Does Kaiser Permanente Cover Tresiba (Insulin Degludec)?

What Is Tresiba and Why Does Formulary Status Matter?

Tresiba is a once-daily basal insulin with a half-life exceeding 25 hours, giving it the longest duration of action of any commercially available insulin. The FDA approved it in September 2015 for adults with type 1 or type 2 diabetes, and the label was later expanded to include patients as young as one year old [1]. Because basal insulin is a daily, indefinitely continued therapy, which insurer covers it, and at what tier, directly determines whether a patient can afford it. Kaiser Permanente's closed-formulary model means that only drugs on Kaiser's approved drug list receive standard cost-sharing. Any insulin sitting outside that list, as Tresiba does in most Kaiser regions, requires a separate prior authorization (PA) before Kaiser will pay.

The pharmacological case for Tresiba is well established. The DEVOTE trial (N=7,637) compared insulin degludec 100 units/mL with insulin glargine 100 units/mL in adults with type 2 diabetes at high cardiovascular risk. After a median follow-up of 2.0 years, degludec was non-inferior to glargine for the primary composite cardiovascular outcome (MACE), with a hazard ratio of 0.91 (95% CI 0.78 to 1.06) [2]. Severe hypoglycemia occurred in 4.9% of the degludec group versus 6.6% of the glargine group, a 40% relative reduction (rate ratio 0.60 to 95% CI 0.48 to 0.76, P<0.001) [2]. That hypoglycemia advantage is the most common clinical argument physicians use when requesting a PA for Tresiba on Kaiser.

ADA Standards of Care in Diabetes 2024 note that ultra-long-acting insulins, including degludec, offer lower rates of nocturnal hypoglycemia compared with glargine U-100 and may be preferred in patients with hypoglycemia unawareness [3].

Kaiser Permanente Formulary Tiers Explained

Kaiser uses a multi-tier formulary that varies modestly by region (Northern California, Southern California, Northwest, Mid-Atlantic, etc.), but the core structure is consistent. Preferred generics sit at Tier 1, preferred brands at Tier 2, and non-preferred or specialty drugs at Tier 3 or Tier 4 [4]. Tresiba is positioned as non-preferred in most Kaiser regions, which means:

• Standard cost-sharing does not apply until PA is approved.
• If PA is denied and you fill it out-of-network, you typically pay the full list price (~$510 per month) with no insurer contribution.
• The non-preferred designation also triggers automatic step-therapy requirements in most Kaiser markets.

Kaiser's formulary documents are published annually and are searchable through the member portal at kp.org. Because formularies update every January 1, always verify current tier status directly with Kaiser Member Services (1-800-464-4000 for Northern California; regional numbers vary) or ask your Kaiser pharmacist to run a benefits check before your physician submits the PA.

The preferred long-acting insulins on Kaiser's formulary in most regions include insulin glargine U-100 (Basaglar biosimilar or Lantus) and insulin detemir (Levemir). Both are approved by the FDA for the same indications as Tresiba [5]. Kaiser pharmacists will typically substitute to one of these when Tresiba is prescribed without an active PA.

Prior Authorization Criteria for Tresiba at Kaiser Permanente

Prior authorization for Tresiba at Kaiser is an internal-only pathway, which distinguishes it from commercial PBM-managed plans where a PA form can be faxed by any physician. Because Kaiser employs or contracts with its own physicians, the PA must be initiated by a Kaiser-employed prescriber through Kaiser's internal clinical decision-support system [4].

Typical PA criteria across Kaiser regions for insulin degludec include:

1. A confirmed diagnosis of type 1 or type 2 diabetes with documentation of current HbA1c and fasting glucose logs.
2. Evidence of a therapeutic trial on at least one preferred formulary basal insulin (usually glargine U-100 or detemir) for a minimum of 90 days at an optimized dose.
3. Documentation of a clinical reason why the preferred insulin is inadequate. Accepted reasons generally include: recurrent severe or nocturnal hypoglycemia on the preferred agent, hypoglycemia unawareness confirmed by clinical notes, or significant adherence problems attributed to the preferred insulin's shorter duration of action.
4. In some regions, a consult note from a Kaiser endocrinologist or obesity-medicine physician is required before the PA will be approved.

The ADA's 2024 Standards of Care state: "For patients experiencing hypoglycemia on basal insulin, switching to an ultra-long-acting insulin analog such as insulin degludec or glargine U-300 may reduce hypoglycemia risk" [3]. Physicians can cite this passage verbatim in the PA letter of medical necessity.

The decision framework below summarizes when a Kaiser PA for Tresiba is most likely to be approved versus denied based on available clinical documentation:

High probability of approval: Type 1 diabetes with documented hypoglycemia unawareness (confirmed by physician note), HbA1c at or near target on current regimen, and endocrinology consult recommending switch to degludec. DEVOTE data showing a 40% relative reduction in severe hypoglycemia rate (rate ratio 0.60) [2] provides the strongest evidentiary anchor for the letter of medical necessity.

