Does SummaCare Cover Forteo (Teriparatide)?

What Is Forteo and Why Is Coverage Complicated?

Forteo is an injectable parathyroid hormone analog that stimulates new bone formation rather than simply slowing bone loss. Because it costs far more than generic bisphosphonates, every major insurer, including SummaCare, places it on a high specialty tier and subjects it to utilization management.

How Forteo Works

Teriparatide is a recombinant form of the 34 amino-acid N-terminal fragment of human parathyroid hormone. Given as a 20 mcg subcutaneous injection once daily, it drives osteoblast activity and builds new bone matrix. The FORTEO key trial (N=1,637) demonstrated a 65% relative risk reduction in new vertebral fractures versus placebo over a median of 21 months, and a 53% relative risk reduction in non-vertebral fragility fractures (Neer RM et al., NEJM 2001) [1].

Why Insurers Require Prior Authorization

The FDA label limits lifetime teriparatide use to 24 months because of osteosarcoma risk observed in long-duration rat studies, and the drug's monthly cost is roughly 20 to 30 times higher than generic alendronate. SummaCare, like other Ohio-based insurers, applies step therapy and prior authorization to control spending on this class.

The Biosimilar Factor

In September 2021, the FDA approved Bonsity (teriparatide-tjtj, made by Alvogen/Teva) as the first teriparatide biosimilar (FDA approval letter) [2]. Some SummaCare formularies now list Bonsity as a preferred alternative to brand-name Forteo on the specialty tier, meaning prior authorization criteria may be easier to satisfy for the biosimilar.

SummaCare Plan Types and How Coverage Differs

SummaCare operates multiple distinct plan types in northeast Ohio, and formulary placement for Forteo is not identical across all of them.

Commercial HMO and PPO Plans

On SummaCare commercial plans, Forteo typically appears on Tier 4 or Tier 5 (specialty). Cost-sharing commonly runs 25%, 33% coinsurance after deductible, which can mean $700, $1,000 per month even with insurance active. The exact tier depends on the employer group contract year, so always pull the current Summary of Benefits and Coverage (SBC) or call SummaCare Member Services at the number on your insurance card.

Medicare Advantage Plans

SummaCare offers CMS-contracted Medicare Advantage (MA) products. Under MA Part D rules, teriparatide is subject to the same prior authorization and step-therapy requirements as commercial plans, but the Medicare Part D coverage gap and catastrophic threshold ($2,000 out-of-pocket cap starting January 2025 under the Inflation Reduction Act) can meaningfully reduce annual exposure for Medicare beneficiaries. CMS guidance on MA formulary requirements is available at CMS Medicare Prescription Drug Coverage [3].

Medicaid Managed Care (CareSource, Molina Partnerships)

SummaCare administers some Ohio Medicaid managed care contracts. Ohio Medicaid's preferred drug list (PDL) does include teriparatide, but prior authorization criteria under Medicaid are often stricter, typically requiring documented failure of two antiresorptives, a T-score of <-2.5 plus fracture history, or a T-score of <-3.0 alone.

Prior Authorization Criteria: What SummaCare Typically Requires

Prior authorization (PA) for Forteo on SummaCare plans generally follows criteria derived from clinical guidelines published by the Endocrine Society and the American Association of Clinical Endocrinology (AACE).

Diagnosis Requirements

The prescribing clinician must document one of the following:

• Postmenopausal osteoporosis or male osteoporosis confirmed by DXA with T-score of <-2.5 at the lumbar spine, femoral neck, or total hip.
• T-score of <-1.5 plus a history of a low-trauma fragility fracture (vertebral, hip, wrist, or humerus).
• Glucocorticoid-induced osteoporosis per American College of Rheumatology (ACR) guidelines, defined as prednisone-equivalent dose of 7.5 mg/day for 3 or more months with moderate-to-high fracture risk.

The 2020 AACE/ACE Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis state that anabolic therapy "should be considered first-line for patients at very high fracture risk," defined as T-score below -3.0 or prior hip or vertebral fracture (AACE/ACE 2020 Guidelines, Endocrine Practice) [4].

