1

Pharmacy Medical Policy Sublingual Immunotherapy with Allergen-specific Extracts (SLIT) Table of Contents
• Policy: Commercial • Policy History • References • Policy: Medicare • Information Pertaining to All Policies • Forms • Coding Information

Policy Number: 681 BCBSA Reference Number: None Related Policies • Quality Care Dosing guidelines apply to the following medications and can be found in Medical Policy

621A

Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity

Note: All requests for outpatient retail pharmacy only (ALL SLIT PRODUCTS ARE EXCLUDED FROM MAIL ORDER) for indications listed and not listed on the medical policy guidelines may be submitted to BCBSMA Clinical Pharmacy Operations by completing the Prior Authorization Form on the last page of this document. Physicians may also call BCBSMA Pharmacy Operations department at (800)366-7778 to request a prior authorization/formulary exception verbally. Patients must have pharmacy benefits under their subscriber certificates.

2 Prior Authorization Information ☒ Prior Authorization ☐ Step Therapy ☒ Quality Care Dosing

Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 Policy last updated 8/2025 Pharmacy (Rx) or Medical (MED) benefit coverage ☒ Rx ☐ MED To request for coverage: Physicians may call, fax, or mail the attached form (Formulary Exception/Prior Authorization form) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043

Individual Consideration: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy applies to Commercial Members:
• Managed Care (HMO and POS),
• PPO and Indemnity • MEDEX with Rx plan • Managed Major Medical with Custom BCBSMA Formulary • Comprehensive Managed Major Medical with Custom BCBSMA Formulary • Managed Blue for Seniors with Custom BCBSMA Formulary

Please refer to the chart below for the formulary and step status of the medications affected by this policy.

    Drug

Formulary Information Standard Formulary Status GRASTEK ® (timothy grass pollen allergen) PA Required ODACTRA ™ (dermatophagoides pteronyssinus/dermatophagoides farina) PA Required ORALAIR ® (anthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen) PA Required RAGWITEK ™ (ambrosia artemisiifolia pollen) PA Required

We may cover at retail pharmacy only Grastek ® when all of the following criteria are met1: • Being used as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis caused by Timothy grass or cross-reactive grass pollens, AND • For use in persons 5 through 65 years of age, AND • Prescribed by a board certified or board eligible allergist or board certified or board eligible Otolaryngologists OR Confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies. *Approvals for treatment when provided are limited to start the time period needed before the expected onset of the allergy-inducing pollen season and continued throughout the pollen season.
We may cover at retail pharmacy only Odactra TM when all of the following criteria are met: • Being used as immunotherapy for treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, AND • Prescribed by a board certified or board eligible allergist or board certified or board eligible Otolaryngologists OR Confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies, AND • For use in persons 5 through 65 years of age.

3 *Approvals for treatment when provided are limited to start the time period needed before the expected onset of the allergy-inducing pollen season and continued throughout the pollen season.

We may cover at retail pharmacy only Oralair ® when all of the following criteria are met1: • Being used as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis, AND • Prescribed by a board certified or board eligible allergist or board certified or board eligible Otolaryngologists OR Confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies, AND • For use in persons 5 through 65 years of age.

*Approvals for treatment when provided are limited to start the time period needed before the expected onset of the allergy-inducing pollen season and continued throughout the pollen season.
We may cover at retail pharmacy only Ragwitek TM when all of the following criteria are met1: • Being used as immunotherapy for treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, AND • Prescribed by a board certified or board eligible allergist or board certified or board eligible Otolaryngologists OR Confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies, AND • For use in persons five (5) through 65 years of age.

*Approvals for treatment when provided are limited to start the time period needed before the expected onset of the allergy-inducing pollen season and continued throughout the pollen season.

**Requests based exclusively on the use of samples will not meet coverage criteria for exception. Additional clinical information demonstrating medical necessity of the desired medication must be submitted by the requesting prescriber for review.

We do not cover the above drugs for other conditions not listed above. CPT Codes / HCPCS Codes / ICD Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. CPT Codes There is no specific CPT code for this service.

Individual Consideration All our medical policies are written for the majority of people with a given condition. Each policy is based on medical science. For many of our medical policies, each individual’s unique clinical circumstances may be considered in light of current scientific literature. Physicians may send relevant clinical information for individual patients for consideration to:

Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Tel: 1-800-366-7778 Fax: 1-800-583-6289

4

Policy History
Date Action 8/2025 Updated age for Odactra indication to 5 and updated references. 3/2024 Updated to change age on Odactra ™ and Oralair. 7/2023 Reformatted Policy. 7/2022 Clarified coding between specialist and a confirmed test. 7/2021 Updated to increase Ragwitek’s age indication with FDA update. 4/2020 Clarified prescribing specialists for all SLITs. 3/2018 Updated to include Odactra™ 6/2017 Updated address for Pharmacy Operations. 4/2017 Added criteria for Otolaryngologists. 8/2015 Updated approved ages for Oralair® 10/2014 Implemented New policy. References

1. GRASTEK® [package insert]. Whitehouse Station, NJ: Merck & CO., Inc.: March 2022.
2. ORALAIR® [package insert]. St-Laurent,Quebec: Paladin Labs., Inc.: Nov 2018.
3. RAGWITEKTM [package insert]. Whitehouse Station, NJ: Merck & CO., Inc.: March 2022.

4. ODACTRA TM [package insert]. Swindon, Wiltshire, SN5 8RU UK: Catalent Pharma Solutions Limited: Feb 2025.

   To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below: http://www.bluecrossma.org/medical-policies/sites/g/files/csphws2091/files/acquiadam- assets/023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf