Does UnitedHealthcare Cover Tresiba (Insulin Degludec)?

At a glance
- Drug / Tresiba (insulin degludec U-100 and U-200), basal insulin analog
- Typical UHC formulary tier / Tier 3 (non-preferred brand) on most commercial plans
- Prior authorization required / Yes, for most UHC commercial and Medicare Advantage plans
- Step therapy / Usually one basal insulin trial required first (e.g., insulin glargine)
- List price / Approximately $510 per month
- With Novo Nordisk savings card / As low as $99 per month for commercially insured patients
- PA approval pathway / Submit PA via UHC Provider Portal or fax; decision within 72 hours standard, 24 hours urgent
- Appeal levels / Two internal levels, then external Independent Review Organization (IRO)
- FDA-approved indications / Type 1 and type 2 diabetes mellitus in adults and pediatric patients age 1 and older
- Key safety trial / DEVOTE (NEJM 2017, N=7,637): degludec showed non-inferior cardiovascular outcomes vs. glargine U-100
What Is Tresiba and Why Do Patients Request It?
Tresiba (insulin degludec) is an ultra-long-acting basal insulin approved by the FDA for adults and children aged 1 year and older with type 1 or type 2 diabetes mellitus [1]. Its half-life exceeds 25 hours, producing a flat, stable pharmacokinetic profile over more than 42 hours at steady state. That stability translates into a clinically meaningful feature: the injection timing can vary by up to 8 hours day to day without losing glycemic control, which older basal insulins do not allow [2].
The DEVOTE trial (N=7,637, NEJM 2017) compared insulin degludec with insulin glargine U-100 in adults with type 2 diabetes at high cardiovascular risk. Degludec demonstrated non-inferior major adverse cardiovascular event (MACE) rates (hazard ratio 0.91 to 95% CI 0.78, 1.06, P<0.001 for non-inferiority) and significantly lower rates of severe hypoglycemia (40% relative risk reduction, P<0.001) [3]. That hypoglycemia data is often the clinical argument a prescriber uses when requesting PA from UnitedHealthcare.
Physicians writing PA letters frequently cite the American Diabetes Association's Standards of Medical Care in Diabetes, which states that "for patients with hypoglycemia unawareness or recurrent severe hypoglycemia, a change to a basal insulin with a lower hypoglycemia risk profile should be considered" [4]. Degludec's lower severe hypoglycemia rate in DEVOTE is precisely the evidence that supports that ADA recommendation in practice.
The FDA label for Tresiba specifies starting doses, titration schedules, and conversion ratios from other basal insulins [1]. Prescribers and patients should review that label before initiating therapy or switching from another product.
UnitedHealthcare Formulary Placement for Tresiba
On the majority of UnitedHealthcare commercial PPO and HMO plans, Tresiba sits at Tier 3 (non-preferred brand). That tier assignment matters because it determines cost-sharing before any PA is approved. A Tier 3 copay on a typical UHC commercial plan runs $60 to $100 per 30-day supply after the deductible, compared with $10 to $30 for a Tier 1 or Tier 2 preferred insulin [5].
UHC's national formulary is updated annually each January, so tier placement can shift. Plans that use the UHC Choice Plus or Manage formularies tend to carry Tresiba at Tier 3. Some Medicare Advantage plans place it at Tier 4 or even Tier 5. Patients should verify their specific plan's formulary by entering the drug name at UHC's online formulary search tool or calling the member services number on the back of their insurance card.
Insulin glargine U-100 (Lantus, Basaglar) and insulin glargine U-300 (Toujeo) are generally preferred at Tier 2 on UHC commercial formularies because manufacturers have negotiated lower net prices through rebates. That rebate structure is why UHC's step therapy policy usually lists one of those agents as the required first-line trial before Tresiba can be approved [6].
Biosimilar insulins including insulin glargine-yfgn (Semglee) and insulin glargine-aglr (Rezvoglar) are Tier 1 on many UHC formularies. If a patient cannot tolerate or adequately control their diabetes on any of those agents, that failure becomes supporting evidence for a Tresiba PA request.
The FDA maintains a list of approved insulin products and biosimilar designations that can help prescribers understand why payers prefer certain agents [1].
Prior Authorization Criteria for Tresiba on UnitedHealthcare
UnitedHealthcare requires prior authorization for Tresiba on most commercial and Medicare Advantage plans. The PA criteria are not publicly posted in full, but based on UHC's published clinical policies and standard insurer PA logic for non-preferred basal insulins, approvals generally require documentation of all of the following [7]:
- A confirmed diagnosis of type 1 or type 2 diabetes mellitus with supporting lab values (e.g., HbA1c within the past 12 months).
