DHS-B-20399 - Emergent Devices - SSJF.pdf

Sole Source Justification Form

Version 7.01 Page 1 of 6

Bulletin Reference Number R-84765 B-20399

Requesting Agency/University Illinois Department of Human Services

Sole Source Justification Form - Part I Section I - General Information

Department/Bureau/Section: IDHS/Substance Use Prevention and Recovery (SUPR)

Need Identified Date: 5/19/2020 Supply/Service Need By Date: 2/1/2021

Project Title: State Opioid Response Overdose Prevention: Narcan

Vendor: Emergent Devices, Inc. (formerly known as Adapt Pharma, Inc.)

Provide a description of the supplies or services required:

The purchase of an Narcan Spray nasal spray is required to respond to Illinois Opioid epidemic. Emergent Devices has a patented nasal delivery method of the medication naloxone. Illinois Department of Human Services will facilitate the ordering and pruchase of the nasal spray Narcan, to enable those without advanced medical training to deliver naxolone to counter an overdose of opioids.

Value: Estimated Value of Initial Term, this Change Order or Amendment: 13,000,000

Will this Sole Source amend a Professional or Artistic Services contract? Yes No

*Sole Source may not be used for amendments for Professional or Artistic Services if the amendment would increase the value by more than 5% of the initial award or extend the term by more than 60 days.

Type: New Sole Source

Section II - Proposed Term

One-Time Purchase Term Contract

Estimated Contract Begin Date: Mar 12, 2021

Estimated Contract End Date: 1/31/2022

Number of Potential Renewals:

Length of Each Renewal in Months:

Total Value of All Renewals:

If a Term Contract, does the term, including renewals, exceed 12 months? Yes No

Section III - Funding Source Select the type of funding to be used (Check all that apply): State Appropriate Funds Federal Funds Other (Explain):

Section IV - Sole Source Justification

This purchase is economically only available from a single source primarily because it is: (If "Other" explain in one sentence)

Patented. Emergent Devices has a patent on nasal spray delivery of naloxone, a lifesaving medication.

Are there secondary justification(s) for this sole source? Yes No

Section V - Purchase History

Has the Agency or University Purchased these supplies or services in the past? Yes No

Section VI - Business Rationale

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Bulletin Reference Number R-84765 B-20399

Requesting Agency/University Illinois Department of Human Services

1. Provide a detailed explanation of the need for the supplies or services:

The Illinois Department of Human Services (IDHS) division of Substance Use Prevention and Recovery (SUPR) submitted an application to the federal agency Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Treatment (CSAT) for the State Opioid Response II (SOR-II) grant in response to Funding Opportunity Announcement (FOA) No. TI-20-012. This is a non-competitive formula-based grant. Illinois was awarded $36,780,089 for each of two grant years beginning September 30, 2020. The purpose of the SOR grants is to support a range of prevention, treatment, recovery support, public education and infrastructure to address the ongoing, severe, opioid overdose crisis in Illinois. Since the grant was written, the overdose crisis has only worsened, especially in conjunction with COVID.

The purchase and distribution of naloxone, the lifesaving medication that reverses opioid overdoses, is one of the required activities of the federal grant. SUPR has been funding some large providers to purchase naloxone in both intramuscular and nasal spray form (called Narcan); however, the impact has not been sufficient and so we we must make it more widely available in response to the increase in overdose across the State. Smaller community-based grassroots outreach organizations, working every day with persons who use opioids, have previously had to request Narcan from these regional SUPR-funded providers, causing delays and even lack of availability of Narcan to these organizations.

To fill these gaps in availability, SUPR will be facilitating online orders for providers to directly order Narcan at no cost, which will permit more widespread availability and greatly improve efforts to combat the crisis.

It will also help SUPR fulfill the required activities of the grant. This work is part of SUPR's comprehensive vision for the State as we work to create a Recovery Oriented System of Care with valuable Medication Assisted Recovery (which includes Narcan) available to all Illinois residents no matter where they live. State cannabis funds will also be used to fund this procurement. Widespread, speedy, efficient distribution of this medication is critical to reducing the overdoses and deaths Illinois is currently experiencing.

