RFQ HT9402-26-Q-9202 NAD.pdf

Department of War Defense Health Agency

Pharmacy and Therapeutics Committee - Uniform Formulary

Request for Quotation

Table of Contents

P art D escription 1 Introduction 2 Instructions and Notices 3 Uniform Formulary Considerations and Evaluation Criteria 4 Government Furnished Information 5 Definitions and Acronyms 6 Appendix 1: Manufacturer Quote Submission Checklist 7 Appendix 2: Uniform Formulary Blanket Purchase Agreement (UF BPA) 8 Appendix 3: Uniform Formulary Additional Discount Program (UF ADP) 9 Appendix 4: NDC Price List

Part 1 - Introduction

1.1. The Department of War (DoW) is required by law (10 U.S.C. § 1074g) to establish an effective, efficient, integrated pharmacy benefits program for the Military Health System (MHS). The law and implementing regulation (32 CFR Section 199.21) describe the process by which the DoW Pharmacy and Therapeutics (P&T) Committee will consider the relative clinical effectiveness and relative cost effectiveness of pharmaceutical agents in a therapeutic class in recommending the selection of agents for the DoW Uniform Formulary (UF) and, for cost sharing purposes, the classification of a pharmaceutical agent as generic, formulary, Basic Core Formulary (BCF), Extended Core Formulary (ECF), or non-formulary (NF). A pharmaceutical agent is a legend FDA-approved drug that is intended for self-administration by the patient in the outpatient setting that are part of the TRICARE pharmacy benefit. Prior to the scheduled P&T Committee review of specified pharmaceutical agents or classes, manufacturers have an opportunity to submit offers that reduce DoW cost of an agent for consideration by the P&T Committee. This process is described herein.

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For ADP quotes

1. Appendix 3, pp18- 24

2. UF ADP Appendix

@ 1:00 PM CST

Part 2 - Instructions and Notices

2.1. Synopsis:

2.1.1. This is a Request for Quotation (RFQ)

for pharmaceutical agents within Drug Classes identified for placement on the UF the DHA may then award UF Blanket Purchase Agreements (UF BPA) and UF Additional Discount Program (UF ADP) Agreements in accordance with.

2.2. Quote Submission Steps:

Step 1: Download Utilization Dataset and National Drug Code (NDC) Price List from website listed in 2.4.

Step 2: Complete applicable pages and price appendices for quote(s) submitted:

2.3. General Information:

Posting Date:

Pre-Quotation Teleconference Date:

Quotes Due:

P&T Committee Meeting Date:

Responses to Clinical Questions Due:

DoW P&T Committee

Information: http://www.health.mil/

PandT

DoW Retail Refund Program POC:

dha.ncr.healthcare-ops.mbx.ufvarr-requests@health.mil

P&T Committee POC Industry Technical Liaison:

dha.san-antonio-tx.healthcare-ops.mbx.pharmacy-opsmbxpod-industry@health.mil

Step 3: Send original signed quote(s) and NDC Price List to RFQ Point of Contact (POC) listed in 2.3 below.

2.3.1. POCs:

RFQ POC:

dha.san-antonio-tx.acquis-procure.mbx.pharmacy-support@health.mil

@ 12:00 PM CST

For BPA quotes

1. Appendix 2, pp11-17

2. UF BPA Appendix

For all quotes Appendix 1, p10 Manufacturer Quote Submission Checklist

2.3.2. RFQ Dates:

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2.4. Pre-Quotation Conference:

2.4.1. There will be a pre-quotation teleconference to review the quoting process and to address industry questions. If interested, a company must register by submitting participant's name, company name, and any advanced questions via e-mail to the RFQ Point of Contact stated in Part 2.3. of this document. These advanced questions will be addressed during the teleconference.

2.4.2. The call-in number and a pre-quotation agenda will be e-mailed to all registered participants.

2.4.3. One-on-one telephone appointments with the Industry Technical Liaison and Contracts Team are available upon request. These appointments are specific to the drug/drug classes specified in the solicitation. Appointments are open from when the solicitation is posted and will close the day the quotes for the subject solicitation are due. The appointment slots will be booked first come, first serve and are available to all offerors. Any presentation materials should be forwarded to the following email inbox ahead of time. If interested, please contact the Industry Technical Liaison at dha.san-antonio-tx.healthcare-ops.mbx.pharm-opsmbxpod-industry@health.mil.

2.5. Instructions:

2.5.1. UF BPA and UF ADP Quotes:

2.5.1.1. 2.5.1.1. DoW solicits and will consider quotes using two different instruments: the UF BPA price quotes and UF ADP refund quotes, formerly referred to as the UF Voluntary Agreement for TRICARE Retail Pharmacy Refunds (UF VARR). Pharmaceutical companies shall submit a UF BPA price quote for prices that will apply to Military Treatment Facilities (MTF) and the TRICARE Mail Order Pharmacy (TMOP). Pharmaceutical companies shall submit a UF ADP quote for refunds that will apply to pharmaceutical agents dispensed by pharmacies in the TRICARE retail network. This network includes long-term care facilities, specialty pharmacies inside physician offices and hospitals, and all other pharmacies identified as part of the TRICARE retail network. While generally similar, each instrument has specific instructions and different submission details.

The Condition Sets and procedures for submitting UF BPA and UF ADP quotes are outlined in the UF BPA Appendix 2 and the UF ADP Appendix 3.

2.5.1.2. Quotes received after the deadline may be rejected by the Contracting Officer. All quotes shall contain original signatures or electronic signatures. The Contracting Officer reserves the right to reject or accept an extension request on a case-by-case basis.

