Uveitis

POLICY NUMBER

L.5.01.509

Abrilada (adalimumab-afzb)

Amjevita (adalimumab-atto)

Cyltezo (adalimumab-adbm)

Hadlima (adalimumab-bwwd)

Hulio (adalimumab-fkjp)

Humira (adalimumab)

Hyrimoz (adalimumab-adaz)

Idacio (adalimumab-aacf)

Simlandi (adalimumab-ryvk)

Yuflyma (adalimumab-aaty)

Yusimry (adalimumab-aqvh)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Uveitis (intraocular inflammation) can be infectious or non-infectious and the approach to therapy depends upon the etiology, location and severity of the inflammation. The uvea is the middle portion of the eye. The anterior portion of the uvea includes the iris and ciliary body. The pars plana is the tissue just posterior to the ciliary body and just anterior to the retina. The posterior portion of the uvea is known as the choroid.

Inflammation of the anterior uveal tract is called anterior uveitis and is synonymous with iritis. When the adjacent ciliary body is also inflamed, the process is known as iridocyclitis.

Terms used to describe uveitis posterior to the lens include vitritis, intermediate uveitis, pars planitis, choroiditis, retinitis, chorioretinitis or retinochoroiditis. Panuveitis refers to inflammation in the anterior chamber, vitreous humor and choroid or retina simultaneously.

Posterior or intermediate uveitis and panuveitis are generally not responsive to topical treatment. Options for initial treatment of intermediate or posterior uveitis, or for panuveitis, include periocular injections (i.e. triamcinolone) or intraocular injections (i.e. triamcinolone, dexamethasone). Systemic treatment is generally reserved for resistant inflammation or for patients who cannot be treated with local injections or who have bilateral disease.

Patients with disease that is resistant to initial treatment may require systemic corticosteroid therapy or additional anti-inflammatory or immunosuppressive agents (e.g. cyclosporine, methotrexate, azathioprine, tacrolimus, mycophenolate). In patients with uveitis who are resistant to these therapies, another option is the use of a TNF inhibitor such as adalimumab.

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Hadlima and Simlandi are the adalimumab formulary options effective 01/01/2025. 

The following medications are not covered on any BCBSMS Formulary:

• Abrilada (adalimumab-afzb)

• Amjevita (adalimumab-atto)

• Cyltezo (adalimumab-adbm)

• Hulio (adalimumab-fkjp)

• Humira (adalimumab)

• Hyrimoz (adalimumab-adaz)

• Idacio (adalimumab-aacf)

• Yuflyma (adalimumab-aaty)

• Yusimry (adalimumab-aqvh)

Initial Criteria

Hadlima (adalimumab-bwwd) or Simlandi (adalimumab-ryvk) may be considered medically necessary when ALL of the following criteria are met:

1. The individual has a documented diagnosis of non-infectious intermediate uveitis, posterior uveitis, or panuveitis determined by an ophthalmologist;

2. ONE of the following:

   1. The individual has tried and had an inadequate response to ONE conventional agent (e.g., azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus) after at least 3-month duration of therapy; OR

   2. The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis;

3. ONE of the following:

   1. The individual has failed (see definition of Failure in the Policy Guidelines section) ONE of the following:

      1. oral corticosteroids for a minimum of 2 weeks; OR

      2. periocular or intravitreal corticosteroid injections; OR

   2. The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to BOTH oral corticosteroids and periocular/intravitreal corticosteroids;

4. The individual is not currently being treated with another immunomodulatory agent (i.e., TNF-inhibitor, JAK inhibitor, IL-inhibitor, anti-IgE antibody, Otezla, etc.);

5. The individual does not have any contraindication(s) to therapy with the requested agent; AND

6. The prescribed dosage is within the program quantity limits based on the individual's age and FDA-approved labeled dosage.

Length of Approval: 6 months

Renewal Criteria

Hadlima (adalimumab-bwwd) or Simlandi (adalimumab-ryvk) may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has been previously approved through the BCBSMS PA process;

2. The individual has documented clinical improvement (i.e., reduced frequency of disease flares compared to baseline, reduction in corticosteroid requirements from baseline, and/or stabilization or improvement in anterior chamber cell grade, vitreous haze grade, or visual acuity);

3. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent;

4. The individual is not currently being treated with another immunomodulatory agent (i.e., TNF-inhibitor, IL-inhibitor, anti-IgE antibody, Otezla); AND

5. The prescribed dosage is within the program quantity limits based on the individual’s age and FDA-approved labeled dosage.