2. Provide a list and describe in detail the specifications required to satisfy the need:

The following is needed:

Naloxone single doses in Nasal Spray form.

Medication-Assisted Treatment (MAT) is the use of medications, in combination with counseling and behavioral therapies, to provide a “whole-patient” approach to the treatment of substance use disorders including opioid addiction. SAMHSA requires Medication Assisted Treatment (MAT) as the primary means of treating persons with opioid use disorder, and requires the purchase of naloxone as part of that requirement. The drug generally exists in two forms capable of reversing an overdose: as an injectable solution administered intramuscularly or as a nasal spray. The reason Narcan is popular and used more widely is that anyone can administer the nasal spray version.

Price is $75 for a box of 2 Narcan nasal spray doses. FedEx 2-day delivery included in price. Minimum of 10 boxes per order.

SUPR will be review and conduct order approvals. Emergent Devices will help providers log into their main website for ordering. Orders pre-approved by SUPR will be billed to State of Illinois for payment while the product will be delivered directly to the provider.

Regular reports from Emergent Devices on the organizations placing orders including amount ordered, delivery address, and contact information. The amount of funds expended weekly to assist SUPR in understanding the need and use of Narcan and manage future funding. Vendor will be responsible for monitoring of expiration date of the Narcan for the lots we purchase. Currently Narcan expires after 3 years.

SUPR will create a form for organizations to complete and submit to SUPR, where they will identify their work and request access to purchase Narcan online. SUPR staff will approve the application, and authorize the organizations to place an order with the vendor, utilizing SUPR funding. SUPR will create a list of regular approved organizations that may order on-demand. When necessary, SUPR will have the ability to suspend orders.

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Bulletin Reference Number R-84765 B-20399

Requesting Agency/University Illinois Department of Human Services

3. Provide detail explaining the justification selected in Section IV to explain why the requested supplies or services are the only ones available that can satisfy the agency or university requirements?

The IDHS SOR-II SAMHSA grant application requires the purchase and distribution of naloxone. Naloxone is available in both intramuscular and nasal-spray form. One of the most effective avenues for distribution of naloxone is through friends, family and loved ones of persons who use opioids. While persons who use opioids might be comfortable with naloxone in intramuscular-injection form delivered intravenously (IV), most of the general public is not.

In order to get naloxone into the hands of persons who might unfortunately be with someone experiencing an overdose, the State must make Narcan available more widely. Narcan can be administered easily, with minimal to no training, as compared to filling a syringe and injecting naloxone into the muscle of an overdose victim. It is immediately effective in a person suffering an opioid overdose, and importantly, it is completely harmless to persons who might mistakenly be administered the nasal spray. Importantly, Illinois has passed many "good samaritan" laws related to the administration of naloxone, including PA-096-0361 and PA 099-0480, increasing access to naloxone and empowering non-medical professionals, including family, friends, and other community members, to administer naloxone to prevent a fatal opioid overdose without risking any civil or criminal liability.

4. What are the unique features of the supplies or services that are not available in any other product or by any other vendor? Provide specific quantifiable factors/qualifications:

The Illinois SOR-II grant application references the purchase and wide distribution of naloxone as a critical piece of the approach as Illinois responds to the opioid crisis. In addition it is a requirement of the federal funding from SAMHSA. Rather than providing Narcan funding to larger community-based organizations, the online system will streamline the process and deliver Narcan directly to those organizations that most need it, as quickly as possible. While Emergent Devices is the only manufacturer of Naloxone delivered in nasal-spray form (Narcan). Other manufacturers have attempted to encroach into the market, but failed after litigation for patent infringement.