2.5.2. Price quotes for MTFs and TMOP – (Price Quote Instrument: UF BPA):

2.5.2.1. For each agent that is quoted, there must be a signed UF BPA (for instance, if a pharmaceutical company provides pricing on two different

RFQ HT9402-26-Q-9202 Page 3 of 25 mailto:dha.san-antonio-tx.healthcare-ops.mbx.pharm-opsmbxpod-industry@health.mil mailto:dha.san-antonio-tx.healthcare-ops.mbx.pharm-opsmbxpod-industry@health.mil pharmaceutical agents, there must be two signed UF BPAs to accommodate). The item descriptions and NDC-11 numbers for this class that are covered by Federal Supply Schedule (FSS) contract are listed in the class utilization dataset. A UF BPA price quote for a given pharmaceutical agent must include all the NDC-11s that are included on the FSS contract, unless a request to exclude specific institutional or hospital unit dose packaged NDC-11s are submitted in advance and approved by the DHA Contracting Officer in writing in accordance with paragraph 8 of the UF BPA. Pharmaceutical companies must submit a NDC Price List containing each NDC-11. On the NDC Price List, pharmaceutical companies are required to provide a price per unit of measure (each, gram, mL, etc.) as well as a price per NDC-11 (package price) for each condition set. The NDC-11 package price must equal the price per unit of measure multiplied by the package size/quantity.

2.5.3. Price quotes for the TRICARE Retail Pharmacy Network - (Price Quote Instrument: UF ADP):

2.5.3.1. The item descriptions and NDC-11 numbers for this class, utilized in the last 12 months in the TRICARE retail network, are listed in the class utilization dataset. A UF ADP quote for an agent is required to include all the NDC-11 packages of the pharmaceutical agent(s) that are marketed, including those that are identified in the utilization dataset. Pharmaceutical companies that submit UF ADP quotes must submit a NDC Price List containing each NDC-11. Prior to each UF ADP quote submission, the manufacturer must include the drug(s) on a DoW Retail Refunds Pricing Agreement to honor the pricing standards required by 10 U.S.C 1074g(f).

2.6. Notices:

2.6.1. For some Drug Classes, the DoW may require companies to submit multiple or alternate price and refund quotes contingent upon the number of pharmaceutical agents selected for the UF or Basic Core Formulary. The BCF is a list of medications required to be on formulary at all full-service MTFs. BCF medications are intended to meet the majority of the primary care needs of DoW beneficiaries. Please carefully read the information about submitting multiple or alternate quotes in the RFQ.

2.6.2. The DoW reserves the right to reject, or decline to accept, specific formulations or NDC-11s of a given pharmaceutical agent included on any UF BPA and/or UF ADP quote based on recommendations from the P&T Committee and decision of the Director, DHA or his/her designee.

2.6.3. Although all the formulations (dosage forms and/or strengths) for a given pharmaceutical agent would typically be recommended for the same cost share tier classification, the DoW P&T Committee reserves the right to recommend different cost share tier classifications for a particular formulation of a given agent if the DoW P&T Committee finds significant differences in the clinical effectiveness or cost effectiveness between formulations of a given agent. The DoW will not consider UF

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BPA or UF ADP quotes that are contingent upon market shares. If DHA signs a UF ADP higher than the Federal Ceiling Price (FCP), this does not waive any right of the DoW under 10 U.S.C. 1074g(f). Exclusions approved for UF BPAs do not apply to UF ADPs. The refund quoted in a UF ADP is not contingent on the quoted pharmaceutical agent being selected for inclusion on the BCF or ECF. The DoW will make no attempt to force participating TRICARE retail pharmacies to dispense specific NDC-11s.

2.6.4. The NDC-11 price is the agreed upon price at which DoW will purchase product under the FSS per the UF BPA. Unit of measure prices are used for evaluation and administrative purposes only. In the event there is a discrepancy between the unit price per unit of measure and the NDC-11 price in a UF BPA quote, the government will accept the price that is most advantageous to the government.

2.6.5. In the event the class of drugs specified herein has previously been reviewed, the government solicits quotes for new Blanket Purchase Agreements (BPAs)/Additional Discount Programs (ADPs) to replace any existing BPAs/ADPs.

Part 3 - UF Considerations and Evaluation Criteria

3.1. In accordance with 32 CFR 199.21, the DoW P&T Committee will consider the relative clinical effectiveness and relative cost effectiveness of each class in recommending a cost share tier classification (i.e., generic UF (Tier 1), brand UF (Tier 2), or non-formulary (Tier 3) for each pharmaceutical agent). There is no minimum or maximum number of pharmaceutical agents that may be placed in a given cost share tier classification.

3.2. All pharmaceutical agents recommended for the generic UF (Tier 1) or brand UF (Tier 2) cost share tier on the UF will be considered for inclusion on the BCF/ECF.

The DoW P&T Committee’s intentions for the number of BCF/ECF pharmaceutical agents in each class and subclass are listed in the UF BPA NDC Price List.

3.3. In addition to clinical effectiveness, per 32 CFR 199.21(a)(3)(ii), the DoW P&T Committee will consider the UF BPA price quote and UF ADP refund quote as part of its evaluation of the relative cost effectiveness of pharmaceutical agents in recommending the selection of agents for the UF, and the classification of a pharmaceutical agent in the generic, formulary, or non-formulary cost share tier. The DoW P&T Committee will consider the BCF or the ECF UF BPA price quote as part of its evaluation of the relative cost effectiveness of pharmaceutical agents in recommending the selection of one or more agents for inclusion on the BCF or ECF. Any existing UF BPAs or UF ADPs will not be considered. The evaluation price for each pharmaceutical agent will be:

• For the MTF and TMOP dispensing venues:

1. A UF BPA price quote

2. If there is no UF BPA quote, the lower of:

a) Big 4 price as listed on the first day of the month preceding the DoW P&T meeting.

