20170725_-_2017-N-66822_-_Appendix_-_Supplemental_Tables.pdf

Appendix: Supplemental Tables

Appendix: Supplemental Tables

Table 1. ARV medications to be included in reporting

Brand Generic Name

Multi-class Combination Products

Atripla efavirenz, emtricitabine and tenofovir disoproxil fumarate

Complera emtricitabine, rilpivirine, and tenofovir disoproxil fumarate

Evotaz atazanavir sulfate, combicistat

Prezcobix cobicistat, darunavir ethanolate

Stribild elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Combivir lamivudine and zidovudine

Emtriva emtricitabine

Epivir lamivudine

Epzicom abacavir and lamivudine

Hivid zalcitabine, dideoxycytidine (no longer marketed)

Retrovir zidovudine, azidothymidine

Trizivir abacavir, zidovudine, and lamivudine

Truvada tenofovir disoproxil fumarate and emtricitabine

Videx EC enteric coated didanosine

Videx didanosine, dideoxyinosine

Viread tenofovir disoproxil fumarate

Zerit stavudine, Ziagen abacavir sulfate

Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Edurant rilpivirine

Intelence etravirine

Rescriptor delavirdine

Sustiva efavirenz

Viramune nevirapine

Viramune XR nevirapine

Protease Inhibitors (PIs)

Agenerase Amprenavir (no longer marketed)

Aptivus tipranavir

Crixivan indinavir

Fortovase saquinavir (no longer marketed)

Invirase saquinavir mesylate

Kaletra lopinavir and ritonavir

Lexiva Fosamprenavir Calcium

Norvir ritonavir

Prezista darunavir

Reyataz atazanavir sulfate

Viracept nelfinavir mesylate

Fusion Inhibitors

Fuzeon enfuvirtide http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Atripla&SearchType=BasicSearch http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202123s000lbl.pdf http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203100s000lbl.pdf http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Combivir&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Emtriva&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Epivir&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Epzicom&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Hivid&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Retrovir&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Trizivir&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Truvada&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Videx%20EC&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Videx&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Viread&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Zerit&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Ziagen&SearchType=BasicSearch http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202022s000lbl.pdf http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Intelence&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Rescriptor&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Sustiva&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Viramune&SearchType=BasicSearch http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201152s000lbl.pdf http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Agenerase&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Aptivus&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Crixivan&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Fortovase&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Invirase&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Kaletra&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Lexiva&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Norvir&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Prezista&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Reyataz&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Viracept&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Fuzeon&SearchType=BasicSearch

Entry Inhibitors - CCR5 co-receptor antagonist

Selzentry maraviroc

HIV integrase strand transfer inhibitors

Isentress raltegravir

Tivicay dolutegravir

Vitekta elvitegravir

Table 2. Approved generic formulations of antiretroviral drugs used for HIV treatment

Generic Name Manufacturer Name lamivudine and zidovudine tablets USP, 150 mg/300 mg Hetero Labs Limited abacavir tablets USP, 300 mg Mylan Pharmaceuticals, Inc.

Nevirapine tablets USP, 200 mg Prinston Pharmaceutical, Inc.

nevirapine tablets USP, 200 mg Apotex Corporation nevirapine tablets USP, 200 mg Matrix Laboratories Limited nevirapine tablets USP, 200 mg ScieGen Pharmaceuticals, Inc nevirapine tablets USP, 200 mg Mylan Pharmaceuticals, Inc.

nevirapine tablets USP, 200 mg Hetero Labs Limited, Unit-

III

nevirapine tablets USP, 200 mg Micro Labs Limited nevirapine tablets USP, 200 mg Strides, Inc.

nevirapine tablets USP, 200 mg Cipla Limited nevirapine tablets USP, 200 mg Aurobindo Pharma Limited nevirapine oral suspension USP, 50 mg/5 mL Aurobindo Pharma Limited lamivudine and zidovudine tablets, 150 mg/300 mg Aurobindo Pharma Limited lamivudine and zidovudine tablets, 150 mg/300 mg Lupin Limited lamivudine and zidovudine tablets, 150 mg/300 mg TEVA Pharmaceuticals

USA

zidovudine Injection USP, 10 mg/mL, packaged in 200 mg/20 mL Single-use Vials

PharmaForce Inc.

didanosine (ddI) delayed release capsules, 125 mg, 200 mg, 250 mg, and 400 mg

Matrix Laboratories Limited zidovudine 60 mg tablets for pediatric dosing † Aurobindo Pharma Limited stavudine for oral solution, 1 mg/mL Aurobindo Pharma Limited stavudine capsules (15 mg, 20 mg, 30 mg, and 40 mg) Aurobindo Pharma Limited http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Selzentry&SearchType=BasicSearch http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Isentress&SearchType=BasicSearch http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204790s001lbl.pdf stavudine capsules (15 mg, 20 mg, 30 mg, and 40 mg) Hetero Drugs Limited didanosine (ddI) delayed release capsules, 125 mg, 200 mg, 250 mg, and 400 mg

Aurobindo Pharma Limited zidovudine oral solution USP, 50 mg/5 mL, oral solution -zidovudine, AZT, azidothymidine, ZDV (Pediatric formulation - 50 mg/ 5 mL)

Cipla Limited zidovudine, AZT, azidothymidine, ZDV (300 mg tablet) Matrix Laboratories, Inc.

