AIDS Drug Assistance Monitoring Project: Appendix 6 MEDICAL CRITERIA AND OTHER FORMULARY RESTRICTIONS

APPENDIX 6 :
MEDICAL CRITERIA AND OTHER FORMULARY RESTRICTIONS

State	Medical Criteria for Access to Drugs and Other Restrictions
Arkansas	Clients' incomes must be at or below 100% of federal poverty level and must have CD4 cell counts of less than 500 to access antiretrovirals.
Delaware	The following agents will be provided for a four week period of illness only, not as prophylaxis: erythropoietin (Epogen) filgrastim (Neupogen) ganciclovir (oral only). Alternative funding must be applied for at the time of initiation of therapy. A negative response from a drug company or other entity must be presented before extension will be considered.
Florida	Protease inhibitors: Due to be added April 1, 1997. Medical requirements will be: CD4 <350, viral load >10,000, or symptomatic. Access will occur in phases: 1. Current clients (as of 1/30/97, approx. 1,000) will have access first; 2. On April 15, current clients receiving protease inhibitors through industry patient assistance programs will be transferred to the state ADAP for protease inhibitor coverage (program has asked manufacturers for 90 day grace period); 3. Any new clients or people receiving drugs through Title I.
Georgia	Maximum combination of two drugs (two prescriptions per month). 3TC, below 350 CD4 cells. Protease inhibitors, below 100 CD4 cells. Clients must have applied for Medicaid. Only consistently compliant patients will be eligible.
Hawaii	Prior authorization is required for the following drugs: indinavir (Crixivan), ritonavir (Norvir), saquinavir (Invirase), nelfinavir (Viracept), erythropoietin (Procrit, Epogen), filgrastim (Neupogen), cidofovir (Vistide), probenecid, foscarnet (Foscavir), and ganciclovir (Cytovene).
Idaho	Antiretrovirals: HIV+ and CD4 <500. PCP Prophylaxis: <200 CD4. MAC Prophylaxis: <100 CD4. Medical eligibility guidelines established for protease inhibitors to be implemented 2/97: need to have been on a two drug combination and failed (defined by increasing viral load) to get protease inhibitors (program currently covers only one protease inhibitor, indinavir (Crixivan).
Illinois	Ganciclovir is only covered in IV form, not oral. It is not available via mail order. Beginning April 1, 1997, there will be a $1,000 per month per client cap on benefits. The formulary categorizes drugs into five categories. These represent priorities for coverage. 1 - Antiretrovirals; 2 - PCP prophylaxis and treatment; 3 - Drugs for the prophylaxis and treatment of OIs and antimicrobials; 4 - Drugs for the treatment of neoplasms; 5 - Other drugs requiring prior approval, including bone marrow stimulants. (Nothing in this category is included on the formulary at this time). The program also provides an enrollment card that can be used at a network of retail pharmacies throughout the state to obtain up to a 14 day supply of emergency drugs (i.e. antimicrobials to treat an acute infection).
Indiana	Protease inhibitors and nevirapine (Viramune) are due to be added April 1, 1997. Azithromycin and fluconazole will also be added at this time. Clarithromycin, which is on the formulary, is being deleted April 1. There may be additional CD4 and viral load count requirements for access to protease inhibitors.
Kansas	Ganciclovir is provisionally available in oral form only, for the treatment of active CMV retinitis. The request for reimbursement for oral ganciclovir must be accompanied by a physicianís statement that the medication is being prescribed for the treatment of active CMV retinitis.
Kentucky	Protease inhibitors are only available through the Protease Inhibitor Pilot Project (PIPP). This program currently covers a maximum of 30 people. Financial eligibility for protease inhibitors: income at or below 200% of FPL, adjusted for family size. (Currently, no asset requirement for access to protease inhibitors but this should be added within 1-3 months). Medical eligibility for protease inhibitors: HIV+, CD4 count < 200, viral load >10,000 copies; failure of combination RT inhibitor treatment.
