HIV PrEP Pre-Proposal Conference Slides_December 20 2019.pdf

HIV PrEP Distribution-Pre-Exposure Prophylaxis Implementation and Dissemination Pre-Proposal Conference

Ending the HIV Epidemic: A Plan for America

December 2019

Welcome & Introductions

• Office of Acquisition Management and Policy (OAMP) Alexandra B. Garcia, Contracting Officer Carolyn Taylor, Contract Specialist

• Office of General Counsel Will Chang, Deputy General Counsel

• Office of Infectious Disease and HIV/AIDS Policy (OIDP) Tammy Beckham, DVM, PhD Director Deputy Assistant Secretary for Infectious Diseases Michael Daley, Contracting Officer Representative

Agenda

Introduction

OASH Mission and Vision

Program Overview

Next Steps / Procurement Process

Questions and Discussion

OASH: The Roadmap For A Healthier Nation

HEALTH

TRANSFORMATION

Catalyze a health promoting culture

HEALTH

INNOVATION

Foster novel approaches and solutions

HEALTH

RESPONSE

Respond to emerging health challenges

HEALTH

OPPORTUNITY

Advance health opportunities for all

Leading America to Healthier Lives

OFFICE OF THE

ASSISTANT SECRETARY

FOR HEALTH

• Provide trusted data and information to serve HHS, the federal government, states and localities, and the general public

• Convene partners federal agencies, state and local, professional societies, NGOs, academia, civil society, commercial partners, patient advocates

• Develop novel initiatives gain situational awareness, identify gaps, build teams, set a common agenda, support infrastructure, transition to Operational Divisions

• Organize and lead national initiatives

Office of the Assistant Secretary for Health (OASH)

• OASH oversees the Department’s key public health offices and programs, a number of Presidential and Secretarial advisory committees, 10 regional health offices across the nation, and the Office of the Surgeon General and the U.S. Public Health Service Commissioned Corps.

• OASH Priorities:

• Opioids

• HIV

• Vaccine Confidence

• Increased Vaccinations

• Health Disparities

• Sickle Cell Disease

• Prevention across the board

Office of Infectious Disease and

HIV/AIDS Policy

Organization, Mission and Priorities

“We have a once-in-a-generation opportunity to end the HIV epidemic in the United States.”

“Now is the time.”

State of the Union Address, February 5, 2019

County contributing to 50% new HIV diagnoses in 2016 / 2017

State with disproportionate rural burden in 2016 / 2017

48 Counties, 7 States With Substantial Rural HIV Burden DC And San Juan Account For 50% Of New Diagnoses

Ending The HIV Epidemic: A Plan For America

DIAGNOSE

All people with HIV as early as possible after infection

TREAT

People with HIV rapidly and effectively to reach sustained viral suppression

PREVENT

New HIV transmissions by using proven interventions, including pre-exposure prophylaxis (PrEP) and syringe services programs (SSPs)

RESPOND

Quickly to potential HIV outbreaks to get needed prevention and treatment services to people who need them

ACHIEVING THE GOALS

75% reduction in new HIV infections in 5 years and at least 90% reduction in 10 years.

GOAL

What Is PrEP And Why Do We Want To Increase Its Use?

• Pre-exposure prophylaxis (PrEP) is taking a medication that can help prevent the transmission of HIV.

• PrEP medications can work to prevent HIV transmission when taken before exposure to HIV through sex or injection drug use.

• PrEP medication is safe and highly effective for preventing HIV if used daily as prescribed, but much less effective when not taken consistently.

PrEP Donation

• Provides medication for individuals who are at risk for HIV and who are uninsured.

• Medications for up to 200,000 people per year.

• HHS bears all other costs: verifying patient eligibility, enrolling eligible patients, building a network of participating pharmacies, distributing the donated medication, and processing claims.

• Gilead also manufactures Descovy® (emtricitabine/tenofovir alafenamide), which was approved by the FDA as pre-exposure prophylaxis against HIV, in October, 2019. The donation from Gilead may also include Descovy®.

• Given the urgent need to reach those at risk for HIV, HHS awarded Gilead a six-month contract to administer the distribution of donated PrEP medication to eligible recipients.

• During that six-month period, HHS will hold a full and open competition to select a longer-term contractor or contractors.

Gilead donated Truvada™ for PrEP to HHS to expand access for uninsured patients in the U.S. (Announced May 9, 2019)

PrEP Medication Distribution – Procurement Mechanisms

• Initial Procurement Mechanism

• September, 2019 – HHS award to Gilead for PrEP dissemination

• Gilead to utilize its pre-existing patient assistance program

• 6 month POP; 4,250 recipients

• $6M total value; costs for reimbursement of Gilead’s vendors

• Future Procurement Mechanism

• Full and Open Competition - HIV PrEP Distribution-Pre-Exposure Prophylaxis

Implementation and Dissemination (75R60220R00001) – December 13, 2019 release

“Go Live” of HHS PrEP Program Ready, Set, PrEP!

Launched December 3rd, 2019

Call-In Center 855.447.8410

Online Portal GetYourPrEP.com

Ready, Set, PrEP

• Landing Page: Splash page on HIV.gov with basic information about the program, directing individuals and providers to the Ready, Set, PrEP portal and call center.

• Enrollment Page: GetYourPrEP.com for eligibility determination and enrollment (call center also available).

HIV.gov Landing Page

Web Interface

• Fact Sheets - Brief overviews of Ready, Set, PrEP Program for:

• Consumers

• Providers

• Federally Qualified Health Centers

• Indian Health Service

• Printed Materials for health centers, healthcare professionals, pharmacies, etc.

• Posters and Information Card: Directing consumers to website, call center for more information.

Facebook Advertisement

Branding and Supporting Materials

• Fact Sheets

• Healthcare Professionals

• Consumers

• Posters

• FAQ documents

• Information Cards

• Social Media Content and Tool Kit

• Digital and Radio Advertisements

• Pharmacy Education and Awareness

Materials Information Card

Fact Sheet

Poster

Materials to Assist with Implementation

The slides that follow are meant to illustrate an example of an enrollment and distribution protocol. It does not capture all necessary components as set forth in the RFP, nor does it necessarily represent the most efficient process for enrollment or distribution. The government encourages innovative suggestions in RFP responses.

HUB & HUB-Plus Functions

• HUB: Engagement, Enrollment, Patient & Provider Support

• Call Center

• Web Portal

• Adherence

• HUB-Plus: Verify that Patient Lacks Prescription-Drug Coverage

• HUB-Plus: Issue Voucher (BIN, Group, and Member#) & Claims Adjudication

• Pharmacy Support

• Wholesale-Distributor Interface.

• HUB-Plus: Mail-Order Pharmacy

• HUB-Plus: Current or Prior 12-Month Gilead MAP Enrollment

Patient Journey: Web Portal or Call Center

Yes

• Transmit prescription to HUB OR attest that patient has PrEP-medication prescription.

• Does patient have prescription-drug coverage?

• Attests YES: If requested, HUB links to programs that may help with cost share.

• Attests NO or I DON’T KNOW: HUB electronically verifies.

• If uninsured: HUB issues voucher with BIN, group, and member number.

• Would patient like mail order?

• YES: HUB transmits prescription and voucher to mail-order pharmacy. OR patient sends prescription and voucher to mail-order pharmacy.

• NO: HUB provides list of nearest brick-and-mortar pharmacies and HUB transmits prescription and voucher to selected pharmacy. OR patient brings prescription and voucher to pharmacy.

No

• If patient is HIV positive, HUB links patient to appropriate resources.

• If patient is HIV negative and not at risk, but has questions, HUB links patient to appropriate resources.