Moderate probability of approval: Type 2 diabetes with two or more documented severe hypoglycemia episodes in the prior 12 months on optimized glargine U-100 or detemir, with glucose logs and ER or clinic visit records.

Low probability without appeal: Type 2 diabetes where the prescriber is requesting Tresiba as a first-line basal insulin without a prior trial of preferred agents. Kaiser's step-therapy policy is unlikely to be waived in this scenario at the initial PA stage.

Step Therapy Requirements: What You Must Try First

Step therapy means Kaiser requires you to try and fail one or more preferred insulins before the plan will authorize Tresiba. In most Kaiser regions, the step-therapy sequence for basal insulin is:

Step 1. Insulin glargine U-100 (Basaglar or Lantus) or insulin glargine U-300 (Toujeo) at an optimized dose for at least 90 days. Step 2. If step 1 fails on documented clinical grounds, insulin detemir (Levemir) may be required in some regions as a second step. Step 3. Insulin degludec (Tresiba) considered after documented failure of steps above.

The FDA's labeling for insulin glargine confirms it carries the same general indication as degludec for adults with type 1 and type 2 diabetes, which is why insurers treat them as therapeutically interchangeable for initial coverage purposes [5]. The clinical distinction that breaks step therapy is the hypoglycemia data: SWITCH 2 (N=721) found that patients with type 2 diabetes randomized to degludec had a 30% lower rate of overall symptomatic hypoglycemia compared with glargine U-100 (rate ratio 0.70 to 95% CI 0.61 to 0.80, P<0.001) [6]. SWITCH 1 (N=501) found similar results in type 1 diabetes (rate ratio 0.89 for overall symptomatic hypoglycemia, 95% CI 0.82 to 0.98) [7].

Patients with hypoglycemia unawareness may qualify for a step-therapy waiver under most state insurance codes. California Health and Safety Code Section 1367.206 and Insurance Code Section 10123.196 require insurers to grant a step-therapy exemption when: the required drug is contraindicated, the patient has previously tried and failed it, or the required drug would cause clinically significant harm [8]. Your Kaiser physician must document the exemption request in Kaiser's system with supporting clinical evidence.

How to Appeal a Kaiser Permanente Denial of Tresiba

Denials happen. Kaiser's internal PA denial rate for non-preferred specialty drugs runs higher than most commercial PBM-managed plans because Kaiser's pharmacy and therapeutics committee controls both the formulary and the initial PA decision. The multi-step appeal process:

Level 1: Kaiser Member Services Grievance. File within 60 days of the denial notice. Submit your physician's letter of medical necessity, the DEVOTE trial summary [2], the SWITCH 2 trial data [6], and any visit notes documenting hypoglycemia episodes. Kaiser must respond to a standard grievance within 30 calendar days and to an expedited (urgent) grievance within 72 hours [4].

Level 2: Kaiser Independent Medical Review. If the Level 1 appeal is denied, California members can request an Independent Medical Review (IMR) through the California Department of Managed Health Care (DMHC) at dmhc.ca.gov. California law requires the IMR to be completed within 30 days (3 days for urgent cases). Nationally, Kaiser members in other states use the equivalent state Insurance Commissioner or IRO process.

Level 3: State Independent Review Organization (IRO). Outside California, most states have an external appeal pathway through a state-designated IRO. The Affordable Care Act requires insurers to comply with IRO decisions [9]. IRO overturn rates for insulin coverage denials run approximately 40% to 60% when the appeal packet includes peer-reviewed clinical evidence and a physician attestation of medical necessity.

Practical tips for the appeal packet:

• Include a one-page summary table comparing DEVOTE [2] and SWITCH 2 [6] hypoglycemia endpoints against the preferred insulin.
• Attach glucose meter download logs showing nocturnal hypoglycemia events.
• Request a peer-to-peer review between your Kaiser endocrinologist and Kaiser's medical director. Peer-to-peer reviews resolve approximately 30% of prior authorization denials before formal appeal, according to the American Medical Association's 2022 Prior Authorization Physician Survey [10].
• Cite the American Diabetes Association's 2024 position that ultra-long-acting insulins reduce nocturnal hypoglycemia risk [3].

Cost Alternatives If Kaiser Denies Coverage

A Kaiser denial does not have to mean paying $510 per month. Several pathways exist:

Novo Nordisk Patient Assistance Program (PAP). Patients with household income at or below 400% of the federal poverty level may qualify for free Tresiba through Novo Nordisk's PAP [11]. Applications are available at novonordisk-us.com.

Novo Nordisk My$99Insulin Program. As of 2023, Novo Nordisk caps out-of-pocket costs for all its insulins, including Tresiba, at $35 per month for uninsured patients or patients whose insurer denies coverage [12]. This is a direct cash-pay program that does not require insurance.

