Cover Story

Insulin prices reach tipping point; diabetes advocates, stakeholders demand new solutions

Calls to reduce insulin prices are getting louder, yet people with diabetes continue to pay more every year for a drug WHO deems an essential medicine. According to 2017 data from the Health Care Cost Institute, insulin prices, which tripled from 2002 to 2013, continue to climb, nearly doubling between 2012 and 2016. For people with diabetes and employer-sponsored insurance, the average price for a 40-day supply of insulin rose from $344 to $666 during those same years, according to the report.

During that same period, the average list price of the four insulin categories — short-acting insulin, long-acting insulin, rapid-acting insulin vials and rapid-acting insulin pens — increased between 15% and 17% per year, according to data from the American Diabetes Association’s Insulin Access and Affordability Working Group, published in 2018.

“Insurance for many people continues to change, as people continue to bear more of the cost for insulin,” Aaron J. Kowalski, PhD, chief mission officer for the JDRF, told Endocrine Today. “There is increased visibility of the problem — you hear continuing stories of people who are rationing their insulin. It is a culmination of all these issues now crystallizing, and people are realizing that we need a change.”

Pharmaceutical companies and pharmacy benefit managers will either reduce insulin prices on their own or be forced to through legislation, according to Alvin C. Powers, MD.

Photo by Jessica Kimber, Vanderbilt University Medical Center. Printed with permission.

The numbers and patient stories have caught the attention of the federal government. In April, the three manufacturers of insulin, Eli Lilly, Novo Nordisk and Sanofi, and the nation’s three largest pharmacy benefit managers, CVS Health, Express Scripts and Optum RX, appeared together before Congress to respond to the growing protest over insulin access, at times blaming one another for high list prices.

The outcry — from the public and U.S. government alike — is spurring changes. In the months since the congressional hearings, Eli Lilly and Sanofi announced new plans to offer bigger discounts, including the introduction of an “authorized generic” insulin. In April, the insurer Cigna and its pharmacy benefit manager (PBM) division, Express Scripts, introduced a plan to cap out-of-pocket insulin costs for eligible plan members. In May, Colorado capped copayments for insulin at $100 a month, regardless of the type or supply required, with insurance companies absorbing the balance. Still, insulin manufacturers and other stakeholders are calling for more comprehensive solutions.

“All the activity in this space in the last few months is remarkable,” Alvin C. Powers, MD, director of the Vanderbilt Diabetes Center and director of the division of diabetes, endocrinology and metabolism at Vanderbilt University Medical Center, told Endocrine Today. “The role of the American Diabetes Association and groups like the Endocrine Society cannot be underestimated. This began as an initiative through ADA back in 2017 when they launched an online petition and 500,000 people signed it. All of this snowballed and generated momentum that galvanized everyone. Now, [insulin pricing] is all anyone can talk about.”

‘Highly correlated’ price trends

The high price of insulin is not a problem reserved for medically indigent patients. Robert H. Eckel, MD, professor of medicine in the divisions of endocrinology, metabolism and diabetes and cardiology at the University of Colorado Denver Anschutz Medical Campus, recalled stopping in a pharmacy while on a recent trip to Paris.

He was shopping for lower-cost insulin for his children.

“I had told my sons that their Christmas gift would be a surprise,” Eckel, who has two adult sons with type 1 diabetes, told Endocrine Today. “It was not bringing home new pairs of designer jeans. My French was good enough that I was able to convince the woman at the pharmacy that I was a physician and that I had a need to buy insulin to save money in the states. ... We got the message across that I wanted to buy all the insulin she had.”

Eckel said he did the math: Using insurance copays, his sons would have paid five times more than what he paid in Paris, where he ultimately saved thousands of dollars.

As physicians, “we respond to crises, and this has become a crisis,” Powers said. “It became highly visible, and now, there is a lot of energy. The PBMs and pharma understand that they are being scrutinized. If they don’t come forward with solutions that reduce insulin costs, the government is likely to step in and do things that they won’t like.”

