Specialty Drugs Requiring Precertification

Line(s) of Business: Original Effective Date: HMO; PPO; QUEST Integration 10/01/2015 Medicare Advantage Current Effective Date: 12/20/2019

I. DESCRIPTION A specialty drug is a drug that is typically high in cost (greater than $600 per month) and has one or more of the following characteristics:  Specialized patient training on the administration of the drug (including supplies and devices needed for administration) is required.  Coordination of care is required prior to drug therapy initiation and/or during therapy.  Unique patient compliance and safety monitoring requirements.  Unique requirements for handling, shipping and storage.  Restricted access or limited distribution.

The intent of this policy is to provide notification of the designated specialty drug (s) approved by the Food and Drug Administration (FDA). Precertification of the drug will be required on the launch date of the drug. See VI. Appendices section below. This policy applies to drugs covered under the medical benefit and under the prescription drug rider benefit.

For Medicare Advantage members, please refer to Section IV Program Exception – Medicare Advantage.

II. CRITERIA/GUIDELINES A. Precertification is required for specialty drugs, effective once the drug is commercially available. Refer to Appendices A, B and C for the lists of drugs requiring precertification. B. A specialty drug is covered (subject to Limitations/Exclusions and Administrative Guidelines) when the following criteria are met: 1. It is prescribed for an FDA approved indication. a. Its use is consistent with the manufacturer’s prescribing information. b. When the FDA-approved indication lacks patient selection specificity, the patient meets the eligibility criteria for the clinical study or studies upon which the FDA approval was based. 2. When a specialty drug is requested for an off-label indication, the Off-Label Drug Use Policy criteria must be met.

III. LIMITATIONS/EXCLUSIONS A. When a request for a specialty drug is approved, coverage is based on a trial of therapy concept. The drug will be initially approved for 3 months. Specific measurable response(s) should be Specialty Drugs Requiring Precertification 2

identified and documented at the time of initial approval. Continuation of the drug is covered for an additional 12 months if the patient demonstrates a measurable response. B. This policy does not apply to specialty drugs with an existing policy. If there is an existing policy, coverage will be based on policy criteria. Refer to Appendices B and C for the list of drugs requiring precertification for which there is a policy.

IV. PROGRAM EXCEPTION – MEDICARE ADVANTAGE For Medicare Advantage members, a National Coverage Determination (NCD) or Local Coverage Determination (LCD) may apply.

Please refer to Appendix A for drugs requiring precertification. Medical benefit drugs marked with an asterisk (*) are not covered under Medicare Part B. Pharmacy benefit drugs covered under Medicare Part D may be subject to formulary restrictions and other special requirements. Refer to the current HMSA Medicare Advantage Formulary for details.

V. ADMINISTRATIVE GUIDELINES A. Precertification is required for specialty drugs. Precertification of the drug will be required on the launch date of the drug. At the time precertification is being requested, please refer to Appendix A for the list of drugs requiring precertification in accordance with criteria stated in this policy. To precertify, please complete the CVS Caremark prior authorization request form (available on October 1, 2015). Please include the following documentation:

1. Clinical information supporting the diagnosis. 2. Proposed treatment plan.

B. Specialty drugs listed in Appendix A will be reviewed on a regular basis and a determination will be made regarding continuation of the precertification requirement and/or development of a policy.

VI. APPENDICES

Appendix A: Drugs requiring precertification from CVS Caremark in accordance with criteria stated in this policy.

 Medical benefit drugs (mostly injectable/infused dosage forms) Brand/Generic Name Route of FDA Approved Date Drug Launch Date Administration Adakveo (crizanlizumab-tmca) IV infusion November 15, 2019 November 19, 2019 Aimovig (erenumab-aooe)* Subcutaneous May 17, 2018 May 18, 2018 Ajovy (fremanezumab-vfrm)** Subcutaneous September 14, 2018 September 17, 2018 Beovu (brolucizumab-dbll) Intravitreal October 7, 2019 October 9, 2019 Brineura (cerliponase alfa) Intraventricular April 27, 2017 May 4, 2017 Cablivi (caplacizumab-yhdp) IV infusion February 6, 2019 February 25, 2019 Subcutaneous Cinqair (reslizumab) IV infusion March 23, 2016 April 25,2016 Cosentyx (secukinumab)* Subcutaneous February 13, 2015 February 25, 2015 Crysvita (burosumab-twza) Subcutaneous April 17, 2018 April 23, 2018 Specialty Drugs Requiring Precertification 3