The need for creative new programs supported by the SOR-II grant is of critical importance in addressing a recent rise in opioid overdose and death beginning with the COVID crisis. In the past, SUPR has funded various providers to perform Overdose Education and Naloxone Distribution (OEND) to combat the crisis. The OENDs were required to purchase and distribute naloxone to smaller organizations in their specific counties or regions. Allowing smaller organizations and even hospitals to order Narcan directly from Emergent Devices, and to receive it quickly, rather than ordering it through a third party will expand the reach of our naloxone outreach and distribution in the State.

In addition, the SUPR-funded OENDs will be relieved of the administrative burden of ordering, storing, and distributing Narcan to these smaller organizations - administrative work that takes away from the important substance use disorder work they could be doing in their communities.

While injectable naloxone is available from a large variety of manufacturers and distributors, only Emergent Devices can provide the nasal spray form. Emergent Devices is the only FDA approved manufacturer of nasal delivered Narcan. There are no other manufacturers currently producing nasal naloxone, the preferred delivery method for members of the public who might need Narcan in an emergency. We need to make this lifesaving medication widely available to respond to the opioid overdose crisis in Illinois. An award to Emergent Devices will allow for rapid distribution of this lifesaving drug during the current opioid overdose epidemic. No other Vendor can provide this product.

5. Has the Agency or University considered alternative supplies or services to satisfy their need? Yes No

5a. If no, why weren't alternatives evaluated?

No other Vendor can provide this product.

6. Are there resellers or distributors?

Yes No N/A

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Bulletin Reference Number R-84765 B-20399

Requesting Agency/University Illinois Department of Human Services

7. What efforts were made to get the best possible price (i.e. did the agency/university negotiate) and how did you determine the price for this purchase is considered fair and reasonable?

The $75 price for a box of two Nasal Narcan doses is the current best price for a government entity ordering from Emergent Devices and includes Fed Ex 2-day delivery, minimum order is 10 boxes. Based on market research, the price ranges from $140.00-$199.00 for a box of two Nasal Narcan doses. There are no generic manufacturers or bulk discounts at this time.

8. Will this purchase obligate the State to this vendor for future purchases such as maintenance, licensing or continuing need?

Yes No

9. What will be the financial or other impact to the State if this sole source is not approved and a competitive bid is required?

IDHS/SUPR will not be fulfilling its obligations to the residents of Illinois to do everything possible to reduce the overdose and death associated with the opioid epidemic and now, COVID.

The Illinois Department of Public Health reports that in 2019, there were 2,233 deaths related to opioids. They also report that in the first half of 2020, there was a 38% increase in opioid overdose deaths compared to the same time period in 2019. For the same time period, there was a 55% increase in opioid-related deaths in the city of Chicago, and these deaths disproportionately affect black males. Cook County reports similar alarming trends.

Visits to the ER for opioid overdose in Illinois have risen every year since 2013, with over 14,000 reported by IDPH in 2019. The SOR-II funds which total $36,780,089 for each of two years are meant to be spent on medication to reduce overdose and death, and to distribute the medication widely.

In 2019, the Society of Actuaries and actuarial consulting firm Milliman estimated of the financial cost of the opioid crisis in the U.S. to be $179 billion.

10. Is there any additional information you would like to add to justify this sole source?

COVID-19 has led to an alarming increase in opioid overdose deaths in Illinois. The serious impact of the opioid crisis, amplified by the devastation of COVID-19, affects the residents of the state of Illinois in profound ways. It is incumbent upon us to make the most timely and efficient use of the resources that are available to address this crisis. IDHS/SUPR's request for sole source approval to award funding in support of Emergent Devices' product through the SAMHSA federal grant award is critical to enabling us to meet that goal.

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Bulletin Reference Number R-84765 B-20399

Requesting Agency/University Illinois Department of Human Services

Section VII

Requesting Department Representative

Requesting Department Signature Required

I know and understand the contents of this Sole Source Justification and attest that all statements are true and correct and the fairness and reasonableness of the price was adequately confirmed.