Maine	Protease inhibitors currently can be used by a maximum of 12 clients at a time.
Maryland	Doctorís prescription can be refilled twice, then a new prescription must be obtained. No restrictions on combination therapy.
Massachusetts	Fluconazole covered for treatment but not prophylaxis of fungal infections; also covered for maintenance of cryptococcal meningitis. Ketoconazole covered for treatment but not prophylaxis of fungal infections. Acyclovir covered for treatment but not prophylaxis of herpes zoster & simplex. Acyclovir, fluconazole, & ketaconazole have been approved for acute treatment, but not as prophylaxis. The program covers a one-time 7-day treatment supply of acyclovir and a one-time 14-day treatment supply of fluconazole or ketaconazole. Refills of these medications must be pre-approved by HDAP.
Michigan	Fluconazole reimbursable if clotrimazole and ketoconazole fails or if treating cryptococcal meningitis. Topical and IV ketoconazole not reimburseable. Prior authorization required for amphotericin B. 3TC (Epivir, lamivudine) and protease inhibitors have to be used according to a specific treatment protocol. The use of generic brands is encouraged when available and appropriate.
Minnesota	Suggested guidelines: atovaquone: treatment of acute PCP. Prophylaxis in patients intolerant to TMP/SMX, dapsone and aerosolized pentamidine; dronabinol: CD4 count <100 and 5% of weight loss, CD4 count <100 and nausea; fluconazole: CD4 count <100, prior cryptococcal infection and/or fungal infections not responsive to Nizoral or topical antifungal agents; itraconazole: CD4 count <100, prior histoplasmosis and/or fungal infections not responsive to Nizoral or topical antifungal agents; leucovorin: receiving trimetrexate or pyrimethamine; megestrol acetate: CD4 count <100 and 5% weight loss; indinavir and ritonavir: patients prescribed one protease inhibitor at a time; saquinavir: intolerant of indinavir or ritonavir.
Mississippi	zidovudine (AZT, Retrovir): <500 CD4); didanosine (ddI, Videx): <500 CD4, toxicity or treatment failure with AZT; zalcitabine (ddC, HIVID): same as ddI; lamivudine (3TC, Epivir): <400 CD4; stavudine (d4T, Zerit): <400 CD4; pentamidine: <200 CD4; fluconazole (Diflucan): one months supply, conditional upon application to Pfizer patient assistance program, and a CD4 count of 500 or less, diagnosis of a related opportunistic infection; azithromycin (Zithromax): CD4 count of 200 or less or diagnosis of MAC or MAI; dapsone: <200 CD4; acyclovir (Zovirax): <500 CD4; sertraline (Zoloft): diagnosis of depression; ganciclovir (Cytovene): oral only - maintenance therapy for persons with defined CMV retinitis.
Missouri	The formulary is divided into two parts, General Medications and Protease Inhibitors. General Medications includes all covered drugs except protease inhibitors, including antiretroviral medications. Protease Inhibitors includes the three currently FDA-approved protease inhibitors and the six antiretrovirals that are also on the General Medications formulary. The Bureau of HIV/AIDS Care suggests that physicians consider the following criteria for the protease inhibitors program, but they are guidelines only: Current CD4 <500 or evidence of a rapidly falling CD4 count; current viral load >10,000; Clientís history of compliance with a medication regimen or probable cause to believe that the client will adhere to therapy. Clients on the General Medication Program within ADAPóthe formulary of which does not include protease inhibitors but does include antiretroviralsómay use this source of funding to meet Medicaid spenddown. Clients on the protease inhibitors program may not have access to any form of Medicaid.
Nevada	Fluconazole is available for treatment only, not prophylaxis.
