UnitedHealthcare® Commercial Medical Benefit Drug List Review at Launch List

Last Updated: August 12, 2021

Table of Contents Page Related Commercial Policy Instructions for Use ...... 1 • Review at Launch for New to Market Benefit Considerations ...... 1 List History/Revision Information ...... 2 Related Oxford Policy • Review at Launch for New to Market Medications

Instructions for Use

This Review at Launch (RAL) Medication List provides the listing of medications that are excluded from the medical benefit until the date the medication is reviewed by UnitedHealthcare or are reviewed against available clinical evidence.

The Review at Launch Medication List applies to: UnitedHealthcare Commercial plan members, including All Savers and affiliate plans such as UnitedHealthcare of the Mid-Atlantic, UnitedHealthcare Oxford, Neighborhood Health Partnership and UnitedHealthcare of the River Valley.

This list is supported by the applicable Review at Launch for New to Market Medications Medical Benefit Drug Policy.

When determining whether Review at Launch applies to the individual member, the member specific benefit plan document must be referenced. The terms of the member specific benefit plan document [e.g., Certificate of Coverage (COC), Schedule of Benefits (SOB), and/or Summary Plan Description (SPD)] may differ greatly from the standard benefit plan upon which this Medical Benefit Drug Policy is based. In the event of a conflict, the member specific benefit plan document supersedes the applicable Medical Benefit Drug Policy and List. All reviewers must first identify member eligibility, any federal or state regulatory requirements, and the member specific benefit plan coverage prior to use of this Medical Benefit Drug Policy. Other Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary.

Benefit Considerations

This medication list applies to certain newly launched medications that are healthcare provider administered and are currently under review by the UnitedHealthcare Pharmacy and Therapeutics (P&T) Committee. The medications may be excluded from coverage while the medication is listed on this document or will be reviewed against available clinical evidence, which includes applicable Medical Benefit Drug Policies.

RAL Date HCPCS Codes Medication 02/01/2021 C9077, J3490 Cabenuva™ (cabotegravir/rilpivirine) 02/17/2021 C9079, J3490, J3590 Evkeeza™ (-dgnb) 03/05/2021 C9399, J3490, J3590 Nulibry™ (fosdenopterin) 06/09/2021 C9399, J3490, J3590 Aduhelm™ (aducanumab) 06/14/2021 C9399, J3490, J3590 Ryplazim® (plasminogen, -tvmh) 08/06/2021 C9399, J3490, J3590 Saphnelo™ (anifrolumab-fnia)

Review at Launch Medication List Page 1 of 3 UnitedHealthcare Commercial Medical Benefit Drug List Last Updated 08/06/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

RAL Date HCPCS Codes Medication 08/12/2021 C9399, J3490, J3590 Nexviazyme™ (avalglucosidase alfa-ngpt)

