ADAP Monitoring Provider Prescribing Patterns. Amanda Bowes, NASTAD Christine Rivera and Dr. Charles Gonzalez, NYS AIDS Institute

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1 ADAP Monitoring Provider Prescribing Patterns Amanda Bowes, NASTAD Christine Rivera and Dr. Charles Gonzalez, NYS AIDS Institute

2 WEBINAR ETIQUETTE All questions or comments can be shared either via the webinar chat function or phone/audio. To mute your individual phone line: Use the mute function on your phone Use the mute function on your computer (i.e., click the mute button on the left-hand corner of the Zoom window) Do NOT place your phone on hold at any time. 2

3 AGENDA ADAP Monitoring Prescribers: HRSA/HAB Policy New York State AIDS Institute Presentation Summary of HIV ARV drug interactions Overview of the DHHS adolescent and adult ARV guidelines NYS ADAP-based ARV intervention practices Discussion 3

4 ADAP Monitoring Prescribers: HRSA/HAB Policy 4

5 ADAP MONITORING PRESCRIBERS: HRSA/HAB POLICY Health Resources & Services Administration HIV/AIDS Bureau (HRSA/HAB) Ryan White HIV/AIDS Program (RWHAP) Part B AIDS Drug Assistance Program (ADAP) Manual: HIV/AIDS Treatment Guidelines. HHS develops Federal guidelines on the appropriate administration of HIV/AIDS treatments, including antiretroviral therapies, and medications for the prevention and treatment of opportunistic infections. The Guidelines are regularly updated using the latest scientific research findings by expert panels. ADAPs and other RWHAP recipients that provide HIV/AIDS medications must ensure that clients receive medication therapies consistent with current Federal HIV/AIDS treatment guidelines. 5

6 ADAP MONITORING PRESCRIBERS: HRSA/HAB POLICY HRSA/HAB Clinical Quality Management Policy Clarification Notice 15-02: Quality assurance refers to a broad spectrum of activities aimed at ensuring compliance with minimum quality standards. Quality assurance activities include the retrospective process of measuring compliance with standards (e.g., HHS guidelines, professional guidelines, service standards). Site visits and chart reviews are examples of commonly used quality assurance activities. 6

7 ADAP MONITORING PRESCRIBERS: HRSA/HAB POLICY HAB HIV Performance Measures: ADAP: AIDS Drug Assistance Program: 7

8 New York State AIDS Institute Presentation 8

9 Discussion 9

10 The challenges of implementing a clinical antiretroviral intervention model into the real world of ADAP Christine A. Rivera, Director Office of HIV Uninsured Care Programs AIDS Institute New York State Department of Health christine.rivera@health.ny.gov Charles John Gonzalez, M.D., Associate Medical Director for Science and Policy/OMD AIDS Institute New York State Department of Health charles.gonzalez@health.ny.gov August 8, 2017

11 HIV / AIDS Services in New York State Continuum of Access to Health Related Services through Medicaid and the HIV Uninsured Care Programs Comprehensive planning and community involvement About the AIDS Institute bout/index.htm 2

12 HIV ARV Drug Interactions Charles J. Gonzalez, MD NYDOH AIDS Institute 3

13 HIV Therapy Effective HIV Therapy is defined as the use of 3 (or more) fully active ARV medications, with at least 2 agents having different mechanisms or targets in the viral replication cycle. 4

14 HIV Therapy Effective HIV Therapy is by definition polypharmacy. With most running through the Hepatitic cytochrome P450 system*. *Cytochrome P450 enzymes are essential for the metabolism of many medications. Although this class has more than 50 enzymes, 6 of them metabolize 90 percent of drugs; the two most significant enzymes are CYP3A4 and CYP2D6. 5

15 HIV Therapy Within the 5 classes of HIV medications there are intra and extra class interactions and toxicities. The 5 classes are NRTIs, NNRTIs, PIs, Entry Inhibitors & Integrase Inhibitors Some interactions are exploited (synergistic): ritonavir (Norvir) as an enhancing or boosting agent for other Protease Inhibitors. Some are therapeutically antagonistic: D4t with ZVD. 6

16 Antiretroviral Interactions 7

17 Antiretroviral Interactions 8

18 DHHS

19 DHHS

20 New York ADAP System In-house, self directed, real time, electronic pharmacy claim processing and adjudication system using NCPDP D.0 standard. 3,500 network pharmacies adjudicating 3,000 claims per day. Prospective system edits include: Individual, provider and drug covered. Maximum monthly drug quantity (unit) limits. Antiretroviral utilization edits. Antiretroviral contraindicated edits. 11