New Hampshire	Dosage and administration shall follow FDA-approved guidelines as indicated in the Physicianís Desk Reference (PDR), i.e, no off-label use allowed. All drugs are covered in any dose form. Ganciclovir is only available for treatment on an emergency basis with prior authorization. Treatment will only be provided for maintenance therapy after an acute episode; primary prophylaxis will not be reimbursed. A two-week supply will be provided while patients are applying to the manufacturerís Patient Assistance Program and/or NH Medicaid.
New Mexico	Use of oral ganciclovir (ganciclovir capsules) requires the prior approval of HIV/AIDS Bureau Medical Director.
New York	Combination anti-HIV therapy is currently limited to three drugs. IVIG is restricted to prevention of bacterial infections in children ONLY. Methadone is covered only for pain relief; ADAP does not cover methadone maintenance. Prior authorization required on two drugs: epoetin alfa and filgrastim. Epoetin alfa requires pre-treatment lab values of (1) hemoglobin < 10 g/d and/or hematocrit < 30% AND (2) serum erythropoietin level g < 500 u/ml (except in renal failure patients). Filgrastim requires (1) patient receiving myleosuppresive chemotherapy OR (2) non-chemotherapy patients with drug-induced neutropenia and ANC < 500 (pre-treatment), or HIV disease and ANC < 500 (pretreatment).
North Carolina	Labeled uses only. No IV drug coverage (e.g., ganciclovir is only available in the oral formulation).
North Dakota	nelfinavir (Viracept) requires prior approval. The formulary list also states: ìDrugs not included on this list but requested for HIV-related conditions will be considered on an individual basis.î
Oklahoma	Protease inhibitors require prior authorization. Beginning April 1, 1997 there is a $6,000 yearly cap per client. This does not include protease inhibitors. Access to protease inhibitors is limited to a maximum of 75 clients at a time.
Puerto Rico	Current treatment guidelines: CD4 >500, viral load <10,000 AZT /3TC. TB prevention (if indicated) with isoniazid and vitamin B6. Influenza vaccine, Varivax, Pneumovax, and hepatitis B vaccine. CD4 201-499, viral load >10,000 AZT/3TC/protease inhibitor. TB prevention (if indicated) with isoniazid and vitamin B6. Influenza vaccine. CD4 100-200, viral load >10,000 AZT/3TC/protease inhibitor. TB prevention (if indicated) with isoniazid and vitamin B6. PCP prevention with TMP/SMX (Septra) or dapsone. Fluconazole antifungal prophylaxis at 100 mg/wk. Alpha-interferon available for Kaposiís sarcoma, hepatitis B or hepatitis C. Treatment for active TB. Treatments for other opportunistic infections. CD4 <99, viral load >100,000 AZT/3TC/protease inhibitor, with a note to consider the side effects versus the benefits of stopping treatment. Fluconazole antifungal prophylaxis at 100 mg/wk. Azithromycin for MAC prophylaxis. Treatment for active TB. Treatments for other opportunistic infections.
Rhode Island	Rhode Island has a system known as MED-FI. This system is a complex way of allocating clients a yearly spending limit based on their financial resources (ìFIî) and their medical status (ìMEDî). Basically, those worst off in terms of their MED and their FI get the largest allocation.. This system was developed by a pharmacy consulting company when the program was concerned about lack of resources. The program notes that ìAt present, we expect that client MED-FI allocations will be approximately sufficient to cover the cost of the most needed RIAID formulary medications.î However, should the situation change then MED-FI may come into play and limit access for some clients.
South Dakota	Limit of $5,000 in benefits to each client during 1997 fiscal year, starting April 1, 1997.
Tennessee	Saquinavir and ritonavir will be offered on a prior approval basis only. The ADAP currently follows the HIV treatment guidelines offered by TennCare. These state that antiretroviral therapy is warranted if a person is symptomatic, and/or has a CD4 <500 and viral load >5,000 or has CD4 >500 but viral load >30,000. Initial therapy is two nucleosides. Goal of therapy is reducing viral load and increasing CD4 after 8 weeks of therapy. A protease inhibitor may be added if a partial response is being achieved, but a protease inhibitor should not be added to a failing nucleoside regimen. At least one new nucleoside should be started with a protease inhibitor if initial regimen fails. The definition of treatment failure is vague, but a viral load of >30,000 and/or decreasing CD4 count are mentioned. Indinavir (Crixivan) is generally suggested as the first line protease inhibitor. Protease inhibitors will not be offered to clients with a history of non-compliance.
