Medical World News: Policy Updates

Congress' Diabetes Caucus Seeks Transparency, Value-Based Contracts to Control Insulin Prices

Value-based contracts and alternative payment models that remove rebates are just 2 ways that policy makers could rein in skyrocketing insulin prices, according to a new report from the Congressional Diabetes Caucus, a bipartisan group that spent a year asking why prices have soared over the past decade for a hormone some patients need to stay alive.

The report came on the first day of November, which is Diabetes Awareness Month. With the report, came word that Sanofi would expand a program¹ to help reduce out-of-pocket costs for those who use insulin.

Out-of-pocket costs for insulin can exceed $600 a month, and some patients now ration insulin or skip doses. This spring, the CDC reported² a rise in hospitalizations from diabetic ketoacidosis, which can occur when patients miss insulin doses.

Insulin manufacturers have been under fire for more than a year over rising costs. All 3 major companies—Sanofi, Novo Nordisk, and Eli Lilly—are involved in federal litigation³ over pricing practices, which has stalled over whether pharmacy benefit managers (PBMs) should be sued at the same time.

The Caucus, led by US Representatives Tom Reed (R-New York) and Diana DeGette (D-Colorado), reached conclusions somewhat similar to the plaintiffs in the lawsuit. In its report,⁴ the group found that the current system of rebates paid to PBMs, which critics say distorts prices across a range of therapies, hits especially hard in the insulin market.

The report outlines the complex insulin delivery supply chain and an even more byzantine reimbursement system, which entices various parts of the supply chain to make more money as the cost of insulin rises. Both wholesalers and PBMs make money when insulin is sold at a price greater than its acquisition cost. But then manufacturers pay PBMs rebates to encourage access to formulary, which causes insulin prices to rise to cover that spread.

Confidentiality agreements have kept information on rebates under wraps, but the report said that data show they can amount to as much as 40%. A lawsuit filed last month by the Minnesota attorney general contained redacted information that appeared to discuss a rebate contract.

Caucus members called for capping out-of-pocket costs for prescription drugs that treat chronic conditions, because skipping medication can make the disease worse. “When patients do not adhere to their prescribed chronic condition treatment plans, they often times make unnecessary visits to the hospital, where they receive expensive care,” the report states.

“Capping out-of-pocket costs for life-sustaining drugs like insulin could help patients better manage their diabetes and avoid adverse outcomes leading to unnecessary hospitalizations.”

Other policy recommendations focused on breaking apart these incentives for higher pricing:

• Value-based contracts between insulin makers and PBMs would reward the supply chain for better outcomes instead of encouraging patients to skip insulin.
• Alternative payment models that remove rebates could be required in Medicare and Medicaid.
• Patient out-of-pocket costs should be linked to negotiated prices, not wholesale costs.
• Policy makers should promote the development of follow-on products by taking on patent extensions.
• Generic manufacturers should be able to make older insulins that the top 3 manufacturers have pulled off the market.
• More transparency is needed at every step, and manufacturers should be required to disclose list prices.
• Policy makers should standardize formulary appeals and limit the number of formulary changes per year.

Sanofi’s announcement,¹ which is available to qualifying patients, previously offered 2 insulins at a discounted price. The revised program, available at all US pharmacies, will offer all Sanofi insulins at a set price: $99 for a 10 mL vial or $149 for a box of pens. Company officials said some patients will save up to $3000 a year.

When Sanofi launched the Insulins VALyou Savings Program program, “Our goal was to support as many uninsured and underinsured people living with diabetes as we could, and we pledged to explore how to increase affordable access in the future,” said Michelle Carnahan, North America head of Diabetes and Cardiovascular, Sanofi.

“We’re making good on that pledge today by expanding this program. While we are off to a good start, we know that many people continue to look for more affordable insulin options. We hope the expansion and increased awareness of this program will allow more people to benefit from it.”

References:

1. Sanofi expands insulins VALyou savings program, helping more people living with diabetes [press release]. Bridgewater, NJ: Sanofi; November 1, 2018. prnewswire.com/news-releases/sanofi-expands-insulins-valy- ou-savings-program-helping-more-people-living-with-diabetes-300741477.html. Accessed November 2, 2018.
2. Benoit SR, Zhang Y, Geiss LS, Gregg EW, Albright A. Trends in diabetic ketoacidosis hospitalizations and in-hospital mortality—United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2018;67(12):362-365. doi: 10.15585/mmwr.mm6712a3.
3. Caffrey M. Out-of-pocket costs for insulin are a problem. litigants in case disagree on who is at fault. The American Journal of Managed Care^® website. ajmc.com/newsroom/out-of-pocket-costs-for-insulin-are-a-prob- lem-litigants-in-case-disagree-on-who-is-at-fault. Published March 22, 2018. Accessed November 2, 2018.
4. DeGette D, Reed T. Insulin: a lifesaving drug too often out of reach. Congressional Diabetes Caucus website. diabetescaucus-degette.house.gov/sites/diabetescaucus.house.gov/files/Congressional%20Diabetes%20Cau- cus%20Insulin%20Inquiry%20Whitepaper%20FINAL%20VERSION.pdf. Accessed November 2, 2018.