In an analysis of claims data from more than 35 million individuals published in May in JAMA Network Open, Nathan E. Wineinger, PhD, assistant professor in the department of integrative structural and computational biology at Scripps Research, California, and colleagues observed that 17 of the top-selling brand-name drugs — among them, nine diabetes therapies — more than doubled in cost over 6 years. These included insulin lispro (Humalog, Eli Lilly; 117% increase), regular and NPH insulin (Humulin, Eli Lilly; 117% increase) and insulin aspart (NovoLog, Novo Nordisk; 118% increase).

Wineinger and colleagues analyzed prescription-level pharmacy claims data from 2012 to 2017 via Blue Cross Blue Shield Axis, a database with information for more than 35 million individuals with private pharmaceutical insurance in the United States. The drugs in the analysis exceeded $500 million in U.S. sales or $1 billion in worldwide sales, reached at least 100,000 total pharmacy claims and were covered under insurance for at least 3 years. Primary outcome was total price paid of each claim, including median sum of out-of-pocket and insurance costs paid by patients or insurers for common prescriptions.

“What was disheartening was our observation that prices among drugs that treat similar conditions, like insulins, had highly correlated price trends, more so than any other products,” Wineinger told Endocrine Today. “At the same time, these drugs had some of the largest relative price increases. I would hope that competition, in this case among insulin manufacturers, would keep prices down. Instead, it appears that competitors are responsive to one another, but not in a way that lowers prices for consumers.”

In addition, prices paid were correlated with third-party estimates of changes in drug net prices, suggesting that the current drug rebate system increases overall costs.

Aaron J. Kowalski

“What was shocking was how near universal these price increases were,” Wineinger said. “When we pulled price data from another source ... these prices being paid are seen in the net price data as well. One conclusion we can make is the rebate system that is incentivizing high list prices isn’t controlling the cost at the end of the day.”

Insulin rationing

In a study published in January, Kasia J. Lipska , MD, MHS, clinical investigator with the Yale-New Haven Medical Center for Outcomes Research and Evaluation at Yale University, and colleagues surveyed 199 clinic patients with type 1 or type 2 diabetes prescribed insulin within the past 6 months who had an outpatient visit at the Yale Diabetes Center from June to August 2017 (56.2% women; 60.8% white; 41.7% with type 1 diabetes). The primary outcome was cost-related underuse of insulin in the past 12 months, defined by a positive response to any of six questions about using less insulin than prescribed, stopping insulin or not filling an insulin prescription because of cost. Researchers examined the association between cost-related underuse and poor glycemic outcomes.

“The study was inspired by patients I was seeing in clinic who told me stories about the inability to obtain affordable insulin,” Lipska told Endocrine Today. “Some patients brought me bills to look at. Others would say, ‘No way, I can’t increase my Lantus dose.’ As the debate about insulin prices was starting, people said to me, ‘You have these stories, but how common is this?’ That led me to document it. Were these just anecdotes?”

Within the survey cohort, 25.5% reported cost-related insulin underuse, and the type of prescription drug coverage was not associated with cost-related underuse. Compared with patients who did not report cost-related underuse, those who did were nearly three times more likely to have an HbA1c of at least 9% (OR = 2.96; 95% CI, 1.14-8.16).

“The findings actually did surprise me,” Lipska said. “One in four patients are rationing insulin. If anything, at Yale Diabetes Center, I thought the problem would be less widespread because we have good statewide coverage for insulin for patients covered by Medicaid. Instead, we found that insulin rationing was widespread and common. This is the direct effect of the high price of insulin. It is unconscionable, and it has to change.”

‘Filling gaps in the system’

In March, Eli Lilly announced it would introduce an authorized generic version of insulin lispro injection in the U.S., promising a list price 50% lower than the current Humalog list price. The lower-priced version is called “insulin lispro” and is the same molecule as Humalog, according to the company. The list price of a single vial is $137.35, according to Lilly. The list price of a five-pack of KwikPens is $265.20.

The insulin is made available through a Lilly subsidiary, ImClone Systems. Humalog will also remain available for people who want to continue accessing it through their current insurance plans, according to the company.

“We are committed to ensuring everyone living with diabetes has reasonable access to insulin, and we appreciate congressional interest in this topic,” Michael B. Mason, senior vice president of connected care and insulins at Eli Lilly, told Endocrine Today before the congressional hearing in April. “We remain focused on filling gaps in the system, such as with our lower-priced, authorized generic insulin, until a more sustainable model is achieved.”