Brand/Generic Name Route of FDA Approved Date Drug Launch Date Administration Emgality (galcanezumab-gnlm)* Subcutaneous September 27, 2018 October 1, 2018 Evenity (romosozumab-aqqg) Subcutaneous April 9, 2019 April 16, 2019 Exondys 51 (eteplirsen) IV infusion September 19, 2016 September 23, 2016 Fasenra (benralizumab) Subcutaneous November 14, 2017 November 16, 2017 Gamifant (emapalumab-lzsg) IV infusion November 20, 2018 December 27, 2018 Givlaari (givosiran) Subcutaneous November 20, 2019 November 22, 2019 Haegarda (C1 esterase inhibitor Subcutaneous June 22, 2017 July 13, 2017 [human])* Ilumya (tildrakixumab-asmn) Subcutaneous March 20, 2018 August 21, 2018 Kanuma (sebelipase alfa) IV infusion December 8, 2015 December 14, 2015 Kevzara (sarilumab)* Subcutaneous May 22, 2017 May 24, 2017 Mepsevii (vestronidase alfa-vjbk) IV infusion November 15, 2017 November 27, 2017 Nucala (mepolizumab) Subcutaneous November 4, 2015 November 30, 2015 Ocrevus (ocrelizumab) IV infusion March 28, 2017 March 30, 2017 Onpattro (patisiran) IV infusion August 10,2018 August 18, 2018 Palynziq (pegvaliase-pqpz) Subcutaneous May 24, 2018 May 31, 2018 Prolastin-C (alpha1-proteinase IV infusion September 21, 2017 January 3, 2018 inhibitor [human]) Radicava (edaravone) IV infusion May 5, 2017 May 18, 2017 Revcovi (elapegademase-ivir) Intramuscular October 5, 2018 November 14, 2018 Signifor LAR (pasireotide long Intramuscular December 16, 2014 March 2015 acting) Siliq (brodalumab)* Subcutaneous February 15, 2017 June 21, 2017 Skyrizi (risankizumab-rzaa) Subcutaneous April 23,2019 April 29, 2019 Strensiq (asfotase alfa)* Subcutaneous October 23, 2015 October 26,2015 Sublocade (buprenorphine) Subcutaneous November 30, 2017 December 21, 2017 Takhzyro (lanadelumab-flyo)† Subcutaneous August 23, 2018 September 4, 2018 Taltz (ixekizumab)* Subcutaneous March 22, 2016 April 18, 2016 Tegsedi (inotersen) Subcutaneous October 05, 2018 October 23,2018 Tremfya (guselkumab) Subcutaneous July 13, 2017 July 17, 2017 Triptodur (triptorelin pamoate) Intramuscular June 29, 2017 August 29, 2017 Tymlos (abaloparatide)* Subcutaneous April 28, 2017 May 2, 2017 Ultomiris (ravulizumab-cwvz) IV infusion December 21, 2018 December 24, 2018 Yutiq (fluocinolone acetonide Intravitreal October 12, 2018 December 10, 2018 intravitreal implant) implant * Drug is not covered under Medicare Part B. **Drug is not covered under Medicare Part B unless administered under the direct supervision of a physician. † Drug is not covered under Medicare Part B effective 12/02/2019 unless administered under the direct supervision of a physician.

 Pharmacy benefit drugs (mostly oral/inhaled dosage forms)† Specialty Drugs Requiring Precertification 4

Brand/Generic Name Route of FDA Approved Date Drug Launch Date Administration Doptelet (avatrombopag) Oral May 21, 2018 May 31, 2018 Macrilen (macimorelin) Oral December 20, 2017 June 7, 2018 Mulpleta (lusutrombopag) Oral July 31, 2018 August 22,2018 Oxybryta (voxelotor) Oral November 25, 2019 November 27, 2019 Purixan (mercaptopurine) Oral April 28, 2014 June 6, 2014 Rinvoq (upadacitinib) Oral August 16, 2019 August, 19, 2019 Ruzurgi (amifampridine) Oral May 6, 2019 June 6, 2019 Sunosi (solriamfetol) Oral March 20, 2019 July 2, 2019 Tiglutik (riluzole) Oral September 5, 2018 September 24, 2018 Trikafta (elexacaftor, tezacaftor Oral October 21, 2019 October 22, 2019 and ivacaftor) Vumerity (diroximel fumarate) Oral October 29, 2019 November 4, 2019 Wakix (pitolisant hydrochloride) Oral August 14, 2019 September 26, 2019 † Note for Medicare Advantage members, refer to the Medicare Advantage formulary where coverage may be subject to formulary restrictions and other special requirements.

Appendix B

Medical benefit drugs requiring precertification from CVS Caremark in accordance with existing policies (click on the link to access the list of drugs and the policies).

Appendix C

Pharmacy benefit drugs requiring precertification from CVS Caremark in accordance with existing policies.

