Does Quartz Health Solutions Cover Prolia?

What Is Prolia and Why Is It Prescribed?

Prolia is the brand name for denosumab, a fully human monoclonal antibody that targets RANK-L (receptor activator of nuclear factor kappa-B ligand), a protein that drives osteoclast formation and bone resorption. By blocking RANK-L, denosumab slows bone breakdown and improves bone mineral density (BMD). The FDA approved Prolia on June 1, 2010, for postmenopausal women with osteoporosis at high risk for fracture, and has since extended that approval to men with osteoporosis, patients on glucocorticoid therapy, and men receiving androgen-deprivation therapy (ADT) for non-metastatic prostate cancer. 1

The FREEDOM Trial: Core Evidence

The key FREEDOM trial (N=7,868) showed that denosumab 60 mg every 6 months reduced the risk of new vertebral fractures by 68% (relative risk 0.32, 95% CI 0.26 to 0.41, P<0.001) over 36 months compared to placebo in postmenopausal women with osteoporosis. 2 Hip fracture risk fell by 40% and non-vertebral fracture risk by 20% in the same population. These results form the clinical backbone that insurers, including Quartz, rely on when writing coverage criteria.

FDA-Approved Indications

Prolia carries six distinct FDA-approved indications. 1 The most commonly insured indication is postmenopausal osteoporosis with a T-score at or below -2.5 at the lumbar spine or hip, or a prior fragility fracture. Quartz's prior authorization criteria mirror these FDA indications closely, which means off-label use faces a much steeper approval path.

How Quartz Health Solutions Structures Its Drug Formulary

Quartz Health Solutions, headquartered in Madison, Wisconsin, offers individual, employer-sponsored, and Medicare Advantage plans across Wisconsin and surrounding states. Each plan type carries its own formulary, which is the tiered list of covered drugs. 3

Tier Placement for Prolia

On most Quartz commercial plans, Prolia lands on Tier 3 (preferred specialty) or Tier 4 (non-preferred specialty). Tier 3 typically carries a copay of $50, $150 per fill or a coinsurance rate of 20 to 40% of the drug's allowed cost after the deductible is met. Tier 4 coinsurance often runs 40 to 50%. Because Prolia is administered by injection in a physician's office or infusion center, it may also be billed under the medical benefit (Part B for Medicare, or the medical portion of a commercial plan) rather than the pharmacy benefit, which changes cost-sharing calculations significantly.

Medical Benefit vs. Pharmacy Benefit

When Prolia is dispensed directly through a physician's office and billed as a medical procedure, cost-sharing follows the plan's outpatient drug rules, often a flat specialist visit copay plus a drug administration fee. When billed through specialty pharmacy, the pharmacy benefit tier applies. Patients should confirm with Quartz member services which benefit applies before the first injection. The distinction can mean hundreds of dollars per dose.

Medicare Advantage Plans

Quartz Medicare Advantage plans follow CMS National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) for injectable osteoporosis drugs. 3 Under Medicare Part B, Prolia is covered when a patient meets the statutory definition of "high fracture risk" or has had a fragility fracture. The 2024 Medicare Part B coinsurance rate for physician-administered drugs is generally 20% of the Medicare-allowed amount after the Part B deductible ($240 in 2024). 4

Prior Authorization Requirements for Prolia Under Quartz

Prior authorization (PA) is required for Prolia on virtually every Quartz plan. The PA process exists because Prolia carries a list price exceeding $1,600 per injection. Quartz's clinical criteria for PA approval are based on evidence-based guidelines from the American Association of Clinical Endocrinology (AACE) and the Endocrine Society. 5 6

Typical PA Clinical Criteria

To obtain PA approval, a prescriber generally must document:

1. A DXA-confirmed T-score of -2.5 or lower at the lumbar spine, femoral neck, or total hip, OR a prior fragility fracture. The USPSTF recommends DXA screening for all women 65 and older and for younger postmenopausal women with equivalent fracture risk. 7
2. Step therapy completion: an adequate trial (typically 12 months) of a generic oral bisphosphonate such as alendronate 70 mg weekly or risedronate 35 mg weekly, OR documented intolerance, contraindication, or treatment failure.
3. One of the FDA-approved indications listed on the Prolia label. 1
4. A prescribing physician who is a specialist (endocrinologist, rheumatologist, or gynecologist) or has documented training in metabolic bone disease.

Step Therapy: Bisphosphonates First

Quartz, like most major commercial insurers, follows a step-therapy protocol for osteoporosis drugs. Alendronate (generic, $4, $12/month at most pharmacies) is the standard first-line agent. The AACE 2020 guidelines state: "Pharmacological therapy is recommended for postmenopausal women with osteoporosis and for patients with osteopenia who have a 10-year probability of major osteoporotic fracture of 20% or greater." 6 Bisphosphonates are the first-tier recommendation in that framework. Denosumab becomes a covered option when bisphosphonate therapy is not appropriate or has failed.