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b) FSS price as listed on the first day of the month preceding the DoW P&T meeting.

• For the Retail dispensing venue:

1. UF ADP total calculated retail refund based on the most recent annual non-FAMP (reported to the Department of Veterans Affairs) from which the current annual FCP calculated ceiling is derived.

2. Absent a UF ADP quote, the current price as of the first day of the month preceding the DoW P&T meeting.

3.4. In lieu of clinical presentations, answer the following questions and submit it via e-mail to the Request for Quote (RFQ) Point of Contact stated in Part 2.3, not later than the date stated in Part 2.4.

a) What are properties of the newly approved drug that provide advantages over competitor agents?

b) Which competitor agents does the newly approved drug improve upon and how does it improve upon them?

c) What is the place in therapy for the newly approved drug?

d) Provide information on the Minimum Clinically Important Difference (MCID) for outcomes measured in your studies.

e) Provide information about guidelines that are expected to be modified/adjusted due to the availability of the newly approved drug.

f) Describe any limited distribution process/network that will apply to the newly approved drug.

g) For what other indications or populations is the newly approved drug being studied?

Provide any published and/or unpublished data you have on patient reported outcomes (PROs) and Quality-Adjusted Life Years (QALYs). Please include any relevant MCIDs for these measures.

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Part 4 - Government Furnished Information

4.1. Utilization Dataset: Historical utilization data including quantity dispensed and 30-day equivalents by month are provided in the utilization dataset found at the Utilization Dataset link, located on the DoW P&T UF RFQ Information webpage stated in Part 2.4.

of this document.

Part 5 - Definitions and Acronyms

5.1. Definitions:

DoW P&T Committee Class Evaluation hereinafter referred to as Class” and medications in the Pharmaceutical Agents table referred to as “Agents.”

Step-preferred agent(s): agents available prior to the step therapy criteria process.

Step Therapy – Grandfathering: a prior authorization process requires new patients to complete an adequate trial of the step-preferred agent(s) before a non-step-preferred agent is provided to a new user at any MTF, Retail, or Mail point of service. Unless otherwise noted, patients must have tried an agent in the class in the previous 180 or 365 days (as determined by the P&T Committee) in order to be excluded from the prior authorization process.

Step Therapy – No Grandfathering: a prior authorization process requires all patients, regardless of past medication history to complete an adequate trial of the step-preferred agent(s) before a non-step-preferred agent is provided to a user at any MTF, Retail, or Mail point of service.

Extended Core Formulary: medications in therapeutic classes that are used to support more specialized scopes of practice than those on the Basic Core Formulary.

Basic Care Formulary: medications required to be on the formulary at all full service military treatment facilities (MTFs). BCF medications are intended to meet the majority of the primary care needs of the DoW beneficiaries.

Newly Approved Drugs: Newly approved drugs that are FDA approved under a New Drug Application after August 26, 2015, which require UF review by the P&T Committee (see CFR 199.21(g)(5)).

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5.2. Acronyms:

ADP - Additional Discount Program BCF - Basic Core Formulary BPA - Blanket Purchase Agreement COB - Coordination of Benefits DHA - Defense Health Agency DLA - Defense Logistics Agency DoW - Department of War ECF - Extended Core Formulary FCP - Federal Ceiling Price FHCC - Federal Health Care Center FSS - Federal Supply Schedule IFF - Industrial Funding Fee JNC – Joint National Contract MHS - Military Health System MTF - Military Treatment Facility N-FAMP - Non-Federal Average Manufacturing Price NDC - National Drug Code NF - Non-Formulary P&T - Pharmacy and Therapeutic POD - Pharmacy Operations Division PPI - Producer Price Index TPR - Temporary Price Reduction Tier 1 - Generic (UF) Tier 2 - Brand (UF) Tier 3 - Non-Formulary TMOP - TRICARE Mail Order Pharmacy UF - Uniform Formulary VA - Veterans Administration VA NAC – VA National Acquisition Center WAC - Wholesale Acquisition Cost

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Appendix 1 Manufacturer Quote Submission Checklist

TO BE SUBMITTED WITH ANY BPA AND/OR ADP

QUOTE

RFQ Number: Quote Due Date:

Company: Quote Submission Date:

Checklist Completed By:

UF BPA and ADP Manufacturer Quote Submission Checklist YES NO

1.a. BPAs only: Verify submitted FSS contract number (12 of BPA quote) matches contract number found on the VA NAC Search Tool website.*

1.b. BPAs only: Verify company name on quote matches company name on VA NAC Search Tool website.

2.a. Company agrees to work with DoW Prime Vendor Program for both MTF and mail order?

2.b. Company agrees to open limited distribution channel to Accredo for TRICARE mail order. (Can be for DoW only)

3. Verify each quote submitted (UF BPA and/or UF ADP) is signed and complete.

4. BPAs only: Verify quoted prices are equal to or lower than company’s prices on the FSS, Big4, and JNC by checking the VA NAC Search Tool website.

5. Verify quoted prices per unit for each dosage form and strength of the pharmaceutical agent are the same for all available package sizes (e.g., 30s, 100s, and 1000s).

6. If submitting a quote for BPA, verify BPA quote is submitted for all package sizes.

7. If submitting a quote for ADP, verify ADP quote is submitted for all package sizes.

8. Include NDC Price List as Excel document in quote submission.

9. Please confirm intent to not submit a quote for any red cells on the NDC Price List. Checking “YES” confirms the intent for no quote submitted for red condition sets.

