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Rho Kinase Inhibitor Step Therapy with Quantity Limit program Summary

Policy Number: PH-1141

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies

 

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

10/1/2022              

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Rhopressa®

(netarsudil)

Ophthalmic solution

Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension

1

Rocklatan®

(netarsudil and latanoprost)

Ophthalmic solution

Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension

2

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Open Angle Glaucoma

The American Academy of Ophthalmology (AAO) guidelines for open angle glaucoma indicate that medical therapy is presently the most common initial intervention to lower intraocular pressure (IOP). There are many drugs available for initial therapy and medication choice may be influenced by potential cost, side effects, dosing schedules, and degree of pressure lowering needed. If target IOP is not achieved by one medication, then either switching or adding medications should be considered depending on whether the individual patient has responded to the first medication. The first medication should not be kept in the regimen if there is no response in IOP lowering.(3)

 

Prostaglandin analogs are often considered initial therapy for lowering IOP in patients with glaucoma because they are most efficacious, well tolerated, and instilled once daily. Other agents include beta-blockers, alpha-2 adrenergic agonists, parasympathomimetics, and topical and oral carbonic anhydrase inhibitors. Guidelines recommend prostaglandin analogs as first-line therapy, but do not recommend one particular product over another.(3)

 

The AAO guidelines note the importance of adherence to therapy to achieve goal IOP. The guidelines also note that patients have relatively poor adherence (nearly 45% of patients in one study administered less than 75% of prescribed doses). AAO indicated that dosing, difficulty in administration, comorbidities, cost, and patients running out of medication prior to being able to refill their prescription are the leading causes of poor adherence.(3)

Drops/Bottle and Days of Supply

Dispensed drop size is dependent on a number of factors of ophthalmic solutions including the viscosity, surface tension, design of the dropper tip, and the angle the bottle is held when the drop is dispensed. A number of studies have been completed evaluating the number of drops per bottle for the prostaglandin analogs. These studies determine that overfilling of the bottles is a common occurrence for the prostaglandin analogs with an average of roughly 30 drops/mL for each 2.5 mL bottle.(4-8) With the average of 30 drops/mL, a 2.5 mL bottle should last 37.5 days if patients are treating both eyes.

Safety(1,2)

Rhopressa and Rocklatan do not have any FDA labeled contraindications for use.

REFERENCES                                                                                                                                                                            

Number

Reference

1

Rhopressa prescribing information. Aerie Pharmaceuticals, Inc.   March 2019.

2

Rocklatan prescribing information.  Aerie Pharmaceuticals, Inc. June 2020.

3

National AAO Preferred Practice Pattern-Guidelines: Primary Open Angle Glaucoma (2020). https://www.aaojournal.org/article/S0161-6420(20)31024-1/fulltext.

4

Fiscella R, Wilensky JT, Chiang TH, Walt JG. Efficiency of instillation methods for prostaglandin medications. J Ocul Pharmacol Ther. 2006;22(6):477-82.

5

Frenkel REP, Frenkel M, Toler A. Pharmacoeconomic analysis of prostaglandin and prostamide therapy for patients with glaucoma or ocular hypertension. BMC Ophthalmology. 2007;7:16.

6

Rylander NR, Vold SD, Cost Analysis of Glaucoma Medications. Am J Ophthalmol. 2008;145(1):106-113.

7

Queen, J. H., Feldman, R. M., & Lee, D. A. (2016). Variation in Number of Doses, Bottle Volume, and Calculated Yearly Cost of Generic and Branded Latanoprost for Glaucoma. American journal of ophthalmology, 163, 70–74.e1. https://doi.org/10.1016/j.ajo.2015.11.021

8

Moore, D. B., Beck, J., & Kryscio, R. J. (2017). An objective assessment of the variability in number of drops per bottle of glaucoma medication. BMC ophthalmology, 17(1), 78. https://doi.org/10.1186/s12886-017-0473-8

 

POLICY AGENT SUMMARY STEP THERAPY

Agent Names

Strength

Targeted MSC

Available MSC

Effective Date

RHOPRESSA*netarsudil dimesylate ophth soln

0.02 %

M ; N ; O

N

RHOPRESSA*netarsudil dimesylate ophth soln

0.02 %

M ; N ; O ; Y

N

ROCKLATAN*netarsudil dimesylate-latanoprost ophth soln

0.02 %

M ; N ; O

N

ROCKLATAN*netarsudil dimesylate-latanoprost ophth soln

0.02 %

M ; N ; O ; Y

N

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Agent GPI

Agent Names

Strength

QL Amount

Dose Form

Days Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Effective Date

865270402020

RHOPRESSA*netarsudil dimesylate ophth soln

0.02 %

2.5

MLS

30

Days

865299024020

ROCKLATAN*netarsudil dimesylate-latanoprost ophth soln

0.02 %

2.5

MLS

30

Days

CLIENT SUMMARY – STEP THERAPY

Agent Names

Strength

Client Formulary

RHOPRESSA*netarsudil dimesylate ophth soln

0.02 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

ROCKLATAN*netarsudil dimesylate-latanoprost ophth soln

0.02 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Agent Names

Strength

Client Formulary

RHOPRESSA*netarsudil dimesylate ophth soln

0.02 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

ROCKLATAN*netarsudil dimesylate-latanoprost ophth soln

0.02 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

STEP THERAPY CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Prerequisite Agent(s)

All generic ophthalmic prostaglandins

Target Agent(s) will be approved when ONE of the following is met:

  1. The requested agent is eligible for continuation of therapy AND ONE of the following:

Agents Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy

    1. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
    2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR 
  2. The patient’s medication history indicates use of a prerequisite agent within the past 90 days OR
  3. The patient has an intolerance or hypersensitivity to a prerequisite agent OR
  4. The patient has an FDA labeled contraindication to ALL prerequisite agents

Length of Approval:  12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. The requested quantity (dose) is greater than the program quantity limit AND ONE of the following:
    1. BOTH of the following:
      1. The requested agent does not have a maximum FDA labeled dose for the requested indication AND
      2. Information has been provided to support therapy with a higher dose for the requested indication OR
    2. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. Information has been provided to support why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
    3. BOTH of the following:
      1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
      2. Information has been provided to support therapy with a higher dose for the requested indication

Length of approval: up to 12 months

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.

 

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

 

 

BCBSAL _  PS _ Rho Kinase Inhibitor Step Therapy with Quantity Limit _ProgSum_ 10/1/2022  _