Does MDwise Cover Forteo (Teriparatide)?

What Is Forteo and Why Does It Require Special Coverage Review?

Forteo is a synthetic parathyroid hormone (PTH 1-34) that stimulates bone formation rather than simply slowing resorption. The FDA approved teriparatide in 2002 for postmenopausal women with osteoporosis at high fracture risk, and the indication was later extended to men and patients on long-term glucocorticoids 1. Because Forteo costs roughly $3,000 per month at wholesale acquisition cost and because bisphosphonates such as alendronate cost under $10 per month as generics, every Medicaid plan in the United States, including MDwise, places Forteo on a non-preferred specialty tier with prior authorization requirements.

Teriparatide works by intermittently activating PTH receptors on osteoblasts, increasing bone formation markers and reducing vertebral fracture risk. The key trial by Neer et al. (N=1,637) showed teriparatide 20 mcg/day reduced new vertebral fractures by 65% compared to placebo over a median 19 months (RR 0.35; 95% CI 0.22-0.55) 2. That magnitude of efficacy is why clinicians pursue coverage even when the authorization process is demanding.

MDwise manages pharmacy benefits through Indiana's Medicaid program and applies the Indiana Medicaid preferred drug list (PDL) to most members. Specialty injectables like Forteo sit outside the standard PDL tiers and require a separate clinical review before the plan will pay a claim 3.

MDwise Prior Authorization Criteria for Forteo

MDwise requires a formal prior authorization (PA) for teriparatide. The PA process follows Indiana Medicaid clinical criteria, which align closely with the Endocrine Society's 2019 clinical practice guideline on osteoporosis pharmacotherapy 4.

Typical MDwise PA criteria for Forteo include all of the following:

1. Diagnosis confirmation. A documented diagnosis of osteoporosis defined by a DXA T-score at or below -2.5 at the lumbar spine, total hip, or femoral neck, or a low-trauma fragility fracture at the hip or spine regardless of T-score 5.

2. High fracture risk or prior fracture. The Fracture Risk Assessment Tool (FRAX) 10-year hip fracture probability at or above 3%, or major osteoporotic fracture probability at or above 20%, or a documented vertebral or hip fracture in the prior 24 months 6.

3. Step therapy: bisphosphonate failure. The member must have tried and failed, or have a documented contraindication to, at least one oral bisphosphonate (alendronate 70 mg weekly or risedronate 35 mg weekly) for a minimum of 12 months 7. Failure is defined as a new fracture on therapy, continued significant bone loss on DXA, or intolerable GI adverse effects.

4. Prescriber specialty. Some MDwise authorizations require the prescribing provider to be an endocrinologist, rheumatologist, or other specialist with documented osteoporosis management experience.

5. Duration limit. Authorization is typically granted for 6-month intervals up to a cumulative maximum of 24 months, consistent with FDA labeling warnings about osteosarcoma risk with prolonged use 8.

The Endocrine Society guideline states directly: "We recommend the use of anabolic therapy (teriparatide or abaloparatide) in patients who have had a vertebral or hip fracture, patients who have very low T-scores (below -3.0), or patients who have failed or are intolerant of antiresorptive therapy." 4 Citing this language in the PA letter strengthens the clinical argument for coverage.

How to Submit a Forteo Prior Authorization to MDwise

A well-prepared PA submission reduces denial rates. Providers should gather the following documents before contacting MDwise pharmacy services:

DXA scan report. The most recent bone density scan (within 24 months) with T-scores at all three standard sites. If the T-score is between -2.0 and -2.5 but a fragility fracture is present, include the radiology report confirming the fracture 9.

FRAX calculation printout. Run the WHO FRAX tool at https://www.sheffield.ac.uk/FRAX/ and include the printed result. The National Osteoporosis Foundation (NOF) uses the same thresholds that Indiana Medicaid references in its PDL criteria 5.

Bisphosphonate trial documentation. Include pharmacy fill records, office notes documenting intolerance, or a specialist letter explaining contraindication. Alendronate causes GI irritation in a meaningful fraction of patients; documented GI events are a valid reason to skip the step-therapy requirement 7.

Letter of medical necessity. This is the most important document. The letter must include the clinical rationale, relevant trial data (the Neer et al. 65% vertebral fracture reduction), and explicit alignment with the Endocrine Society guideline recommendation 2.