Date 2/5/2021

Printed Name Kathleen Monahan E-mail Address Kathleen.Monahan@illinois.gov

Phone Number 312-235-9527

State Agency Bureau/Division Head or University Purchasing Director Approval and Signature Required

I know and understand the contents of this Sole Source Justification and attest that all statements are true and correct and the fairness and reasonableness of the price was adequately confirmed. (All prior form fields will lock once this e-signature is completed)

E-mail Address jean.sandstrom@illinois.gov

Phone Number 217-557-9298 Date Feb 20, 2021

Printed Name Jean Sandstrom

Agency Bureau/Division Head or University Purchasing Director and Not a Designee

SPO Approval and Signature Required

I have reviewed and understand the contents of this Sole Source Justification and agree with the State Agency or University determination.

I have reviewed and understand the contents of this Sole Source Justification and do not agree with the State Agency or University determination. As a result, the State Agency or University must explore other sourcing methods to satisfy their need.

State Purchasing Officer Signature Phone Number 217-782-2338 Date Feb 26, 2021

Printed Name Richard (Dick) Welch E-mail Address Richard.Welch@Illinois.gov

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Bulletin Reference Number R-84765 B-20399

Requesting Agency/University Illinois Department of Human Services

Sole Source Justification Form - Part II Section I - General Information

Project Title State Opioid Response Criminal Justice Medication Assisted Treatment Integration

Vendor Emergent Devices, Inc. (formely Adapt Pharma, Inc.)

Initial Date of Procurement Bulletin Posting Mar 3, 2021

Was a Sole Source hearing held per 30 ILCS 500/20-25?

Yes - Complete Section II and III below (Section II will only be visible when this option is selected)

No - Section II not required, go to Section III below Section III - CPO Approval and Signature Required

Based on my review, I authorize the Agency/University to proceed in accordance with the published Notice referenced above.

Based upon my review, I authorize the Agency/University to proceed with the following Changes.

Based on my review, the Agency/University is not authorized to proceed with this sole source as presented and my recommendation is that it be cancelled.

Other

CPO Signature CPO Phone 217-558-2231

Printed Name Ellen H. Daley Date

CPO E-mail Ellen.H.Daley@illinois.gov

Version 7.01 Page of Sole Source Justification Form - Part I Section I - General Information Will this Sole Source amend a Professional or Artistic Services contract?

If yes, what was the original contract value?

*Sole Source may not be used for amendments for Professional or Artistic Services if the amendment would increase the value by more than 5% of the initial award or extend the term by more than 60 days.

Section II - Proposed Term If a Term Contract, does the term, including renewals, exceed 12 months?

If yes, provide a detailed justification including any economic benefit received for agreeing to a multi-year term:

Section III - Funding Source Select the type of funding to be used (Check all that apply):

Section IV - Sole Source Justification Are there secondary justification(s) for this sole source?

Section V - Purchase History Has the Agency or University Purchased these supplies or services in the past?

Term Term From Term To Value Description Contract Number Type Section VI - Business Rationale

1. Provide a detailed explanation of the need for the supplies or services:

2. Provide a list and describe in detail the specifications required to satisfy the need:

3. Provide detail explaining the justification selected in Section IV to explain why the requested supplies or services are the only ones available that can satisfy the agency or university requirements?

4. What are the unique features of the supplies or services that are not available in any other product or by any other vendor? Provide specific quantifiable factors/qualifications:

5. Has the Agency or University considered alternative supplies or services to satisfy their need?

5a. If yes, name the alternative vendors whose supplies or services were evaluated:

5b. If yes, what were the alternatives for each vendor and why were they unacceptable? Be specific with regard to features, characteristics, requirements, capabilities and compatibility:

5c. Explain how the market evaluation was conducted?

*This evaluation is to determine available options within a market. If the evaluation is to determine quality or best suited option, this is not the appropriate source selection. Under no circumstances shall the evaluation consist of testing alternative options. These activities must be conducted in a competitive transparent environment (i.e. IFB or RFP).

5a. If no, why weren't alternatives evaluated?