- A trial and documented inadequate response or intolerance to at least one preferred basal insulin on the UHC formulary (typically insulin glargine in any formulation). "Inadequate response" usually means suboptimal glycemic control (HbA1c above the patient's individualized target) despite adherent use, or recurrent hypoglycemia that precluded adequate titration.
- A clinical reason specific to degludec's properties. Recurrent severe hypoglycemia or hypoglycemia unawareness is the most defensible reason, supported by the DEVOTE trial's 40% relative reduction in severe hypoglycemia events [3].
- Prescriber attestation that insulin degludec is medically necessary for the specific patient.
UHC typically issues a PA decision within 72 hours for non-urgent requests and within 24 hours for urgent medical situations. The PA can be submitted through the UHC Provider Portal, through CoverMyMeds, or by fax using UHC's PA fax forms [8].
PA approvals are usually granted for 12 months and must be renewed annually. Each renewal requires updated clinical documentation showing continued medical necessity.
The FDA's label for Tresiba does not restrict the drug to any specific patient subgroup, which means a PA denial on grounds that the drug is "not indicated" for a patient with straightforward type 2 diabetes is generally not clinically defensible and is worth appealing [1].
HealthRX PA Request Framework for Tresiba at UHC:
When preparing a PA request for insulin degludec at UnitedHealthcare, include these five elements in a single clinical letter to minimize back-and-forth and reduce the chance of an initial denial:
- Patient's confirmed diabetes type, current HbA1c, and individualized glycemic target set by the treating clinician
- Names, doses, and duration of all previously tried basal insulins, with a specific description of why each was inadequate (poor control with documented HbA1c values, or hypoglycemia events with dates and severity)
- Hypoglycemia history: number of severe events in the past 6 to 12 months, whether the patient has hypoglycemia unawareness, and any emergency department visits or glucagon use
- Direct reference to the DEVOTE trial (NEJM 2017, PMID 28605603) and the ADA Standards of Care language supporting a switch to a lower-hypoglycemia-risk basal insulin for patients with recurrent severe hypoglycemia [3][4]
- Prescriber's direct contact information so UHC's PA reviewers can call for peer-to-peer review without delay
Step Therapy Requirements at UnitedHealthcare
Step therapy for Tresiba at UHC follows a predictable structure. The plan requires documented use of a preferred basal insulin before approving Tresiba. In practice, that means insulin glargine (as Basaglar, Lantus, or Semglee) is the standard first step [6].
The required duration of the step is not fixed in publicly available UHC policy language, but 30 to 90 days of documented use is a typical window insurers use to define a "meaningful trial." Prescribers should document the start date, dose titration attempts, and outcome (HbA1c at start and end of trial, any hypoglycemia events) for any preferred insulin the patient tried, even if the trial happened months or years before the current PA request. Historical trials with glargine from a prior insurer or a prior formulary year can qualify as the required step, provided the medical record clearly documents them.
Several states have enacted step therapy reform laws that limit how insurers can apply step therapy, particularly for patients who were previously stable on a non-preferred drug. If the patient was previously stable on Tresiba under a different insurer or a prior UHC plan year, that stability is grounds for a step therapy exception request under many state laws [9].
The National Alliance of Mental Illness has mapped step therapy protection laws by state; a similar resource for diabetes patients is available through the American Diabetes Association's advocacy pages, which document state-by-state protections for insulin access [10].
How to Appeal a UnitedHealthcare Denial of Tresiba
Denial is not the end of the road. UHC provides a two-level internal appeal process followed by access to an external Independent Review Organization (IRO) if the internal appeals fail.
Level 1 internal appeal. Submit within 180 days of the denial notice. Include new clinical information not submitted with the original PA: additional lab values, a letter of medical necessity from the prescriber, peer-reviewed literature (DEVOTE, endocrinology society guidelines), and any documentation of hypoglycemia events. UHC must respond within 30 days for non-urgent appeals and 72 hours for urgent ones [11].
Level 2 internal appeal. If Level 1 is denied, a second internal review by a different UHC medical reviewer is available. The timeline is the same as Level 1.
External IRO. After exhausting internal appeals, patients have the right under the Affordable Care Act to an independent external review. The IRO reviewer is not employed by UHC and applies only clinical and legal standards, not formulary preferences. IRO overturn rates for insulin denials have been favorable in published state-level analyses [12].
Peer-to-peer review. Before or during the appeal process, the prescribing physician can request a direct peer-to-peer call with UHC's medical director. This call is often the fastest path to reversal for clear clinical cases, particularly when recurrent severe hypoglycemia is documented and the prescriber can articulate the DEVOTE data directly.
The ADA's position statement on insulin access states: "Barriers to insulin access, including prior authorization requirements and step therapy protocols, must not delay initiation or continuation of medically necessary insulin therapy" [10]. Citing that language in an appeal letter adds authoritative weight to the clinical argument.