In an email interview, Mason said a comprehensive solution requires commitment from all stakeholders in the health care system.

“Until a comprehensive solution is reached, we will continue our affordability solutions that provide thousands of people each month with access to insulin at significantly reduced cost or for free,” Mason said.

Similarly, Sanofi announced in May that it would expand its “Insulins Valyou Savings Program.” Under the enhanced discounts, which went into effect June 8, uninsured patients pay $99 to access their Sanofi insulins (Lantus, Toujeo, Admelog and Apidra), with a valid prescription, for up to 10 boxes of pens and/or 10 mL vials per month. The prior program offered one set price for each 10 mL vial ($99) or box of pens ($149).

“Since 2012, the net price of Sanofi insulins has declined by 25%, yet patient out-of-pocket costs have continued to rise,” Jon Florio, manager of diabetes communications for Sanofi, told Endocrine Today. “Over the same period, the price of our most prescribed insulin, Lantus, has actually fallen over 30%, while average out-of-pocket costs for patients with commercial insurance and Medicare has risen approximately 60%. It is our belief that growing rebates and declining net prices should result in lower out-of-pocket costs for patients, but that is not always the case.”

Kasia J. Lipska

In remarks before the congressional committee in April, Douglas J. Langa, executive vice president of North America operations and president of Novo Nordisk, said that, in addition to a diabetes patient assistance program and co-pay assistance programs, the company has partnered with Walmart since 2000 to offer human insulin for approximately $25 a vial. In 2017, Novo Nordisk partnered with CVS Health and ESI to expand the $25 human insulin offering to thousands more pharmacies nationwide.

“Last year, we also started to provide human insulin in a convenient pen injection device through Walmart,” Langa said. “Through the CVS Health and ESI programs, commercially eligible patients can purchase this same Novo Nordisk insulin for around $25 at 68,000 pharmacies in the CVS Health retail network and 40,000 ESI participating pharmacies. In total, through these partnerships, Novo Nordisk estimates that it is currently providing high quality, affordable Novo Nordisk-manufactured human insulin to over 500,000 people.”

Critics of pharmaceutical company programs note that discount programs do not benefit everyone; Medicare and Medicaid bar patients from using pharmaceutical company-funded discount coupons or programs, whereas insured patients with high-deductible plans can still fall through the cracks.

In an interview with Endocrine Today,Rep. Joe Kennedy III, D-Mass., who serves on the U.S. House Committee on Energy and Commerce’s Oversight and Investigations Subcommittee, which is investigating insulin prices, called such programs “temporary solutions” and said more comprehensive steps must be taken at the federal level.

“Any proposal that will increase access to affordable insulin should be a welcome development, but temporary solutions intended to lessen accountability and congressional oversight should not be mistaken for systemic reforms that lower prices of lifesaving pharmaceuticals,” Kennedy said. “From cracking down on patent abuses to increased transparency to strengthened accountability for price gouging, Congress needs to consider addressing every leverage point we have at our disposal because people are dying due to unaffordable medication. In the wealthiest nation on earth, our neighbors should not be dying because they have been priced out of life.”

State solutions

On May 22, Gov. Jared Polis of Colorado signed the first bill in the nation that will cap insulin copays for people with private insurance at $100 per month, regardless of the number of vials needed. The new law also enlists the Colorado attorney general to investigate the rising price of insulin in the state and make recommendations to the general assembly for further action. In a statement, LaShawn McIver, MD, senior vice president of government affairs and advocacy for the ADA, called the legislation “monumental.”

Rep. Dylan Roberts, D-Colo., who co-sponsored the legislation and whose brother died from complications of type 1 diabetes, called the soon-to-be-law “just a start.”

“I look forward to working with the attorney general’s office on their investigation and to bring forward more legislation for transparency and lower costs for Coloradans with diabetes,” Roberts said in a statement.

Powers, who called the Colorado law interesting, said it could serve as an example to other states, but could also go further.

“This law will cover all forms of insulins, not just low-cost insulins. It is an example of how the government may intervene in this area, and that would bring down cost,” Powers said. “Now, that of course assumes everyone is insured. If you’re uninsured, you’re still in trouble. Those are the people we see rationing and in dire straits.”