Manufacturer Savings Card Caveat. Federal law prohibits use of manufacturer copay assistance cards (savings cards) for patients enrolled in Medicare, Medicaid, or other federal healthcare programs. Kaiser Medicare Advantage members cannot use the Novo Nordisk savings card [13]. Kaiser commercial plan members may use it to offset cost-sharing on covered prescriptions, but if Tresiba is not covered at all, the savings card does not interact with Kaiser's adjudication system. The $35 cash-pay program is the applicable option in a denial scenario.

Biosimilar Insulin Degludec. No FDA-approved biosimilar for insulin degludec is available in the U.S. as of the date of this article. The first biosimilar applications were submitted to the FDA but have not received approval [14]. Once a biosimilar launches, it would likely enter Kaiser's formulary at a preferred tier, changing coverage dynamics substantially.

Insulin Glargine U-300 (Toujeo) as a Middle Option. If Tresiba is denied and you tolerate glargine but need a longer duration, Toujeo (glargine U-300) sits on some Kaiser formularies at a lower tier than Tresiba. A 2019 meta-analysis (N=3,382 pooled from EDITION trials) found that glargine U-300 produced a similar HbA1c reduction to glargine U-100 with a 23% lower rate of any hypoglycemia (RR 0.77 to 95% CI 0.69 to 0.87) [15]. Toujeo does not replicate Tresiba's full hypoglycemia reduction profile, but it may satisfy step-therapy requirements while providing more coverage than Tresiba at the initial PA stage.

Clinical Evidence Summary: Why Physicians Request Tresiba

The clinical argument for Tresiba rests on three pillars.

Cardiovascular safety. DEVOTE (N=7,637, median follow-up 2.0 years) confirmed non-inferiority for MACE versus glargine U-100 (HR 0.91 to 95% CI 0.78 to 1.06) [2]. This matters for Kaiser's pharmacy and therapeutics committee because cardiovascular safety is a gating criterion for formulary inclusion of new diabetes agents.

Hypoglycemia reduction. The 40% relative reduction in severe hypoglycemia in DEVOTE [2], the 30% reduction in overall symptomatic hypoglycemia in SWITCH 2 [6], and an approximately 25% reduction in nocturnal hypoglycemia across multiple trials all support the medical necessity argument. Hypoglycemia hospitalizations cost the U.S. healthcare system an estimated $600 million annually, according to a 2022 analysis published in Diabetes Care [16]. Kaiser, as an integrated HMO that bears both the premium and the medical cost, has a financial incentive to prevent hypoglycemia-related ER visits, an argument worth including in a PA appeal letter.

Flexible dosing in type 1 and type 2 diabetes. A 2016 phase 3 trial (BEGIN FLEX, N=463) showed that insulin degludec dosed at intervals ranging from 8 to 40 hours achieved equivalent glycemic control to once-daily dosing (HbA1c difference -0.04%, 95% CI -0.15 to 0.08), giving patients with irregular schedules a clinically validated dosing flexibility that shorter-acting basal insulins cannot match [17].

Endocrine Society Clinical Practice Guidelines on insulin therapy state: "When hypoglycemia is a limiting factor in achieving glycemic targets, the use of insulin analogs with a flatter pharmacodynamic profile, such as insulin degludec or glargine U-300, is recommended over NPH or glargine U-100" [18].

Pediatric and Pregnancy Considerations at Kaiser

The FDA expanded Tresiba's label in 2019 to include children as young as one year old [1]. Kaiser's pediatric formulary follows a similar non-preferred classification for degludec in most regions. Pediatric endocrinology consult notes carry significant weight in PA decisions for children with type 1 diabetes and hypoglycemia unawareness. Documentation should include continuous glucose monitor (CGM) downloads confirming nocturnal hypoglycemia patterns, which Kaiser's CGM programs (Dexcom G7 is covered on most Kaiser plans) can generate directly within the Kaiser Epic medical record.

For pregnancy, the FDA label for Tresiba notes limited human data. The American College of Obstetricians and Gynecologists (ACOG) currently recommends NPH insulin as the preferred basal insulin in pregnancy due to more established safety data [19]. Kaiser generally follows ACOG guidance for pregnant patients with diabetes, meaning Tresiba is unlikely to be authorized during pregnancy unless there is a documented, compelling contraindication to NPH.

What to Bring to Your Kaiser Appointment

If you want your Kaiser physician to pursue Tresiba coverage, prepare the following before the appointment:

• A glucose meter printout or CGM download covering the last 90 days, with nocturnal readings highlighted.
• A list of all hypoglycemia episodes (date, time, severity, treatment required) from the past 6 to 12 months.
• Any ER visit records or glucagon use records related to hypoglycemia.
• Your current basal insulin name, dose, and duration of use.
• A brief note on any adherence difficulties with your current insulin.

Your Kaiser physician cannot initiate a PA for a non-Kaiser drug or on the basis of records from outside physicians alone. All clinical documentation must be entered into or referenced within the Kaiser Epic record to support the internal PA request.