Specialty pharmacy coordination. Forteo is dispensed through specialty pharmacies, not retail chains. MDwise members should confirm which specialty pharmacy the plan has contracted with before the PA is approved, because the dispensing pharmacy must be in-network for the claim to pay.

MDwise PA decisions are generally issued within 3 business days for standard reviews and 24 hours for urgent requests, per Indiana Medicaid managed-care contract requirements 10.

What Happens If MDwise Denies the Forteo PA?

A denial is not the end of the road. Indiana Medicaid regulations require MDwise to provide a written denial with specific clinical reasons. Members and providers have the right to appeal within 10 days of the denial for an expedited appeal or 30 days for a standard appeal.

First-level appeal. Submit additional clinical documentation. If the original PA lacked a specialist letter, add one. If fracture imaging was not included, include it now. The appeal goes to MDwise's internal medical review team.

Second-level appeal (external review). If the first-level appeal fails, members can request an external independent review through the Indiana Office of Medicaid Policy and Planning. External reviewers apply standard-of-care criteria, not plan-specific PDL criteria, which may favor approval when the clinical evidence clearly supports anabolic therapy 10.

State fair hearing. Members can also request a state fair hearing through the Indiana Family and Social Services Administration (FSSA). This is a formal administrative process with a hearing officer and typically results in a decision within 90 days.

Expedited PA for fracture patients. A member who has just sustained a hip or vertebral fracture qualifies for an expedited PA under federal managed-care rules. The 24-hour decision standard applies. Providers should mark these submissions "URGENT" and include the emergency department or inpatient discharge summary 10.

Clinical Evidence Supporting Teriparatide Use in High-Risk Patients

The strength of the clinical evidence matters when building a PA or appeal. Forteo's efficacy in reducing vertebral and non-vertebral fractures is well established across multiple trials and patient populations.

The key Neer 2001 trial (N=1,637 postmenopausal women) demonstrated a 65% relative risk reduction in new vertebral fractures with teriparatide 20 mcg/day versus placebo (RR 0.35; P<0.001) and a 53% reduction in non-vertebral fragility fractures over a median 19 months 2.

In male osteoporosis, Orwoll et al. (N=437) showed teriparatide increased lumbar spine BMD by 5.9% at 11 months versus 0.5% with placebo (P<0.001), a finding that supported the FDA label expansion to men 11.

For glucocorticoid-induced osteoporosis, Saag et al. (N=428 to 36 months) found teriparatide reduced vertebral fractures by 90% compared to alendronate (incidence 0.6% vs. 6.1%; P<0.004), establishing teriparatide as superior to bisphosphonates in this subgroup 12.

The American Association of Clinical Endocrinologists (AACE) 2020 osteoporosis guidelines recommend teriparatide as a first-line option for patients with a T-score at or below -2.5 plus a prior fragility fracture, noting that anabolic agents should precede antiresorptives in very-high-risk patients to maximize bone formation before transitioning to maintenance therapy 13.

Bone mineral density gains with teriparatide are substantial. A Cochrane systematic review of 13 trials found teriparatide increased lumbar spine BMD by a mean of 8.6% over 12-24 months compared to placebo 14. Those gains do not persist after stopping the drug, which is why sequential antiresorptive therapy (denosumab or zoledronic acid) is recommended immediately after the 24-month teriparatide course 4.

Alternatives If Forteo Is Not Covered by MDwise

If MDwise denies Forteo and the denial cannot be overturned, several options may achieve comparable fracture risk reduction:

Abaloparatide (Tymlos). This PTH-related protein analog received FDA approval in 2017 and showed an 86% reduction in new vertebral fractures versus placebo in the ACTIVE trial (N=2,463; 18 months) 15. Some payers that deny teriparatide will authorize abaloparatide because it sits on a different PDL position. Providers should check MDwise's current PDL for Tymlos coverage status.

Romosozumab (Evenity). A sclerostin inhibitor approved in 2019, romosozumab 210 mg monthly for 12 months reduced vertebral fractures by 73% versus placebo in the FRAME trial (N=7,180) 16. Cardiovascular risk is a concern; the FDA label includes a boxed warning for patients with prior MI or stroke 17. PA criteria for romosozumab are similarly stringent.