Length of Approval: 12 months 

Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Medication Failure

Medication failure is defined as disease progression at generally accepted doses as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.

BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

07/01/2016: New policy added. Policy number L.5.01.509.

02/07/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

02/06/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

01/21/2019: Added drug name to the top of the policy.

02/05/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Removed Retisert® and added Humira (adalimumab) to the top of the policy. Added statement to perform a formulary drug search on your patient's member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member's benefit plan. Added policy statement that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Medically necessary statement revised to indicate treatment in patients 2 years of age and older. Policy section updated regarding dosing for adult and pediatric patients. Sources section updated.

02/10/2020: Medically necessary policy statement updated to add the following: "(intraocular injection of glucocorticoid, oral prednisone at appropriate dose, etc.)." Sources updated.

07/13/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Humira (adalimumab). Policy section updated to revise initial and renewal evaluation criteria for Humira (adalimumab). Added statement that services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Added information regarding BCBSMS request for medical records and defined medication failure. Sources updated.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

05/13/2024: Policy description updated to add indications for Hadlima (adalimumab-bwwd) and Simlandi (adalimumab-ryvk). Initial and renewal evaluation criteria updated regarding Humira (adalimumab), Hadlima (adalimumab-bwwd), and Simlandi (adalimumab-ryvk). Sources updated.

05/31/2024: Policy updated to state that Hadlima or Simlandi are the adalimumab formulary options for new starts effective 07/01/2024.

11/01/2024: Added list of drugs to the top of the policy. Policy description revised to remove drug indications. Policy section revised to state the following: 1) The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. 2) Hadlima and Simlandi are the adalimumab formulary options effective 01/01/2025. Policy statements updated to remove Humira (adalimumab) and its indications. Added renewal criteria for Hadlima (adalimumab-bwwd) and Simlandi (adalimumab-ryvk). Added statement that the following medications are not covered on any BCBSMS Formulary: Abrilada (adalimumab-afzb), Amjevita (adalimumab-atto), Cyltezo (adalimumab-adbm), Hulio (adalimumab-fkjp), Humira (adalimumab), Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Yuflyma (adalimumab-aaty), and Yusimry (adalimumab-aqvh). Sources updated. Effective 01/01/2025.

12/02/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated with minor changes. Medically necessary policy statement criteria revised to state that the individual has a documented diagnosis of non-infectious intermediate uveitis, posterior uveitis, or panuveitis determined by an ophthalmologist. Revised medically necessary criteria regarding duration of therapy. Added statement that the individual is not currently being treated with another immunomodulatory agent. Renewal criteria revised regarding clinical improvement. Sources updated.

SOURCE(S)

1. Abrilada prescribing information. Pfizer Laboratories Div Pfizer Inc. January 2025. Last accessed September 2025.

2. Amjevita prescribing information. Amgen Inc. August 2024. Last accessed September 2025.

3. Cyltezo prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. August 2025. Last accessed September 2025.

4. Glenn J, Dick A, et al. Adalimumab in Patients with Active Noninfectious Uveitis. N Engl J Med 2016; 375:932-943. DOI: 10.1056/NEJMoa1509852

5. Hadlima prescribing information. Organon LLC. June 2024. Last accessed September 2025.

6. Hulio prescribing information. Biocon Biologics Inc. February 2025. Last accessed September 2025.

7. Humira prescribing information. AbbVie Inc. July 2025. Last accessed September 2025.

8. Hyrimoz prescribing information. Sandoz Inc. July 2025. Last accessed September 2025.

9. Idacio prescribing information. Fresenius Kabi USA, LLC. October 2024. Last accessed September 2025.

10. Simlandi prescribing information. Teva Pharmaceuticals USA, Inc. February 2025. Last accessed September 2025.

11. The Standardization of Uveitis Nomenclature (SUN) Working Group. Am J Ophthalmol. 2005; 140:509-516.

12. Yuflyma prescribing information. Celltrion USA, Inc. March 2025. Last accessed September 2025.

13. Yusimry prescribing information. Coherus BioSciences, Inc. May 2025. Last accessed September 2025.

CODE REFERENCE

None