Cancer Surpasses CVD as Leading Cause of Death in High-Income Counties

Although mortality from both cancer and cardiovascular disease (CVD) has steadily decreased in recent decades, CVD mortality has decreased more rapidly, resulting in cancer surpassing CVD as the leading cause of death in high-income counties in the United States, according to a new study.¹ However, CVD is still more likely to be the leading cause of death in low-income counties.

These findings mirror state-level data, which has shown that CVD was consistently the leading cause of death in the United States from 1950 to 2014, but starting in 2000, cancer mortality surpassed heart disease mortality in 2 states: Alaska and Minnesota. By 2014, cancer became the leading cause of death in 22 states.

“Heart disease has been the primary cause of death since the shift toward chronic disease as the leading cause of death in the United States in the early 1900s,” wrote the study researchers. But mortality rates have decreased, which “has been largely attributed to decreased smoking, improved awareness of diet and physical inactivity as risk factors, and better treatment of cardiovascular risk factors and acute coronary syndromes.”

As this shift continues, despite increasing rates of obesity and diabetes,² researchers have estimated that cancer is expected to surpass CVD as the leading cause of death nationwide by 2020. Seeking to understand how this transition is occurring in regions with different levels of economic development, researchers examined US death records from 2003 to 2015 from the National Center for Health Statistics’ Multiple Cause of Death mortality files.

The researchers identified a total of 32,510,810 deaths across 3143 counties. During the study period, the age- and sex-adjusted mortality rate decreased by 12% in the total population, 7% in the lowest-income counties, and 15% in the highest-income counties.

Mortality rates for heart disease decreased by 28% (30% in high-income counties vs 22% in low-income counties), and cancer mortality rates decreased by 16% (18% in high-income counties vs 11% in low-income counties). CVD was the leading cause of death in 79% of all counties in 2003 compared with 59% in 2015, and cancer was the leading cause of death in 21% of counties in 2003 compared with 41% in 2015.

The transition to cancer as the leading cause of mortality in the United States occurred earlier in high-income countries than in low-income counties and earlier for Asian Americans, Hispanics, and non-Hispanic whites than for blacks and American Indians/Alaska Natives.

Expanding on these disparities, the researchers wrote: “Our data indicate continued disparities in cardiovascular and cancer mortality between blacks and other racial/ethnic groups, even in the highest-income quintiles. Blacks had higher overall mortality than any other group.”

However, the findings also suggest greater improvements for blacks than all other racial/ethnic groups for all-cause, CVD, and cancer mortality during the study period.

References:

1. Hastings KG, Boothroyd DB, Kapphahn K, et al. Socioeconomic differences in epidemiologic transition from heart disease to cancer as the leading cause of death in the United States, 2003 to 2015: an observational study [published online November 13, 2018]. Ann Intern Med. doi: 10.7326/M17-0796.
2. Caffrey M. Gallup-Sharecare report shows how diabetes ranks grew across the US. The American Journal of Managed Care^® website. www.ajmc.com/newsroom/gallupsharecare-report-shows-how-diabetes-ranks-grew- across-the-us. Published November 13, 2018. Accessed November 13, 2018.

ADA Embraces CV Risk Calculator, Calls for Using GLP-1s Before Insulin in Type 2 Diabetes

The growing connection between treatment for diabetes and management of cardiovascular risk bore more fruit December 17, 2018, with the release of the American Diabetes Association (ADA) 2019 Standards of Medical Care in Diabetes, which marked the first the time the chapter on cardiovascular disease management was endorsed by the American College of Cardiology (ACC).

ADA’s new Standards of Care endorse the use of ACC’s and Atherosclerotic Cardiovascular Disease (ASCVD) Risk Estimator Plus, which assesses a person’s 10-year ASCVD risk in people with diabetes.

A separate change updates ADA’s recommendation for injectable medication in patients with type 2 diabetes (T2D): in most cases, those who need additional help lowering glucose should start with glucagon-like peptide-1 (GLP-1) receptor agonists before adding basal insulin or switching to a GLP-1/ insulin combination therapy.¹

The update comes less than a month after ADA similarly endorsed the cardiologists’ new pathway for patients with T2D and ASCVD. The updated ADA standards feature new language on the role of sodium glucose co-transporter 2 (SGLT2) inhibitors and GLP-1 receptor agonists in T2D care, and the need to consider heart failure in overall diabetes care.²

“For prevention and management of both ASCVD and heart failure, cardiovascular risk factors should be systematically assessed at least annually in all patients with diabetes,” the recommendation states. The ADA document notes that risk scores and biomarkers have been developed for secondary prevention, which could help identify patients who could be candidates for lipid- lowering therapies.