21 ADAP ARV Interventions Guiding Principles Do no harm. Assure uninterrupted access to safe combinations of antiretroviral medications. Respect the clinician patient relationship. 12

22 Retrospective Utilization Review Does not deny access to medications at the pharmacy. Provides the opportunity to review the whole picture especially for events that appear contraindicated. Can cope with the reality of linear prescription filling, disparate prescription refills and changes in therapy. 13

23 Prospective Utilization Review Denies access to medications at the pharmacy. Change in regimens, discontinued medications and misunderstandings can be cleared up before the potential for harm. For Antiretroviral (ARV) interventions there is no available software for purchase the interventions developed by New York ADAP were created using current standards of care and Public Health Service (PHS) guidelines. 14

24 Prospective Antiretroviral Utilization Edits: An ARV drug utilization error / denial occurs if; The same ingredient appears more than once. The combination includes more than 5 ARV s or more than 2 Protease Inhibitors. The intervention is set high enough to prevent a manual review of a majority of regimens and low enough to prevent unintended misuse, fraud or misunderstandings between the patient, provider and pharmacist. ARV denials can be overridden with clinical justification and approval. Overrides are systemically tracked and time limited. 15

25 ARV Contraindicated Edits Evolving standards of care (PHS guidelines), changes in available agents and new fixed dose ARV combinations fueled the concept of more sophisticated interventions. Table 8* of the DHHS guidelines was used as a starting point. Adapted for emerging contraindications as they developed. Established dose specific interventions to prevent false positives from being denied at the point of sale. * This is now Table 10 in the current DHHS guidelines 16

26 What do you need? Staff Support a clinician who has lived in the real world and consistently reaches for the ideal. Sufficient capacity to manage the manual process of override requests. A sound understanding of the linear nature of filling patterns, i.e. mono-therapy cannot be denied prospectively. The ability to timely adapt the Public Health Service/DHHS (DHHS) guidelines to your claim processing system. 17

27 In the Beginning Reviewed the ARV utilization patterns for a recent quarter. Participant must have the same combination filled more than twice during each quarter to reduce the impact of changes in regimens on the analysis. Identified 20 contraindicated combinations. Developed a hierarchy of contraindicated combinations; urgent (no exception), weekly, quarterly. 18

28 The 2017 Interaction List Stavudine and Zidovudine (interfering mechanisms of action within same ARV class) Indinavir and Atazanavir (toxic interaction within same ARV class) Multiple NNRTI s (>1) (interfering mechanisms of action within same ARV class) Darunavir and Lopinavir-Ritonavir (toxic interaction within same ARV class) Tenofovir (TDF) and Tenofovir alafenamide (TAF) (overdose with same ARV metabolic agent) Tenofovir or TAF with Standard dose Didanosine (400mg) (toxic interaction within this ARV class) Etravirine with Tipranavir, Nelfinavir, Atazanavir, Fosamprenavir, or Indinavir (toxic interaction) Etravirine with Full dose Ritonavir (> 600mg/daily) (toxic interaction) The clinical use of full dose Ritonavir is now rare; this specific contraindication is in place as a fail-safe to forestall immediate deleterious consequences. Multiple Intergrase Inhibitors (>1) (interfering mechanisms of action within same ARV class) Cobicistat with Ritonavir (toxic interaction) 19

29 Prospective ARV Edits Urgent (with explanation) The following combinations are denied at the Point of Sale (pharmacy): Zerit (stavudine) and Retrovir (zidovudine) Contraindicated antagonistic effect. Crixivan (indinavir) and Rayataz (atazanavir) Increased potential for hyperbilirubinemia. Multiple NNRTI s Increased potential for resistance and toxicity. Prezista (darunavir) and Kaletra (lopinavir/ritonavir) Kaletra lowers Prezista levels by 50%. Viread (tenofovir) and Videx (didanosine) > 250mg per day Increases the risk of pancreatitis lowering the dose of Videx helps mitigate this issue. Intelence (etravirine) with Aptivus (tipranavir), Viracept (nelfinavir), Reyataz (atazanavir), Lexiva (fosamprenavir) Crixivan (indinavir) These Protease Inhibitors decrease etravirine levels Intelence (etravirine) must not be used with them even when boosted. Intelence (etravirine) with full dose Norvir (ritonavir) Intelence (etravirine) should not be co-administered with full dose Norvir (ritonavir) (defined as greater than 400 mg of ritonavir daily) etravirine levels are decreased by 46% with co-administration. 20