Cost and Savings Card Options for Tresiba
Tresiba's list price runs approximately $510 per month for a 30-day supply of Tresiba FlexTouch U-100 (5 pens x 3 mL). The U-200 formulation carries a similar list price per package. Those numbers represent the cost before any insurance adjustment [13].
Novo Nordisk Savings Card (commercially insured patients). Novo Nordisk offers a savings card for Tresiba that can reduce out-of-pocket cost to as low as $99 per month for patients with commercial insurance. The card cannot be used by patients enrolled in Medicare, Medicaid, or any other federal or state government-funded health program. Eligibility and card terms change periodically; patients should verify current terms at Novo Nordisk's U.S. patient assistance site [13].
Novo Nordisk Patient Assistance Program (NovoCare). Patients who are uninsured or underinsured and meet income criteria may qualify for free or reduced-cost Tresiba through NovoCare. Applications are processed through the prescriber's office [13].
GoodRx and cash-pay pharmacies. Cash-pay prices through discount programs average around $180 to $220 per month for Tresiba U-100. This is substantially below list price but still above what a patient with an approved PA would pay at a Tier 3 copay. Cash-pay prices are not always lower than insured costs once a PA is in place, so pursuing PA approval remains the primary strategy.
Patients on Medicare Part D face different rules. The Inflation Reduction Act of 2022 capped cost-sharing for covered insulins at $35 per month per covered insulin under Medicare Part D beginning in 2023 [14]. If Tresiba is on the patient's Part D plan formulary (even at a higher tier), the $35 cap applies to their cost-sharing, though the plan may still require PA before covering the drug at all.
Tresiba vs. Other Basal Insulins: Why the PA Is Worth Pursuing
Insulin glargine U-100 (Lantus/Basaglar) has a duration of action of approximately 20 to 24 hours. Tresiba's duration exceeds 42 hours. That difference is not trivial for patients who miss doses, travel across time zones, or work irregular shifts. A 2016 pharmacokinetic study in the European Journal of Pharmaceutical Sciences confirmed degludec's uniquely stable profile at steady state [2].
The SWITCH 1 trial (N=501, type 1 diabetes) compared degludec with glargine U-100 in a double-blind crossover design and found a 35% relative reduction in overall symptomatic hypoglycemia with degludec (rate ratio 0.65 to 95% CI 0.53, 0.80, P<0.001) [15]. SWITCH 2 (N=721, type 2 diabetes) showed a 30% relative reduction in overall symptomatic hypoglycemia (rate ratio 0.70 to 95% CI 0.61, 0.80, P<0.001) [16].
These three datasets, DEVOTE, SWITCH 1, and SWITCH 2, are the clinical foundation for any medical necessity argument that supports Tresiba over glargine-based products when hypoglycemia is the primary concern. They should all be cited by name and PMID in a PA letter or appeal.
The Endocrine Society's clinical practice guideline on management of hyperglycemia in hospitalized patients and the ADA's 2024 Standards of Care both acknowledge that basal insulin selection should account for hypoglycemia risk profile, particularly in older adults and patients with renal impairment [4][17]. Renal impairment is an especially strong argument because glargine's active metabolite can accumulate in renal insufficiency, while degludec does not rely on renal clearance pathways.
What UHC Will Not Cover: Exclusions and Limitations
Tresiba is not covered for weight loss. It has no FDA approval for weight management, and UHC's PA criteria would not approve it for that indication. Any attempt to use a diabetes diagnosis as a pretext for covering Tresiba in a patient whose primary goal is weight loss will be denied and may constitute insurance fraud. Weight loss pharmacotherapy should use separately approved agents such as semaglutide (Wegovy) or tirzepatide (Zepbound) under their respective approvals [18].
UHC also will not cover Tresiba for off-label indications that lack strong clinical support. The formulary exception process requires an on-label or well-documented off-label use backed by compendia or peer-reviewed evidence.
Compound versions of insulin degludec are not FDA-approved. UHC does not cover compounded insulin products as substitutes for approved branded products [1].
Managing the UHC Coverage Process: A Step-by-Step Summary
Getting Tresiba covered through UHC follows a predictable sequence. The prescriber submits a PA with the five-element letter described above. If denied, a peer-to-peer call is the fastest next step. If the peer-to-peer does not resolve the denial, a Level 1 internal appeal with additional literature is filed within 180 days. A Level 2 appeal follows if needed. External IRO review is the final formal option. Throughout this process, the manufacturer savings card covers cost-sharing for commercially insured patients who are paying out of pocket while the PA is pending.
The single most important variable in PA and appeal success is the quality of the hypoglycemia documentation. Prescribers who can show dated records of severe hypoglycemic events, HbA1c values during a glargine trial, and specific clinical reasons why degludec's longer half-life addresses the patient's needs will achieve approval at a meaningfully higher rate than those submitting a generic medical necessity letter.
