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AIDS Drug Assistance Program ADAP Grantee Report Proposed Grantee-Level Variables 06/29/2011 Page 1 COVER PAGE Grantee Contact Information 1. Grantee name: 2. Grant number: 3. ADAP number: 4. D-U-N-S number: – 5. - Grantee address: a. Street: b. City: State: c. ZIP Code: __ __ __ __ __ - __ __ __ __ 6. Contact information for the ADAP Coordinator/Administrator: a. Name: b. Title: c. Phone #: (__ __ __) __ __ __ - __ __ __ __ d. Fax #: (__ __ __) __ __ __ - __ __ __ __ e. E-mail: 7. Indicate the six month reporting period for which you are submitting data:  April 1 – September 30  October 1 – March 31 06/29/2011 Page 2 Section 1: Programmatic Summary Submission Section 1 (Items 1–7) should be completed for each six month period. Please review the Instructions for Completing the ADAP Grantee Report to ensure that you respond to each item appropriately. A. PROGRAM ADMINISTRATION 1. Please indicate which of the following limits applied to your ADAP during the reporting period. For each item that applied, complete the blank with the information requested on that limit. (Check all that apply)  Waiting list anytime during the reporting period  Enrollment cap Max number of enrollees __________  Capped expenditure Monetary cap $______per client  Drug-specific enrollment caps for ARVs or Hepatitis C medications - Please specify below for each medication that has an enrollment cap: Medication _____________________Max number of enrollees ______ 2. Indicate which of the following developments or changes occurred in your program during this reporting period: (Check all that apply)      3. Project budget deficit Change in income eligibility criteria (please specify _______________________________________) Change in medical eligibility criteria (please specify _______________________________________) Added medications to the formulary Deleted medications from the formulary Please indicate the maximum ADAP eligibility requirements as a percentage of Federal Poverty Level (FPL): ________________ % 4. Please indicate which of the following activities your ADAP uses to coordinate with Medicaid or a State-only Pharmacy Assistance Program: (Check all that apply)       Online interface Dual application Coordinated benefits Retroactive billing Other (please specify ____________________________) We have no coordination with Medicaid or State-only ADAP 01/27/2011 Page 3 B. FUNDING 5. Please enter the funding received during this reporting period from each of the following sources (if no funding was received enter “0"): Amount Received (to nearest dollar) Funding Source a. Total contributions from Part A EMA(s)/TGAs $ b. Total contributions from Part B Base Funding $ c. Total contributions from Part B Supplemental Funding $ d. State contributions (other than Ryan White or Required State Match Funds) $ e. Carry-over of Ryan White funds from previous year $ f. Manufacturer Rebates $ g. Other Negotiated Rebates $ h. All Insurance Reimbursements, including Medicaid $ Resources received this reporting period (Total of a through h) $ C. EXPENDITURES 6. For each of the following categories, please enter total expenditures for this reporting period: a. Expenditure Category Pharmaceuticals $ b. Dispensing and other administrative costs $ c. Insurance coverage (including co-pays, deductibles, and premiums) $ d. Under the ADAP Flexibility Policy - Adherence $ e. Under the ADAP Flexibility Policy - Access $ f. Under the ADAP Flexibility Policy - Monitoring $ Total ADAP expenditures this quarter $ 01/27/2011 Total Cost Page 4 D. ADAP MEDICATION FORMULARY 7. Please provide information on Antiretroviral (ARV), hepatitis B, hepatitis C and ‘A1’-OI medications currently on your ADAP formulary. If you added an ARV medication to your ADAP formulary during this reporting period, please note that and provide the date that it was added. a. Grantee-level Formulary Information - Antiretroviral Medications Included In Formulary GENERIC NAME BRAND NAME Category Added to Formulary this Reporting Period Med Date Added Added?  abacavir Ziagen NRTIs  MM/DD/YYYY  abacavir, zidovudine, and lamivudine Trizivir NRTIs  MM/DD/YYYY  abacavir/lamivudine Epzicom NRTIs  MM/DD/YYYY  didanosine, ddI, dideoxyinosine Videx NRTIs  MM/DD/YYYY  efavirenz, emtricitabine, tenofovir disoproxil fumarate Atripla NRTIs  MM/DD/YYYY  FTC, emtricitabine Emtriva NRTIs  MM/DD/YYYY  lamivudine and zidovudine Combivir NRTIs  MM/DD/YYYY  lamivudine, 3TC Epvir NRTIs  MM/DD/YYYY  stavudine, d4T Zerit NRTIs  MM/DD/YYYY  tenofovir disoproxil fumarate Viread NRTIs  MM/DD/YYYY  tenofovir disoproxil/emtricitabine Truvada NRTIs  MM/DD/YYYY  zalcitabine, ddC, dideoxycytidine Hivid NRTIs  MM/DD/YYYY  zidovudine, AZT, azidothymidine, ZDV Retrovir NRTIs  MM/DD/YYYY  delavirdine, DLV Rescriptor NNRTIs  MM/DD/YYYY  efavirenz Sustiva NNRTIs  MM/DD/YYYY  Etravirine (TMC-125) Intelence NNRTIs  MM/DD/YYYY  nevirapine, BI-RG-587 Viramune NNRTIs  MM/DD/YYYY 01/27/2011 Page 5 Included In Formulary GENERIC NAME BRAND NAME Category Added to Formulary this Reporting Period Med Date Added Added?  