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Coverage Authorization Requests and Appeals Guide

*Requests may originate from subscriber, HCP, or legal representative. Please note for Medicare Part D subscribers: Under the Medicare Part D prescription drug benefit program, a Part D plan enrollee, the enrollee’s representative, or the enrollee’s doctor or other prescriber can request a coverage determination, including a request for a tiering or formulary exception. A request for a coverage determination can be made orally or in writing. An enrollee, the enrollee’s representative, or the enrollee’s prescriber may submit a written request for a coverage determination in any format.

†Please note that the Centers for Medicare & Medicaid Services has developed “REQUEST FOR MEDICARE PRESCRIPTION DRUG COVERAGE DETERMINATION” model forms that are posted on their website. For more information, visit https://www.cms.gov/medicare/appeals-and-grievances/medprescriptdrugapplgriev/coveragedeterminationsandexceptions.html.

Writing a Tiering ExceptionRequest Letter

A tiering exception is a type of coverage determination. This type of exception is used when a medication is on a plan’s formulary, but it is placed in a non-preferred tier that has a higher co-pay or co-insurance. Plans may make a tier exception when the drug is demonstrated to be medically necessary. The healthcare provider (HCP) submits a Tiering Exception Request Letter to request that the medication be offered at a lower co-pay that is usually reserved for preferred drugs. A Tiering Exception Request Letter can help make medication more affordable for patients covered through Medicare or TRICARE who may not be eligible to participate in savings programs. This resource, Writing a Tiering Exception Request Letter, provides information to HCPs when drafting a Tiering Exception Request Letter. A checklist is included below on what to include in the letter. Sample letters are attached to this document and include useful information that many health plans require to process the request. The patient’s medical records and a Letter of Medical Necessity (LMN) are submitted with the letter. The Tiering Exception Request Letter may originate from the patient, HCP, or legal representative.* Both the prescribing HCP and patient should sign the letter. Plans often have specific Tiering Request Forms that must be used. These forms may be downloaded from each plan’s website. Follow the plan’s requirements when requesting FORTEO® (teriparatide [rDNA origin] 20mcg daily injection); otherwise, treatment may be delayed.†

TIERING EXCEPTION REQUEST LETTER CONSIDERATIONSInclude the patient’s full name, plan identification number, and date of birth

Add the prescribing HCP’s name, relationship to the requestor, National Provider Identifier (NPI) number, specialty, address, telephone number/fax number, and date of submissionRecord the patient’s current diagnosis Provide a copy of the patient’s records with the following details:

— Patient’s history, diagnosis and specific International Classification of Diseases (ICD) code(s), and present-day condition and symptoms — Patient’s recent history of infection(s), along with any allergies and existing comorbidities

Note the fracture site(s) and dates Supply the bone mineral density T-score at the femoral neck, total hip, or lumbar spine as

measured by DXA scanDocument prior osteoporosis treatments and the duration of each treatment

— Describe the rationale for why each treatment was discontinued List the main reasons for requesting a tiering exception for FORTEO Explain and attest to why the plan’s preferred formulary agents are not appropriate for the patient

(eg, medications have been or will be ineffective, not as effective, or adverse effects) — List dates of trial of preferred agents

If this letter serves as an appeal, include the case number from the denial letter, a copy of the denial letter, and a response to the denialInclude an LMNInclude a statement of financial hardship, written by the patient

The following information is presented for informational purposes only and is not intended to provide reimbursement or legal advice. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. Providers are encouraged to contact third-party payers for specific information on their coverage policies. For more information, please call 1-866-4-FORTEO (1-866-436-7836).

Please see Important Safety Information on page 6. Please click to access full PrescribingInformation, including Boxed Warning about osteosarcoma, and Medication Guide. Pleasesee User Manual included with the device.

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To whom it may concern:

My name is [HCP’s name], and I am a [board-certified medical specialty] [NPI]. I am writing to request a tiering exception for my patient,* [patient’s name], who is currently a member of [name of health plan]. The request is for FORTEO® (teriparatide [rDNA origin] 20mcg daily injection), which is medically appropriate and necessary for this patient who has been diagnosed with osteoporosis at high risk for fracture, [ICD code(s)]. I am requesting that FORTEO be made available to my patient as a preferred medication.