zidovudine, AZT, azidothymidine, ZDV (100 mg capsule) Cipla Limited didanosine (ddI) for oral solution (pediatric powder), 10 mg/mL Aurobindo Pharma Limited zidovudine, AZT, azidothymidine, ZDV (100 mg capsule) Aurobindo Pharma LTD.

zidovudine, AZT, azidothymidine, ZDV (300 mg tablet) Aurobindo Pharma Limited zidovudine oral solution USP, 50 mg/5 mL, oral solution -zidovudine, AZT, azidothymidine, ZDV (Pediatric formulation - 50 mg/ 5 mL)

Aurobindo Pharma Limited zidovudine, AZT, azidothymidine, ZDV (300 mg tablet) Ranbaxy Laboratories Limited zidovudine, AZT, azidothymidine, ZDV (300 mg tablet) Roxane Laboratories didanosine (ddI) delayed release capsules Barr Laboratories, Inc.

Table 3.

Column 1 Column 2 Column 3 Column 4

State Number of pharmacies data is collected from in

Universe of pharmacies in 2015 (provide reference)

Percentage within state (Column 2/Column 3)

State 1 # # %

State 2 # # %

State 3 # # %

…etc # # %

District of Columbia # # %

Territory A # # %

US Total # # %

Table 4.

Column 1 Column 2 Column 3

State Number of transactions in 2015

Percentage within state (Column 2/total transactions)

State 1 # %

State 2 # %

State 3 # %

…etc # %

District of Columbia # %

Territory A # %

US Total # %

Table 5.

Column 1 Column 2 Column 3 Column 4

State Number of ARV transactions in

Percentage of ARV data linked to DX data within state

Percentage of ARV data linked to DX data and had race/ethnicity available

State 1 # % %

State 2 # % %

State 3 # % %

…etc # % %

District of Columbia

Territory A # % %

US Total # % %

Table 6.

Column 1 Column 2 Column 3

Payment type Number of transactions in

Percentage (Column 2 /total transactions)

Cash # %

Medicaid - Other # %

Managed Care Organizations # %

Workman’s Compensation # %

Medicare - part B # %

Medicare - unknown # %

Unclassified # %

Private Insurance # %

Alternative pay type 1 # %

Unknown # %

ALL Transactions #

Table 7.

Column 1 Column 2 Column 3

Pharmacy Class Number of transactions in 2015

Number of transactions in 2015

Percentage (Column 2 / total transactions)

Governmental # %

Institutional # %

Retail Chain # %

Retail Independent # %

Unknown # %

Mail order # % etc # %

ALL Transactions # %

Table 8: Listing of the required data elements that should be reported for each pharmaceutical transaction record to meet the requirements of this PWS. Vendors may propose additional data elements or solutions in addition to these data elements described below:

Data Element Description

Patient-level Data

Patient Age Age in years

Patient Age Stata Stratified Age Group

Patient County County of patient residence

Patient MSA Metropolitan Statistical Area of patient residence

Patient DOB Patient date of birth - MMYYYY

Patient Gender Code Male, Female, Not specified.

Patient Race/Ethnicity Race/Ethnicity of patients, when available

Patient ID Unique ID assigned to the patient.

Patient Location Code Type of location where patient is located at time of transaction (e.g., home, nursing home, long-term/extended care, skilled care facility, acute care facility, outpatient, etc.)

Patient Location Text Text description of location associated with patient location code.

Patient State State of patient residence

Patient Zip3 The first 3 digits of the Patient Zip Code field, when available

Medical Claims Data

Medical Diagnosis Patient level diagnosis associated with prescription (ICD-9/ICD- 10)

Medical Procedure Billing or requests for reimbursement can be for either CPT codes or HCPCS Codes.

Date of Diagnosis/Procedure Services

When the service took place- MMDDYYYY

Provider Type Where the service took place (inpatient, outpatient, office, clinic, etc)

Payment Type Third party/Medicaid/Medicare/Cash

Drug Data

Date Rx Written Date format

Date of Service Date format

# of Refills Authorized Number of refills authorized for the prescription.

Fill Number Number indicating whether the prescription is an original or a refill.

Product Name Text description of therapeutic agent prescribed

Product NDC National Drug Code

Product Strength Description of product strength

Quantity Dispensed Quantity of the drug dispensed

# Days Supply Estimated number of day the prescription will last

Channel Retail/Mail order

Prescriber ID ID assigned to the prescriber

Prescriber Specialty Specialty of prescriber

Prescriber ZIP ZIP of Prescriber

Prescriber State State of Prescriber

Prescriber Taxonomy Code The taxonomy is defined as a classification scheme that codifies provider type and provider area of specialization.

Prescription Service Reference Number

Pharmacy prescription number

Service Provider ID & Qualifier

ID assigned to a pharmacy or provider.

Service Provider Zip Code 5-digit zip code of the pharmacy providing the service

Therapeutic Class & Qualifier Code

Code assigned to product being reported.

Therapeutic Class Description

Code assigned by contracting organization to identify the therapeutic use of the product being reported.

Therapeutic Use Code & Description

A text description of the Therapeutic Use Code

Payment Type Type of claim.

Transaction Code Specifies type of transaction, e.g., billing, reversal, rebill

Unit of Measure Unit associated with Product dosage and strength (e.g., each, grams, milliliters)

YEAR YYYY

time_received Time of Transaction

Pharmacy ID Unique and persistent Pharmacy ID

Record ID