing effect of higher insulin prices on these potential savings.

Study Synopsis and Perspective

Americans with diabetes are experiencing more financial hardship from medical bills than Americans without diabetes, even when they have health insurance, new research shows.

Results from an analysis of data from the National Health Interview Survey in 2013 to 2017 on medical bills among adults ages 18 to 64 years were published in the February issue of Circulation: Cardiovascular Quality and Outcomes. Cesar Caraballo, MD, of the Center for Outcomes Research and Evaluation, Yale New Haven Health, New Haven, Connecticut, and colleagues, led the study.

Nearly 2 in 5 of the 8967 adults with diabetes surveyed reported financial hardship from medical bills, including medical debt or the inability to afford needed medical care. This hardship, in turn, was associated with high financial distress, food insecurity, cost-related nonadherence, and foregone or delayed medical care.

"Our study findings illuminate the health- and nonhealth-related consequences as a potential side effect of burdensome medical bills from diabetes mellitus management... These findings underscore the need for price transparency and clear communication with patients and their families on costs of care," said Dr Caraballo and colleagues.

"Great consideration should be taken on presenting less expensive but still effective treatment options, as well as a need to comprehend patient's insurance coverage and financial obligations in our management decision-making processes," they added.

The older Medicare population is not immune either.

Another study -- this one on costs affecting the insulin-requiring Medicare population age 65 and older -- found that provisions in the Affordable Care Act intended to reduce the effect of the Medicare Part D "doughnut hole" were counteracted by rising insulin prices.

Those findings were published in the April issue of Diabetes Care by Chien-Wen Tseng, MD, of the department of family medicine and community health, University of Hawaii, Honolulu, and colleagues.[2]

"Lower insulin prices and other solutions are necessary to improve access to treatment for Medicare beneficiaries with diabetes," Dr Tseng and colleagues assert.

Medical-Related Financial Hardship Brings Other Issues

The 8967 adults ages 18 to 64 years with diabetes included in the National Health Interview Survey study by Dr Caraballo and colleagues would extrapolate to represent about 13.1 million individuals across the United States.

They were a mean age of 51.6 ± 10.3 years, and 49.1% were women.

Annually during the survey, 41.1%, corresponding to 5.4 million nationally, were part of families reporting financial hardship from medical bills, including 15.6% (corresponding to 2 million) reporting they were unable to pay their medical bills at all.

Inability to pay bills at all was most prevalent among persons who were low-income and uninsured (39.1%) and least common among middle- or high-income and insured (8.5%) individuals.

Nevertheless, of the 3613 adults reporting financial hardship because of medical bills, 83.2% were, in fact, insured.

In turn, among individuals with diabetes, persons in families with vs without financial hardship because of medical bills had higher financial distress (52.1% vs 25.4%), food insecurity (30% vs 12.8%), cost-related nonadherence (34.7% vs 9.1%), and foregone/delayed medical care (55.5% vs 21.6%) (all P < .001).

These associations remained significant after adjustment for sociodemographic, economic, and clinical confounders.

All these adverse factors were significantly greater among persons with vs without diabetes in the survey.

In summary, after adjustment for known confounders, individuals with vs without diabetes were at greater risk for overall financial hardship (adjusted odds ratio [aOR] = 1.27), high financial distress (aOR, = 1.14), food insecurity (aOR = 1.27), cost-related nonadherence (aOR =1.43), and foregone/delayed medical care (aOR = 1.3).

Stuck in the Doughnut Hole: Rising Insulin Prices

Meanwhile, the study by Tseng and colleagues examined Medicare Part D coverage, which applies to the 3.1 million beneficiaries who require insulin (type 1 and type 2 diabetes).

In the Part D coverage gap (also referred to as the "doughnut hole") -- which dates back to the Medicare Modernization Act of 2003 -- beneficiaries pay a percentage of the drug's price until they reach the point of catastrophic coverage.

To minimize that burden, the Affordable Care Act incrementally reduced beneficiaries' cost-sharing during the gap, from 100% of the drug price in 2010 to 25% in 2019. At the same time, manufacturers were required to provide greater discounts during the gap, reaching 70% by 2019.