Federal proposals

In announcing findings from a 2018 bipartisan insulin pricing inquiry, Reps. Diana DeGette, D-Colo., and Tom Reed, R-N.Y., co-chairs of the Congressional Diabetes Caucus, noted that value-based contracting, a system that sets the cost of a drug based on its efficacy, could serve as a potential model to lower insulin costs.

“Another good theory is to have rebates tied to how effective the drug is,” Wineinger said. “If a drug is particularly effective, we would require fewer rebates, so then the price is actually closer to what the drug lists at vs. if the drug tends not to be as effective.”

But insulin, the co-chairs noted, could prove a more difficult candidate for such a program, also known as a VBC, in part because of the biology of diabetes and its typical care regimen. Stakeholders also pointed to administrative and operational barriers, lack of technologic infrastructure, and challenging or vague regulations as obstacles to implementing VBCs specifically for insulin.

“Given the rarity of these contracts, stakeholders were asked to describe hypothetical insulin VBCs,” DeGette and Reed wrote in their summary report. “Some respondents said that an insulin VBC would likely be outcomes-based, involving metrics such as HbA1c levels. Others replied that this type of contract would be based on prespecified endpoints, such as insulin adherence or persistence thresholds. In either case, stakeholders reiterated that it would be difficult to develop an insulin-specific VBC.”

In May, HHS enacted one of the first concrete steps toward President Donald J. Trump’s pledge to lower drug prices, in finalizing a federal rule requiring the list prices of certain drugs be mentioned in television ads. Eckel, who is also president-elect of medicine and science for the ADA, said much more must be done to increase pricing transparency.

“The evidence that we have obtained shows much of the blame does reside with the PBMs, but that is not the only issue,” Eckel said. “Rebates and copays have not met the need.”

Kowalski said JDRF is “cautiously optimistic” that real solutions may come from Washington soon.

Robert Eckel

“The tone on the hill was very positive in terms of appreciating the challenges, and it was completely bipartisan, which is encouraging to us that both Republicans and Democrats are aligned on this needing to be fixed,” Kowalski said.

Balancing price, innovations

As the debate about pricing continues, Powers said health care providers must be proactive in screening patients with diabetes for cost issues that may restrict access to insulin.

“Physicians have a responsibility to understand how their patients pay for their insulin and then have an educated discussion with them,” Powers said. “Physicians need to talk with their patients about the different types of insulins — which vary considerably by cost — and match the right insulin for the right person at the right time. People with diabetes can be treated with regular or NPH insulin. Is another insulin worth three times more?”

Still, other experts noted that recent advances in rapid-acting insulins have improved outcomes and quality of life for people with diabetes. A balance must be struck, those experts said, between lowing insulin costs and spurring innovation.

“Sometimes, people will argue that we haven’t seen any innovation in insulins, so how is it so expensive? Well, we actually have,” said Kowalski, who noted he used bovine and porcine insulins when he first received his type 1 diagnosis. “JDRF is very focused on next-generation insulins. There is still a big unmet need here. There is still a lot of hyperglycemia. There is still a lot of hypoglycemia. We could use faster-acting insulins. We’re excited about the potential of what we call glucose-responsive insulins. We do want to see the next generations of these drugs and not get stuck here.”

Lipska said engaged stakeholders must be “loud and clear” in putting pressure on federal legislators to change regulations that will force all actors in the insulin supply chain to lower the price of insulin.

“This is as good a chance as we have now,” Lipska said. “There are congresspeople pushing for changes. What Colorado did is a step in the right direction, but it doesn’t change the price of insulin, and it leaves people without private insurance out. If we force a lower list price of insulin, that would have a far more widespread effect.” – by Regina Schaffer

Editor’s note: CVS Health, Express Scripts, Optum RX and Novo Nordisk did not respond to multiple requests for an interview.

Disclosures: Eckel reports he serves on advisory boards for Kowa and Sanofi/Regeneron. Kowalski is chief mission officer for the JDRF. Lipska, Powers and Wineinger report no relevant financial disclosures.

Click here to read the POINTCOUNTER, "Will more biosimilar agents help lower the high cost of insulin?"

