Subject: Antiviral-HIV specific

Status	Drug	PR	PR-QL	PR-AL	ST	M EX‡
P	abacavir tab
P	abacavir/lamivudine/zidovudine
P	didanosine ec cap
P	lamivudine
P	lamivudine/zidovudine
P	nevirapine/ er
P	stavudine
P	zidovudine
P	Aptivus®  (tipranavir)
P	Emtriva®  (emtricitabine)
P	Kaletra®  (lopinavir-ritonavir)
P	Lexiva™  (fosamprenavir)
P	Norvir®  (ritonavir)
P	Prezista®  (darunavir)
P	Reyataz®  (atazanavir)
P	Sustiva®  (efavirenz)
P	Truvada®  (emtricitabine-tenofovir)	X
P	Videx®  (didanosine)
P	Viread®  (tenofovir disoproxil fumarate)
NP	Atripla®  (efavirenz-emtricitabine-tenofovir disoproxil fumarate)
NP	Crixivan®  (indinavir)
NP	Complera®  (emtricitabine-rilpivirine-tenofovir)
NP	Edurant™  (rilpivirine)
NP	Epzicom®  (abacavir-lamivudine)
NP	Fuzeon®  (enfuvirtide)
NP	Intelence™  (etravirine)
NP	Invirase®  (saquinavir-hg)
NP	Isentress®  (raltegravir chew/tab)
NP	Rescriptor®  (delavirdine)
NP	Selzentry®  (maraviroc)
NP	Stribild™  (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate)	X
NP	Tivicay®  (dolutegravir)
NP	Triumeq®  (abacavir/ dolutegravir/ lamivudine )	X			X	X
NP	Trizivir®  (abacavir-lamivudine-zidovudine)
NP	Viracept®  (nelfinavir)
NP	Viramune XR®  (nevirapine)
FE	Combivir®  (lamivudine-zidovudine)				X	X
FE	Epivir®  (lamivudine)					X
FE	Retrovir®  (zidovudine)					X
FE	Videx EC®  (didanosine)					X
FE	Viramune®  (nevirapine)				X	X
FE	Zerit®  (stavudine)				X	X
FE	Ziagen®  (abacavir)				X	X

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Stribild, Triumeq, and Truvada are subject to precertification. If precertification requirements apply Aetna considers these drugs to be medically necessary for those members who meet all of the following precertification criteria:

For Stribild

• A documented diagnosis of human immunodeficiency virus (HIV), AND
• A documented viral load assay AND CD4 count indicating that the patient is stable on Stribild (stable or increase in CD4 counts AND viral load <50 copies/ml) (FOR renewals/continuations ONLY)
• For treatment naïve patients only, a documented resistance test within the past 3 months demonstrating virologic susceptibility to all of the following components of Stribild: elvitegravir, emtricitabine, and tenofovir AND
  • A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of Atripla (efavirenz-emtricitabine-tenofovir) or a documented resistance test within the past 3 months demonstrating virologic resistance to efavirenz OR
  • A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of Truvada, Reyataz, and Norvir (emtricitabine-tenofovir, atazanavir, ritonavir) in combination or documented resistance test within the past 3 months demonstrating virological resistance to atazanavir.

For Triumeq

• A documented diagnosis of human immunodeficiency virus (HIV)
  AND
• A documented trial of one month of the medication's preferred alternatives abacavir, lamivudine, and dolutegravir.

For Truvada

• A documented diagnosis of human immunodeficiency virus (HIV) OR
• A documented diagnosis of initiating therapy for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk AND documentation of all of the following:
  • A negative HIV antibody test taken:
    • Immediately before starting Truvada for PrEP AND
    • Every 3 months thereafter while on therapy
  • Confirmation that creatinine clearance value >/=60 mL/min before initiating Truvada for PrEP AND
    • Serum creatinine and calculate creatinine clearance checks performed at 3 months after initiation and then every 6 months thereafter

NOTE: Members may receive a 30 days’ supply of medication upon initial request of Truvada for PrEP diagnosis. After 30 days, above criteria must be met.

 

2. Step Therapy Criteria

Under some plans, including plans that use an open or closed formulary, Combivir, Triumeq, Viramune, Zerit, and Ziagen are subject to step- therapy.  Aetna considers this drug to be medically necessary for those members who meet the following step-therapy criterion:

For Combivir, Viramune, Zerit, and Ziagen

• A documented trial of one month of the medication's preferred generic equivalent alternative

For Triumeq

• A documented trial of one month of concomitant use of the preferred alternatives, abacavir, lamivudine, and dolutegravir.

If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member’s treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section II below).

3. Medical Exception Criteria

Combivir, Viramune, Zerit, and Ziagen are currently listed on the Aetna Formulary Exclusions and Step-Therapy lists. Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary or that require step-therapy criteria, unless a medical exception is granted. Aetna considers this drug to be medically necessary for those members who meet the following criteria:

Triumeq is currently listed on the Aetna Step-Therapy List.* If it is medically necessary for a member to be treated initially with this medication, Aetna considers this medication to be medically necessary for those members who meet the criteria specified below:

Epivir, Retrovir, and Videx EC are currently listed on the Aetna Formulary Exclusions List.* Therefore, these drugs are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted.  Aetna considers these drugs to be medically necessary for those members who meet any of the following criteria:

For Combivir, Epivir, Viramune, Zerit, and Ziagen

• A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of the medication's preferred generic equivalent alternative

For Retrovir and Videx EC

• A documented contraindication or intolerance or allergy or failure of an adequate trial of one month of a preferred generic alternative

For Triumeq 

• A documented diagnosis of human immunodeficiency virus (HIV). AND The member has a documented contraindication to, intolerance to, or failure to one of the preferred alternatives, abacavir, lamivudine, and dolutegravir.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
2. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
3. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
4. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
5. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically. 
6. Sandford, JP, Gilbert, DN, Moellering, RC, Sande, MA: Sanford Guide to Antimicrobial Therapy, Therapy, 40th  edition, 2010.
7. Panel on Antiretroviral Guidelines for Adult and Adolescents. Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. Department of Health and Human Services.. Updated April 8, 2015. Available at http://aidsinfo.nih.gov/Guidelines/Default.aspx?MenuItem=Guidelines Accessed (May 28, 2015)
8. Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States – May 2010 accessed 1-17-11 : http://aidsinfo.nih.gov/contentfiles/PerinatalGL.pdf
9. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection – August 2010. accessed 1-17-11 : http://aidsinfo.nih.gov/contentfiles/PediatricGuidelines.pdf

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 11, 2015