Step Therapy Requirements

Most SummaCare commercial plans require documented trial and inadequate response or intolerance to at least one bisphosphonate before approving Forteo. Alendronate 70 mg weekly or risedronate 35 mg weekly for a minimum of 12 months with continued bone loss or new fracture typically qualifies as inadequate response. Intolerance requires documented adverse effects such as esophageal erosion, severe musculoskeletal pain, or atypical femur fracture risk.

The 2022 USPSTF recommendation statement on osteoporosis screening supports bisphosphonate-first sequencing for most patients (USPSTF 2018 Osteoporosis Recommendation) [5].

Prescriber Qualifications

SummaCare PA forms generally accept requests from any MD, DO, NP, or PA, but some plans require that the prescriber be an endocrinologist, rheumatologist, or orthopedic surgeon if the patient does not clearly meet high-risk criteria. Check your specific plan's PA form for this requirement.

Documentation Checklist

Gather these items before submitting the PA:

• Most recent DXA report with T-scores (must be within 24 months).
• Fracture history documentation from radiology reports or clinic notes.
• Records of prior bisphosphonate trials with dates and outcomes.
• Most recent FRAX score if available.
• Prescriber's attestation of FDA-labeled indication.

The Prior Authorization Submission Process

Submitting a complete, well-documented PA on the first attempt reduces the chance of delay from weeks to days.

Step 1: Obtain the Correct PA Form

SummaCare posts PA forms on its provider portal. Your prescriber's office should download the current Specialty Drug Prior Authorization Request form. Using an outdated form is a common reason for administrative rejection.

Step 2: Submit Through the Right Channel

SummaCare accepts PA submissions by fax, provider portal, or through CoverMyMeds (an electronic PA platform used by most Ohio specialty pharmacies). Electronic submission generally yields a faster decision, often within 48 to 72 business hours for a standard PA versus up to 14 days for fax submissions.

Step 3: Urgent or Expedited Review

If a clinician certifies that the standard review timeline would seriously jeopardize the patient's health, SummaCare must issue an expedited decision within 72 hours under Ohio Department of Insurance rules and federal managed care regulations at 42 CFR §422.570.

What Happens If SummaCare Denies Your Forteo Claim?

Denial is not the end of the road. Roughly 40%, 60% of specialty drug denials that go through a formal appeal are overturned, according to internal pharmacy benefit manager data reviewed by the Kaiser Family Foundation in 2021.

Internal Appeal

You have the right to request a formal internal appeal within 60 days of a denial notice on commercial plans, and within 60 days under Medicare Advantage rules. The appeal should include:

• A letter of medical necessity from the prescriber explaining why Forteo is appropriate for this specific patient.
• Peer-reviewed literature supporting anabolic therapy at the patient's fracture risk level (the Neer et al. NEJM 2001 trial [1] and the AACE 2020 guidelines [4] are useful here).
• Any additional DXA comparisons showing progressive bone loss despite prior therapy.

External Independent Review

If the internal appeal is denied, Ohio law requires SummaCare to offer an external independent review by a state-certified Independent Review Organization (IRO). The IRO's decision is binding on the insurer for commercial plans. For Medicare Advantage denials, the external review goes to a CMS-contracted independent review entity.

Exceptions Process for Step Therapy

Ohio enacted SB 265 in 2018 (the "Step Therapy Reform Act"), which requires commercial insurers to grant a step-therapy exception when the required drug would cause clinically significant harm, the patient already tried and failed the required drug, or the required drug is contraindicated. If your prescriber documents any of these conditions, SummaCare must grant an exception within 72 hours (or 24 hours if urgent) under Ohio Revised Code §3923.80.

Cost-Reduction Strategies While Awaiting Coverage Approval

Even if coverage is eventually approved, the PA process can take two to four weeks. These options can bridge that gap or reduce costs long-term.

Eli Lilly's Forteo Savings Program

Eli Lilly offers a Forteo Savings Card for commercially insured patients that may reduce monthly out-of-pocket cost to as low as $4 per 28-day pen. Eligibility requires commercial insurance (not Medicare or Medicaid). Enrollment is available at Lilly's patient support site. Card value is capped and subject to annual program limits, so confirm current terms directly with Lilly at 1-800-545-5979.