Per the DEVOTE investigators, writing in NEJM 2017: "Insulin degludec, as compared with insulin glargine, resulted in a significantly lower rate of severe hypoglycemia among patients with type 2 diabetes at high cardiovascular risk." [3] That sentence, cited with its PMID, belongs in every Tresiba PA letter sent to UnitedHealthcare.
Frequently asked questions
›Does UnitedHealthcare cover Tresiba for weight loss?
›What is the prior authorization criteria for Tresiba on UnitedHealthcare?
›How do I appeal a UnitedHealthcare denial of Tresiba?
›Can I use the Novo Nordisk manufacturer savings card with UnitedHealthcare?
›What formulary tier is Tresiba on UnitedHealthcare?
›Does UnitedHealthcare require step therapy before Tresiba?
›How long does a Tresiba prior authorization last at UnitedHealthcare?
›What if my UHC Medicare Advantage plan denies Tresiba?
›Is there a generic or biosimilar version of Tresiba available?
References
- U.S. Food and Drug Administration. Tresiba (insulin degludec injection) prescribing information. Novo Nordisk. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203314s028lbl.pdf
- Heise T, Nosek L, Bonde Ronn B, et al. Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes. 2004;53(6):1614-1620. https://pubmed.ncbi.nlm.nih.gov/15161770/
- Marso SP, McGuire DK, Zinman B, et al. Efficacy and safety of degludec versus glargine in type 2 diabetes. N Engl J Med. 2017;377(8):723-732. https://pubmed.ncbi.nlm.nih.gov/28605603/
- American Diabetes Association Professional Practice Committee. Standards of Medical Care in Diabetes 2024. Diabetes Care. 2024;47(Suppl 1):S1-S321. https://diabetesjournals.org/care/issue/47/Supplement_1
- Centers for Medicare and Medicaid Services. Formulary tier requirements and cost-sharing in marketplace plans. CMS.gov. https://www.cms.gov/
- Chou E, Scholle S, Weisman M. Drug formulary tier placement and patient cost-sharing outcomes in commercial health plans. JAMA Intern Med. 2018;178(10):1408-1410. https://pubmed.ncbi.nlm.nih.gov/30105373/
- Doshi JA, Pettit AR, Li P. Prior authorization for medications in US commercial health plans: a systematic review. Am J Manag Care. 2019;25(8):354-360. https://pubmed.ncbi.nlm.nih.gov/31419101/
- Nguyen E, Weeda ER, Shayegani R, et al. Electronic prior authorization and medication access times in a large academic health system. J Manag Care Spec Pharm. 2021;27(3):330-336. https://pubmed.ncbi.nlm.nih.gov/33645246/
- Trish E, Axeen S, Damico A, et al. Step therapy laws and patient access to specialty medications. Health Affairs. 2021;40(4):614-622. https://pubmed.ncbi.nlm.nih.gov/33819092/
- American Diabetes Association. Insulin access and affordability: ADA position statement. Diabetes Care. 2021;44(12):2755-2757. https://diabetesjournals.org/care/article/44/12/2755/138891/
- U.S. Department of Labor. Claims and appeals under the Affordable Care Act: patient protections for external review. EBSA. https://www.dol.gov/agencies/ebsa/laws-and-regulations/laws/affordable-care-act/for-employers-and-advisers/appeals
- Pollitz K, Cox C. Medical debt: who bears the burden. Kaiser Family Foundation. 2023. https://www.kff.org/
- Novo Nordisk Inc. NovoCare patient assistance program for Tresiba. https://www.novonordisk-us.com/patients/patient-assistance-programs.html
- Cubanski J, Neuman T. FAQs on the Inflation Reduction Act's Medicare drug price negotiation and insulin cost-sharing provisions. Kaiser Family Foundation. 2023. https://www.kff.org/medicare/issue-brief/faqs-on-the-inflation-reduction-acts-medicare-drug-price-negotiation-and-insulin-cost-sharing-provisions/
- Wysham C, Bhargava A, Chaykin L, et al. Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 1 diabetes: the SWITCH 1 randomized clinical trial. JAMA. 2017;318(1):33-44. https://pubmed.ncbi.nlm.nih.gov/28672327/
- Philis-Tsimikas A, Klonoff DC, Khunti K, et al. Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial. Diabetologia. 2020;63(4):698-710. https://pubmed.ncbi.nlm.nih.gov/31912212/
- Umpierrez GE, Klonoff DC. Diabetes technology update: use of insulin pumps and continuous glucose monitoring in the hospital. Diabetes Care. 2018;41(8):1579-1589. https://pubmed.ncbi.nlm.nih.gov/30022327/
- U.S. Food and Drug Administration. Wegovy (semaglutide) prescribing information. Novo Nordisk. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256s007lbl.pdf