Does Blue Cross Blue Shield of Michigan Cover Forteo?

What Forteo Is and Why Coverage Is Complex

Teriparatide is a 34-amino-acid fragment of human parathyroid hormone that stimulates new bone formation rather than simply slowing resorption. The FDA first approved Forteo in November 2002 for postmenopausal women with osteoporosis at high fracture risk, and later expanded the indication to men and glucocorticoid-induced osteoporosis. [1]

Because teriparatide is a self-injected biologic delivered via a prefilled pen, insurers classify it as a specialty drug. Specialty drugs carry the highest cost-sharing tier on most formularies, which is why understanding BCBSM's specific criteria before writing the prescription saves time for both the clinician and the patient.

The Anabolic Advantage Over Bisphosphonates

The key randomized controlled trial of teriparatide (N=1,637) demonstrated a 65% relative reduction in new vertebral fractures and a 53% relative reduction in nonvertebral fragility fractures compared with placebo over a median 19 months of follow-up (P<0.001 for vertebral fractures). [2] Those numbers matter to insurers, but they also require supporting documentation showing that simpler, cheaper agents were tried first.

Oral bisphosphonates such as alendronate cost less than $30 per month generic. Insurers argue that most patients should attempt bisphosphonate therapy before escalating to a $3,000-per-month anabolic agent, which is the foundation of step-therapy requirements.

FDA Label Restriction: 2-Year Lifetime Limit

The FDA label for Forteo carries a black-box warning regarding osteosarcoma risk observed in rat studies and limits cumulative use to no more than 2 years during a patient's lifetime. [1] BCBSM authorization approvals typically mirror this limit, granting initial approval for 6 months and renewing up to a 24-month cumulative total.

How BCBSM Formularies Classify Forteo

Commercial PPO and HMO Plans

On the BCBSM Blue Preferred PPO and Blue Care Network HMO formularies, teriparatide sits at Specialty Tier (Tier 4 or Tier 5 depending on the specific plan year). Specialty-tier drugs typically require the member to pay a percentage of the drug's cost (coinsurance) rather than a fixed copay, meaning out-of-pocket responsibility scales with the drug's price.

A standard BCBSM commercial plan with 20% specialty coinsurance and no specialty maximum benefit could leave a patient paying $640-$700 per 28-day pen. Plans with a specialty out-of-pocket cap are more manageable, but members must confirm that cap with their plan documents or a benefits coordinator.

Medicare Advantage and Dual-Eligible Plans

BCBSM administers several Medicare Advantage plans in Michigan, including BCN Advantage and Blue Cross Medicare Plus Blue. On these plans, teriparatide is generally covered under Part D when dispensed through a contracted specialty pharmacy, not under Part B (which covers physician-administered drugs). [3]

The Medicare Part D coverage gap ("donut hole") has been capped at 25% patient cost-sharing for brand-name drugs since 2020 under the Bipartisan Budget Act of 2018, but catastrophic thresholds still apply. [3] Patients on Medicare Advantage should ask specifically whether their plan uses BCBSM's standard formulary or a custom formulary negotiated for their employer or union group.

Employer and Self-Funded Plans

Michigan employers who self-fund their health benefits and use BCBSM as an administrative-services-only (ASO) vendor may have customized formulary tiers or different prior-authorization criteria. A patient whose card says "Blue Cross Blue Shield of Michigan" may actually be on a plan that differs from BCBSM's published standard formulary. Calling the Member Services number on the back of the insurance card is the only definitive way to confirm coverage terms.

Prior Authorization Criteria BCBSM Typically Applies

Prior authorization for teriparatide under BCBSM commercial plans commonly requires all of the following elements. Individual plan criteria vary, and physicians should obtain the current criteria document directly from BCBSM before submitting.

Diagnosis and Bone Density Requirements

1. Confirmed diagnosis of osteoporosis by DXA scan showing T-score at or below -2.5 at the lumbar spine, total hip, or femoral neck.
2. OR a documented low-trauma (fragility) fracture of the hip, spine, or wrist after age 50, which may satisfy criteria even without a qualifying T-score.
3. OR severe osteoporosis defined as T-score at or below -3.0, which may bypass the step-therapy requirement in some plan criteria.

The 2023 American Association of Clinical Endocrinology (AACE) guidelines designate teriparatide as a first-line option for "very high-risk" patients, defined as those with a recent fragility fracture (within 12 months), multiple fractures, or a T-score below -3.0. [4] Quoting the AACE guidelines directly in the prior-authorization request strengthens the medical-necessity argument.