Tseng and colleagues analyzed 9 insulins, including the top 5 by 2017 Part D spending ($8.2 billion or 62% of Part D insulin expenditures), averaging monthly and out-of-pocket cost requirements across plans nationwide, with cost projections based on 50 U/d and no other medications.

From 2014 to 2019, the average annual insulin price rose 55%, from $3819 to $5917.

Monthly out-of-pocket cost for insulin in the covered (predoughnut) phase rose 18%, from $49 to $58. Accounting for all Part D phases, the projected yearly out-of-pocket cost for insulin increased 11% from $1199 to $1329.

In contrast, if insulin prices had not risen and instead remained at 2014 levels, annual out-of-pocket cost would have dropped 19% to $967 because of lower coinsurance in the gap.

This was not uniform, though. Lantus® pens had the lowest price increase (19%), and for that, the annual out-of-pocket costs dropped by $167; however, if the price had not risen, patients would actually have saved $292.

With Levemir®, which had the greatest price increase (165%), annual out-of-pocket costs increased by $992 instead of falling by $297 had the price remained unchanged.

In 2019, 8 of 9 insulin prices exceeded $4800 annually, with patients' projected out-of-pocket costs surpassing $1000 under a standard Part D plan.

Of concern, Tseng and colleagues said, "Insulin list prices continue to rise, driven by multiple complex factors including manufacturers competing by offering greater proprietary rebates to pharmacy benefit managers for formulary placement.

"Since measures to close the Part D gap were fully implemented in 2019, future price increases will not be counteracted unless new policies are enacted to reduce patients' cost-sharing," they concluded.

US prices for insulin have come under intense scrutiny in recent years. Around a quarter of patients with diabetes are said to ration use of this medication -- which, for persons with type 1 diabetes, is essential for life -- because of high costs.

Patients and parents of children with diabetes have long protested, and some states have started to cap prices: most recently, Illinois, which has said that no person covered by state-regulated commercial health insurance plans should pay more than $100 per month for insulin.[3]

Caraballo and Tseng have reported no relevant financial relationships.