List History/Revision Information

Date Summary of Changes 08/06/2021 • Added Nexviazyme™ (avalglucosidase alfa-ngpt) 08/06/2021 • Added Saphnelo™ (anifrolumab-fnia) 07/01/2021 Removed Amondys 45™ (casimersen) and Oxlumo™ (lumasiran); prior authorization requirements effective Jul. 1, 2021 Updated applicable HCPCs codes to reflect quarterly edits: o Cabenuva: Replaced C9399 with C9077 o Evkeeza: Replaced C9399 with C9079 06/14/2021 • Added Ryplazim® (plasminogen, human-tvmh) 06/09/2021 • Added Aduhelm™ (aducanumab) 06/07/2021 • Removed Empaveli™ (pegcetacoplan) [Refered to Medical Benefit Drug Policy titled Self- Administered Medications effective June 6, 2021; directed to pharmacy benefit]. 05/20/2021 • Added Empaveli™ (pegcetacoplan) 03/05/2021 • Added Nulibry™ (fosdenopterin) 03/01/2021 • Added Amondys 45™ (casimersen) 02/17/2021 • Added Evkeeza™ (evinacumab-dgnb) 02/01/2021 • Added Cabenuva™ (cabotegravir/rilpivirine) 01/01/2021 • Removed Scenesse® (afamelanotide), Uplinza™ (inebilizumab-cdon), and Viltepso™ (Viltolarsen); prior authorization requirements effective Jan. 1, 2021 12/07/2020 Added Oxlumo™ (lumasiran) 10/01/2020 Removed Monoferric™ (ferric derisonmaltose), Tepezza™ (teprotumumab-trbw), and Vyepti™ (-jjmr); prior authorization requirements effective Oct. 1, 2020 08/18/2020 Added Viltepso™ (Viltolarsen) 07/01/2020 Removed Adakveo® (crizanlizumab-tmca), Avsola™ (infliximab-axxq), Givlaari® (givosiran), Reblozyl® (luspatercept-aamt), and Vyondys 53™ (golodirsen); prior authorization requirements effective Jul. 1, 2020 06/19/2020 Added Scenesse® (afamelanotide) and Uplinza™ (inebilizumab-cdon) 04/01/2020 Added Vyepti™ (eptinezumab-ijmr) 03/01/2020 Added Avsola™ (infliximab-axxq) 02/01/2020 Added Monoferric™ (ferric derisonmaltose) and Tepezza™ (teprotumumab-trbw) 01/22/2020 Removed Xembify® [Immune Globulin Subcutaneous (Human) – klhw] [prior authorization requirements apply Jan. 1, 2020; refer to the Medical Benefit Drug Policy titled Immune Globulin (IVIG and SCIG) for coverage guidelines] 12/16/2019 Added Givlaari® (givosiran) and Vyondys 53™ (golodirsen) 11/25/2019 Added Adakveo® (crizanlizumab-tmca) and Reblozyl® (luspatercept-aamt) 10/01/2019 Removed Evenity™ (-aqqg), Zolgensma® (onasemnogene abeparvovec-xioi), and Cutaquig® [Immune Globulin Subcutaneous (Human) – hipp]; prior authorization requirements effective October 1, 2019 08/01/2019 Added Xembify® [Immune Globulin Subcutaneous (Human) – klhw] 07/01/2019 Removed Ultomiris™ (ravulizumab-cwvz); prior authorization requirements effective Jul. 1, 2019 06/10/2019 Added Cutaquig® [Immune Globulin Subcutaneous (Human) – hipp] 05/29/2019 Added Zolgensma® (onasemnogene abeparvovec-xioi)

Review at Launch Medication List Page 2 of 3 UnitedHealthcare Commercial Medical Benefit Drug List Last Updated 08/06/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

Date Summary of Changes 04/15/2019 Added Evenity™ (romosozumab-aqqg) 04/01/2019 Removed Gamifant® (emapalumab-lzsg) and Revcovi™ (elapegademase-lvlr); prior authorization requirements effective Apr. 1, 2019 01/01/2019 Added Ultomiris™ (ravulizumab-cwvz) Removed Ilumya™ (tildrakizumab-asmn) and Onpattro™ (patisiran); prior authorization requirements effective Jan. 1, 2019 11/20/2018 Added Gamifant® (emapalumab-lzsg) Removed Panzyga® (immune globulin intravenous, human-ifas); prior authorization requirements for HCPCS code J1599 previously in effect 11/08/2018 Added Panzyga® (immune globulin intravenous, human-ifas) 10/09/2018 Added Revcovi™ (elapegademase-lvlr) 10/01/2018 Removed Crysvita® (-twza); prior authorization requirements effective Oct. 1, 2018 08/15/2018 Added Onpattro™ (patisiran) 06/26/2018 Added Ilumya™ (tildrakizumab-asmn) 04/23/2018 Added Crysvita® (burosumab-twza) 04/01/2018 Removed Luxturna™ (voretigene neparvovec-rzyl); prior authorization requirements effective Apr. 1, 2018 01/01/2018 New list; includes Luxturna™ (voretigene neparvovec-rzyl)

Review at Launch Medication List Page 3 of 3 UnitedHealthcare Commercial Medical Benefit Drug List Last Updated 08/06/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.