amprenavir Agenerase PIs  MM/DD/YYYY  atazanavir sulfate Reyataz PIs  MM/DD/YYYY  darunavir Prezista PIs  MM/DD/YYYY  Fosamprenavir Calcium Lexiva PIs  MM/DD/YYYY  indinavir, IDV, MK-639 Crixivan PIs  MM/DD/YYYY  lopinavir and ritonavir Kaletra PIs  MM/DD/YYYY  nelfinavir mesylate, NFV Viracept PIs  MM/DD/YYYY  ritonavir, ABT-538 r Norvi PIs  MM/DD/YYYY  saquinavir Fortovase PIs  MM/DD/YYYY  saquinavir mesylate, SQV Invirase PIs  MM/DD/YYYY  tipranavir Aptivus PIs  MM/DD/YYYY  enfuvirtide, T-20 Fuzeon FIs  MM/DD/YYYY  Raltegravir (RGV or MK0518) Isentress Integrase Inhibitors  MM/DD/YYYY  maraviroc Selzentry or Celsentri CCR5 Antagonists  MM/DD/YYYY 01/27/2011 Page 6 b. Grantee-level Formulary Information – A1-OI Medications Included in GENERIC NAME Formulary 01/27/2011 BRAND NAME  acyclovir Zovirax  amphotericin B Fungizone  azithromycin Zithromax  cidofovir Vistide  clarithromycin Biaxin  clindamycin Cleocin  famciclovir Famvir  fluconazole Diflucan  flucytosine Ancobon  fomivirsen Vitravene  foscarnet Foscavir  ganciclovir Cytovene  Isoniazid (INH) Lanizid, Nydrazid  itraconazole Sporonox  leucovorin calcium Wellcovorin  peginterferon alfa-2a PEG-Intron  pentamidine Nebupent  pentavalent antimony —  prednisone Deltasone, Liquid Pred, Metocorten, Orasone, Panasol, Prednicen-M, Sterapred  probenecid — Page 7 Included in Formulary GENERIC NAME BRAND NAME  pyrazinamide (PZA) —  pyrimethamine Daraprim, Fansidar  ribavirin Virazole, Rebetol, Copegus  rifabutin Mycobutin  rifampin (RIF) Rifadin, Rimactane  sulfadiazine (oral generic) Microsulfon  trimethoprim-sulfamethoxazole (TMP/SMX) Bactrim, Septra  valacyclovir Valtrex  valganciclovir Valcyte “A1" Opportunistic Infection Medications* “* A – Both strong evidence for efficacy and substantial clinical benefit support recommendation for use; should always be offered 1 –Evidence from ≥1correctly randomized, controlled trials. Source: Guidelines for Preventing Opportunistic Infections Among HIV-Infected Persons – 2002; Recommendations of the U.S. Public Health Service and the Infectious Diseases Society of America”. 01/27/2011 Page 8 c. Grantee-level Formulary Information – Hepatitis B Medications Included in Formulary GENERIC NAME BRAND NAME  entecavir Baraclude  lamivudine Epivir-HBV  interferon alfa-2b Intron A  adefovir dipivoxil Hepsera  peginterferon alfa-2a Pegasys  telbivudine Tyzeka d. Grantee-level Formulary Information – Hepatitis C Medications Included in Formulary 01/27/2011 GENERIC NAME BRAND NAME  interferon alfa-2b Intron A  recombinant interferon alfa-2a Roferon-A  consensus interferon or interferon alfacon-1 Infergen  peginterferon alfa-2a Pegasys  peginterferon alfa-2b PEG-Intron  peginterferon alfa-2a + ribavirin Copegus and Pegasys  peginterferon alfa-2b and ribavirin PEG-Intron and Rebetol  interferon alfa-2b and ribavirin Intron A and Rebetol  recombinant interferon alfa-2a and ribavirin Roferon and Ribavirin Page 9 Section 2: Annual Submission Section 2 (Items 8-11) should be completed only once each year for the previous 12-month period A. PROGRAM ADMINISTRATION 8. Please indicate the frequency of re-certification of client eligibility:  Annual  Semiannual (every 6 months)  Other, please specify _______________________________ 9. Please indicate the clinical eligibility criteria required to enroll in the ADAP in your State/Territory: (Check all that apply)     HIV+ CD4 (what is your CD4 count requirement? _____________________________) Viral load (what is your VL count requirement? _____________________________) Other (please specify: _____________________________) B. COST SAVING STRATEGIES 10. Please check all that apply to your Drug Pricing Program: (Check all that apply)      340B Rebate Direct purchase Prime vendor Alternative Method Demonstration Project Other drug discount program (not 340B) (please specify ____________________________) C. SOURCES AND AMOUNTS OF ADAP FUNDING – THIS WILL BE PREPOPULATED BY HAB AND IS FOR REVIEW PURPOSES ONLY. 11. ADAP funding received for this fiscal year from each of the following Ryan White HIV/AIDS program sources: Funding Source Amount Received (to nearest dollar) a. ADAP earmark $ b. ADAP Supplemental Drug Treatment Grant Award $ c. State Match for Supplemental Drug Treatment Award $ ADAP resources received (total of a through c) $ 01/27/2011 Page 10