Documented Bisphosphonate Failure or Intolerance

A patient qualifies to skip step therapy if the medical record shows:

• Esophageal disease, achalasia, or inability to remain upright for 30 minutes (standard oral bisphosphonate contraindications). 8
• Renal impairment: an estimated GFR <35 mL/min/1.73m² is a contraindication to alendronate and risedronate. 8
• A new fragility fracture while on bisphosphonate therapy for at least 12 months.
• Documented severe gastrointestinal adverse effects leading to discontinuation.

How to Submit a PA Request

1. The prescriber's office submits a PA form through Quartz's provider portal or by fax.
2. The form must include the most recent DXA report (T-scores), FRAX 10-year fracture probability score, a summary of prior therapy, and the ICD-10 diagnosis code (M81.0 for age-related osteoporosis without fracture; M80.08 for age-related osteoporosis with fracture).
3. Quartz's pharmacy benefit manager (PBM) reviews the request; standard turnaround is 72 hours, and urgent requests must be processed within 24 hours under federal ACA rules. 9
4. If approved, the PA is typically valid for 24 months, with renewal required at each authorization period.

What Happens If Quartz Denies PA for Prolia?

A denial is not the end of the road. Federal law and Wisconsin state insurance regulations give Quartz members strong appeal rights, and the denial rate for appeals with complete clinical documentation is lower than many patients expect.

Internal Appeal

File a written internal appeal within 180 days of receiving the denial notice. The appeal should include:

• A letter from the prescribing physician explaining why Prolia is medically necessary for this specific patient.
• Peer-reviewed literature supporting denosumab in the patient's specific clinical scenario. The FREEDOM trial 2 and the AACE guidelines 6 are directly relevant.
• DXA results, FRAX scores, and any imaging showing fracture.
• Documentation of bisphosphonate intolerance or contraindication, if applicable.

Quartz must respond to a standard internal appeal within 30 days for non-urgent requests or 72 hours for urgent/concurrent care requests. 9

External Review

If the internal appeal fails, Wisconsin residents can request an independent external review through the Wisconsin Office of the Commissioner of Insurance (OCI). External reviewers are board-certified physicians with no financial relationship to Quartz. Federal ACA rules require that external review decisions be binding on the insurer. 9

Expedited Appeal for Urgent Clinical Situations

If stopping Prolia mid-course poses serious health risk (for example, a patient on long-term denosumab therapy faces rebound vertebral fractures if the drug is abruptly discontinued), a physician can request an expedited appeal. Studies show that discontinuing denosumab without transitioning to a bisphosphonate leads to rapid bone loss and multiple vertebral fractures within 12 to 24 months. 10 This clinical urgency is recognized in expedited-appeal criteria.

Prolia Manufacturer Assistance Programs

Even when insurance approval is pending or denied, Amgen offers financial assistance that can reduce or eliminate out-of-pocket costs.

Amgen FIRST STEP Program

The Amgen FIRST STEP program provides Prolia at no cost to eligible uninsured patients and assists commercially insured patients with copay costs. Eligibility is based on household income and insurance status. Commercially insured patients may receive up to $1,200 per year in copay assistance. Patients can enroll at amgensupportivecare.com or by calling 1-888-762-6436.

Amgen Safety Net Foundation

For patients below 500% of the federal poverty level who are uninsured or underinsured, the Amgen Safety Net Foundation may provide Prolia free of charge. 11

340B Program

Patients receiving care at a federally qualified health center (FQHC) or other 340B-covered entity may access Prolia at the 340B discounted price, which can be 25 to 50% below the commercial list price. 12

Clinical Guidelines Supporting Prolia Use

Understanding which guidelines Quartz reviewers reference helps prescribers write stronger PA requests.

AACE/ACE 2020 Osteoporosis Guidelines

The AACE 2020 clinical practice guidelines for postmenopausal osteoporosis explicitly place denosumab as a Tier 1 agent (alongside bisphosphonates) for patients at very high fracture risk, defined as a T-score at or below -3.0, a prior hip or vertebral fracture, or a FRAX 10-year major fracture probability of 30% or more. 6 The guideline states: "For patients at very high risk of fracture, anabolic or anti-remodeling agents with greater efficacy may be preferred over bisphosphonates." Denosumab meets that anti-remodeling category.

Endocrine Society 2019 Postmenopausal Osteoporosis Guidelines

The Endocrine Society's 2019 guidelines (published in the Journal of Clinical Endocrinology and Metabolism) recommend denosumab as an alternative to bisphosphonates for women who cannot tolerate oral therapy or have renal insufficiency. 5 The guideline notes that denosumab 60 mg every 6 months produces sustained BMD gains at the lumbar spine and hip over 10 years of treatment in the FREEDOM Extension study (N=4,550). 13

USPSTF Screening Recommendation

The USPSTF recommends screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in women 65 years and older and in younger postmenopausal women who have increased fracture risk (Grade B recommendation). 7 A documented DXA result is a prerequisite for nearly every insurer's PA criteria, including Quartz.

