MMIT Reality Check on Type 2 Diabetes (SGLT2 and Combo) (3Q2023)

Payer Coverage:

A review of market access for type 2 diabetes (SGLT2 and combo) treatments shows that under the pharmacy benefit, about 43% of the lives under commercial formularies are covered with utilization management restrictions. Around 22% of the lives under Medicare formularies are not covered for at least one of the drugs.

For about 57% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 69% of the lives require a single step. Around 16% of payer-controlled pharmacy benefit covered lives require prior authorization, with 70% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Expands Jardiance Patient Population

In June 2023, the FDA expanded the patient population of Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Co.’s Jardiance (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar along with diet and exercise in children at least 10 years old with type 2 diabetes. It is the first and only SGLT2 inhibitor approved for this patient population.

Copay Amounts Have Significant Impact on Cardiovascular Medication Adherence

People with higher copays are significantly less likely to adhere to their commonly prescribed cardiovascular medications than those with low copays, according to a study published this month in JAMA Network Open. Utibe R. Essien, M.D., the study’s lead author, tells AIS Health the variations in adherence based on copays are “striking” and could have broader implications if some of the drugs are approved for obesity as expected and become even more widely used.

The researchers examined 94,610 people with Type 2 diabetes and/or heart failure who were prescribed a glucagon-like peptide-1 (GLP-1) receptor agonist or a sodium-glucose cotransporter 2 (SGLT2) inhibitor between Jan. 1, 2014, and Sept. 30, 2020. The study participants were enrolled in UnitedHealthcare plans and were broken into categories based on their copays: low (less than $10 per month), medium (from $10 to $50 per month) and high ($50 or more per month).

Compared with the low copay group, people in the medium and high copay groups were 38% and 53%, respectively, less likely to adhere to their GLP-1 prescriptions and 33% and 32% less likely to adhere to their SGLT2 medications.

Mark Cuban Cost Plus Drug Co. Will Sell Branded Janssen, IBSA Drugs

Mark Cuban Cost Plus Drug Co., the wholesale, direct-to-consumer drug manufacturer and pharmacy launched by the eponymous entrepreneur, will sell brand-name diabetes drugs from Janssen, a division of Johnson & Johnson. Invokana (canagliflozin), Invokamet (canagliflozin-metformin HCl) and Invokamet XR (canagliflozin-metformin HCl) are now available from the startup, according to an April 3 tweet. Invokana will cost $243.90 for a 30-day supply, while Invokamet and Invokamet XR will each cost $244.20 for a 60-day supply.

Key Findings:

Market Events Drive Changes

In June 2023, the FDA expanded the patient population of Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Co.’s Jardiance (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar along with diet and exercise in children at least 10 years old with type 2 diabetes. In January 2020, the FDA approved the companies’ Trijardy XR (empagliflozin/linagliptin/metformin hydrochloride extended-release tablets) to lower blood sugar in adults with type 2 diabetes, along with diet and exercise. The drug is the first triple combination product with Jardiance for the indication. There is a very thin pipeline for this indication, with only a single active agent in Phase III trials currently.

Competitive Market Landscape

Eli Lilly and Co./Boehringer Ingelheim Pharmaceuticals, Inc. is the biggest player in this market, followed by AstraZeneca, with Johnson & Johnson and Merck & Co., Inc. lagging behind the top powerhouses. Now that many of the agents in this class also provide the additional benefit of a reduction in the risk of cardiovascular death, there is less of a difference among the therapeutic benefits of each agent. Competition is largely driven by contracts, with each company seeking to edge out the competitors by gaining the most widespread preferred coverage status.

Pharmacy Benefit Implications

Coverage for the drugs is via the pharmacy benefit. Overall the agents in this indication enjoy widespread coverage by a majority of payers. Most patients will have numerous options to choose from depending on their formulary, though which agents are considered preferred will depend on contracts and rebates. Most of the agents, including several extended-release combo agents, have good to great preferred status and great overall coverage. Agents that are considered non-preferred or non-formulary often have restrictive requirements to access.

Key Players in Market:

reality-check-diabetes-type-2-sglt2-player

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AIS Health Staff

AIS Health Staff

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