Texas	Priority 1 Medications and Criteria: AZT, ddI, ddC, d4T: HIV infection and <18 yrs old or HIV+ and CDC classification B or C (symptomatic) or HIV + and <500 CD4 (asymptomatic). A MAXIMUM of two reverse transcriptase inhibitors will be provided. AZT also available for pregnant mother and newborn in accordance with new FDA labeling. 3TC: must be used with one of the above (AZT, ddI, ddC or d4T) and same medical criteria must be met. Saquinavir, ritonavir or indinavir: Plasma RNA viral load >10,000. A MAXIMUM of one protease inhibitor will be furnished with a MAXIMUM of two reverse transcriptase inhibitors. Protease inhibitors will be provided for NON-MEDICAID clients only. TMP/SMX (Bactrim/Septra), Dapsone/trimethoprim: <200 CD4 or symptomatic HIV disease for >2 weeks, children <13 yrs with ACTG clinical indicators. Acyclovir: acute or chronic herpetic infections. IVIG: <18 yrs old. Priority 2 Medications and Criteria: Aerosolized pentamidine: <200 CD4 or symptomatic HIV disease for >2 weeks, children <13 yrs with ACTG clinical indicators. IV Pentamidine: 13 yrs old or younger. Fluconazole: Cryptococcal meningitis or candida esophagitis. Itraconazole: Histoplasmosis or blastomycosis. Clarithromycin: Current or previous diagnosis of MAC. Azithromycin: Current or previous diagnosis of MAC and failed or intolerant to clarithromycin. Ganciclovir: CMV disease which has resulted in retinitis or infections of other major organs or organ systems. Megestrol acetate: Cachexia or anorexia with weight loss of >10% baseline body weight or loss of greater than 20% of baseline body weight. Priority 3 Medications and Criteria (currently not available): alpha-interferon: Disseminated KS with >200 CD4, amphotericin B: progressive, potentially fatal disseminated fungal infections. Atovaquone: mild to moderate PCP and intolerant of TMP/SMX, rifabutin: <100 CD4, ethambutol: current or previous diagnosis of MAC.
Vermont	Prior authorization required for protease inhibitors. There is currently a waiting list for protease inhibitors as access has been capped at 17 people, although this may end April 1, 1997. Some restrictions may apply to the CMV treatments: cidofovir (Vistide), foscarnet (Foscavir) and ganciclovir (Cytovene).
Virginia	Medical criteria for protease inhibitors: CD4 count <500 or less or a viral load of >10,000. Protease inhibitors must be used in combination with other antiretrovirals. Nelfinavir (Viracept) is only available with a medical exemption form the treating physician. Antiretrovirals: CD4 count <500 or a viral load of >10,000 for AZT, ddI, ddC or d4T (pregnant women can receive AZT at any CD4 cell count). TMP/SMX, dapsone, aerosolized pentamidine: <200 CD4; Rifabutin or azithromycin: <100 CD4. People unable to tolerate indinavir (Crixivan) or who develop resistance may receive another FDA-approved protease inhibitor (this will be considered on an individual basis). Rifabutin is only available to clients receiving it through ADAP prior to November 1, 1996, and for clients unable to take azithromycin. Protease inhibitor utilization currently capped at 282 clients.
Wyoming	$2,000 assigned to each client per year. Program attempts to reimburse any treatment prescribed by physician. May soon increase limit to $3,000 per client/per year. Amphotericin B is available as a cream only, according to the formulary list.

Appendix 5

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Last modified: 7/19/97
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