30 Prospective ARV Edits - Urgent Selzentry (maraviroc) Selzentry (maraviroc) an entry inhibitor requires CCR5 using virus for efficacy; evidence of CCR5 using virus (trophic assay) from a commercial laboratory is required. Selzentry (maraviroc) and Delavirdine Maraviroc dose should be decreased to 150 mg twice daily Selzentry (maraviroc) with protease inhibitors Maraviroc dose should be decreased to 150 mg twice daily when co-administered with a PI other than Aptivus (tipranavir/ritonavir) or Lexiva (fosamprenavir/ritonavir). Selzentry (maraviroc) with Lexiva (fosamprenavir) or Aptivus (tipranavir/ritonavir) and no other boosted PI Maraviroc dose should be 300 mg twice daily Selzentry (maraviroc) and Viramune (nevirapine) and no PI Maraviroc dose should be 300 mg twice daily Selzentry (maraviroc) and Eduant (rilpivirine) and no PI Maraviroc dose should be 300 mg twice daily Selzentry (maraviroc) with Sustiva (efvarenz) or Intelence (etravirine) and no PI Maraviroc dose should be 600 mg twice daily. When co-administered with a PI other than tipranavir/ritonavir or fosamprenavir/ritonavir. Maraviroc dose should be decreased to 150 mg twice daily. 21

31 The current list of absolute contraindicated & monitored anti-retroviral (ARV) combinations Absolute Stavudine with Zidovudine Indinavir with Atazanavir Multiple NNRTI s (more than 1) Darunavir with Lopinavir-Ritonavir (Kaletra) Tenofovir or TAF with Standard dose Didanosine (400mg) Etravirine with Tipranavir, Nelfinavir, atazanavir, Fosamprenavir, or Indinavir* Etravirine with Full dose Ritonavir (> 600mg/daily)* Maraviroc without a CCR5 co-receptor trophism assay result Multiple Integrase Inhibitors (more than 1) Cobicistat with Ritonavir The list of 7 absolute contraindicated drug combinations is in actuality a compendium of 16 different contraindicated ARV drug or dosing combinations. Relative or Monitored Dosing Emtricitabine with Lamivudine Delavirdine with Ritonavir Delavirdine with Cobicistat Full dose Ritonavir (> 600mg/daily) with any Protease Inhibitor Didanosine with Stavudine Darunavir with Saquinavir *indicates Etravirine related dosage modifications. 22

32 Weekly Retrospective Interventions Weekly runs identify combinations for follow-up with the clinician data is reviewed for 45 days prior to the event to mitigate the impact of changes in regimens; Agenerase Oral (amprenavir) Risk of toxicity from porpylene glycol not recommended in children under 4, during pregnancy or in those with hepatic or renal insufficiency. FTC / Emtriva (emtricitabine) and 3TC / Epivir (lamivudine) Similar resistance profile and no additive benefit. Lexiva (fosamprenavir) and Kaletra (lopinavir/ritonavir) Levels of lopinavir increased by 35% and fosamprenavir decreased by 60%. Full Norvir with Double Protease Inhibitors Increased risk for cardiac complications. Rescriptor (delavirdine) and Norvir (ritonavir) Decreased norvir levels by 50% and exacerbated boost effect on other PI s. Prezista (darunavir) and Invirase (saquinavir) Invirase lowers Prezista levels by 30%. 23

33 Quarterly Retrospective Interventions The following combinations are identified for quarterly review and possible intervention: Videx and d4t Mono NRTI Dual NRTI Triple NRTI Saquinavir no Norvir boost Reyataz and Viread no Norvir boost Reyataz and Sustiva no Norvir boost 24

34 Quarterly Report Chart 25

35 Quarterly Interventions Digging Deeper Review of coverage shows that 60% of quarterly contraindicated events are for mono or dual therapy. 50% of individuals with a quarterly edit event also had another form of drug coverage. 40% of quarterly events resolve in the subsequent quarter indicating they may have been changes in regimens or a misunderstanding between the patient, clinician and pharmacist. 26

36 Responsible Parties The Pharmacy, provider and patient triangle. The Clinician for contraindicated events that occur as part of the weekly intervention, ADAP requires a physician to attest to the contraindication and that they are aware their patient is on this combination. The above named patient is seen regularly in my practice for HIV disease management. I am aware of the concerns raised above and have informed my patient of the potential deleterious interactions. To my knowledge, I am the only prescriber of his/her ARV therapy. Based on clinical findings, I can justify this patient s continuation on this regimen. Signed - Hawkeye Pierce, MD February 30,

37 Summary The contraindication approach did not yield any cost savings to ADAP*. The approach saves health care coverage programs by preventing adverse clinical events, complications and hospitalizations. Ongoing and continued refinement to the process is necessary. Continuous monitoring of the guiding principle do no harm is required unintended consequences can be devastating. * Cost savings were not the motivation or intention for the ADAP contra-indicated ARV intervention systems. 28

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