7/18/2019
`
`What's Behind the Rising Costs of Insulin | For Better | US News
`
`te;:lo .#A
`
`HEALTH
`
`Insulin Costs Are Skyrocketing. This Is Why.
`
`Plus, what to do if you're a patient.
`
`By Dr. Kevin Campbell, Contributor June 29, 2018
`
`ACCORDING TO THE Centers for Disease Control and Prevention, more than 30 million Americans have
`diabetes – representing nearly 10 percent of our population. Those with Type 1 (insulin dependent)
`diabetes must inject daily insulin in order to survive. While Type 2 diabetes is far more common than
`Type 1, nearly one-third of those with Type 2 must also inject insulin on a daily basis. For some, the cost
`of diabetic supplies – particularly insulin – can lead to negative health consequences. In the last several
`decades, insulin prices have skyrocketed.
`
`Insulin, discovered in 1921 has no generic competitors – only brand-name products are produced. A
`new study was presented in late June at the American Diabetes Association's annual scientic sessions
`showing that the cost of insulin results in nearly 25 percent of patients not taking insulin as they should.
`"Self-rationing" of insulin by patients can result in serious and potentially life-threatening complications
`such as blindness, loss of limbs, kidney failure and even death. Many patients are going to pharmacies
`only to nd out that they must pay hundreds – if not thousands – of dollars for insulin.
`
`[Read: 8 Complications of Diabetes.]
`
`What Is Diabetes? A Quick Primer
`
`Diabetes occurs when your body can no longer handle sugars as they're ingested as food or drink. In
`Type 1 diabetes, the pancreas (an organ which makes insulin) no longer functions properly, and the only
`solution is to use articially produced insulin either from injections or from an insulin pump. In Type 2
`diabetes, the body can no longer respond to insulin and becomes "resistant." In both types, blood sugar
`uctuations can be harmful to multiple organs and create lifelong complications. While there's no cure
`for Type 1 diabetes, Type 2 can be reversed with diet, weight loss and exercise (in some cases). All
`patients with Type 1 diabetes must have daily insulin – some with Type 2 diabetes require insulin, while
`others can be treated with oral medications.
`
`https://health.usnews.com/health-care/for-better/articles/2018-06-29/whats-behind-the-rising-costs-of-insulin
`
`1/7
`
`Mylan Ex.1090
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`7/18/2019
`
`What's Behind the Rising Costs of Insulin | For Better | US News
`
`D> x
`
`Why Is Insulin So Expensive?
`
`Insulin is a biologic compound that can be dicult and expensive to produce. There are several reasons
`it's become increasingly expensive – some are due to the biology and process involved in the
`manufacturing, and some are related to government regulations and the pharmaceutical industry's
`desire to continue to make a prot. From a biologic standpoint, insulin is created for human use by
`either "growing" an animal pancreas to produce insulin suitable for injection or by using recombinant
`DNA techniques that create bacteria that can produce large amounts of insulin for human use. Almost
`all insulin is created through the use of recombinant DNA techniques. Historically, pharmaceutical
`companies have simply made modications to existing insulin types rather than work on the production
`of a "generic" or biosimilar product. While certainly possible, it's a bit more complicated to create a
`biosimilar form of insulin that would meet the standard for Food and Drug Administration approval.
`Moreover, the development of a generic or biosimilar insulin would be incredibly costly for the
`manufacturer but of a great benet to patients.
`
`[Read: 6 Ways to Save Money on Your Diabetes Medications.]
`
`From a regulatory perspective, insulin makers are protected from generic competitors under patent law.
`A patent allows a manufacturer to sell a product unchallenged for a certain number of years prior to
`approving a generic. In many cases, insulin makers continue to "tweak" current insulin products in order
`to extend their exclusivity rights. In addition, there's little incentive for pharmaceutical companies to
`spend millions of dollars to develop a cheaper alternative. Because insulin is considered a "biologic"
`drug, the FDA approval process is far more stringent and can take much longer than for other types of
`drugs. In addition, the FDA process is very costly for drug manufacturers. In the case of most generic
`alternatives, the generic can reduce costs by nearly 80 percent. In the case of insulin (because even a
`generic is expensive to produce), it's estimated that a generic form will only reduce costs by 20 percent.
`Unfortunately, it's my belief that the large manufacturers of insulin – Sano, Eli Lilly and Novo Nordisk –
`are working to make the development of generic insulins more dicult. In fact, Sano has led lawsuits
`against both Merck and Mylan to prevent them from going to market with a generic lantus insulin (the
`Sano blockbuster drug).
`
`https://health.usnews.com/health-care/for-better/articles/2018-06-29/whats-behind-the-rising-costs-of-insulin
`
`2/7
`
`Mylan Ex.1090
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`7/18/2019
`
`What's Behind the Rising Costs of Insulin | For Better | US News
`
`D> x
`
`X
`
`What Can Be Done? A Call to Action
`
`The patents on the latest insulin analogues are expiring, and there's now a pathway for FDA approval.