Calls to reduce insulin prices are getting louder, yet people with diabetes continue to pay more every year for a drug WHO deems an essential medicine. According to 2017 data from the Health Care Cost Institute, insulin prices, which tripled from 2002 to 2013, continue to climb, nearly doubling between 2012 and 2016. For people with diabetes and employer-sponsored insurance, the average price for a 40-day supply of insulin rose from $344 to $666 during those same years, according to the report.

During that same period, the average list price of the four insulin categories — short-acting insulin, long-acting insulin, rapid-acting insulin vials and rapid-acting insulin pens — increased between 15% and 17% per year, according to data from the American Diabetes Association’s Insulin Access and Affordability Working Group, published in 2018.

“Insurance for many people continues to change, as people continue to bear more of the cost for insulin,” Aaron J. Kowalski, PhD, chief mission officer for the JDRF, told Endocrine Today. “There is increased visibility of the problem — you hear continuing stories of people who are rationing their insulin. It is a culmination of all these issues now crystallizing, and people are realizing that we need a change.”

Pharmaceutical companies and pharmacy benefit managers will either reduce insulin prices on their own or be forced to through legislation, according to Alvin C. Powers, MD.

Photo by Jessica Kimber, Vanderbilt University Medical Center. Printed with permission.

The numbers and patient stories have caught the attention of the federal government. In April, the three manufacturers of insulin, Eli Lilly, Novo Nordisk and Sanofi, and the nation’s three largest pharmacy benefit managers, CVS Health, Express Scripts and Optum RX, appeared together before Congress to respond to the growing protest over insulin access, at times blaming one another for high list prices.

The outcry — from the public and U.S. government alike — is spurring changes. In the months since the congressional hearings, Eli Lilly and Sanofi announced new plans to offer bigger discounts, including the introduction of an “authorized generic” insulin. In April, the insurer Cigna and its pharmacy benefit manager (PBM) division, Express Scripts, introduced a plan to cap out-of-pocket insulin costs for eligible plan members. In May, Colorado capped copayments for insulin at $100 a month, regardless of the type or supply required, with insurance companies absorbing the balance. Still, insulin manufacturers and other stakeholders are calling for more comprehensive solutions.

PAGE BREAK

“All the activity in this space in the last few months is remarkable,” Alvin C. Powers, MD, director of the Vanderbilt Diabetes Center and director of the division of diabetes, endocrinology and metabolism at Vanderbilt University Medical Center, told Endocrine Today. “The role of the American Diabetes Association and groups like the Endocrine Society cannot be underestimated. This began as an initiative through ADA back in 2017 when they launched an online petition and 500,000 people signed it. All of this snowballed and generated momentum that galvanized everyone. Now, [insulin pricing] is all anyone can talk about.”

‘Highly correlated’ price trends

The high price of insulin is not a problem reserved for medically indigent patients. Robert H. Eckel, MD, professor of medicine in the divisions of endocrinology, metabolism and diabetes and cardiology at the University of Colorado Denver Anschutz Medical Campus, recalled stopping in a pharmacy while on a recent trip to Paris.

He was shopping for lower-cost insulin for his children.

“I had told my sons that their Christmas gift would be a surprise,” Eckel, who has two adult sons with type 1 diabetes, told Endocrine Today. “It was not bringing home new pairs of designer jeans. My French was good enough that I was able to convince the woman at the pharmacy that I was a physician and that I had a need to buy insulin to save money in the states. ... We got the message across that I wanted to buy all the insulin she had.”

Eckel said he did the math: Using insurance copays, his sons would have paid five times more than what he paid in Paris, where he ultimately saved thousands of dollars.

As physicians, “we respond to crises, and this has become a crisis,” Powers said. “It became highly visible, and now, there is a lot of energy. The PBMs and pharma understand that they are being scrutinized. If they don’t come forward with solutions that reduce insulin costs, the government is likely to step in and do things that they won’t like.”