6. Are there resellers or distributors?

7. What efforts were made to get the best possible price (i.e. did the agency/university negotiate) and how did you determine the price for this purchase is considered fair and reasonable?

8. Will this purchase obligate the State to this vendor for future purchases such as maintenance, licensing or continuing need?

8a. If yes, please provide details regarding future obligations and/or needs:

9. What will be the financial or other impact to the State if this sole source is not approved and a competitive bid is required?

10. Is there any additional information you would like to add to justify this sole source?

Section VII Requesting Department Signature Required I know and understand the contents of this Sole Source Justification and attest that all statements are true and correct and the fairness and reasonableness of the price was adequately confirmed.

State Agency Bureau/Division Head or University Purchasing Director Approval and Signature Required I know and understand the contents of this Sole Source Justification and attest that all statements are true and correct and the fairness and reasonableness of the price was adequately confirmed. (All prior form fields will lock once this e-signature is completed) SPO Approval and Signature Required Sole Source Justification Form - Part II Section I - General Information Was a Sole Source hearing held per 30 ILCS 500/20-25?

Section II - Sole Source Hearing Details The State posted to the Illinois Procurement Bulletin a description of the State's need, the justification for the sole source decision, and information regarding the opportunity to submit comments and testify at a public hearing. Notice of the hearing was also posted outside of the hearing room 48 hours prior to the hearing.

The public hearing was conducted for the purpose of receiving testimony regarding the sole source determination. The Hearing Officer recommends the following:

The following relevant documents are attached:

Section III - CPO Approval and Signature Required 9.0.0.2.20101008.1.734229 Ellen.H.Daley@illinois.gov

The purchase and distribution of naloxone, the lifesaving medication that reverses opioid overdoses, is one of the required activities of the federal grant. SUPR has been funding some large providers to purchase naloxone in both intramuscular and nasal spray form (called Narcan); however, the impact has not been sufficient and so we we must make it more widely available in response to the increase in overdose across the State. Smaller community-based grassroots outreach organizations, working every day with persons who use opioids, have previously had to request Narcan from these regional SUPR-funded providers, causing delays and even lack of availability of Narcan to these organizations.

To fill these gaps in availability, SUPR will be facilitating online orders for providers to directly order Narcan at no cost, which will permit more widespread availability and greatly improve efforts to combat the crisis.

It will also help SUPR fulfill the required activities of the grant. This work is part of SUPR's comprehensive vision for the State as we work to create a Recovery Oriented System of Care with valuable Medication Assisted Recovery (which includes Narcan) available to all Illinois residents no matter where they live. State cannabis funds will also be used to fund this procurement. Widespread, speedy, efficient distribution of this medication is critical to reducing the overdoses and deaths Illinois is currently experiencing.

Q2Answer: The following is needed:

Naloxone single doses in Nasal Spray form.

Medication-Assisted Treatment (MAT) is the use of medications, in combination with counseling and behavioral therapies, to provide a “whole-patient” approach to the treatment of substance use disorders including opioid addiction. SAMHSA requires Medication Assisted Treatment (MAT) as the primary means of treating persons with opioid use disorder, and requires the purchase of naloxone as part of that requirement. The drug generally exists in two forms capable of reversing an overdose: as an injectable solution administered intramuscularly or as a nasal spray. The reason Narcan is popular and used more widely is that anyone can administer the nasal spray version.

Price is $75 for a box of 2 Narcan nasal spray doses. FedEx 2-day delivery included in price. Minimum of 10 boxes per order.

SUPR will be review and conduct order approvals. Emergent Devices will help providers log into their main website for ordering. Orders pre-approved by SUPR will be billed to State of Illinois for payment while the product will be delivered directly to the provider.

Regular reports from Emergent Devices on the organizations placing orders including amount ordered, delivery address, and contact information. The amount of funds expended weekly to assist SUPR in understanding the need and use of Narcan and manage future funding. Vendor will be responsible for monitoring of expiration date of the Narcan for the lots we purchase. Currently Narcan expires after 3 years.