The changes come as the FDA weighs possible changes to practice-changing cardiovascular outcomes trials, which emerged a decade ago in the wake of concerns about the safety of some classes of glucose-lowering treatments for diabetes. Not only did these trials demonstrate that SGLT2 inhibitors and GLP-1 receptor agonists did not cause heart attacks, strokes, or cardiovascular death, but the studies showed that some treatments offered cardiovascular benefits.

More trials are under way to study additional benefits to patients with heart failure or chronic kidney disease (CKD), and the ADA recommendations address the usefulness of SGLT2 inhibitors and GLP-1 receptor agonists for patients with CKD.

The 2019 Standards of Care also carry forward ADA’s previous statements about the need to make insulin more affordable and the recent joint statement with the European Association for the Study of Diabetes on treatment for hypertension in people with diabetes.

Additional updates discuss diabetes technology, medical nutrition, reducing therapeutic inertia, managing diabetes in overweight youth, and simplifying or scaling back medication for persons with diabetes who 65 years of age or older.

“The latest evidence-based research continues to provide critical information that can optimize treatment options and improve patient outcome and quality of life,” ADA Chief Scientific, Medical and Mission Officer William T. Cefalu, MD, said in a statement, noting the importance of the collaboration with ACC and the alignment of recommendations.

References:

1. American Diabetes Association. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2019. Diabetes Care. 2019; 42(suppl 1): S90-S102. doi: 10.2337/dc19-S009.
2. American Diabetes Association. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes—2019. Diabetes Care. 2019; 42(suppl 1): S103-S123. doi: 10.2337/dc19-S010.

Biosimilars Could Drastically Reduce the Cost of Insulin

Despite the fact that insulin is indispensable for approximately 100 million people with diabetes worldwide, an estimated half of those patients have no reliable supply of insulin, due in large part to cost.

A newly published study¹ in BMJ Global Health sought to assess the cost to produce insulin and to examine how biosimilar insulin, if manufactured on a large scale, could reduce the cost of treatment for patients with diabetes.

The investigators designed formulae for estimating competitive, but profitable, prices for biosimilar insulin using the cost of an active pharmaceutical ingredient (API) and excipients either exported from India or based on quotes from biosimilar manufacturers, the cost of formulation into vials, development and regulatory costs, and a margin for operating expenses and profit.

Given the figures available, the authors calculated an estimated cost of production per vial of $1.45 to $9.64. They then arrived at the following estimated prices for biosimilar insulin treatment (in vial presentation) per patient per year:

• Regular human insulin: $48 to $71
• Neutral protamine Hagedorn insulin: $49 to $72
• Insulin glargine: $78 to $108
• Insulin lispro: $95 to $130
• Insulin aspart: $95 to $129
• Insulin glulisine: $94 to $128
• Insulin detemir: $283 to $365
• Insulin degludec: $98 to $133

Worldwide, current prices are far higher. Given government procurement prices for these drugs in multiple nations, including the United States (where insulins are regulated as drugs and not as biologics, and where subsequent-entry products are treated as follow-ons, rather than biosimilars), prices for regular human insulin are a median of 1.2 to 1.8 times the estimated prices, and current prices of insulin glargine, insulin lispro, and insulin aspart are a median of 5.6 to 7.8, 2.7 to 3.7, and 2.6 to 3.5 times higher, respectively, than the estimated biosimilar prices.

“Comparison of estimated prices with recent government procurement prices suggests that robust competition in the human insulin and insulin analogue market would lead to sizeable savings in most countries and that current manufacturers could set significantly lower prices while still making a profit,” write the study’s authors.

The authors also note that prices could go even lower, as prices for APIs are falling: “Even at the low volumes currently being exported from India, the linear regression models showed an 18% yearly decrease in price for exported human insulin API and a 27% yearly decrease for insulin glargine. It would be reasonable to expect that with increasing biosimilar production, API prices will continue to fall.”

The authors call for national policies, such as tenders and special incentives, to spur biosimilar competition among multiple competitors and to help generate these substantial cost savings for health systems and for patients with diabetes.

Reference:

1. Gotham D, Barber MJ, Hill A. Production costs and potential prices for biosimilars of human insulin and insulin analogues. BMJ Glob Health. 2018;3(5):e000850. doi: 10.1136/bmjgh-2018-000850.

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