In an analysis of claims data from more than 35 million individuals published in May in JAMA Network Open, Nathan E. Wineinger, PhD, assistant professor in the department of integrative structural and computational biology at Scripps Research, California, and colleagues observed that 17 of the top-selling brand-name drugs — among them, nine diabetes therapies — more than doubled in cost over 6 years. These included insulin lispro (Humalog, Eli Lilly; 117% increase), regular and NPH insulin (Humulin, Eli Lilly; 117% increase) and insulin aspart (NovoLog, Novo Nordisk; 118% increase).

PAGE BREAK

Wineinger and colleagues analyzed prescription-level pharmacy claims data from 2012 to 2017 via Blue Cross Blue Shield Axis, a database with information for more than 35 million individuals with private pharmaceutical insurance in the United States. The drugs in the analysis exceeded $500 million in U.S. sales or $1 billion in worldwide sales, reached at least 100,000 total pharmacy claims and were covered under insurance for at least 3 years. Primary outcome was total price paid of each claim, including median sum of out-of-pocket and insurance costs paid by patients or insurers for common prescriptions.

“What was disheartening was our observation that prices among drugs that treat similar conditions, like insulins, had highly correlated price trends, more so than any other products,” Wineinger told Endocrine Today. “At the same time, these drugs had some of the largest relative price increases. I would hope that competition, in this case among insulin manufacturers, would keep prices down. Instead, it appears that competitors are responsive to one another, but not in a way that lowers prices for consumers.”

In addition, prices paid were correlated with third-party estimates of changes in drug net prices, suggesting that the current drug rebate system increases overall costs.

Aaron J. Kowalski

“What was shocking was how near universal these price increases were,” Wineinger said. “When we pulled price data from another source ... these prices being paid are seen in the net price data as well. One conclusion we can make is the rebate system that is incentivizing high list prices isn’t controlling the cost at the end of the day.”

Insulin rationing

In a study published in January, Kasia J. Lipska , MD, MHS, clinical investigator with the Yale-New Haven Medical Center for Outcomes Research and Evaluation at Yale University, and colleagues surveyed 199 clinic patients with type 1 or type 2 diabetes prescribed insulin within the past 6 months who had an outpatient visit at the Yale Diabetes Center from June to August 2017 (56.2% women; 60.8% white; 41.7% with type 1 diabetes). The primary outcome was cost-related underuse of insulin in the past 12 months, defined by a positive response to any of six questions about using less insulin than prescribed, stopping insulin or not filling an insulin prescription because of cost. Researchers examined the association between cost-related underuse and poor glycemic outcomes.

“The study was inspired by patients I was seeing in clinic who told me stories about the inability to obtain affordable insulin,” Lipska told Endocrine Today. “Some patients brought me bills to look at. Others would say, ‘No way, I can’t increase my Lantus dose.’ As the debate about insulin prices was starting, people said to me, ‘You have these stories, but how common is this?’ That led me to document it. Were these just anecdotes?”

PAGE BREAK

Within the survey cohort, 25.5% reported cost-related insulin underuse, and the type of prescription drug coverage was not associated with cost-related underuse. Compared with patients who did not report cost-related underuse, those who did were nearly three times more likely to have an HbA1c of at least 9% (OR = 2.96; 95% CI, 1.14-8.16).

“The findings actually did surprise me,” Lipska said. “One in four patients are rationing insulin. If anything, at Yale Diabetes Center, I thought the problem would be less widespread because we have good statewide coverage for insulin for patients covered by Medicaid. Instead, we found that insulin rationing was widespread and common. This is the direct effect of the high price of insulin. It is unconscionable, and it has to change.”

‘Filling gaps in the system’

In March, Eli Lilly announced it would introduce an authorized generic version of insulin lispro injection in the U.S., promising a list price 50% lower than the current Humalog list price. The lower-priced version is called “insulin lispro” and is the same molecule as Humalog, according to the company. The list price of a single vial is $137.35, according to Lilly. The list price of a five-pack of KwikPens is $265.20.

The insulin is made available through a Lilly subsidiary, ImClone Systems. Humalog will also remain available for people who want to continue accessing it through their current insurance plans, according to the company.

“We are committed to ensuring everyone living with diabetes has reasonable access to insulin, and we appreciate congressional interest in this topic,” Michael B. Mason, senior vice president of connected care and insulins at Eli Lilly, told Endocrine Today before the congressional hearing in April. “We remain focused on filling gaps in the system, such as with our lower-priced, authorized generic insulin, until a more sustainable model is achieved.”