10. If BPA or ADP sheet in NDC Price List is blank, confirm intent to quote on BPA or ADP ONLY by checking “YES”.

* https://www.vendorportal.ecms.va.gov/NAC/Pharma/List

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Appendix 2 Manufacturer Quote Uniform Formulary – Blanket Purchase

Agreement (UF BPA)

1. PRICE QUOTE FOR INCLUSION ON UNIFORM FORMULARY: By submitting this UF BPA price quote, company name stated in Paragraph 15 (henceforth, Company), agrees to provide pharmaceutical agents to military medical treatment facilities (MTFs) (Note: MTFs is inclusive of Captain James A. Lovell Federal Health Care Center (FHCC)), and the TRICARE Mail Order Pharmacy (TMOP) at the prices quoted at the attached Appendices in cooperation with the DoW Prime Vendor Program. Company agrees to hold its UF BPA price quote valid for 180 days. DHA requests that companies offer additional discounts that are equal to or less than any existing price reductions currently provided from the approved FSS pricelist and/or National Contract (NC) prices.

This price quote is contingent upon the pharmaceutical agent(s) being included on the DoW UF. If the price quote is also contingent upon the number of different pharmaceutical agents selected for the UF, that condition shall be identified in the NDC Price Lists to this document. In addition to clinical effectiveness, per 32 CFR 199.21(a)

(3) (ii), the DoW Pharmacy and Therapeutics (P&T) Committee will consider the price quote as part of its evaluation of the relative cost effectiveness of pharmaceutical agents in recommending the selection of agents for the UF, and the classification of a pharmaceutical agent in the generic, formulary, or non-formulary cost share tier.

Assuming the DoW P&T Committee’s relative cost effectiveness analysis determines that a pharmaceutical agent should not be recommended for exclusion from the UF, the P&T Committee will apply the standards described in 32 CFR 199.21(j) to determine whether the pharmaceutical agent should be placed in the generic or formulary cost share tier. Should the DoW P&T Committee review the therapeutic class relevant to the pharmaceutical agent(s) contained in the Company’s UF BPA price quote, and make recommendations consistent with the Company’s UF BPA price quote, and should the Director, Defense Health Agency (DHA) or his/her designee, make a final decision to accept that recommendation, a DHA Contracting Officer will establish a UF BPA that incorporates the UF prices quoted for the pharmaceutical agents in the attached Appendices by completing Paragraph 16 below. The establishment of a UF BPA with a pharmaceutical company for a generic (multi-source) pharmaceutical agent does not establish that pharmaceutical company as the sole source of supply for the pharmaceutical agent. However, in the event of existing Joint DoW/Veterans Administration (VA) contracts, UF BPA quotes will not be accepted for generic (multi-source) pharmaceutical agents.

2. PRICE QUOTE FOR INCLUSION ON BASIC CORE FORMULARY OR EXTENDED

CORE FORMULARY: The Basic Core Formulary (BCF) and Extended Core Formulary (ECF) are subsets of the UF. The DoW P&T Committee determines whether a pharmaceutical agent is to be evaluated for the BCF or the ECF. Company agrees to provide pharmaceutical agents to MTFs at the prices quoted in the attached Appendices, contingent upon the pharmaceutical agent(s) being included on the BCF or the ECF. Company agrees to hold its UF BPA price quote valid for 180 days. DHA requests that companies offer additional discounts that are equal to or less than any existing price reductions currently provided from the approved FSS pricelist and/or National Contract (NC) prices.

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If the price quote is also contingent upon the number of different pharmaceutical agents selected for the BCF or the ECF, that condition shall be identified at the attached Appendices to this document. In addition to clinical effectiveness, per 32 CFR 199(a)(3)(ii), the DoW P&T Committee will consider the BCF or the ECF price quote as part of its evaluation of the relative cost effectiveness of pharmaceutical agents in recommending the selection of one or more agents for inclusion on the BCF or ECF.

Should the DoW P&T Committee recommend the inclusion of the Company’s pharmaceutical agent(s) on the BCF or the ECF, and should the DHA Director or his/ her designee, make a final decision to accept that recommendation, a DHA Contracting Officer will establish a UF BPA that incorporates the BCF or ECF prices quoted for the pharmaceutical agents in the attached Appendices by completing Paragraph 16 below.

The establishment of a UF BPA with a pharmaceutical company for a generic (multi-source) pharmaceutical agent does not establish that pharmaceutical company as the sole source of supply for the pharmaceutical agent. However, in the event of existing joint DoW/VA contracts, UF BPA quotes will not be accepted for generic (multi-source) pharmaceutical agents.

3. SCOPE: Upon execution of the UF BPA, prices will be provided to the DoW Prime Vendor via the Defense Logistics Agency (DLA) Troop Support. The agents in this UF BPA may not be Trade Agreement Act (TAA) compliant, or may become non-compliant, subsequent to execution. The ordering activity, DLA, is responsible for TAA compliance, or obtaining necessary approvals, in accordance with its own policies.

4. EFFECTIVE DATE and PERIOD OF RESULTING PRICING AGREEMENT: The agreement will be effective upon signature of the Contracting Officer. However, prices will not be effective until loaded into the electronic pricing database by DLA upon receipt of the signed copy by the Contracting Officer. Prices will be loaded into the electronic pricing database by DLA on a date agreed to between the DLA and the Company;

however, prices shall be effective in the DOD’s Prime Vendor systems for MTFs and TMOP purchases no later than 14 calendar days after the date this agreement is signed by the DHA Contracting Officer. However, the date that the formulary status changes and any restrictions are applied is the date the DHA Director or his/her designee, makes the final UF decision or the effective date specified by the DHA Director or his/her designee. The agreement will continue until 1) the drug class that contains this pharmaceutical agent(s) is/are reevaluated and any resulting changes implemented; or

2) it is otherwise terminated in accordance with Paragraph 8, Prices and Price Changes, or Paragraph 9, Termination, stated below. If the drug class containing this pharmaceutical agent(s) is/are reevaluated, this UF BPA, and the prices contained therein, will terminate when the prices in any follow- on UF BPA become effective, but no later than 14 calendar days after the follow-on UF BPA is signed.