In the past, [patient’s name] has attempted other treatments for osteoporosis, but those trials have failed due to either inadequate efficacy or lack of tolerability.

Past Treatment(s)† Start/Stop Dates Reason(s) for Discontinuing

The patient’s present treatment(s) are as follows:

Current Treatment(s)† Start/Stop Dates Outcome(s)

Currently, [patient’s name] has the following unresolved symptoms:

• [Symptom 1]

• [Symptom 2]

Along with this letter, I have enclosed a copy of the patient’s medical records and a Letter of Medical Necessity. The letter describes why FORTEO is medically necessary for my patient’s care over the preferred drugs listed in the plan’s formulary. [Explain why lower-tiered formulary drugs would not be as effective as FORTEO.]

The reason I am requesting a tiering exception is because the cost associated with FORTEO’s assigned tier would present a financial burden to [patient’s name]. Furthermore, it prevents my patient from utilizing a medication that will help treat osteoporosis.

[Date][Formulary director][Name of health plan][Mailing address]

Re: [Patient’s name] [Plan Identification number][Date of birth][Case identification]

Sample wording from page 4 of this document can be added here if this appeal has been previously denied by the plan.

Please detail all that apply and add additional lines as necessary.

* Requests may originate from subscriber, HCP, or legal representative. Please note for Medicare Part D subscribers: Under the Medicare Part D prescription drug benefit program, a Part D plan enrollee, the enrollee’s representative, or the enrollee’s doctor or other prescriber can request a coverage determination, including a request for a tiering or formulary exception. A request for a coveragedetermination can be made orally or in writing. An enrollee, the enrollee’s representative, or the enrollee’s prescriber may submit a written request for a coverage determination in any format.

†Identify drug name, strength, dosage form, and therapeutic outcome.

HCPs can follow this format for patients who are NOT currently receiving treatment with FORTEO

Please see Important Safety Information on page 6. Please click to access full Prescribing Information,including Boxed Warning about osteosarcoma, and Medication Guide. Please see User Manual includedwith the device.

Sample Tiering Exception Request LetterA Tiering Exception Request Letter is used when FORTEO® (teriparatide [rDNA origin] 20mcg daily injection) is on a health plan’s formulary but is placed in a non-preferred tier that has a higher co-pay or co-insurance. This step may require the HCP to submit an LMN with the Tiering Exception Request Letter.

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To summarize, I consider FORTEO to be the best option in successfully treating [patient’s name]’s osteoporosis. Please contact me, [physician’s name], at [physician’s telephone number] for a peer-to-peer review or to answer any pending questions.

Sincerely,

[Physician’s name and signature] [Patient’s name and signature][Physician’s medical specialty][Physician’s NPI][Physician’s practice name][Phone #][Fax #]

Encl: Medical records, Letter of Medical Necessity, statement of financial hardship from [patient’s name],previous denial letter (if this is an appeal), medical notes in response to the denial (if this is an appeal)

FORTEO® (teriparatide [rDNA origin] 20mcg daily injection)

Please see Important Safety Information on page 6. Please click to access full Prescribing Information, including Boxed Warning about osteosarcoma, and Medication Guide. Please see User Manual included with the device.

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Sample wording from page 4 of this document can be added here if this appeal has been previously denied by the plan.

Please detail all that apply and add additional lines as necessary.

To whom it may concern:

My name is [HCP’s name], and I am a [board-certified medical specialty] [NPI]. I am writing to request a tiering exception for my patient,* [patient’s name], who is currently a member of [name of health plan]. The request is for FORTEO® (teriparatide [rDNA origin] 20mcg daily injection), which is medically appropriate and necessary for this patient who has been diagnosed with osteoporosis, [ICD code(s)]. The patient was receiving treatment with FORTEO [dose, frequency] but had to discontinue treatment due to [HCP to list reason (eg, change in plan’s formulary list or patient changed health plans during the past year)]. Therefore, I am requesting that FORTEO be made available to my patient as a preferred medication.

