CurrentHealth NetPolicy CP CPA.343

Clinical Policy: Non-Preferred Dipeptidyl Peptidase-4 (DPP-4) Inhibitors

Defines medical necessity criteria, initial and continuation approval requirements, limitations, formulary redirection and product-specific generic-use requirements for non-preferred DPP-4 inhibitor agents for commercial line of business. Applies to listed DPP-4 inhibitor products including single-agent and combination products (except DPP-4/SGLT2 combos which refer to separate policy).

Policy Summary

PayerHealth Net

PolicyClinical Policy: Non-Preferred Dipeptidyl Peptidase-4 (DPP-4) Inhibitors

Policy CodePolicy CP CPA.343

Change TypeMultiple non-material updates (additions and clarifications)

Effective DateNov 16, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria; prior authorization required for listed non-preferred DPP-4 agents.

POLICY UPDATE CHANGES

Added newly approved Brynovin (sitagliptin oral solution) to criteria.

Specified trial duration for preferred sitagliptin-containing product should be 3 consecutive months.

Added requirement that brand Onglyza and Kombiglyze XR users must use generic saxagliptin or saxagliptin/metformin unless contraindicated.

Added requirement that brand Nesina users must use generic alogliptin unless contraindicated.

Directs combination DPP-4/SGLT2 requests to SGLT2 policy CP CPA.347.

12 monthsApproval duration

>=3 monthsRequired metformin trial

>=3 months

Coverage Summary

Scope: This policy defines medical necessity criteria, initial and continuation approval requirements, limitations, formulary redirection and product-specific generic-use requirements for non-preferred DPP-4 inhibitor agents for the commercial line of business and applies to listed single-agent and combination DPP-4 products. Subject: Non-Preferred DPP-4 Inhibitors prior authorization criteria. Coverage stance: covered_with_criteria. Definition/background: DPP-4 inhibitors are indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The policy lists specific products including sitagliptin, saxagliptin, linagliptin, alogliptin and sitagliptin- or linagliptin- or saxagliptin-containing metformin combination products, and includes product-specific requirements and limitations. Administrative note: requests for combination DPP-4/SGLT2 products are redirected to policy CP CPA.347.

Initial Therapy Criteria

Initial Approval Criteria

DPP-4 inhibitors are medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of type 2 diabetes mellitus
Member is >= 18 years of age18 years or older
Age requirement
Prior therapy requirements
- Failure of >= 3 consecutive months of metformin unless contraindicated or clinically significant adverse effects are experienced>= 3 consecutive months
  Prior metformin trial
- Failure of >= 3 consecutive months of a preferred sitagliptin-containing product (sitagliptin, sitagliptin/metformin, sitagliptin/metformin XR) unless clinically significant adverse effects are experienced, all are contraindicated, OR request is for Brynovin and member is unable to swallow tablets>= 3 consecutive months (preferred sitagliptin trial)
  Preferred sitagliptin trial requirement may be waived if contraindication, adverse effects, or Brynovin swallowing issue
Member is either
- Antidiabetic medication-naive and requested agent is intended for concurrent use with metformin due to HbA1c >= 8.5% (HbA1c drawn within the past 3 months)>= 8.5% (drawn within past 3 months)
- Not antidiabetic medication-naive (i.e., prior therapy requirements above met)
If request is for brand Onglyza or Kombiglyze XR, member must use generic saxagliptin or generic saxagliptin/metformin unless contraindicated or clinically significant adverse effects are experienced
Brand-to-generic redirection
If request is for brand Nesina, member must use generic alogliptin unless contraindicated or clinically significant adverse effects are experienced
Brand-to-generic redirection
Dose does not exceed the FDA approved maximum recommended doseFDA maximum recommended dose
See Dosage and Administration section

Continuation Therapy (Renewal) Criteria

Continued Therapy (Renewal) Criteria

Continued therapy is approved when the following are met:

ALL of the following

Member status
- Member is currently receiving medication via the Centene benefit
- Member has previously met initial approval criteria
Member is responding positively to therapy
Clinical response documentation required
If request is for brand Onglyza or Kombiglyze XR, member must use generic saxagliptin or saxagliptin/metformin unless contraindicated or clinically significant adverse effects are experienced

Other Diagnoses / Indications and Exclusions

Other Diagnoses/Indications

Coverage for uses other than type 2 diabetes mellitus:

ANY of the following

For drugs ON the formulary (commercial, marketplace) or PDL (Medicaid): follow no coverage criteria policy CPCPA.190 for commercial
For drugs NOT on the formulary (commercial, marketplace) or PDL (Medicaid): follow non-formulary policy CPCPA.190 for commercial
If requested use (diagnosis, age, dosing) is NOT specifically listed under section 'Diagnoses/Indications for which coverage is NOT authorized' AND initial criteria do not apply, refer to off-label use policy CP.CPA.09 for commercial

Diagnoses/Indications NOT authorized

Coverage is NOT authorized for:

Provider Actions & Prior Authorization Requirements

Prior Authorization

Authorization required

Provider must submit documentation (office chart notes, lab results or other clinical information) showing the member has met the approval criteria. Prior authorization is required for the listed non-preferred DPP-4 agents.

Documentation Required

HbA1c documentation

If the member is antidiabetic medication‑naive and the requested DPP‑4 agent will be started concurrently with metformin, submit an HbA1c result drawn within the past 3 months demonstrating a value ≥ 8.5%.

Applicable Codes & Referenced Policies

Referenced policies/IDsmixed

CP CPA.343	Reference Number of this clinical policy
CPCPA.190	No coverage / non-formulary policy referenced
CP.CPA.09	Off-label use policy referenced
CPPHARM.03A/03B	Continuity of care state addendums referenced
CP CPA.347	SGLT2 Inhibitors policy referenced for combination DPP-4/SGLT2 products

Clinical Evidence & Guidelines

Evidence/guidelines: Guideline references cited in the policy include the ADA Standards of Medical Care in Diabetes 2024 and AACE/ACE guidance documents (AACE/ACE 2023 and AACE 2022 guidance). Safety and background evidence notes: there are postmarketing warnings of acute pancreatitis and limited pancreatitis data for several sitagliptin-containing and other products; certain agents (Onglyza and Kombiglyze) should not be used for diabetic ketoacidosis; and DPP-4 inhibitors are not indicated for patients with type 1 diabetes.

Background & Definitions

Background: DPP-4 inhibitors are FDA-indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Listed products requiring authorization include sitagliptin (including Brynovin oral solution), saxagliptin, linagliptin, alogliptin and combination metformin products (e.g., sitagliptin/metformin, linagliptin/metformin, saxagliptin/metformin, alogliptin/metformin). Limitations of use include: not for use in type 1 diabetes; Onglyza and Kombiglyze should not be used to treat diabetic ketoacidosis; and several products (Brynovin, Jentadueto, Tradjenta, Zituvimet/Zituvio, etc.) have not been studied in patients with a history of pancreatitis, indicating limited pancreatitis data.

Definitions: DPP-4 inhibitors — Dipeptidyl peptidase-4 inhibitors used as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Revision History

201/09/16clarification

Clarified that the preferred sitagliptin-containing product trial duration should be 3 consecutive months per previously approved P&T approach (1Q 2022 annual review).

12.06.23brand-to-generic redirection

Per December SDC update, added requirement that members requesting brand Onglyza or Kombiglyze XR must use generic saxagliptin or generic saxagliptin/metformin unless contraindicated or clinically significant adverse effects exist.

12.06.23brand-to-generic redirection

Per December SDC update, added requirement that members requesting brand Nesina must use generic alogliptin unless contraindicated or clinically significant adverse effects exist.