Zitter Pulse Check: Diabetes (August 2022)

Coverage

Diabetes is a high-cost category with an increasing number of therapies that treat the condition. To help stakeholders absorb datapoints and perceptions from all directions and synthesize those insights into a tangible strategy for diabetes, Zitter Insights surveys a leading panel of pharmacy and therapeutics (P&T) decision makers at payers and integrated delivery networks. The Managed Care Biologics and Injectables Index combines deep payer insights with the industry standard in market access information to produce quarterly reports and insights summaries on leading specialty brands.

Payer Management

Payers with almost all lives said they consider managing diabetes agents a high or very high priority. Medicare and commercial payers with around half of lives said they take an aggressive approach in managing these drugs. About two-thirds of endocrinologists said they are highly satisfied with the available diabetes treatments, but Medicare payers with more than half of lives expressed average satisfaction.

Payers with almost half of commercial lives and those representing about two-thirds of Medicare lives said there is a high level of disease burden for people with diabetes. More than half of endocrinologists agreed with that assessment. Payers with more than four-fifths of commercial lives stated that products to treat the condition have a high budget impact.

Key Findings

Teplizumab

In March 2022, Provention Bio, Inc. said that the FDA had accepted its resubmission of a Biologics License Application (BLA) for teplizumab, an anti-CD3 monoclonal antibody, for the delay of progression to Stage 3 clinical type 1 diabetes in at-risk individuals. The move followed the FDA’s rejection of the first BLA submission in 2021 due to a study failing to show pharmacokinetic comparability to a substance manufactured for historic clinical trials, according to the company. In June 2022, the manufacturer said that the FDA had extended the drug’s review period by three months to Nov. 17, 2022. Payers with more than three-fourths of commercial and Medicare lives were at least somewhat aware of the agent. About half of endocrinologists expressed the same level of awareness.

Biosimilars

As of late August 2022, the FDA had approved two biosimilars of Sanofi’s insulin glargine Lantus: Viatris Inc.’s Semglee (insulin glargine-yfgn), which was approved as interchangeable in June 2020, and Eli Lilly and Co.’s Rezvoglar (insulin glargine-aglr), approved in December 2021. Payers representing more than three-quarters of Medicare lives said they plan to advantage Lantus over Rezvoglar, while those with more than one-third of lives expect to advantage the biosimilar over its reference drug. Payers with more than half of commercial lives anticipate advantaging Semglee over Lantus, noting Semglee’s interchangeable status. Respondents with more than half of Medicare lives and those with almost two-thirds of commercial lives said they will manage the two biosimilars at parity.

Physician Prescribing

Lantus was the top insulin prescribed by endocrinologists during the year prior to the survey, followed by Novo Nordisk’s Tresiba (insulin degludec). Among the glucagon-like peptide 1 (GLP-1) agonists, the most prescribed were Novo Nordisk’s Ozempic (semaglutide) and Eli Lilly and Co.’s Trulicity (dulaglutide). Jardiance (empagliflozin) from Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Co. was the most popular sodium-glucose cotransporter 2 (SGLT2) inhibitor, followed closely by AstraZeneca’s Farxiga (dapagliflozin).

Trends

Efficacy

Message: “Teplizumab is a monoclonal antibody administered by IV infusion daily for a 14-day course in patients at risk of developing type 1 diabetes. Teplizumab delayed the onset of stage 3 type 1 diabetes by two years on average as compared to placebo. Side effects were minor, and overall teplizumab was well tolerated.”

Payer Thoughts: “As teplizumab is administered by IV infusion, it will be covered under the medical benefit for the majority of insurers rather than under the pharmacy benefit. It looks promising from an efficacy perspective, and safety does not appear to be a major concern. I would be interested in seeing how much insulin use is decreased in those patients who use this therapy, also if there is likely to be an effect in the type 2 diabetes population.”

Congress Won’t Act on Insulin Prices for Commercial Market

Although Congress is on the brink of passing a landmark prescription drug price reform bill as part of the Inflation Reduction Act (IRA) — Democratic leadership in the House of Representatives plans to vote on the bill Friday — the legislation will not include any provisions that impose price controls on insulin sold to patients with commercial insurance. D.C. insiders tell AIS Health, a division of MMIT, that they do not expect separate, standalone legislation to make it through Congress any time soon, which shines a spotlight on new insulin benefits announced by major carriers like UnitedHealth Group.

Subscribers to AIS’s RADAR on Drug Benefits may read the in-depth article online

Pharmacist Care Managers Could Help Improve Diabetes Outcomes

Pharmacists and other non-physician care managers can improve the quality of diabetes care in the primary care setting, but structural issues make it difficult to fully leverage their potential, according to research published in the July issue of the journal Health Affairs.

Subscribers to AIS’s RADAR on Drug Benefits may read the in-depth article online

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