Zoledronic acid (Zometa/Reclast). For patients who cannot tolerate oral bisphosphonates, annual intravenous zoledronic acid 5 mg reduced hip fractures by 41% and vertebral fractures by 70% in HORIZON-Key Fracture Trial (N=7,765; 36 months) 18. This is far less expensive and is generally preferred on MDwise formulary. It may not produce the degree of new bone formation that teriparatide achieves, but it is a realistic option for members who need antiresorptive coverage.

Denosumab (Prolia). 60 mg subcutaneous injection every 6 months reduced vertebral fractures by 68% in FREEDOM (N=7,868; 36 months) 19. Denosumab is often preferred by Medicaid plans over Forteo because its cost per injection is lower and it is administered only twice yearly.

Lilly's patient assistance program. If MDwise denies Forteo and all appeals are exhausted, Eli Lilly offers the Lilly Cares Foundation program, which may provide Forteo at no cost for patients who meet income criteria (generally up to 400% of the federal poverty level). Providers can access the application at the Lilly Cares website.

Special Populations: Glucocorticoid-Induced Osteoporosis and Forteo Coverage

Patients on long-term glucocorticoid therapy (prednisone 5 mg or more daily for 3 or more months) represent a distinct population where teriparatide has demonstrated superiority over bisphosphonates. The ACR 2022 guidelines on glucocorticoid-induced osteoporosis recommend anabolic therapy as the preferred initial treatment for very-high-risk patients on long-term steroids rather than reserving it for bisphosphonate failures 20.

For MDwise members on chronic glucocorticoids, providers should document the prednisone dose, duration, and indication in the PA letter and cite the Saag 2019 trial data showing 90% vertebral fracture reduction with teriparatide versus alendronate 12. This population may bypass the standard step-therapy requirement because the ACR guideline explicitly places teriparatide at the top of the treatment algorithm for very-high-risk glucocorticoid users.

Monitoring Requirements While on Teriparatide

If MDwise approves Forteo, ongoing monitoring is required both to satisfy continued authorization renewals and to ensure patient safety:

DXA at 12 months. Bone density should be measured 12 months after starting teriparatide to document response. A lumbar spine BMD increase of 3% or more is the expected minimum response; absence of response should prompt reassessment 4.

Calcium and serum calcium monitoring. Teriparatide causes transient hypercalcemia in approximately 11% of patients. Serum calcium should be checked at baseline and at 1 month, then periodically. The FDA label recommends avoiding Forteo in patients with hypercalcemia or conditions predisposing to hypercalcemia 8.

Urine calcium. Twenty-four-hour urine calcium at baseline and 3 months helps identify patients developing hypercalciuria, particularly in those with a history of nephrolithiasis 5.

Vitamin D and calcium supplementation. The AACE guideline recommends calcium 1,000-1 to 200 mg daily (preferably dietary) and vitamin D 800-1 to 000 IU daily as adjuncts to all osteoporosis pharmacotherapy 13.

Sequential therapy planning. Because BMD gains reverse rapidly after stopping teriparatide without follow-on antiresorptive therapy, providers should plan the sequential agent (denosumab or zoledronic acid) before the 24-month teriparatide course ends. The DATA-Switch trial (N=94) showed that switching from teriparatide to denosumab produced continued BMD gains of 6.6% at the lumbar spine over the subsequent 24 months, whereas the reverse sequence was less effective 21. Providers should begin a new PA for the sequential agent at least 60 days before the Forteo authorization expires.

How MDwise Pharmacy Benefits Compare to Other Indiana Medicaid Plans

MDwise is one of three Medicaid managed-care organizations (MCOs) in Indiana, alongside Anthem and CareSource. All three MCOs must comply with Indiana Medicaid's PDL, but each may apply slightly different clinical criteria for PA and step therapy 10.

Across all three Indiana Medicaid MCOs, Forteo is a non-preferred specialty drug requiring PA. The practical difference between plans often comes down to how strictly they apply the 12-month bisphosphonate trial requirement and whether they accept specialist-only prescribing. If a member is switching MCOs during open enrollment, comparing the specific PA criteria for Forteo and its alternatives before enrollment is a practical step.

Indiana Medicaid members can call the MDwise member services line at 1-800-356-1204 to request a copy of the current Forteo PA criteria and the specific specialty pharmacy list approved for teriparatide dispensing. Members should request this in writing so they have a record of the plan's stated requirements.