The FRAX Tool and Coverage Decisions

FRAX (Fracture Risk Assessment Tool), developed by the WHO Collaborating Centre for Metabolic Bone Diseases at the University of Sheffield, calculates a patient's 10-year probability of hip fracture and major osteoporotic fracture based on clinical risk factors with or without BMD. 14 A FRAX 10-year major fracture probability at or above 20% or a hip fracture probability at or above 3% triggers the National Osteoporosis Foundation's pharmacotherapy threshold, and Quartz PA reviewers routinely cite this threshold in coverage decisions.

Prolia vs. Alternative Covered Osteoporosis Drugs

When Prolia PA is denied or coverage is limited, understanding the clinical alternatives helps patients and prescribers choose the next step.

Oral Bisphosphonates (Generic, Usually Tier 1)

Alendronate 70 mg weekly and risedronate 35 mg weekly are Tier 1 generics on most Quartz formularies. Alendronate reduced vertebral fracture risk by 47% over 3 years in the FIT trial (N=2,027) among women with prior vertebral fracture. 15 These drugs are appropriate for most patients with intact renal function and no esophageal disease.

Zoledronic Acid (Reclast, Infusion)

Zoledronic acid 5 mg IV once yearly is covered under the medical benefit on most Quartz plans, often without a step-therapy requirement because the IV route bypasses gastrointestinal tolerability concerns. The HORIZON-PFT trial (N=7,736) showed zoledronic acid reduced hip fracture risk by 41% over 3 years. 16 For patients who cannot tolerate oral bisphosphonates, this is often the fastest path to an approved covered alternative while pursuing Prolia PA.

Romosozumab (Evenity) and Teriparatide (Forteo)

Romosozumab 210 mg subcutaneous monthly and teriparatide 20 mcg daily subcutaneous are anabolic agents reserved for very high fracture risk. Both face even stricter PA requirements than Prolia under most Quartz plans, typically requiring a prior trial of both bisphosphonate and denosumab or documentation of very high FRAX risk. 17

Practical Steps for Patients Seeking Prolia Coverage Through Quartz

Getting Prolia covered requires organized clinical documentation and proactive communication.

Step 1: Get a DXA Scan and FRAX Score

No PA request succeeds without a current DXA report (within the past 24 months) and a calculated FRAX score. Ask your provider to document the T-scores at the lumbar spine, femoral neck, and total hip.

Step 2: Document Prior Therapy or Contraindications

If you have taken alendronate or risedronate, provide pharmacy records, prescriber notes, and any documentation of adverse effects. If you have a contraindication (renal disease with GFR <35, esophageal disorder), get a lab report or specialist letter.

Step 3: Ask Your Prescriber to Submit a Clinical Letter With the PA

A one-page letter citing specific trial data (FREEDOM, AACE guidelines) and explaining why Prolia is the appropriate choice for this patient, rather than generic bisphosphonates, meaningfully improves approval rates.

Step 4: Enroll in Amgen FIRST STEP While PA Is Pending

Enrollment takes 10 to 15 minutes by phone (1-888-762-6436) and can cover the first injection at no cost while the PA process is underway.

Step 5: Use the Quartz Member Advocate Line

Quartz member services (the number is on the back of your insurance card) can confirm your specific plan's PA criteria, fax numbers for submission, and current appeal timelines. Always get the representative's name and call reference number.

Key Safety Considerations That May Affect Coverage Decisions

Prolia's safety profile includes risks that prescribers must document and monitor. Insurers sometimes reference these in coverage criteria.

Hypocalcemia

Denosumab can cause hypocalcemia, particularly in patients with vitamin D deficiency or renal impairment. The FDA label requires that hypocalcemia be corrected before initiating treatment, and all patients must receive adequate calcium and vitamin D supplementation. 1 Documented calcium and 25-OH vitamin D levels strengthen a PA submission.

Osteonecrosis of the Jaw (ONJ)

ONJ occurs in fewer than 1 in 10,000 patients treated with Prolia for osteoporosis (far more common at the higher doses used in oncology). 18 Dental clearance before starting therapy is standard of care.

Rebound Vertebral Fractures on Discontinuation

As noted above, abrupt discontinuation of denosumab without transitioning to a bisphosphonate produces rapid, severe bone loss. A 2017 case series found multiple vertebral fractures in 7 of 22 patients who stopped denosumab without a bridging bisphosphonate. 10 This safety issue means that once Prolia is started, continuity of coverage is clinically necessary, not merely convenient.