Step Therapy: Bisphosphonate Failure or Contraindication

Most BCBSM plans require documented trial of at least one FDA-approved oral bisphosphonate (alendronate, risedronate, or ibandronate) for a minimum of 3-6 months, with inadequate response defined as a new fracture or continued bone loss on DXA. Exceptions to step therapy are accepted when:

• The patient has Barrett's esophagus, active esophageal disease, or documented intolerance causing the bisphosphonate to be discontinued.
• The patient has hypocalcemia requiring treatment before any antiresorptive can be used safely.
• Chronic kidney disease with eGFR <35 mL/min/1.73m², at which level oral bisphosphonates carry increased risk of renal accumulation. [5]
• The prescribing physician documents medical necessity for anabolic therapy as the most clinically appropriate initial option, with supporting AACE or NOF guideline language.

High-Risk Features That Expedite Approval

Documenting any of the following in the prior-authorization letter substantially increases the likelihood of approval without extended step-therapy delays:

• Multiple vertebral fractures visible on imaging.
• Prior hip fracture.
• Patient currently on systemic glucocorticoids (prednisone 5 mg/day or more for 3 or more months), which qualifies under the FDA's glucocorticoid-induced osteoporosis indication. [1]
• FRAX 10-year hip fracture probability above 3% or major osteoporotic fracture probability above 20%, per the National Osteoporosis Foundation thresholds. [6]

The Prior Authorization Submission Process

What the Prescriber Must Submit

A complete prior-authorization package for teriparatide at BCBSM typically includes:

• A completed BCBSM specialty drug PA request form (available through NaviNet or by calling the PA hotline at the number on the provider's BCBSM portal).
• Most recent DXA report with T-scores and Z-scores, dated within 2 years.
• Documentation of previous bisphosphonate trial (prescription history from the pharmacy or chart notes) OR a letter of medical necessity explaining contraindication.
• ICD-10 diagnosis codes: M81.0 (age-related osteoporosis without pathological fracture) or M80.00x (age-related osteoporosis with pathological fracture, unspecified site), plus any applicable fracture codes.
• Most recent serum calcium, vitamin D (25-OH), and creatinine/eGFR values.

Turnaround Times and Urgent Requests

Standard PA decisions from BCBSM are required within 14 calendar days under Michigan state law for non-urgent requests. Urgent requests, defined as situations where delay would seriously jeopardize the patient's health, must be decided within 72 hours. [7] Physicians can designate a request as urgent in the PA submission and should document the clinical rationale for urgency.

Specialty Pharmacy Dispensing

BCBSM routes most specialty drugs through its own specialty pharmacy network or through Walgreens Specialty Pharmacy (formerly BioScrip) as a preferred dispenser. Forteo requires refrigeration and patient training on the injection device, which specialty pharmacies are equipped to provide. Dispensing Forteo through a retail pharmacy that is not in the specialty network may result in non-covered or out-of-network cost-sharing.

What to Do If BCBSM Denies Forteo Coverage

First-Level Appeal

If BCBSM denies the prior-authorization request, the member and prescriber have the right to file a first-level internal appeal within 180 days of the denial notice (commercial plans) or within 60 days (Medicare Advantage, per CMS regulations). [8] The appeal letter should:

• Cite the AACE 2023 Clinical Practice Guidelines for Osteoporosis, which support anabolic therapy as initial treatment for very-high-risk patients. [4]
• Attach peer-reviewed literature demonstrating superior fracture reduction with teriparatide vs. Bisphosphonates in high-risk populations. The 2019 VERO trial (N=680) showed teriparatide reduced new vertebral fractures by 56% compared with risedronate over 24 months (P<0.001). [9]
• Include a letter from the treating endocrinologist or osteoporosis specialist stating that anabolic therapy is medically necessary.

Independent External Review

Michigan law requires insurers to offer an independent external review for adverse coverage decisions involving medical necessity. [7] Patients can request this review after exhausting internal appeals. The external reviewer is a board-certified physician in the relevant specialty who is not employed by the insurer.

CMS Grievance Process for Medicare Advantage

Medicare Advantage members who are denied coverage can escalate to a Qualified Independent Contractor (QIC) review through the CMS appeals process. If the QIC upholds the denial, further escalation to an Administrative Law Judge is available for claims above $180 (2024 threshold). [8]

Biosimilars: Bonsity and Tyloos as Coverage Alternatives

The FDA approved Bonsity (teriparatide injection, Teva Pharmaceuticals) in June 2021 as a biosimilar to Forteo, and Tyloos (teriparatide, Radius Health) received approval in 2022. [10] BCBSM formularies may place biosimilar teriparatide on a lower tier than brand Forteo, reducing patient cost-sharing while maintaining the same clinical efficacy.