In the past, [patient’s name] has attempted other treatments for osteoporosis, but those trials have failed due to either inadequate efficacy or lack of tolerability.

Past Treatment(s)† Start/Stop Dates Reason(s) for Discontinuing

The patient’s present treatment(s) are as follows:

Current Treatment(s)† Start/Stop Dates Outcome(s)

Along with this letter, I have enclosed a copy of [patient’s name]’s medical records [include medical records dating back to the initial FORTEO prescription] and a Letter of Medical Necessity. The letter describes why FORTEO is medically necessary for my patient’s care over the preferred drugs listed in the plan’s formulary. [Explain why lower-tiered formulary drugs would not be as effective as FORTEO. If the patient is currently being treated with FORTEO, explain the benefits they have experienced since starting FORTEO and the expected outcomes if FORTEO were to be discontinued.]

[Date][Formulary director][Name of health plan][Mailing address]

Re: [Patient’s name] [Plan identification number][Date of birth][Case identification]

* Requests may originate from subscriber, HCP, or legal representative. Please note for Medicare Part D subscribers: Under the Medicare Part D prescription drug benefit program, a Part D plan enrollee, the enrollee’s representative, or the enrollee’s doctor or other prescribercan request a coverage determination, including a request for a tiering or formulary exception. A request for a coverage determination can be made orally or in writing. An enrollee, the enrollee’s representative, or the enrollee’s prescriber may submit a written request for a coverage determination in any format.

†Identify drug name, strength, dosage form, and therapeutic outcome.

HCPs can follow this format for patients who HAVE been treated with FORTEO and have had treatment interruptions

Please see Important Safety Information on page 6. Please click to access full Prescribing Information,including Boxed Warning about osteosarcoma, and Medication Guide. Please see User Manual includedwith the device.

Sample Tiering Exception Request LetterA Tiering Exception Request Letter is used when FORTEO® (teriparatide [rDNA origin] 20mcg daily injection) is on a health plan’s formulary but is placed in a non-preferred tier that has a higher co-pay or co-insurance. This step may require the HCP to submit an LMN with the Tiering Exception Request Letter.

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When comparing [patient’s name]’s osteoporosis before and after starting FORTEO for [enter length of time on FORTEO], the results confirm that FORTEO is medically necessary for managing the disease. The reason I am requesting a tiering exception for my patient is because the cost associated with FORTEO’s assigned tier has presented a financial hardship for [patient’s name].

To summarize, I consider FORTEO to be the best option in successfully treating my patient’s osteoporosis. Please contact me, [physician’s name], at [physician’s telephone number] for a peer-to-peer review or to answer any pending questions.

Sincerely,

[Physician’s name and signature] [Patient’s name and signature][Physician’s medical specialty][Physician’s NPI][Physician’s practice name][Phone #][Fax #]

Encl: Medical records, Letter of Medical Necessity, statement of financial hardship from [patient’s name],previous denial letter (if this is an appeal), medical notes in response to the denial (if this is an appeal)

Sample Tiering Exception Request LetterHCPs can follow this format for patients who HAVE been treated with FORTEO® (teriparatide [rDNA origin] 20mcg daily injection), and have had treatment interruptions

Please see Important Safety Information on page 6. Please click to access full Prescribing Information, including Boxed Warning about osteosarcoma, and Medication Guide. Please see User Manual included with the device.

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PP-TE-US-0783 05/2017 ©Lilly USA, LLC 2017. All rights reserved.

Tiering Exception AppealIf this Tiering Exception Request Letter is an appeal, sample copy should include the following:

This is a tiering exception appeal. I have included a copy of the original denial letter and medical notes in response to the denial.

For appeals,* include the following: • A copy of the denial letter• Medical notes, written by the prescribing physician, in response to the denial letter

IMPORTANT SAFETY INFORMATION INDICATIONS AND USAGEFORTEO is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, and for the treatment of men and women with osteoporosis associated with sustained, systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fractureHigh risk for fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapyFORTEO is administered as a 20-microgram once-daily dose and is available in a 2.4-mL prefilled delivery device for subcutaneous injection over 28 days.

