Hidradenitis Suppurativa (HS)

POLICY NUMBER

L.5.01.435

Abrilada (adalimumab-afzb)

Amjevita (adalimumab-atto)

Bimzelx (bimekizumab-bkzx)

Cosentyx (secukinumab)

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

Hidradenitis suppurativa (HS), is a chronic inflammatory skin condition that primarily affects the folliculopilosebaceous unit. The disease most often involves the intertriginous axillary, groin, perianal, perineal, genital, and inframammary skin. The clinical course is highly variable, ranging from relatively mild cases characterized by the recurrent appearance of papules, pustules and a few inflammatory nodules to severe cases demonstrating deep fluctuant abscesses, draining sinuses, and severe, rope-like scars.

Treatment of HS may include non-pharmacologic measures, topical and systemic medications, surgery, or laser/light interventions. The severity of HS influences the approach to treatment. The three-stage Hurley clinical staging system is used to define disease severity in the clinical setting.

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)

• Bimzelx (bimekizumab-bkzx)

• Cyltezo (adalimumab-adbm)

• Hulio (adalimumab-fkjp)

• Humira (adalimumab)

• Hyrimoz (adalimumab-adaz)

• Idacio (adalimumab-aacf)

• Yuflyma (adalimumab-aaty)

• Yusimry (adalimumab-aqvh)

Initial Criteria

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

1. ONE of the following:

   1. The individual is 18 years of age or older; OR

   2. The individual is 12 years of age or older and the request is for adalimumab;

2. The individual has a diagnosis of hidradenitis suppurativa (HS) with documented Hurley Stage II or III;

3. ONE of the following:

   1. The individual has moderate to severe disease and has failed (see definition of Failure in the Policy Guidelines section) at least ONE conventional agent (≥3 months use) as evidenced by medical records and/or pharmacy printout;

   2. The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents used in the treatment of HS; OR

   3. The individual’s medication history indicates use of another biologic immunomodulator agent indicated for the treatment of HS;

4. The prescriber is a board certified dermatologist or has consulted with a board certified dermatologist;

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

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

7. BOTH of the following:

   1. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage; AND

   2. If Cosentyx 300 mg every 2 weeks is requested, the individual has tried and had an inadequate response to Cosentyx 300 mg every 4 weeks after at least a 3-month duration of therapy.

Length of Approval: 12 months

Renewal Criteria

Cosentyx (secukinumab), 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 for the requested agent through the BCBSMS PA process;

2. The individual has documented clinical improvement (i.e., slowing of disease progression or decrease in symptom severity and/or frequency);

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

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.); AND

5. The prescribed dosage is within the program quantity limits based on 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 (for ≥3 months use) 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

02/17/2016: New policy added.

05/26/2016: Policy number L.5.01.435 added.

08/09/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

10/18/2016: Policy description updated regarding Hurley Stage II (moderate disease). Policy statements unchanged.

08/15/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

11/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. 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. Added 12 month length of approval.

02/05/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added statement to perform a formulary drug search on the 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. Policy description updated regarding FDA approved indications. Policy statement revised to state that Humira may be considered medically necessary when the listed criteria are met. Medically necessary statement revised to update the age requirement from "18 years" to "12 years." Added recommended dosage regimen for adolescents. Sources updated. Code Reference section updated to add HCPCS code J0135 and L73.2. Effective 01/01/2019.

10/01/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding Hurley Stage I, II, and III. Policy statement updated to add documentation requirements. Sources updated.

07/13/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding the three-stage Hurley clinical staging system. Policy section revised to add initial and renewal evaluation criteria. 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 Exceptions updated. 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.

07/01/2023: Policy description tables for Hurley Stage II and III revised to change "Humira" to "Adalimumab." Policy statements for initial and renewal evaluation updated to include Amjevita (adalimumab-atto) and Hadlima (adalimumab-bwwd) as medically necessary or approved when the specified criteria are met. Added statement that Abralida (adalimumab-afzb), Cyltezo (adalimumab-adbm), Hulia (adalimumab-fkjp), Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Yuflyma, and Yusimry (adalimumab-aqvh) are considered not medically necessary as other formulary options exist for the treatment of Hidradenitis Suppurativa. Sources updated.

03/08/2024: Policy updated to state that Amjevita (adalimumab-atto) is considered not medically necessary as other formulary options exist for the treatment of Hidradenitis Suppurativa.

05/13/2024: Policy section revised to add Simlandi (adlimumab-ryvk) as medically necessary when the listed criteria are met. Sources updated.

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

11/01/2024: Policy description updated regarding hidradenitis suppurativa, treatment, and the three-stage Hurley clinical staging system. 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. Medically necessary statement updated to remove Humira (adalimumab) and add Cosentyx as medically necessary when the listed criteria are met. Policy criteria updated to add age requirement. Revised criteria to state that the prescriber is a board certified dermatologist or has consulted with a board certified dermatologist. Revised policy statement to state 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. Code Reference section updated to add HCPCS code J3247 to the Covered Codes table. Added HCPCS codes J0135, Q5131, and Q5132 to the Not Covered/Non-Formulary Codes table. Effective 01/01/2025.

01/01/2025: Code Reference section updated to add new HCPCS codes J0139, Q5140, Q5141, Q5142, Q5143, Q5144, and Q5145.

12/02/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy updated to add Bimzelx (bimekizumab-bkzx) to the list of drugs. Policy description updated with minor changes to tables. Policy section updated to add Bimzelx (bimekizumab-bkzx) to the list of medications not covered on BCBSMS Formulary. Medically necessary criteria updated regarding individuals with medication history indicating use of another biologic immunomodulator agent for the treatment of HS. Added medically necessary criteria regarding request for Cosentyx. Added "JAK inhibitor" to the list of immunomodulatory agents. Sources updated. Code Reference section updated to remove HCPCS code J3247.

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. Bimzelx prescribing information. UCB, Inc. June 2025. Last accessed November 2025.

4. Cosentyx prescribing information. Novartis Pharmaceuticals Corporation. August 2025. Last accessed September 2025.

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

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

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

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

9. Hidradenitis suppurativa: Management. UpToDate. Last updated May 22, 2024. https://www.uptodate.com/contents/hidradenitis-suppurativa-management

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

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

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

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

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Not Covered/Non-Formulary Codes

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