Study Highlights

  • Using National Health Interview Survey data from 164,696 individuals surveyed from 2013 to 2017, the investigators identified 8967adults ≤ 64 years old with a self-reported diagnosis of diabetes mellitus.
  • These 8967 adults represented 13.1 million individuals annually across the United States.
  • Mean age was 51.6 ± 10.3 years; 49.1% were female.
  • Among 41.1% who reported being part of families with financial hardship from medical bills, 83.2% were insured, and 15.6% reported being unable to pay medical bills at all.
  • Odds of being in families with financial hardship from medical bills were greater in persons who lacked insurance, were non-Hispanic black, had low income, or had high-comorbidity burden, according to multivariate analyses.
  • Among respondents unable to pay bills, there was a high prevalence of high financial distress (70.5%), food insecurity (49.4%), cost-related nonadherence (49.5%), and foregone or delayed medical care (74%).
  • Compared with respondents without diabetes, respondents with diabetes had greater odds of financial hardship from medical bills (aOR = 1.27 [95% CI: 1.18, 1.36]) or any of its consequences, including high financial distress (aOR = 1.14 [95% CI: 1.05, 1.24]), food insecurity (aOR = 1.27 [95% CI: 1.16, 1.4]), cost-related medication nonadherence (aOR = 1.43 [95% CI: 1.3, 1.57]), and foregone or delayed medical care (aOR = 1.3 [95% CI: 1.2, 1.4]).
  • In turn, among individuals with diabetes, persons in families with vs without financial hardship because of medical bills had higher financial distress (52.1% vs 25.4%), food insecurity (30.0% vs 12.8%), cost-related nonadherence (34.7% vs 9.1%), and foregone/delayed medical care (55.5% vs 21.6%) (all P < .001).
  • Adjustment for sociodemographic, economic, and clinical factors did not abolish the significance of these associations.
  • All these adverse factors were significantly greater among persons with vs without diabetes in the survey.
  • According to their findings, the investigators concluded that nonelderly patients with diabetes have a high prevalence of financial hardship from medical bills, with harmful health and nonhealth-related consequences.
  • The findings highlight the need for price transparency and clear communication with patients and their families regarding costs of care, including options for less expensive but still effective treatment.
  • Management decision-making processes should consider patients’ insurance coverage and financial obligations.
  • Investigators in the second study noted that insulin price and affordability affects the 70% of Medicare beneficiaries who have Part D drug coverage, which requires significant deductibles and copayments without capping out-of-pocket costs.
  • Medicare Part D has a coverage gap, or doughnut hole, in which beneficiaries pay a percentage of drug price until reaching catastrophic coverage.
  • From 2010 to 2019, the Affordable Care Act incrementally decreased patients’ cost sharing during the gap from 100% to 25% of a drug’s full list price (excluding manufacturer rebates) whereas manufacturers were required to provide greater price discounts during the gap, up to a 70% discount by 2019.
  • Using 2014 and 2019 Medicare formulary and pricing files, the investigators analyzed 9 insulins, including the top 5 insulins, by 2017 Part D spending ($8.2 billion or 62% of Part D insulin expenditures).
  • Average annual insulin price rose 55%, from $3819 in 2014 to $5917 in 2019.
  • Monthly out-of-pocket cost for insulin in the covered phase increased from $49 to $58 (18%).
  • Projected yearly out-of-pocket cost for insulin rose from $1199 to $1329 (11%), accounting for all Part D phases.
  • Had insulin prices stayed at 2014 levels, annual out-of-pocket cost would have decreased by 19% to $967 because of lower coinsurance in the gap, which varied with the magnitude of insulin price increases.
  • The lowest price increase was for the Lantus pen (19%), with decrease in annual out-of-pocket costs of $167 (−13%), but had prices remained at 2014 levels, patients would have saved $292 (−23%).
  • The greatest price increase was for Levemir (165%), with $992 increase (79%) in annual out-of-pocket costs whereas they would have fallen $297 (−24%) had prices remained unchanged.
  • 8 of 9 insulin prices exceeded $4800 annually in 2019, and patients’ projected out-of-pocket costs under a standard Part D plan exceeded $1000.
  • From 2014 to 2019, closing the coverage gap would have lowered out-of-pocket costs for insulin by 19% if prices had stayed at 2014 levels.
  • In 2019, patients paid a lower percentage of insulin price (47.5% decreased to 25%) during the gap whereas manufacturers gave higher discounts (50% increased to 70%), but patients’ projected out-of-pocket costs increased 11% because insulin prices rose by 55%.
  • Had insulin prices increased with inflation by 8.4% from 2014 to 2019, policies to lower Part D cost sharing would have reduced patients’ out-of-pocket costs.
  • According to their findings, the investigators concluded that strategies to lower patients’ out-of-pocket cost by closing the Medicare Part D coverage gap were mostly outweighed by higher insulin prices.
  • To improve access to treatment for Medicare beneficiaries with diabetes, lower insulin prices and other solutions are needed.
  • Insulin list prices continue to rise because of manufacturer competition by offering greater proprietary rebates to pharmacy benefit managers for formulary placement.
  • Future price increases will not be counteracted unless new policies are enacted to lower patients’ cost-sharing, as measures to close the Part D gap were fully implemented in 2019.
  • Proposals to ensure medication access include eliminating rebates and basing patient and Medicare cost-sharing on lower actual prices; passing on rebate savings to patients; capping out-of-pocket spending; accelerating generic drug competition; and allowing Medicare to negotiate prices with manufacturers.
  • Limitations of this study include projecting annual cost-sharing according to use of a single insulin and no other medications.

Clinical Implications

  • Nonelderly patients with diabetes have a high prevalence of financial hardship from medical bills, with harmful health and nonhealth-related consequences, according to an analysis of National Health Interview Survey data from 2013 to 2017 by Caraballo and colleagues.
  • Strategies to lower patients’ out-of-pocket cost by closing the Medicare Part D coverage gap were mostly outweighed by higher insulin prices, according to an analysis of 2014 and 2019 Medicare formulary and pricing files by Tseng and colleagues.
  • Implications for the Healthcare Team: The healthcare team should in patient care meetings implement management decision-making processes. The team should collaborate to determine individualized patient needs and consider patients’ insurance coverage and financial obligations.

 

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