RXMP-07 Denosumab and biosimilars, Non-Cancer Related Indications Form

Denosumab and biosimilars, Non Cancer Related Indications
Shortcuts Updated on 12/23/2025

Page 1 of 3 Policy Number RXMP-07 Line of Business Medicaid & Medicare Effective Date 4/1/2026 Revision Date 12/23/2025

Products Prolia Biosimilars Bildyos (denosumab-nxxp), Conexxence (denosumab-bhntz), Jubbonti (denosumab-bbdz), Ospomyv (denosumab-dssb), Stoboclo (denosumab-bmwo) Xgeva Biosimilars Bilprevda (denosumab-nxxp), Bomyntra (denosumab-bhnt), Osenvelt (denosumab-bhnt), Wyost (denosumab-bbdz), Xbryk (denosumab-dssb)

Override(s)
Approval Duration
Prior Authorization
1 year

Denosumab Medical Benefit
Denosumab Pharmacy Benefit
Quantity Limit
(Non-preferred) Authorization Required
Non-Formulary, PA Required

J0897, Injection, denosumab, 1 mg (prolia/xgeva) Prolia (denosumab) 60mg/mL injection 60mg (60 units) every 6 months (Preferred) Authorization Required Formulary, PA Required

C9399, Injection, denosumab-nxxp (bildyos/bilprevda), biosimilar, 1mg
Bildyos 60mg/mL (denosumab-nxxp) injection 60mg (60 units) every 6 months
Q5158, Injection, denosumab-bhntz (conexxence/bomyntra), biosimilar, 1mg
Conexxence 60mg/mL (denosumab-bhnt) injection 60mg (60 units) every 6 months
Q5136, Injection, denosumab-bbdz (jubbonti/wyost), biosimilar, 1 mg
(Preferred) Jubbonti (denosumab-bbdz) 60mg/mL injection

60mg (60 units) every 6 months
Q5157, Injection, denosumab-bmwo (stoboclo/osenvelt), biosimilar, 1mg (Preferred) Stoboclo (denosumab-bmwo) 60mg/mL injection

60mg (60 units) every 6 months
Q5159, Injection, denosumab-dssb (ospomyv/xbryk), biosimilar, 1mg
Ospomyv (denosumab-dssb) 60mg/mL injection 60mg (60 units) every 6 months Medicare (new starts)/Medicaid preferred agents: Jubbonti or Stoboclo

Bisphosphonate Medical Benefit Drugs
Quantity Limit
(Preferred) Authorization Required
J1740, Injection, ibandronate sodium, 1mg (Boniva)
3mg/3mL (1mg/1ml) every 90 days J3489, Injection, zoledronic acid, 1mg (Reclast)
5mg every 365 days
J2430, Injection, pamidronate disodium, 30mg (Aredia) 90mg/dose
Bisphosphonate Pharmacy Rx Benefit Drugs Quantity Limit Formulary, PA Not Required
alendronate (Fosamax) 5mg, 10mg tablet 1 tablet per day
alendronate (Fosamax) 35mg, 70mg tablet 4 tablets per 28 days calcitonin-salmon (Fortical, Miacalcin) 200unit/actuation nasal spray 3.7mL per 30 days Nonformulary, PA required
ibandronate sodium (Boniva) 150mg tablet 1 tablet per 30 days risedronate (Actonel) 5mg, 30mg, 35mg, 150mg tablet

5mg: 1 tab per day,
30mg: (for Paget’s disease only) 1 tablet per day limited to 2 months initial approval & 2 months COC. 35mg: 4 tablets per 28 days

Denosumab and biosimilars, Non Cancer Related Indications
Shortcuts Updated on 12/23/2025

Page 2 of 3 150mg: 1 tablet per 30 days

Note for Pharmacy Staff:
For QUEST & non-ABD members with cancer, send ADRC referral with chart notes.
For Medicare, for all diagnosis, send to high risk assessment.