5. PARTICIPATING ENTITIES: Ordering activities are MTFs (inclusive of FHCC) and TMOP. MTF prices specified herein will apply to all transactions for the specified pharmaceuticals made by DoW MTF pharmacies, TRICARE US Family Health Plan Designated Providers, and the U.S. Coast Guard. TMOP prices will apply to all transactions for the specified pharmaceuticals made by the TMOP contractor to replenish stock used to fill prescriptions for TRICARE beneficiaries through the TMOP. “Other Government” ordering activities are excluded from utilizing these UF BPA prices.

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The ordering activity is not defined by the Prime Vendor utilized.

6. EXTENT OF GOVERNMENT OBLIGATION: This price quotation imposes no obligation on DoW to purchase any product. If a UF BPA is signed by both parties, DoW will be obligated only to the extent of authorized transactions actually made pursuant to that agreement, according to the pharmaceutical agent’s inclusion on the UF, cost share tier classification on the UF, and inclusion on the BCF or the ECF.

7. FINAL APPROVAL BY GOVERNMENT: In submitting this UF BPA price quote, the Company understands the DoW P&T Committee will consider these prices in determining the cost of the pharmaceutical agent to the Government as part of its relative cost effectiveness evaluation. The prices in the UF BPA price quotation will not be accepted, or UF BPA executed until such time as the Director, DHA or his/her designee, approves the recommendation of the DoW P&T Committee. Pursuant to 10 U.S.C. 1074g and 32 CFR 199.21, the recommendations of the DoW P&T Committee and the final decisions of the Director, DHA or his/her designee are not limited by the condition sets for which price quotes are solicited.

8. PRICES and PRICE CHANGES:

(a) Company agrees to provide its products at prices no higher than those submitted here, in any resulting UF BPA for at least one calendar year following the date of that UF BPA. However, during the time period that the UF BPA is in effect, Company may offer price decreases at any time for at least one year duration.

(b) The price per unit of measure for a given dosage form and strength (each, gram, mL, etc.) of the pharmaceutical agent will be the same for all available package sizes (e.g., 30s, 100s, 1000s) within a given dispensing venue. Quotes must include all National Drug Codes (NDCs) available for purchase by the Government and on the Company’s FSS Interim Agreement for quoted form and strength. Company requests for exception to the same price per unit of measure across package sizes must be submitted in writing to the Contracting Officer not less than 14 calendar days prior to the quote due date. It is within the Government’s sole discretion to grant an exception. The Contracting Officer may be contacted using the address in Paragraph

11. If an exception is granted by the Government, the DoW P&T Committee’s relative cost evaluation for that dosage form and strength will use the price per unit of measure from the package size with the highest price per unit of measure. Company requests to exclude institutional or Hospital Unit Dose packaged NDCs must be submitted in writing to the Contracting Officer not less than 14 calendar days prior to the quote due date. The Contracting Officer may be contacted using the address in Paragraph 11. The Government’s decision on exclusion of institutional or Hospital Unit Dose packaged NDCs or exception(s) to the same price per unit of measure across package sizes will be provided to the Company no more than seven calendar days after receipt of the request. The Government decision is final and not subject to appeal.

(c) If after two calendar years following the date of this UF BPA, and no more frequently than biannually thereafter, and there has been an increase in the price reflected on Company’s FSS contract/Interim Agreement (either CPI or Public Law increase), the Company may request to increase its price under the UF BPA.

However, in no event shall a price increase exceed the Big 4 price and/or the percentage increase in the Producer Price Index (PPI), Industry Data, as published

RFQ HT9402-26-Q-9202 Page 13 of 25 by the Bureau of Labor statistics, U.S. Department of Labor, for Pharmaceutical Preparation Manufacturing over the time period elapsed since the UF BPA price was last agreed upon (documented by the date of the Contracting Officer Signature). Company shall provide advance notice to the Contracting Office in writing within 30 days of the month the agreement was signed, if Company desires a PPI price increase. If a request is not made within this time, a request can be made the following year on the same month; however, the baseline index will only go back 24 months (2 years). Modification requests submitted shall utilize the latest PPI as follows: 1st through 20th of the month submitted shall use the PPI of the previous month and 21st through the end of the month shall utilize the current months PPI when it is released by BLS. The PPI price increase and effective date will be incorporated via a modification to this agreement by mutual agreement of the parties. Exceptions are at the discretion of the contracting officer.

(d) If during the life of the UF BPA, the FSS or Big 4 prices, including DoW TPRs, become lower than the UF BPA prices, DoW reserves the right to order at those prices. The Company agrees the Contracting Officer may unilaterally terminate the UF BPA if the FSS or Big 4 prices become lower than the UF BPA prices, including DoW TPRs, unless the parties agree to decrease the UF BPA prices.

(e) When a new NDC-11 for the same drug is added to the Company’s FSS, DoW may consider adding the new NDC-11 to the UF BPA on the condition that the Company offers it at no more than the current BPA price.

9. TERMINATION: Except as provided in Paragraph 4, Effective Date and Period of Resulting Pricing Agreement and Paragraph 8, Prices and Price Changes, above, either party may terminate this UF BPA by providing written notice to the other. Such notice shall be effective one hundred twenty (120) days, or earlier if all parties agree, following receipt of notice of termination by the other party. If the Company’s existing FSS Interim Agreement for any pharmaceutical agent(s) quoted in this UF BPA terminates for any reason (except where new FSS contract(s) for the same item(s) is/are negotiated), this UF BPA automatically expires.