In an email interview, Mason said a comprehensive solution requires commitment from all stakeholders in the health care system.

“Until a comprehensive solution is reached, we will continue our affordability solutions that provide thousands of people each month with access to insulin at significantly reduced cost or for free,” Mason said.

Similarly, Sanofi announced in May that it would expand its “Insulins Valyou Savings Program.” Under the enhanced discounts, which went into effect June 8, uninsured patients pay $99 to access their Sanofi insulins (Lantus, Toujeo, Admelog and Apidra), with a valid prescription, for up to 10 boxes of pens and/or 10 mL vials per month. The prior program offered one set price for each 10 mL vial ($99) or box of pens ($149).

PAGE BREAK

“Since 2012, the net price of Sanofi insulins has declined by 25%, yet patient out-of-pocket costs have continued to rise,” Jon Florio, manager of diabetes communications for Sanofi, told Endocrine Today. “Over the same period, the price of our most prescribed insulin, Lantus, has actually fallen over 30%, while average out-of-pocket costs for patients with commercial insurance and Medicare has risen approximately 60%. It is our belief that growing rebates and declining net prices should result in lower out-of-pocket costs for patients, but that is not always the case.”

Kasia J. Lipska

In remarks before the congressional committee in April, Douglas J. Langa, executive vice president of North America operations and president of Novo Nordisk, said that, in addition to a diabetes patient assistance program and co-pay assistance programs, the company has partnered with Walmart since 2000 to offer human insulin for approximately $25 a vial. In 2017, Novo Nordisk partnered with CVS Health and ESI to expand the $25 human insulin offering to thousands more pharmacies nationwide.

“Last year, we also started to provide human insulin in a convenient pen injection device through Walmart,” Langa said. “Through the CVS Health and ESI programs, commercially eligible patients can purchase this same Novo Nordisk insulin for around $25 at 68,000 pharmacies in the CVS Health retail network and 40,000 ESI participating pharmacies. In total, through these partnerships, Novo Nordisk estimates that it is currently providing high quality, affordable Novo Nordisk-manufactured human insulin to over 500,000 people.”

Critics of pharmaceutical company programs note that discount programs do not benefit everyone; Medicare and Medicaid bar patients from using pharmaceutical company-funded discount coupons or programs, whereas insured patients with high-deductible plans can still fall through the cracks.

In an interview with Endocrine Today,Rep. Joe Kennedy III, D-Mass., who serves on the U.S. House Committee on Energy and Commerce’s Oversight and Investigations Subcommittee, which is investigating insulin prices, called such programs “temporary solutions” and said more comprehensive steps must be taken at the federal level.

“Any proposal that will increase access to affordable insulin should be a welcome development, but temporary solutions intended to lessen accountability and congressional oversight should not be mistaken for systemic reforms that lower prices of lifesaving pharmaceuticals,” Kennedy said. “From cracking down on patent abuses to increased transparency to strengthened accountability for price gouging, Congress needs to consider addressing every leverage point we have at our disposal because people are dying due to unaffordable medication. In the wealthiest nation on earth, our neighbors should not be dying because they have been priced out of life.”

PAGE BREAK

State solutions

On May 22, Gov. Jared Polis of Colorado signed the first bill in the nation that will cap insulin copays for people with private insurance at $100 per month, regardless of the number of vials needed. The new law also enlists the Colorado attorney general to investigate the rising price of insulin in the state and make recommendations to the general assembly for further action. In a statement, LaShawn McIver, MD, senior vice president of government affairs and advocacy for the ADA, called the legislation “monumental.”

Rep. Dylan Roberts, D-Colo., who co-sponsored the legislation and whose brother died from complications of type 1 diabetes, called the soon-to-be-law “just a start.”

“I look forward to working with the attorney general’s office on their investigation and to bring forward more legislation for transparency and lower costs for Coloradans with diabetes,” Roberts said in a statement.

Powers, who called the Colorado law interesting, said it could serve as an example to other states, but could also go further.