Medicare Criteria Medicare Part B Coverage Criteria
Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. • No LCD/NCD/LCA found as of 10/25/2025. Review the criteria below Medicare Part B 90-Day Transition Period For new Medicare members, a 90-day transition period applies. During this time, if a member is currently on an active course of the requested treatment, including when furnished by an out-of-network provider, Coverage and Step Therapy do not apply. After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage. Medicare Part B Step Therapy Criteria Prolia & biosimilar denosumab for the indications listed below:
• Osteoporosis
• Androgen deprivation-induced bone loss in patients with prostate or breast cancer treatment Prolia & biosimilar denosumab (new starts): Inadequate response to or contraindication to oral bisphosphonate (e.g. alendronate) or injectable bisphosphonate (e.g., ibandronate, zoledronic acid) AND one of the biosimilars [(e.g., Jubbonti or Stoboclo)]. Continuation Critiera for Approval for Medicare/Medicaid
See Renewal Criteria on the sections below

CLINICAL CRITERIA FOR APPROVAL FOR MEDICARE/MEDICAID: NOTE: Pharmacy staff: For QUEST & non-ABD members with cancer, send ADRC referral with chart notes.

Approval Criteria Products Bildyos, Conexxence, Jubbonti (preferred), Ospomyv, Prolia, and Stoboclo (preferred) Diagnosis
Osteoporosis
Line of Business Medicare and Medicaid Approval Length Initial/Renewal Request: 1 year
Override Type Authorization required
Initial Criteria

1. Diagnosis of osteoporosis (e.g., postmenopausal osteoporosis, glucocorticoid-induced osteoporosis, or male osteoporosis); AND
2. Member is 18 years of age or older; AND
3. Member is at very high risk for fractures, evidenced by one of the following: a. The member had an osteoporotic fracture in the past 12 months b. The member’s bone mineral density (BMD) T-score at hip or spine is -3.0 or lower
   c. BMD T-score at hip or spine is -2.5 or lower AND the member had a major osteoporotic fracture on the hip, spine, forearm, wrist or upperarm) AND
4. One of the following:
   a. The member has completed a 3 – year trial of maximum dose oral or IV bisphosphonate therapy b. All bisphosphonates are contraindicated or the member has experienced adverse side effects
   c. The member has experienced a loss of BMD while on bisphosphonate therapy

Denosumab and biosimilars, Non Cancer Related Indications
Shortcuts Updated on 12/23/2025

Page 3 of 3 d. The member has experienced a lack of BMD increase after 12 or more months of bisphosphonate therapy e. The member has experienced an osteoporotic fracture or fragility fracture while receiving bisphosphonate therapy AND

5. For the request for Jubbonti or Stoboclo– Approve for 1 year; OR
6. For the request for Bildyos, Conexxence, Ospomyv, and Prolia, the member has tried and failed, is contraindicated, or been intolerant to at least two biosimilars (e.g., Jubbonti and Stoboclo) OR an FDA MedWatch Adverse Event Reporting has been submitted for the biosimilars.
   Renewal Criteria
7. Diagnosis of osteoporosis (e.g., postmenopausal osteoporosis, glucocorticoid-induced osteoporosis, or male osteoporosis); AND
8. Documentation showing that the member has been responding positively to therapy (e.g., no new fractures, stabilization or increase in BMD T-score, decrease in bone resorption markers, or reduction in bone pain); AND
9. For the request for Conexxence, Jubbonti, or Stoboclo– Approve for 1 year; OR

10. For the request for Bildyos, Ospomyv, and Prolia, the member has tried and failed, is contraindicated, or been intolerant to at least two biosimilars (e.g., Conexxence, Jubbonti, Stoboclo) OR an FDA MedWatch Adverse Event Reporting has been submitted for the biosimilars.

    FDA Indications, Dosing & Administration:

    References

11. Prolia (denosumab) [prescribing information]. Thousand Oaks, CA: Amgen Inc; April 2025.
12. Humphrey MB, Russell L, Danila MI, et al. 2022 American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Rheumatol. 2023;75(12):2088-2102. doi:10.1002/art.42646 [PubMed 37845798]
13. Wolters Kluwer. Denosumab. In: Lexicomp Online. Facts & Comparisons. Updated April 2025. Accessed July 7,

14. https://online.lexi.com

    Change History

15. Updated preferred agents, 12/23/2025 Drug Name Indications Dosage/Administration Polia and biosimilars
    Androgen deprivation-induced bone loss in patients with prostate/breast cancer treatment
    60mg SQ once every 6 months
    Osteoporosis, fracture risk reduction (males and females)
    Osteoporosis, glucocorticoid-induced