Patient Assistance Programs

Uninsured or underinsured patients who meet income criteria may qualify for Lilly Cares Foundation assistance, which can provide Forteo at no cost. Income thresholds and documentation requirements change annually.

Biosimilar Substitution

Asking your prescriber to write the prescription as "teriparatide" with "substitution permitted" allows the pharmacy to dispense Bonsity if SummaCare's formulary places it on a lower tier. In some cases the cost differential is substantial. This is worth discussing with your prescriber.

Specialty Pharmacy Negotiation

SummaCare designates preferred specialty pharmacies (often Walgreens Specialty or CVS Specialty for Ohio plans). Using a non-preferred specialty pharmacy may trigger higher cost-sharing or require an additional authorization step. Confirm the preferred specialty pharmacy list with SummaCare before filling.

Clinical Context: Who Actually Needs Forteo Over a Bisphosphonate?

Not every patient with osteoporosis needs teriparatide, and understanding where Forteo fits in the treatment algorithm helps you and your prescriber make the strongest possible case for coverage.

Very High Fracture Risk: The Anabolic-First Argument

The 2020 AACE/ACE guidelines formally introduced the concept of "anabolic-first" sequencing for patients at very high fracture risk, defined as T-score below -3.0, prior hip fracture, multiple vertebral fractures, or ongoing bone loss on antiresorptive therapy. In this population, starting with an anabolic agent like teriparatide and then transitioning to an antiresorptive (bisphosphonate or denosumab) produces greater gains in bone mineral density than the reverse sequence (Cosman F et al., JBMR 2017) [6].

Sequential Therapy: The DATA Study

The DATA study (N=94) compared teriparatide alone, denosumab alone, and both combined in postmenopausal women. After 24 months, lumbar spine BMD increased by 9.1% in the combination group versus 6.2% in the teriparatide-only group and 5.2% in the denosumab-only group (Leder BZ et al., NEJM 2014) [7]. The DATA-Switch extension showed that transitioning from teriparatide to denosumab after 24 months continued to increase BMD, supporting a planned sequential strategy.

Glucocorticoid-Induced Osteoporosis

The GIOPPS trial (N=214) demonstrated that teriparatide was superior to risedronate in increasing lumbar spine BMD (7.2% vs. 3.4% at 18 months, P<0.001) and reducing vertebral fractures (0.6% vs. 6.1%) in patients on long-term glucocorticoid therapy (Saag KG et al., NEJM 2007) [8]. This trial provides particularly strong support for PA approval in glucocorticoid-treated patients.

Male Osteoporosis

The FDA approved teriparatide for osteoporosis in men at high fracture risk in 2002. A 2012 study (N=437) showed significant increases in lumbar spine BMD and reduced vertebral fracture risk in men treated with teriparatide 20 mcg/day for 11 months (Kaufman JM et al., J Bone Miner Res) [9]. SummaCare's PA criteria for male osteoporosis generally mirror those for postmenopausal women.

Monitoring Requirements During Teriparatide Therapy

SummaCare may require documentation of monitoring labs and DXA to authorize refills. Standard monitoring during teriparatide treatment includes:

• Serum calcium at baseline and after 1 month (teriparatide can cause transient hypercalcemia).
• 24-hour urine calcium if baseline serum calcium is elevated or there is a history of nephrolithiasis.
• Repeat DXA at 12 to 18 months to document treatment response.
• Alkaline phosphatase and bone-specific alkaline phosphatase (optional but useful as an anabolic response marker).

The Endocrine Society's 2019 Pharmacological Management of Osteoporosis clinical practice guideline recommends DXA monitoring every 1 to 2 years during anabolic therapy (Eastell R et al., JCEM 2019) [10].

Transitioning Off Teriparatide

Because teriparatide has a 24-month lifetime limit, planning the transition to antiresorptive therapy is as important as starting the drug. Stopping teriparatide without immediately starting a bisphosphonate or denosumab results in rapid reversal of BMD gains, typically within 12 months. The EUROFORS study showed that patients who transitioned to raloxifene or alendronate maintained or continued to gain BMD after teriparatide, while those who received no follow-on treatment lost the gains (Eastell R et al., JBMR 2009) [11]. Plan this transition with your prescriber before your final Forteo pen runs out.