CurrentMedical Mutual - OhioPolicy N/A

InPen Smart Insulin Pen

Defines prior-authorization and coverage criteria for the InPen reusable Bluetooth-enabled smart insulin pen system under the pharmacy/specialty drug benefit; intended for providers and pharmacy operations processing requests for members eligible under Medical Mutual - Ohio.

Policy Summary

PayerMedical Mutual - Ohio

PolicyInPen Smart Insulin Pen

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective Date

Next Review DateDec 18, 2025

Key ActionSubmit prior authorization requests and support medical necessity with requested documentation; approve only if the patient meets the listed coverage criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Initial approval duration

1Extended approval duration

>=7Minimum patient age condition

Authorization Criteria for InPen

Recommended Authorization Criteria — Diabetes Mellitus

Coverage of InPen is recommended when ALL of the following are met:

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ALL of the following

Patient is 7 years of age or older OR patient is younger than 7 years of age and will be using InPen with adult supervision
Either meet age >=7 OR <7 with adult supervision
Patient will be using InPen with Humalog, Novolog, or Fiasp
Pen compatible with Lilly Humalog U-100 3 mL, Novo Nordisk U-100 3 mL, and Novo Nordisk Fiasp U-100 3 mL cartridges
Patient will use U-100 insulin only
U-100 concentration required
Patient has access to a device that can install and use the InPen app (iOS 10 or later or Android 6 or later)
Examples: smartphone, tablet; mobile OS requirement: iOS 10+ or Android 6+
Patient is able and willing to visit a healthcare provider regularly and test blood glucose levels as recommended by their provider
Patient must be willing/able to perform recommended BG testing and follow-up

Conditions Not Recommended for Approval

Not recommended when the requested use is not listed in the Recommended Authorization Criteria or when evidence/safety is limited:

ANY of the following

Uses or indications not listed in the Recommended Authorization Criteria
Requests for other uses will be reviewed case-by-case for evidence of efficacy and medical necessity
Circumstances with limited or preliminary data or potential safety concerns
Not an exhaustive list; policy may be updated as new evidence becomes available; case-by-case review may occur

Prior Authorization & Documentation

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for pharmacy benefit coverage of InPen; approval should be granted only for patients who meet the policy's recommended authorization criteria. Initial approvals are for 1 year and extended approvals, when allowed, are for 1 year.

Documentation Required

Documentation availability upon request

The Company may request additional documentation to support medical necessity, including patient records, test results, and/or provider credentials; failure to provide requested documentation may result in denial of reimbursement.

Clinical and Product Background

InPen is an FDA-cleared smart insulin pen system that combines a reusable Bluetooth-enabled insulin pen with a companion mobile app. The system records insulin injections and provides dose recommendations based on current blood glucose, insulin dose, and active insulin, and is prescription-only. The pen injector is compatible with Humalog U-100 3 mL cartridges, Novolog (Novo Nordisk) U-100 3 mL cartridges, and Fiasp U-100 3 mL cartridges, and allows dialing doses from 0.5 to 30 units in 0.5-unit increments.

InPen is intended for users who are willing and able to perform recommended blood glucose testing, maintain diabetes self-care skills, and visit a healthcare provider regularly. It is not recommended for individuals who are unable or unwilling to test blood glucose as recommended, nor for blind or visually impaired users without assistance. The InPen mobile app requires a device capable of installing the app (examples: smartphone or tablet) running iOS 10 or later or Android 6 or later.