I Don’t Know

• HUB links patient to options for closest low- or no-cost provider with PrEP experience based on HHS list - e.g., FQHC or other HHS grantees, sub-grantees, or affiliates.

Is PrEP right for you or your patient?

Payment

Dispense at Brick-and-Mortar Pharmacy with WAC Reimbursement

Gilead

Wholesale Distributor

HUB

Donating PharmacyHHS

Donating pharmacy dispenses out of customary, commercial inventory and obtains replacement bottles through usual channels.

Qualified Eligible Patient (QEP)

Buyer

Any Authorized Wholesale DistributorBottle

Invoice & Data

Wholesale Distributor & HUB Fees

Bottle

Payment

Bottle

WAC

Invoice & Data

Wholesale Distributor Fees

Invoice & Data

Payment

Bottle

Rx & Voucher

WAC

Claim

Bottle Rx & Voucher

Voucher

The slides illustrate an example of an enrollment and distribution protocol. It does not capture all necessary components as set forth in the RFP. Nor does it necessarily represent the most efficient process for enrollment or distribution. The government encourages innovative suggestions in RFP responses.

Dispense at Mail-Order Pharmacy with Reimbursement or Backfill

Gilead

HUB

Mail-Order Pharmacy

HHS

Pharmacy dispenses out of customary, commercial inventory and obtains replacement bottles through usual channels or from Gilead.

QEP

Any Authorized Wholesale Distributor

Bottle Rx & Voucher

Actual Acquisition Cost & Dispense Fee

Voucher

Rx & Voucher

Claim Or Bottle Request (Or Directly to Gilead)

Payment

Bottle

Payment

Bottle

Invoice & Data

Dispense & HUB Fees

Invoice & Data or Bottle Request

Actual Acquisition Cost

In Lieu of Actual Acquisition Cost, Replacement Bottle

The slides illustrate an example of an enrollment and distribution protocol. It does not capture all necessary components as set forth in the RFP. Nor does it necessarily represent

Dispense at Brick-and-Mortar Pharmacy with Backfill

Gilead

HUB

Donating Pharmacy

HHS

Pharmacy dispenses from customary, commercial inventory and obtains replacement bottles from Gilead.

QEP

Invoice & Data

HUB Fees

Data & Bottle Request

Bottle

Bottle Voucher

Bottle Request (Or Directly to Gilead)

Rx & Voucher

Rx & Voucher

The slides illustrate an example of an enrollment and distribution protocol. It does not capture all necessary components as set forth in the RFP. Nor does it necessarily represent

Next Steps / Procurement Process

Key Contract Objectives

1. Determination of Eligibility and Enrollment Processes

2. Insurance Status Verification

3. Call Center

4. Online Portal

5. Wholesaler Logistical Services

6. Issuance of Card of Voucher to Qualified Eligible Patients, and Claims Processing for

Reimbursement of Network Pharmacies

7. Client Resource System

8. Auditable Process to Verify Access to Donated Product

9. Establish and Administer Network of Mail Order Pharmacies

Estimated Procurement Timeline

Late October

Pre-solicitation Released

Mid December

Solicitation Released

January 10, 2020 Questions Due 12:00pm EST

February 13, 2020 Proposals Due 2:00pm EST

Late February

Oral

Presentations

Late March

Congressional Notification and Award

Issued

Late September

Go Live!

Questions and Discussion

Contact Information

Contract Specialist:

Carolyn Taylor Ctaylor@hrsa.gov (301)443-6508

Contracting Officer:

Alexandra B. Garcia agarcia@hrsa.gov

(301) 443-5116 mailto:Ctaylro@hrsa.gov mailto:agarcia@hrsa.gov

WWW.HIV.GOV

WWW.HHS.GOV/OIDPOffice of Infectious Disease and HIV/AIDS Policy

Office of the Assistant Secretary for Health Department of Health and Human Services @HIVgov