Document History 10/01/2015 Original effective date 11/2015 Added Imlygic, Onivyde, Yondelis, Strensiq and Lonsurf 03/2016 Added Bendeka, Darzalex, Empliciti, Kanuma, Nucala, Portrazza, Alecensa, Cotellic, Keveyis, Ninlaro, Orkambi, Odomzo, Purixan, Tagrisso, Uptravi, Veltassa and Zepatier 04/2016 Added Cinqair, Taltz and Inflectra 06/2016 Added Evomela, Hymovis, Tecentriq and Nuplazid 08/2016 Removed Praluent and Repatha 12/2016 Added Lartruvo, Exondys 51 and Signifor LAR 01/2017 Added Spinraza; updated Strensiq and Taltz; removed Zepatier 02/2017 Added Siliq and Emflaza 03/2017 Added Probuphine 04/2017 Added Dupixent, Austedo and Ocrevus 05/2017 Added Alunbrig, Brineura, Imfinzi, Rydapt and Tymlos 06/2017 Added Kevzara and Radicava. Updated Dupixent and Siliq. 08/2017 Added Tremfya 03/2018 Removed Dupixent, Hymovis, Inflectra, Probuphine, and Spinraza 04/2018 Added Sublocade Specialty Drugs Requiring Precertification 5

05/2018 Added Aliqopa, Besponsa, Erleada, Fasenra, Haegarda, Hemlibra, Mepsevii, Mvasi, Mylotarg, Parsabiv, Symdeko, Triptodur, and Trogarzo. Removed Alecensa, Alunbrig, Austedo, Bendeka, Cotellic, Emflaza, Evomela, Lonsurf, Ninlaro, Nuplazid, Orkambi, Odomzo, Rydapt, Targrisso, and Uptravi. 06/2018 Added Crysvita, Jynarque, and Tavalisse 06/2018 Added Prolastin-C, Bavencio, and Rituxan-Hycela. Removed Trogarzo and Mvasi. 07/2018 Added Aimovig, Braftovi, Mektovi, Olumiant, Palynziq, Rebinyn, and Yonsa 08/2018 Added Takhzyro, Onpattro, Poteligeo, ILumya, Galafold, Orkambi, Mulpleta, Lenvima, Orilissa, Tibsovo, Macrilen, Doptelet Removed Mektovi, Braftovi 09/2018 Added Azedra. Removed Orkambi and Lenvima 10/2018 Removed Erleada and Tibsovo 10/2018 Added Ajovy, Copiktra, Emgality, Libtayo, Tiglutik, and Vizimpro 10/2018 Added Epidiolex 10/2018 Removed Doptelet, Epidiolex, Jynarque, Keveyis, Mulpleta, Olumiant, Symdeko, Tavalisse, and Yonsa 10/2018 Added Doptelet, Mulpleta 10/2018 Added Lumoxiti and Talzenna 11/2018 Removed Galafold 11/2018 Added Tegsedi and Lorbrena 11/2018 Added drug launch dates. Added Revcovi 12/2018 Added Oxervate 12/2018 Added Daurismo, Vitrakvi, Xospata 12/2018 Added Signifor LAR launch date 12/2018 Added Yutiq 12/2018 Removed Aliqopa, Mylotarg, and Rebinyn 01/2019 Added Gamifant, Ultomiris and Firdapse 01/2019 Removed Hemlibra 02/2019 Added Elzonris 02/2019 Removed Azedra 03/2019 Removed Bavencio, Besponsa, Darzalex, Elzonris, Empliciti, Imfinzi, Imlygic, Lartruvo, Libtayo, Lumoxiti, Onivyde, Opdivo, Portrazza, Poteligeo, Rituxan Hycela, Tecentriq, Unituxin, and Yondelis. Extended reauth approval duration to 12 months 03/2019 Added Inbrija and Spravato 04/2019 For Spravato, no PA required for QUEST 04/2019 Added Mavenclad and Mayzent 04/2019 Added Evenity 05/2019 Added Skyrizi 05/2019 Added Vyndaqel 06/2019 Added Zolgensma 06/2019 Removed Spravato and Zolgensma – please contact HMSA at 808-948- 6464, option #4 for Spravato or Zolgensma review 06/2019 Added Cablivi and Ruzurgi 07/2019 Added Sunosi. Removed Vyndaqel. 07/2019 Removed Copiktra, Daurismo, Firdapse, Inbrija, Lorbrena, Mavenclad, Mayzent, Orilissa, Oxervate, Talzenna, Veltassa, Vitrakvi, Vizimpro, Xospata 08/2019 Ajovy, Aimovig, Emgality, Haegarda, Kevzara, Tymlos not covered under Part B per updated Noridian SAD list 10/2019 Added Beovu 10/2019 Added Trikafta 11/2019 Added Rinvoq, Wakix. Removed Parsabiv 11/2019 Added Vumerity 11/2019 Skyrizi and Takhzyro not covered under Part B per updated SAD list 11/2019 Added Adakveo Specialty Drugs Requiring Precertification 6

11/2019 Annual review 12/20/2019 Revision effective date 12/2019 Added Givlaari and Oxbryta 12/2019 Removed Skyrizi as SAD, per Noridian update.