“This law will cover all forms of insulins, not just low-cost insulins. It is an example of how the government may intervene in this area, and that would bring down cost,” Powers said. “Now, that of course assumes everyone is insured. If you’re uninsured, you’re still in trouble. Those are the people we see rationing and in dire straits.”

Federal proposals

In announcing findings from a 2018 bipartisan insulin pricing inquiry, Reps. Diana DeGette, D-Colo., and Tom Reed, R-N.Y., co-chairs of the Congressional Diabetes Caucus, noted that value-based contracting, a system that sets the cost of a drug based on its efficacy, could serve as a potential model to lower insulin costs.

“Another good theory is to have rebates tied to how effective the drug is,” Wineinger said. “If a drug is particularly effective, we would require fewer rebates, so then the price is actually closer to what the drug lists at vs. if the drug tends not to be as effective.”

But insulin, the co-chairs noted, could prove a more difficult candidate for such a program, also known as a VBC, in part because of the biology of diabetes and its typical care regimen. Stakeholders also pointed to administrative and operational barriers, lack of technologic infrastructure, and challenging or vague regulations as obstacles to implementing VBCs specifically for insulin.

“Given the rarity of these contracts, stakeholders were asked to describe hypothetical insulin VBCs,” DeGette and Reed wrote in their summary report. “Some respondents said that an insulin VBC would likely be outcomes-based, involving metrics such as HbA1c levels. Others replied that this type of contract would be based on prespecified endpoints, such as insulin adherence or persistence thresholds. In either case, stakeholders reiterated that it would be difficult to develop an insulin-specific VBC.”

PAGE BREAK

In May, HHS enacted one of the first concrete steps toward President Donald J. Trump’s pledge to lower drug prices, in finalizing a federal rule requiring the list prices of certain drugs be mentioned in television ads. Eckel, who is also president-elect of medicine and science for the ADA, said much more must be done to increase pricing transparency.

“The evidence that we have obtained shows much of the blame does reside with the PBMs, but that is not the only issue,” Eckel said. “Rebates and copays have not met the need.”

Kowalski said JDRF is “cautiously optimistic” that real solutions may come from Washington soon.

Robert Eckel

“The tone on the hill was very positive in terms of appreciating the challenges, and it was completely bipartisan, which is encouraging to us that both Republicans and Democrats are aligned on this needing to be fixed,” Kowalski said.

Balancing price, innovations

As the debate about pricing continues, Powers said health care providers must be proactive in screening patients with diabetes for cost issues that may restrict access to insulin.

“Physicians have a responsibility to understand how their patients pay for their insulin and then have an educated discussion with them,” Powers said. “Physicians need to talk with their patients about the different types of insulins — which vary considerably by cost — and match the right insulin for the right person at the right time. People with diabetes can be treated with regular or NPH insulin. Is another insulin worth three times more?”

Still, other experts noted that recent advances in rapid-acting insulins have improved outcomes and quality of life for people with diabetes. A balance must be struck, those experts said, between lowing insulin costs and spurring innovation.

“Sometimes, people will argue that we haven’t seen any innovation in insulins, so how is it so expensive? Well, we actually have,” said Kowalski, who noted he used bovine and porcine insulins when he first received his type 1 diagnosis. “JDRF is very focused on next-generation insulins. There is still a big unmet need here. There is still a lot of hyperglycemia. There is still a lot of hypoglycemia. We could use faster-acting insulins. We’re excited about the potential of what we call glucose-responsive insulins. We do want to see the next generations of these drugs and not get stuck here.”

Lipska said engaged stakeholders must be “loud and clear” in putting pressure on federal legislators to change regulations that will force all actors in the insulin supply chain to lower the price of insulin.

“This is as good a chance as we have now,” Lipska said. “There are congresspeople pushing for changes. What Colorado did is a step in the right direction, but it doesn’t change the price of insulin, and it leaves people without private insurance out. If we force a lower list price of insulin, that would have a far more widespread effect.” – by Regina Schaffer

Editor’s note: CVS Health, Express Scripts, Optum RX and Novo Nordisk did not respond to multiple requests for an interview.

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Disclosures: Eckel reports he serves on advisory boards for Kowa and Sanofi/Regeneron. Kowalski is chief mission officer for the JDRF. Lipska, Powers and Wineinger report no relevant financial disclosures.

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