Transfer or Sale of Agents – The Company is required to notify the Contracting Officer within 1 business day upon transferring assets used in the contract, per FSS contract, Ref. FAR 52.212-4 Contract Terms and Conditions, Commercial Items (t)(2)(i) and Public Law 102-585. The Company shall facilitate the transfer of this BPA and/or ADP to the new Company. The transfer will be accomplished via modification to be signed by the Government and both Companies.

10. GENERAL PROVISIONS: The Company must have an existing FSS contract / Interim Agreement for any pharmaceutical agent(s) quoted in this UF BPA at the time the UF BPA is executed. All terms of Company’s FSS contract or Interim Agreement apply to this agreement.

(a) FSS Interim Agreements: A UF BPA may be issued under an FSS Interim Agreement. If the FSS Interim Agreement expires, ends, or terminates without a successor definitive FSS contract, the UF BPA automatically terminates. If the Interim Agreement is superseded by a definitive FSS contract, the parties agree that this UF BPA automatically transfers under that FSS contract if all of the

RFQ HT9402-26-Q-9202 Page 14 of 25 successor FSS contract prices are no less than the UF BPA prices for identical NDCs. The parties agree to administratively change the contract number under paragraph 12 below by modification. If a successor definitive FSS prices are less than the UF BPA, see paragraph 8(d) above.

(b) DoW Condition Set Provisions:

1) All generic agents may be on the UF.

2) All generic agents are eligible to be used before the step therapy and are not included in Condition Set scenarios.

3) Generic agents may be on the BCF and are not included in Condition Set scenarios.

4) Generic agents will be used in cost analysis at the lowest available price.

5) Brand name agents with generic equivalents are only available if medically necessary. The pharmacy benefits program mandates substitution of generic drugs listed with an “A” rating in the current Approved Drug Agents with Therapeutic Equivalence Evaluations (Orange Book) published by the Federal Drug Administration unless sufficient clinical justification from the prescriber is submitted.

6) If a generic formulation of a branded product becomes available, DHA reserves the right to use the generic formulation of the branded product as the step-preferred agent.

7) BCF agents are approved by generic name, dose and form.

8) DHA reserves the right to evaluate a combination agent’s merit either as a single entity or relative to the component agents.

9) DHA reserves the right to evaluate an agent’s various formulations as individual brand agents or view the formulations as one brand agent.

10) Step-preferred agent(s) are agents available prior to the step therapy criteria process. Prior Authorizations based on step therapy may be placed on any agent.

11) Prior Authorizations based on clinical criteria may be placed on any agent.

12) All prices quoted must include applicable FSS Industrial Funding Fee (IFF). All package sizes must be expressed as whole numbers using numeric characters only. Any alpha-numeric package size information provided must be included in the drug name field. Price per unit of measure must be shown to four decimal places.

13) Package prices must equal unit of measure prices multiplied by the package size. A quote must be submitted for each strength and dosage form identified by NDC number (11 digits) on the attached Appendices.

NOTE: The P&T Committee has excluded most NDCs for Hospital Unit Dose packaging and injectable forms covered for outpatient use by the TRICARE pharmacy benefit program.

11. Issuing contracting office:

Pharmacy Contracting Officer Defense Health Agency 7800 IH 10 West Suite 400 San Antonio, TX 78230

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TO BE SUBMITTED BY MANUFACTURER

12. Company’s current FSS Contract Number / FSS Interim Agreement number:

13. DoW P&T Committee designated Drug Class/Subclass and Drug Name quoted:

Drug Name:

Drug Class:

Drug Subclass:

14. The Company point(s) of contact for the administration and management of this agreement:

Name: Phone:

POC #1 Title: Alt Phone:

Address: Email:

CAGE CODE:

Name: Phone:

POC #1 Title: Alt Phone:

Address: Email:

Signature: Date:

Name: Title:

Official Name of Company Submitting Quote:

15. By signing this agreement, the company agrees to work with the DoW Prime Vendor Program established for drug distribution.

16. Authorized Agent

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16. Agreement (to be completed by the DHA Contracting Officer)

A UF BPA is hereby established between the Company (listed above) and the DoW for the pharmaceutical agents and applicable prices quoted in the attached Appendices for those condition sets listed below based on the final decision of the Director, DHA or his/her designee.

Pharmaceutical agent(s) on the UF for the TRICARE Mail Order Pharmacy (TMOP)

Condition Set:

Pharmaceutical agent(s) on the UF for the Military Treatment Facility (MTF)

Condition Set:

Pharmaceutical agent(s) on the UF for the Basic Core Formulary (BCF)

Condition Set:

UF BPA Number:

Effective Date:

Signature: Date:

DHA Contracting Officer: Marsha L. Petersen

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Appendix 3 Manufacturer Quote

TRICARE Retail Refund – Uniform Formulary

Additional Discount Program (UF ADP)

APPLICABLE LAWS: The parties acknowledge that 32 C.F.R. §199.21(q), effective May 26, 2009 provides that as a condition for placement on the Uniform Formulary (UF), manufacturers are required to agree to honor Federal Ceiling Prices (FCP) for prescriptions filled in TRICARE retail network pharmacies. This also includes long term care facilities, specialty pharmacies, pharmacies inside physician offices and hospitals, and all other pharmacies identified as part of the TRICARE retail network. That regulation implements 10 U.S.C. §1074g(f) which provides:

PROCUREMENT OF PHARMACEUTICALS BY TRICARE RETAIL PHARMACY

PROGRAM: With respect to any prescription filled after January 28, 2008, the TRICARE Retail Pharmacy Program shall be treated as an element of the Department of War (DoW) for purposes of the procurement of drugs by Federal agencies under §8126 to title 38 to the extent necessary to ensure that pharmaceuticals paid for by the DoW that are provided by pharmacies under the program to eligible covered beneficiaries under this section are subject to the pricing standards in such §8126.

GENERAL CONCEPT: UF ADP is contingent upon pharmaceutical agents being placed on the generic (1st tier) or formulary (2nd tier) of the DoW UF. Refund quotes for UF ADPs may be submitted only for pharmaceutical agents that are scheduled for review by the DoW Pharmacy & Therapeutics (P&T) Committee at the next P&T Committee meeting. The DoW P&T Committee will consider refund quotes for UF ADPs as part of its evaluation of the relative cost effectiveness of pharmaceutical agents in recommending the placement of pharmaceutical agents on the DoW UF.

Refund Quote for Inclusion on UF

1. REFUND QUOTE FOR INCLUSION ON THE UNIFORM FORMULARY: By submitting this UF ADP quote, the pharmaceutical manufacturer listed in Paragraph 12 below, henceforth the Company, agrees to provide refunds to the Government based on the accrued utilization of and the refund stated for the pharmaceutical agent(s) listed on the attached UF ADP Appendix. All NDC-11 packages of the pharmaceutical agent(s) marketed during the life of this agreement are covered by this agreement.

The accrued utilization will be based on the listed pharmaceutical agents that are dispensed to eligible beneficiaries by TRICARE network pharmacies under the DoW pharmacy benefits management contract associated with the TRICARE Retail Pharmacy Program. The refund quote(s) for the pharmaceutical agent(s) listed in the UF ADP Appendix is (are) contingent upon such pharmaceutical agent(s) being included on the DoW UF in not worse than the formulary (2nd) cost share tier.

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PSB-26-XXX

The DoW P&T Committee will consider the refund quote for the pharmaceutical agent(s) listed in the UF ADP Appendix in the cost to the Government portion of its evaluation of the relative cost effectiveness of pharmaceutical agents in recommending the selection of agents for the UF, and the classification of a pharmaceutical agent in the generic (1st), formulary (2nd), or non-formulary (3rd) cost share tier. If the DoW P&T Committee determines that a pharmaceutical agent should be recommended for inclusion on the UF, the DoW P&T Committee will also make a recommendation whether the pharmaceutical agent should be placed in the generic or formulary cost share tier in accordance with 32 C.F.R. 199.21(j).If the Director, Defense Health Agency (DHA) or his/her designee, makes a final decision to accept the recommendations of the P&T Committee relative to the pharmaceutical agent(s) contained in the Company’s refund quote and places the pharmaceutical agent(s) on the UF in not worse than the formulary (2nd) cost share tier, the DHA Contracting Officer, on behalf of the Department of War, will establish a UF ADP by completing Paragraph 13, UF ADP Execution, below.

2. SCOPE: The Company’s quoted additional discount percentage refund along with quarterly TRICARE retail pharmacy network utilization for all NDC-11 packages of the pharmaceutical agent(s) will be used to calculate the amount due under this Agreement and the amount to be paid to the Government as outlined in this Agreement.

3. EFFECTIVE DATE and PERIOD OF RESULTING PRICING AGREEMENT: The effective date of UF or Formulary placement shall be the date the Director, DHA, makes the final decision regarding placement of the pharmaceutical agent(s) on the UF. The effective date of the Agreement shall be the date of signature by the DHA Contracting Officer and shall be used in any calculations. The Refund accrual and invoicing will be calculated in accordance with Paragraph 8. The Agreement will continue until the effective date of any change in the classification of the pharmaceutical agent(s) contained in the Agreement as UF agent(s), or is otherwise terminated in accordance with Paragraph 10, Termination, below.

4. ELIGIBLE TRANSACTIONS: The refund will apply to all prescription transactions where a TRICARE retail network pharmacy dispenses the pharmaceutical agent included in the UF ADP Appendix to a DoW beneficiary in accordance with terms of the TRICARE Retail Refund Program (TRRP).

The Company shall not be required to pay a refund under this Agreement with respect to utilization of a pharmaceutical agent, which is not included in the refund process, if such agent was dispensed at a Military Treatment Facility (MTF); TRICARE Home Delivery; non-network retail pharmacies; Indian Health Service (IHS); and Department of Veterans Affairs (VA) pharmacies.

For more information regarding the TRRP, exclusions, and eligibility, please refer to the most recent TRICARE Retail Refund Program Manufacturer Policy & Procedures Guide, found on the Pharmacy Division Information for Pharmaceutical Manufacturers site under Operational Documents or by accessing the following link:

https://health.mil/trrp

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5. FINAL APPROVAL BY THE GOVERNMENT: In submitting this UF ADP refund quote for the pharmaceutical agent(s) listed in the UF ADP Appendix hereto, the Company understands that the DoW P&T Committee will consider the quoted refund(s) in determining the cost of such pharmaceutical agent(s) to the Government as part of its relative cost effectiveness evaluation of such pharmaceutical agent(s). The incorporation of a refund quote into DoW executed UF ADP is contingent upon final decision of the Director, DHA or his/her designee, approving the recommendations of the DoW P&T Committee.

6. EXTENT OF GOVERNMENT OBLIGATION: The placement of the listed pharmaceutical agent(s) in the UF is not worse than the formulary (2nd) cost share tier in accordance with the final decision of the Director, DHA or his/her designee, is a condition of receiving refunds under this Agreement. This Agreement imposes no obligation on the DoW to purchase any product.

7. REFUND:

(a) The Company agrees to hold open its UF ADP refund quote for one hundred-eighty (180) days.

