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FORTEO 1 (teriparatide)TYMLOS 1 (abaloparatide)UTILIZATION MANAGEMENT CRITERIADRUG CLASS:Recombinant Human Parathyroid HormoneBRAND (generic) NAMES: Forteo (teriparatide) Multi-dose prefilled delivery device (pen) containing 28 daily doseof 20 mcgTymlos (abaloparatide) Multi-dose prefilled delivery device (pen) containing 30 dailydose of 80 mcgFDA-APPROVED INDICATIONS:Forteo is recombinant human parathyroid hormone analog (1-34), [rhPTH(1-34)] indicated for: Treatment of postmenopausal women with osteoporosis at high risk for fracture, Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk forfracture, Treatment of men and women with osteoporosis associated with sustained systemicglucocorticoid therapy at high risk for fracture.TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated forthe treatment of postmenopausal women with osteoporosis at high risk for fractureCOVERAGE AUTHORIZATION CRITERIA:Forteo (teriparatide) or Tymlos (abaloparatide) may be eligible for coverage when thefollowing criteria are met:1. The patient is 18 years of age or older; AND2. The patient has a confirmed diagnosis of osteoporosis defined as one of the following:a. a history of vertebral fracture(s) or low trauma or fragility fracture(s) [e.g., priorfracture from minor trauma such as falling from standing height or less] withinthe past 5 year; ORb. The patient has a T-score that is -2.5 or lower; ANDi. The patient has previously been treated with a bisphosphonate orselective estrogen receptor modulator (SERM) and experienced atherapeutic failure or inadequate response; ORii. The patient is unable to receive a bisphosphonate or SERM due to acontraindication/hypersensitivity; ANDBLUE CROSS , BLUE SHIELD and the Cross and Shield Symbols are registered marks of the Blue Cross and Blue Shield Association, anassociation of independent Blue Cross and Blue Shield Plans. BCBSNC is an independent licensee of the Blue Cross and Blue ShieldAssociation. All other marks are the property of their respective owners.Last Revision Date: May 2017Page 1
3. The patient will not be receiving concurrent treatment with a bisphosphonate andSERM; AND4. The patient does not have any of the following conditions where use of thesemedications would not be recommended:a. Hypercalcemiab. Paget’s diseasec. Prior radiation therapy involving the skeletond. Bone metastases or history of skeletal malignanciese. Metabolic bone disease other than osteoporosis; AND5. The duration of treatment will be/is no longer than 2 years during a patient’s lifetime;AND6. The use of Tymlos (abaloparatide) is restricted to postmenopausal women; AND7. Non-Formulary Exception criteria applies on formularies which exclude requestedproduct(s). Satisfactory completion of criteria points (above) may satisfy some, or all,portions of the Non-Formulary Exception Criteria. This criteria is summarized as:a. Request must be for an FDA approved indication; ANDb. Patient must have a trial and failure of up to TWO formulary medications or aclinical contraindication/intolerance to those medications not tried.Duration of approval: 2 years (730 days)QUANTITY LIMIT EXCEPTION CRITERIAQuantities and/or courses of therapy above the program set limit for Forteo and Tymlos maybe eligible for coverage when the following are met:1. The quantity (dose) requested does not exceed the maximum FDA labeled dose,when specified, or to the safest studied dose per the manufacturer’s product insert;OR2. If the quantity (dose) requested exceeds the maximum FDA labeled dose, whenspecified, or to the safest studied dose per the manufacturer’s product insert, then theprescriber must submit documentation in support of therapy with a higher dose for theintended diagnosis (submitted documentation may include medical records OR faxform which reflects medical record documentation that shows the length of time therequested dose has been used, and what other medications and doses have beentried and failed).Medication Name/StrengthForteo 600 mcg/2.4 mLTymlos 3120 mcg/1.56 mLQuantity Limit2.4 mL every 28 days1.56 mL (1 pen) every 30 daysREFERENCES:Forteo (Teriparatide). Prescribing Information. Eli Lilly and Company. Indianapolis, IN. 2012.Tymlos (abaloparatide). Prescribing Information. Radius Health, Inc. Waltham, MA. April, 2017.POLICY IMPLEMENTATION/UPDATE INFORMATIONBLUE CROSS , BLUE SHIELD and the Cross and Shield Symbols are registered marks of the Blue Cross and Blue Shield Association, anassociation of independent Blue Cross and Blue Shield Plans. BCBSNC is an independent licensee of the Blue Cross and Blue ShieldAssociation. All other marks are the property of their respective owners.Last Revision Date: May 2017Page 2
