CurrentCignaPolicy N/A

Bisphosphonates (Oral) Enhanced Step Therapy Policy

Defines enhanced step therapy requirements for selecting oral bisphosphonate products for Cigna-administered health benefit plans, specifying Step 1, Step 2, and Step 3 agents and approval rules for coverage.

Policy Summary

PayerCigna

PolicyBisphosphonates (Oral) Enhanced Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateOct 2, 2024

Key ActionRequire trial of one Step 1 product before approving a Step 2 product; approvals are valid for 1 year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3step levels (Step 1-3)

1 yrapproval duration

G-tube/dysphagiaBinosto exception

No change2024 review

Coverage Criteria

Step therapy coverage criteria

Covered when the step therapy rules below are met:

Step therapy general

Step 1 trial to approve Step 2: If the patient has tried one Step 1 Product, approve a Step 2 Product.1 prior Step 1 product
Step 1+Step 2 trials to approve Step 3: If the patient has tried one Step 1 Product and one Step 2 Product, approve a Step 3 Product.1 prior Step 1 and 1 prior Step 2 product

Binosto special approval: Approve Binosto if the patient has either (A) a gastrostomy tube (G-tube) OR (B) cannot swallow or has difficulty swallowing tablets or capsules.

Policy Summary

PayerCigna

PolicyBisphosphonates (Oral) Enhanced Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateOct 2, 2024

Key ActionRequire trial of one Step 1 product before approving a Step 2 product; approvals are valid for 1 year.

SourceLink

On This Page

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Provider Actions and Prior Authorization

Step Therapy

Step therapy approvals (1 year)

All approvals under this Step Therapy program are provided for a duration of 1 year.

Step 1: alendronate 5, 10, 35, 40 and 70 mg tablets; ibandronate 150 mg tablets; risedronate 5, 30, 35, and 150 mg tablets; risedronate 35 mg delayed-release tablets
Step 2: Atelvia delayed-release tablets
Step 3: Actonel tablets; Binosto effervescent tablets; Boniva tablets; Fosamax tablets; Fosamax Plus D tablets

Denial Risk

Failure to meet step therapy

If the Step Therapy sequencing requirements are not met at the point of service, coverage will be determined by the Step Therapy criteria in this policy. Exceptions outside the stated Step Therapy criteria are considered not medically necessary.

If the patient has tried one Step 1 Product, approve a Step 2 Product.
If the patient has tried one Step 1 Product and one Step 2 Product, approve a Step 3 Product.
Approve Binosto if the patient has a gastrostomy tube (G-tube) or cannot swallow/has difficulty swallowing tablets or capsules.

Note

Coverage determination guidance

Coverage determinations must consider: 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws and regulations; 3) any relevant collateral source materials (including coverage policies); and 4) the specific clinical facts of the particular situation. Medical Directors should exercise clinical judgment and discretion when making individual coverage determinations.

Step Therapy

Step therapy execution

Step sequencing must be followed: Step 1 must be tried before Step 2; one Step 1 trial allows Step 2 approval; similarly, one Step 1 and one Step 2 trial allow Step 3 approval. Binosto may be approved without prior steps when the patient has a G-tube or cannot swallow tablets/capsules.

Step Therapy Details

Step	Products (examples)	Coverage requirement
Step 1	Alendronate tablets (5, 10, 35, 40, 70 mg); Ibandronate 150 mg tablet; Risedronate tablets (5, 30, 35, 150 mg); Risedronate 35 mg delayed‑release tablet	Initial therapy; must be tried before advancing to Step 2
Step 2	Atelvia (risedronate delayed‑release) tablets	Requires trial of one Step 1 product prior to approval of a Step 2 product
Step 3	Actonel tablets; Binosto effervescent alendronate tablets; Boniva tablets; Fosamax tablets; Fosamax Plus D tablets	Requires prior trial of one Step 1 product and one Step 2 product prior to approval of a Step 3 product
Binosto exception	Binosto (effervescent alendronate) — oral solution formulation for patients with swallowing difficulty or for G‑tube administration	May be approved without prior Step 1/2 trials if patient has a gastrostomy tube OR cannot swallow or has difficulty swallowing tablets or capsules

Key Definitions

Binosto — definition and policy notes

DefinitionBinosto: alendronate effervescent tablet (70 mg) formulated to make an oral solution for patients who have difficulty swallowing or require G‑tube administration.

Formulation detailsEffervescent alendronate tablet producing a 70 mg oral solution (Binosto).

Clinical useUsed as an oral solution alternative to alendronate tablets for indications including treatment of postmenopausal osteoporosis and to increase bone mass in men with osteoporosis.

Policy exceptionBinosto may be approved without prior Step 1 or Step 2 trials for patients with a gastrostomy tube (G‑tube) or who cannot swallow tablets or capsules.

Placement in step therapyListed as a Step 3 product in the Step Therapy program (Step 1 → Step 2 → Step 3).

Background

Oral bisphosphonates included in this step therapy program are indicated for the treatment and prevention of osteoporosis and related conditions. The policy groups agents into steps: Step 1 includes alendronate tablets (5, 10, 35, 40, 70 mg), ibandronate 150 mg tablets, and risedronate immediate-release tablets (5, 30, 35, 150 mg) and risedronate 35 mg delayed-release tablets; Step 2 is Atelvia delayed-release tablets; Step 3 includes Actonel tablets, Binosto effervescent tablets (an alendronate oral solution formulation), Boniva tablets, Fosamax tablets, and Fosamax Plus D tablets. Binosto is an effervescent alendronate formulation intended to provide an oral solution for patients who have difficulty swallowing or require alternative administration.

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