WARNING: POTENTIAL RISK OF OSTEOSARCOMAIn male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration. The effect was observed at systemic exposures to teriparatide ranging from 3 to 60 times the exposure in humans given a 20mcg dose. Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe FORTEO® (teriparatide [rDNA origin] injection) only for patients for whom the potential benefits are considered to outweigh the potential risk. FORTEO should not be prescribed for patients who are at increased baseline risk for osteosarcoma (including those with Paget’s disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy involving the skeleton).

CONTRAINDICATIONSHypersensitivity to teriparatide or to any of its excipients. Reactions have included angioedema and anaphylaxis.WARNINGS AND PRECAUTIONSThe following categories of patients have increased baseline risk of osteosarcoma and therefore should not be treated with FORTEO: Paget’s disease of bone, pediatric populations and young adults with open epiphyses, or prior external beam or implant radiation therapy.Patients should be encouraged to enroll in the voluntary FORTEO Patient Registry, which is designed to collect information about any potential risk of osteosarcoma in patients who have taken FORTEO. Enrollment information can be obtained by calling 1-866-382-6813, or by visiting www.forteoregistry.rti.org.Cases of bone tumor and osteosarcoma have been reported rarely in people taking FORTEO in the post-marketing period. The causality to FORTEO use is unclear.

The safety and efficacy of FORTEO have not been evaluated beyond 2 years of treatment. The use of FORTEO for more than 2 years during a patient’s lifetime is, therefore, not recommended. Patients with the following conditions also should not receive FORTEO: bone metastases or a history of skeletal malignancies, metabolic bone diseases other than osteoporosis, or hypercalcemic disorders.FORTEO may increase serum calcium, urinary calcium, and serum uric acid. Use with caution in patients with active or recent urolithiasis because of risk of exacerbation. If active urolithiasis or pre-existing hypercalciuria are suspected, measurement of urinary calcium excretion should be considered.Transient orthostatic hypotension may occur with initial doses of FORTEO. In short-term clinical pharmacology studies, transient episodes of symptomatic orthostatic hypotension were observed in 5% of patients. FORTEO should be administered initially under circumstances where the patient can sit or lie down if symptoms of orthostatic hypotension occur.Patients receiving digoxin should use FORTEO with caution because FORTEO may transiently increase serum calcium and hypercalcemia may predispose patients to digitalis toxicity.ADVERSE REACTIONSThe most common adverse reactions in clinical trials include: arthralgia (10.1% FORTEO vs. 8.4% placebo), pain (21.3% FORTEO vs. 20.5% placebo), and nausea (8.5% FORTEO vs. 6.7% placebo). Other adverse reactions include: dizziness, leg cramps, joint aches, and injection site reactions. USE IN PREGNANCY/NURSING MOTHERSFORTEO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Based on animal studies, FORTEO may cause fetal harm. It is not known whether teriparatide is excreted in human milk. Breastfeeding mothers should discontinue nursing or FORTEO, taking into account the importance of treatment to the mother.INSTRUCTIONS FOR FORTEO USEFORTEO is provided as a fixed-dose, prefilled delivery device that can be used for up to 28 days, including the first injection. The delivery device contains 28 daily doses of 20 mcg each. Do not transfer the contents of the delivery device into a syringe. The FORTEO Delivery Device should be stored under refrigeration at 36° to 46° F (2° to 8° C) at all times. Do not use FORTEO if it has been frozen.

TE HCP ISI 24SEP2012For more safety information, please see Medication Guide and Full Prescribing Information, including Boxed Warning regarding osteosarcoma. See Full User Manual that accompanies the delivery device.

*An external review board or hearing may apply in some situations.Sources: 1. Centers for Medicare & Medicaid Services. Part D enrollee grievances, coverage determinations, and appeals. In:Prescription Drug Benefit Manual. Baltimore, MD: Centers for Medicare & Medicaid Services; 2014. https://www.cms.gov/Medicare/Appeals-and-Grievances/MedPrescriptDrugApplGriev/Downloads/Chapter18.zip. Accessed January 26, 2017. 2. FORTEO [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.FORTEO® is a registered trademark of Eli Lilly and Company. FORTEO Connect™ is a trademark of Eli Lilly and Company.