`There are biosimilar forms of insulin that have been approved in Europe, and some are available in the
`U.S. A class action lawsuit has been led against all three manufacturers of insulin, accusing them of
`setting articially high prices in order to provide certain insurance providers with preferred discounts –
`most of which don't get passed on to the patient.
`
`[Read: 11 Ways to Save on Diabetes Supplies.]
`
`For patients, it's important to take action:
`
`1. Talk to your doctor about switching to a less expensive insulin. Make sure you're taking the type of
`insulin that's best for you at the best price point. And ensure your brand of insulin is on your insurance
`company's formulary.
`2. Work with your local, state and U.S. representatives to effect legislative change to better regulate
`pharmaceutical companies and streamline FDA approval process for generic insulins.
`3. Get involved with patient advocacy groups and work together to lower insulin prices. Patient-centered
`organizations are critical to effecting change.
`4. Never attempt to save money by cutting your insulin dose. Take your medications as directed. If you're
`having trouble affording your medicine, talk to your doctor right away, and work to nd a solution
`together.
`
`Best Diabetes Diets
`
`#1
`RANK
`Mediterranean Diet
`DIET NAME
`
`#2
`RANK
`DASH Diet
`
`https://health.usnews.com/health-care/for-better/articles/2018-06-29/whats-behind-the-rising-costs-of-insulin
`
`3/7
`
`Mylan Ex.1090
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`7/18/2019
`
`DIET NAME
`
`What's Behind the Rising Costs of Insulin | For Better | US News
`
`#3 (tie)
`RANK
`The Flexitarian Diet
`DIET NAME
`
`#3 (tie)
`RANK
`Mayo Clinic Diet
`DIET NAME
`
`#3 (tie)
`RANK
`Vegan Diet
`DIET NAME
`
`#3 (tie)
`RANK
`Volumetrics Diet
`DIET NAME
`
`#3 (tie)
`RANK
`Weight Watchers Diet
`DIET NAME
`
`#8 (tie)
`RANK
`Jenny Craig Diet
`DIET NAME
`
`#8 (tie)
`RANK
`MIND Diet
`DIET NAME
`
`#10 (tie)
`RANK
`The Engine 2 Diet
`DIET NAME
`
`#10 (tie)
`RANK
`Ornish Diet
`DIET NAME
`
`DIET Ranking information as of June 27th, 2018
`
`Dr. Kevin Campbell, Contributor
`
`Dr. Kevin R. Campbell is an internationally recognized cardiologist and the CEO of PaceMate, a ...  READ MORE »
`
`https://health.usnews.com/health-care/for-better/articles/2018-06-29/whats-behind-the-rising-costs-of-insulin
`
`4/7
`
`Mylan Ex.1090
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`What's Behind the Rising Costs of Insulin | For Better | US News
`7/18/2019
`Tags: patients, patient advice, diabetes, diabetes type 2, diabetes type 1, American Diabetes Association
`
`HEALTH DISCLAIMER »
`
`RECOMMENDED
`
`The HPV Vaccine for Men
`
`BRANDFUSE
`
`ad content by Rakuten
`Would You Like to Get Cash Back When Online
`Shopping?
`
`LGBTQ Couples and Fertility Treatment
`
`Thumb Joint Replacement Surgery for Arthritis
`
`L> x
`
`11 Questions to Ask Your Cardiologist During Your First Visit
`
`Allergic Rashes in the Summer
`
`https://health.usnews.com/health-care/for-better/articles/2018-06-29/whats-behind-the-rising-costs-of-insulin
`
`5/7
`
`Mylan Ex.1090
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`7/18/2019
`How to Survive Travel Anxiety
`
`What's Behind the Rising Costs of Insulin | For Better | US News
`
`Do Weighted Blankets Help With Anxiety?
`
`Are Summer Colds Worse Than Winter Ones?
`
`How to Safely Exercise With Diabetes
`
`11 Items to Pack in Your Hospital Bag
`
`Load More
`
` 1
`
`CIVIC
`
`RANKINGS
`
`EDUCATION
`
`HEALTH
`
`MONEY
`
`https://health.usnews.com/health-care/for-better/articles/2018-06-29/whats-behind-the-rising-costs-of-insulin
`
`6/7
`
`Mylan Ex.1090
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`7/18/2019
`
`What's Behind the Rising Costs of Insulin | For Better | US News
`REAL ESTATE
`
`TRAVEL
`
`LAW FIRMS
`
`CARS
`
`360 REVIEWS
`
`imEmP1M41Pr!l!Mi!flMi
`ll
`i-;'11 0 C=IVATi-A
`
`About Contact Press Advertise Newsletters
`Store
`
`Jobs Site Map
`
`Copyright 2019 © U.S. News & World Report L.P.
`
`Terms & Conditions/Privacy Policy
`
`https://health.usnews.com/health-care/for-better/articles/2018-06-29/whats-behind-the-rising-costs-of-insulin
`
`7/7
`
`Mylan Ex.1090
`Mylan v. Sanofi - IPR2018-01676
`
`