(b) Refund quotes will be submitted as a percentage (expressed to four (4) decimal places XX.XXXX%) of the most recent annual Non-Federal Average Manufacturer Price (Non-FAMP). This refund, the additional refund, will be added to the refund required by 10 U.S.C. §1074g(f) and 32 C.F.R. §199.21(q), the standard refund. Only one additional refund quote will be submitted for each NDC of the pharmaceutical agent. The additional refund quote shall include all NDC-11 packages from which the pharmaceutical agent is dispensed. The calculation will be based on the most recent annual non-FAMP, which is the annual non-FAMP (reported to the Department of Veterans Affairs) from which the current annual Federal Ceiling Price calculated ceiling is derived. The most recent annual non- FAMP is applicable to all prescriptions filled during a calendar year. When calculating refunds, DoW uses non-FAMP and FCP amounts provided by the VA. DHA will request, from the VA, the current annual FCP and the annual non-FAMP from which it was derived prior to compiling each quarterly invoice. The quoted refund percentage will remain static during the life of the agreement; however, the most recent annual non-FAMP, and thus the calculated refund, may change.

DHA reserves the right to use the Wholesale Acquisition Cost (WAC) in place of non-FAMP for some medications/devices.

During the time period that the UF ADP is in effect, the Company may offer larger refunds at any time. After UF decisions for pharmaceutical agents included in this Agreement are made and while this Agreement is in effect, the Company may submit supplementary performance-based agreements for increased refunds for consideration by the DoW but shall be under no obligation to do so.

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(c) In the event that the Company transfers the right to manufacture the pharmaceutical agent(s) covered by this agreement, whether by change in the Company’s corporate ownership or otherwise, this UF ADP is automatically assigned to the transferee and all terms and conditions of this UF ADP remain in effect. The Company remains liable for all refunds on pharmaceutical agents dispensed within one hundred twenty (120) days after its notification to the Pharmacy Operations Division of the transfer.

8. UTILIZATION ACCRUAL AND INVOICING:

(a) For purpose of calculating the refund in excess of the current FCP, the accrual of TRICARE retail network utilization will begin on the date the Agreement is signed by the Contracting Officer unless otherwise specified by the Contracting Officer. This date will either coincide with or come after the date the Director, DHA, makes the final UF or Formulary decision. The Government shall provide utilization data to the Company on a quarterly basis.

The billing cycle will be calendar quarters, with billing periods of January – March, April – June, July – September, and October – December. Invoices for pharmaceutical agents on the UF ADP will be made available by the DoW with payment due seventy (70) days from the date the utilization data is made available to the manufacturers.

Failure to pay in full without following the outlined dispute resolution process by the designated payment due date, or without an approved extension may result in the termination of this UF ADP and reconsideration by the DoW P&T Committee of the listed pharmaceutical agents’ placement on the UF, in addition to any other remedies available to DoW.

(b) The DoW will provide billing information for the payment of pharmaceutical agents on the UF ADP and reconciliation materials due by the Company, and obtain invoicing information for the Company’s agent listed in Paragraph 12, The Company, below. Invoices will note the billing period and provide a summary of accrued utilization by product listing (NDC-11) for that billing period by unit (tablet, capsule, inhaler, etc.) and the percent refund in this UF ADP. The Company may submit the TRICARE Retail Refunds Reconciliation of Quarterly Utilization with the payment for each invoiced product listed and the dollar total of the refund by product listing (NDC-11) as outlined in the TRICARE Retail Refund Program, Manufacturer Policy and Procedures Guide.

(c) The Company may also obtain reporting of the billing period’s accrued utilization by transaction from DoW on the TRICARE Retail Refund website (TRRWS).

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9. RESOLUTION OF DISAGREEMENTS CONCERNING DATA USED TO

DETERMINE REFUNDS: In the case of a Manufacturer disputing the accuracy of DHA’s utilization data, the refund obligation as to the amount in dispute will be deferred pending good faith efforts to resolve the dispute in accordance with the procedures laid out below. Disputes must be submitted no later than seventy (70) days following the date of the release of the utilization data; the same date that payment is due. Please refer to the Information for Pharmaceutical Manufacturer’s webpage for Refund Payment Due and Dispute Cut-Off Dates. When the dispute is resolved, any refund owed relating to the amount in dispute will be due with interest from the date of the demand letter, consistent with 32 C.F.R. § 199.11, and will be paid by the Manufacturer or credited by DHA by the due date of the next quarterly payment after resolution.

10. TERMINATION: Except as provided in Paragraph 3 of this Agreement, either party may terminate this UF ADP by providing written notice to the other party as identified in Paragraphs 12 and 13 respectively. Such notice shall be effective one hundred-twenty

(120) days following receipt of written notice of termination by the other party. In the event the class of drugs specified herein has previously been reviewed, the Government solicits quotes for new ADPs to replace any existing ADPs. The Government will not consider existing ADP prices in the UF evaluation. Any existing ADP for this class of drugs will be terminated upon the conclusion of the UF decision.

11. UF ADP SUBMISSIONS: Send all submissions electronically to RFQ POC listed in part 2.3.

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12. DoW P&T Committee designated Drug Class/Subclass and Drug Name quoted in this UF ADP

Drug Name:

Drug Class:

Drug Subclass:

13. The Company point(s) of contact for the administration and management of this agreement

Name: Phone:

POC #1 Title: Alt Phone:

Address: Email:

Name: Phone:

POC #2 Title: Alt Phone:

Address: Email:

14. Authorized Agent

Signature: Date:

Name: Title:

Official Name of Company Submitting Quote:

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15. UF ADP Agreement: A TRICARE Retail Refund – UF Additional Discount Program (UF ADP) is hereby established between the Company and the Department of War for the pharmaceutical agents and applicable refunds quoted on the attached UF ADP Appendix based on…