May 2017: New to market Tymlos added to policy.January 2017: Reviewed for ASO Net Results; clarified definition of osteoporosis.January 2016: Added a Quantity Limit to the criteria.Non-Discrimination and Accessibility NoticeDiscrimination is Against the Law Blue Cross and Blue Shield of North Carolina (“BCBSNC”) complies with applicableFederal civil rights laws and does not discriminate on the basis of race, color, nationalorigin, age, disability, or sex. BCBSNC does not exclude people or treat them differently because of race, color,national origin, age, disability, or sex.BCBSNC: Provides free aids and services to people with disabilities to communicateeffectively with us, such as:- Qualified interpreters- Written information in other formats (large print, audio, accessible electronicformats, other formats) Provides free language services to people whose primary language is not English,such as:- Qualified interpreters- Information written in other languages If you need these services, contact Customer Service 1-888-206-4697, TTY andTDD, call1-800-442-7028. If you believe that BCBSNC has failed to provide these services or discriminated inanother way on the basis of race, color, national origin, age, disability, or sex, youcan file a grievance with: BCBSNC, PO Box 2291, Durham, NC 27702, Attention: Civil RightsCoordinator- Privacy, Ethics & Corporate Policy Office, Telephone 919-7651663, Fax 919-287-5613, TTY 1-888-291-1783 civilrightscoordinator@bcbsnc.com You can file a grievance in person or by mail, fax, or email. If you need help filing agrievance, Civil Rights Coordinator - Privacy, Ethics & Corporate Policy Office isavailable to help you. You can also file a civil rights complaint with the U.S. Department of Health andHuman Services, Office for Civil Rights, electronically through the Office for CivilBLUE CROSS , BLUE SHIELD and the Cross and Shield Symbols are registered marks of the Blue Cross and Blue Shield Association, anassociation of independent Blue Cross and Blue Shield Plans. BCBSNC is an independent licensee of the Blue Cross and Blue ShieldAssociation. All other marks are the property of their respective owners.Last Revision Date: May 2017Page 3
Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, orby mail or phone at: U.S. Department of Health and Human Services 200Independence Avenue, SW Room 509F, HHH Building Washington, D.C. 20201 1800-368-1019, 800-537-7697 (TDD). Complaint forms are available athttp://www.hhs.gov/ocr/office/file/index.html. This Notice and/or attachments may have important information about yourapplication or coverage through BCBSNC. Look for key dates. You may need to takeaction by certain deadlines to keep your health coverage or help with costs. You havethe right to get this information and help in your language at no cost. Call CustomerService 1-888-206-4697.ATTENTION: If you speak another language, language assistance services, free of charge, areavailable to you. Call 1-888-206-4697 (TTY: 1-800-442-7028).ATENCIÓN: Si habla español, tiene a su disposición servicios gratuitos de asistencia lingüística.Llame al 1-888-206-4697 (TTY: ��通話， � 1-888-206-4697(TTY：1-800-442-7028）。CHÚ Ý: Nếu bạn nói Tiếng Việt, có các dịch vụ hỗ trợ ngôn ngữ miễn phí dành cho bạn. Gọi số1-888-206-4697 (TTY: 1-800-442-7028).주의: 한국어를 사용하시는 경우, 언어 지원 서비스를 무료로 이용하실 수 있습니다.1-888-206-4697 (TTY: 1- 800-442-7028)번으로 전화해 주십시오.ATTENTION : Si vous parlez français, des services d'aide linguistique vous sont proposésgratuitement. Appelez le 1-888-206-4697 (ATS : 1-800-442-7028). اتصل برقم . فإن خدمات المساعدة اللغوية تتوافر لك بالمجان ، إذا كنت تتحدث اللغة العربية : ملحوظة .1-800-442-7028 : المبرقة الكاتبة .1-888-206-4697LUS CEEV: Yog tias koj hais lus Hmoob, cov kev pab txog lus, muaj kev pab dawb rau koj. Hurau1-888-206-4697 (TTY: 1-800-442-7028).ВНИМАНИЕ: Если вы говорите на русском языке, то вам доступны бесплатные услугиперевода. Звоните 1-888-206-4697 (телетайп: 1-800-442-7028).PAUNAWA: Kung nagsasalita ka ng Tagalog, maaari kang gumamit ng mga serbisyo ng tulongsa wika nang walang bayad. Tumawag sa 1-888-206-4697 (TTY: 1-800-442-7028).સુચના: જો તમે ગુજરાતી બોલતા હો, તો નન:સુલ્કુ ભાષા સહાય સેવાઓ તમારા માટે ઉપલબ્ધ છે . ફોનકરો1-888-206-4697 (TTY: 1-800-442-7028).BLUE CROSS , BLUE SHIELD and the Cross and Shield Symbols are registered marks of the Blue Cross and Blue Shield Association, anassociation of independent Blue Cross and Blue Shield Plans. BCBSNC is an independent licensee of the Blue Cross and Blue ShieldAssociation. All other marks are the property of their respective owners.Last Revision Date: May 2017Page 4
ចំណំ៖ �ិយាយជាភាសាខ្មែរ �កភាសាមាននតលជ់ ��្ទំនាក់ទនំ ងតាម្រយៈបលម៖ 1-888-206-4697 (TTY: 1-800-442-7028)។ACHTUNG: Wenn Sie Deutsch sprechen, stehen Ihnen kostenlos sprachlicheHilfsdienstleistungen zur Verfügung. Rufnummer: 1-888-206-4697 (TTY: 1-800-442-7028).ध्यान दें: यदद आप दिन्दी बोलते िैं तो आपके दलए मफ्ु त में भाषा सिायता सेवाएं उपलब्ध िैं। 1-888-206-4697(TTY: 1-800-442-7028) पर कॉल करें ।້ າພາສາ ລາວ, ການບ່ໍ ເສໂປດຊາບ: ຖ້ າວ່ າທ່ ານເວໍ ິ ລການຊ່ ວຍເຫ້ ານພາສາ, ໂດຍບ່ າ,ຼື ອດັ ຽຄແມ່ ນມ້ ອມໃຫ້ ທ່ ານ. ໂທຣ 1-888-206-4697 (TTY: 1-800-442-7028).ີ ��。1-888-2064697（TTY: ください。BLUE CROSS , BLUE SHIELD and the Cross and Shield Symbols are registered marks of the Blue Cross and Blue Shield Association, anassociation of independent Blue Cross and Blue Shield Plans. BCBSNC is an independent licensee of the Blue Cross and Blue ShieldAssociation. All other marks are the property of their respective owners.Last Revision Date: May 2017Page 5
Forteo (teriparatide) Multi-dose prefilled delivery device (pen) containing 28 daily dose of 20 mcg Tymlos (abaloparatide) Multi-dose prefilled delivery device (pen) containing 30 daily dose of 80 mcg FDA-APPROVED INDICATIONS: Forteo is recombinant human parathyroi