SUPR will create a form for organizations to complete and submit to SUPR, where they will identify their work and request access to purchase Narcan online. SUPR staff will approve the application, and authorize the organizations to place an order with the vendor, utilizing SUPR funding. SUPR will create a list of regular approved organizations that may order on-demand. When necessary, SUPR will have the ability to suspend orders.

Q3Answer: The IDHS SOR-II SAMHSA grant application requires the purchase and distribution of naloxone. Naloxone is available in both intramuscular and nasal-spray form. One of the most effective avenues for distribution of naloxone is through friends, family and loved ones of persons who use opioids. While persons who use opioids might be comfortable with naloxone in intramuscular-injection form delivered intravenously (IV), most of the general public is not.

In order to get naloxone into the hands of persons who might unfortunately be with someone experiencing an overdose, the State must make Narcan available more widely. Narcan can be administered easily, with minimal to no training, as compared to filling a syringe and injecting naloxone into the muscle of an overdose victim. It is immediately effective in a person suffering an opioid overdose, and importantly, it is completely harmless to persons who might mistakenly be administered the nasal spray. Importantly, Illinois has passed many "good samaritan" laws related to the administration of naloxone, including PA-096-0361 and PA 099-0480, increasing access to naloxone and empowering non-medical professionals, including family, friends, and other community members, to administer naloxone to prevent a fatal opioid overdose without risking any civil or criminal liability.

Q4Answer: The Illinois SOR-II grant application references the purchase and wide distribution of naloxone as a critical piece of the approach as Illinois responds to the opioid crisis. In addition it is a requirement of the federal funding from SAMHSA. Rather than providing Narcan funding to larger community-based organizations, the online system will streamline the process and deliver Narcan directly to those organizations that most need it, as quickly as possible. While Emergent Devices is the only manufacturer of Naloxone delivered in nasal-spray form (Narcan). Other manufacturers have attempted to encroach into the market, but failed after litigation for patent infringement.

The need for creative new programs supported by the SOR-II grant is of critical importance in addressing a recent rise in opioid overdose and death beginning with the COVID crisis. In the past, SUPR has funded various providers to perform Overdose Education and Naloxone Distribution (OEND) to combat the crisis. The OENDs were required to purchase and distribute naloxone to smaller organizations in their specific counties or regions. Allowing smaller organizations and even hospitals to order Narcan directly from Emergent Devices, and to receive it quickly, rather than ordering it through a third party will expand the reach of our naloxone outreach and distribution in the State.

In addition, the SUPR-funded OENDs will be relieved of the administrative burden of ordering, storing, and distributing Narcan to these smaller organizations - administrative work that takes away from the important substance use disorder work they could be doing in their communities.

While injectable naloxone is available from a large variety of manufacturers and distributors, only Emergent Devices can provide the nasal spray form. Emergent Devices is the only FDA approved manufacturer of nasal delivered Narcan. There are no other manufacturers currently producing nasal naloxone, the preferred delivery method for members of the public who might need Narcan in an emergency. We need to make this lifesaving medication widely available to respond to the opioid overdose crisis in Illinois. An award to Emergent Devices will allow for rapid distribution of this lifesaving drug during the current opioid overdose epidemic. No other Vendor can provide this product.

The Illinois Department of Public Health reports that in 2019, there were 2,233 deaths related to opioids. They also report that in the first half of 2020, there was a 38% increase in opioid overdose deaths compared to the same time period in 2019. For the same time period, there was a 55% increase in opioid-related deaths in the city of Chicago, and these deaths disproportionately affect black males. Cook County reports similar alarming trends.

Visits to the ER for opioid overdose in Illinois have risen every year since 2013, with over 14,000 reported by IDPH in 2019. The SOR-II funds which total $36,780,089 for each of two years are meant to be spent on medication to reduce overdose and death, and to distribute the medication widely.

In 2019, the Society of Actuaries and actuarial consulting firm Milliman estimated of the financial cost of the opioid crisis in the U.S. to be $179 billion.