It is no secret that diabetes is having serious repercussions on our country. According to the Centers for Disease Control (CDC), 30.3 million people in the United States have diabetes. 23.1 million people have been diagnosed with the disease thus far while 7.2 million people are undiagnosed. Additionally, the CDC’s 2015 statistics state that diabetes is also the 7th leading cause of death.
There are two types of diabetes; type 1 and type 2. Only 5% of the population has type 1 diabetes, as it is commonly diagnosed in children and was formerly known as juvenile diabetes. In type 1 diabetes the body does not produce insulin. Type 2 on the other hand is the most common. In type 2 the body does not use insulin properly. This is known as insulin resistance. The pancreas starts to produce more insulin to keep up with glucose levels in the body though over time it can not produce enough to keep glucose levels stable.
There are many policy aspects to diabetes. The first involves shadow pricing. Shadow pricing is when one company raises its wholesale price for a diabetes medication and then others follow suit over time. With insulin it started with a price hike of Lantus and then a similar increase for Levemir. This has caused several lawsuits to start against Eli Lilly, Novo Nordisk and Sandoz for their alleged dealings in price fixing. The plaintiffs in this case are accusing these three insulin manufacturers of raising list prices in order to gain favor among pharmacy benefit managers (PBMs). These lawsuits are now in Federal District Court as a class action suit. Also the federal government has started to investigate shadow pricing in Congress.
Medicaid and Medicare have been negatively impacted by the effects of diabetes. Medicaid is paying more for insulin and the price hikes for insulin are affecting dual eligible patients in regards to the Medicare donut hole. Many states are strapped for budgetary funds and may start to not cover certain insulin that is more expensive.
Additionally, there are no generics for insulin. Insulin is considered a biologic and not a small-molecule drug. Biosimilars are the only option here and are only up to 30% cheaper than the available brand in the market. Currently, there are only three major insulin manufacturers, which creates not only lack of competition but also issues with patient access.
The National Clinical Care Commission Act was signed into law this year and establishes a public/private commission. This commission will assess current federal programs that support clinical care for diabetes. The commission is also charged with finding inefficiencies and gaps in these programs and will provide recommendations to both Health and Human Services (HHS) and Congress.
Nevada’s approach to diabetes was an interesting one this year as the state passed its version of price transparency specifically targeted at the disease. The state’s new drug pricing law targets diabetes products and requires PBMs and manufacturers among other things to disclose certain pricing and rebate information. This law was signed into law after it was first vetoed by Governor Sandoval (R-NV), as the first draft had much stricter language against price gouging. Both PhRMA and BIO are currently suing the state by arguing that the law creates a constitutional violation and violates patent protection law and trade secrets by asking for price and rebate information. We’ll see how these arguments turn out.
There are Congressional bills currently on point:
H.R. 3124/S.1299 titled the Preventing Diabetes in Medicare Act of 2017 proposes to reduce the occurrence of diabetes in Medicare beneficiaries by extending coverage under Medicare for medical nutrition therapy services to such beneficiaries with pre-diabetes or with risk factors for developing type 2 diabetes.
H.R. 3271/S.1914 titled the Protecting Access to Diabetes Supplies Act of 2017 targets diabetic supplies within competitive bidding. Specifically, the bill requires the Centers for Medicare & Medicaid Services (CMS) to:
– Use specified data to determine whether a bid satisfies certain requirements related to volume of coverage with respect to such products
– Reject a bid if the bidder does not demonstrate its ability to furnish such products in a manner consistent with its bid
– Establish a process to monitor the extent to which an entity continues to cover the product types included in its bid
The Centers for Medicare and Medicaid Services (CMS) may terminate a contract if it determines that an entity, for reasons other than product discontinuation or market-wide shortage, fails to maintain ready access to such products included its bid. Additionally, the bill specifies that an entity furnishing such products to beneficiaries under the program: (1) must furnish to each beneficiary a brand of strips that is compatible with the beneficiary’s home blood glucose monitor, (2) may not attempt to influence or incentivize a beneficiary to switch the brand of either type of product, and (3) must contact and receive a request from a beneficiary no more than 14 days prior to dispensing a refill to the beneficiary.
H.R. 1617 titled the Promoting Access to Diabetic Shoes Act proposes to permit nurse practitioners and physician assistants to satisfy the documentation requirement under the Medicare program for coverage of certain shoes for individuals with diabetes.
Lastly, there are more medical advances on the way to help combat diabetes. The Food and Drug Administration (FDA) has approved Medtronic’s “artificial pancreas” which is the company’s first hybrid closed loop system. The system is the first to both monitor blood glucose levels and adjust insulin levels for type 1 patients. This is all part of the FDA’s plan to encourage development of an artificial pancreas device system, an innovative device that automatically monitors blood glucose and provides appropriate insulin doses in people with diabetes who use insulin. These are devices only and not an actual synthetic pancreas.
The FDA has also approved two combination products that contain long-acting insulin and glucagon-like peptide 1 (GLP-1) receptor agonists. These are the first of their kind of once a day injections to combine these drugs.
Jardinance is the first diabetes drug to be approved for the reduction of risk of cardiovascular death in relation to diabetes. No other diabetes medication has been approved for any sort of cardiovascular benefit, while Basaglar is the first biosimilar of Lantus that has been approved by the FDA. This is not a generic and is not available to be switched out for Lantus by the pharmacist. A physician needs to prescribe it directly and there are no interchangeable biosimilars at this time.
In conclusion, we will wait to see what will happen with the shadow pricing issue as well as how Congress will deal with higher drug prices. Additionally, next year could possibly bring a smaller budget for Medicare and Medicaid further affecting patients with this chronic disease.