Prescribers who write "Forteo" by brand may find that BCBSM's specialty pharmacy automatically substitutes Bonsity if it is the formulary-preferred product, unless the prescription carries a "dispense as written" instruction. Confirming with the specialty pharmacy which teriparatide product is formulary-preferred can prevent a dispensing delay.

The following decision framework summarizes how a prescribing clinician should approach BCBSM coverage for teriparatide:

Step 1. Confirm the patient's exact BCBSM plan (commercial vs. Medicare Advantage vs. ASO employer plan) by calling Member Services.

Step 2. Pull the current formulary and PA criteria for teriparatide from NaviNet or the BCBSM provider portal.

Step 3. Determine whether the patient meets "very high-risk" criteria per AACE 2023 (T-score <-3.0, recent fracture, or multiple fractures). If yes, document this explicitly to support first-line anabolic use and bypass of step therapy.

Step 4. Submit a PA package with DXA results, fracture history, laboratory values, diagnosis codes, and a brief medical-necessity letter citing AACE guidelines and the VERO trial.

Step 5. If denied, file a first-level appeal within 60-180 days (plan-dependent), attach the AACE guidelines and VERO trial data, and request peer-to-peer review with the BCBSM medical director.

Step 6. If the appeal is denied, request an independent external review under Michigan law or the CMS appeals process.

Cost Reduction Options While Awaiting Authorization

Lilly Cares Foundation

Patients who cannot afford Forteo while the PA process unfolds may qualify for Eli Lilly's patient assistance program through the Lilly Cares Foundation. Uninsured patients or those whose insurance does not cover the drug may receive Forteo at no cost if household income is at or below 400% of the federal poverty level. Patients can apply at lillycaresknowledgecenter.com or by calling 1-800-545-6962.

Forteo Savings Card

For commercially insured patients who do have coverage, the Lilly Forteo Savings Card may reduce out-of-pocket costs to as low as $5 per month, subject to eligibility limits and annual maximum savings caps. This card cannot be used for Medicare or Medicaid patients.

340B Pricing at Eligible Facilities

Patients receiving care at a federally qualified health center, rural health clinic, or hospital that participates in the 340B Drug Pricing Program may access teriparatide at substantially reduced prices. Physicians at 340B-covered entities should confirm with their pharmacy team whether teriparatide is available under 340B pricing. [11]

Sequencing Teriparatide With Other Osteoporosis Therapies

Why Sequential Therapy Matters

Teriparatide stimulates bone formation. When it is discontinued without follow-on antiresorptive therapy, the newly formed bone is rapidly resorbed, and BMD gains are substantially lost within 12-18 months. [12] BCBSM may ask, as part of the PA or the discharge plan, what antiresorptive agent will follow the 24-month teriparatide course.

The AACE 2023 guidelines recommend transitioning patients to denosumab or a potent oral bisphosphonate within 1-3 months of completing teriparatide to preserve anabolic gains. [4] Documenting this plan upfront demonstrates clinical comprehensiveness and may strengthen the PA narrative.

Combination or Sequential Use With Denosumab

The DATA study (N=94) showed that patients receiving concurrent teriparatide plus denosumab gained significantly more BMD at the hip (6.3% vs. 2.9% with teriparatide alone at 12 months, P<0.001). [13] BCBSM is unlikely to approve concurrent use of two high-cost specialty agents without compelling clinical documentation, but sequential use (teriparatide followed by denosumab) is an accepted and guideline-supported pathway.

Transition to Zoledronic Acid After Forteo

The SHOTZ extension study demonstrated that patients who received a single infusion of zoledronic acid 5 mg within 6 months of completing a 24-month teriparatide course maintained or further improved spine BMD compared with those who switched to placebo. [14] If the patient cannot tolerate oral bisphosphonates, documenting a plan for annual zoledronic acid infusions post-teriparatide supports the overall treatment rationale in the PA letter.

Glucocorticoid-Induced Osteoporosis: A Separate Coverage Path

Patients who develop osteoporosis secondary to chronic glucocorticoid therapy represent a distinct clinical population. The 2022 American College of Rheumatology guidelines on glucocorticoid-induced osteoporosis recommend teriparatide as the preferred anabolic option for patients at very high fracture risk who are taking prednisone 7.5 mg/day or more for 3 or more months. [15]

BCBSM coverage criteria for glucocorticoid-induced osteoporosis typically require:

• Documentation of current glucocorticoid dose and duration.
• A DXA showing T-score at or below -2.5 OR a fragility fracture occurring during corticosteroid use.
• Evidence of failure or contraindication to bisphosphonate therapy, or explicit guideline-based justification for skipping it.

Citing the 2022 ACR guideline recommendation directly in the PA letter is the most direct way to justify first-line teriparatide in this population. [15]