6505--Lenalidomide (Revlimid) Dose - Brand name or Equal
THIS REQUEST FOR INFORMATION (RFI) / SOURCES SOUGHT NOTICE IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES. THIS IS NOT A SOLICITATION. SUBMISSION OF INFORMATION ABOUT PRICING, DELIVERY, THE M... THIS REQUEST FOR INFORMATION (RFI) / SOURCES SOUGHT NOTICE IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES. THIS IS NOT A SOLICITATION. SUBMISSION OF INFORMATION ABOUT PRICING, DELIVERY, THE MARKET, AND CAPABILITIES IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI FOR PLANNING PURPOSES IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government at this time. This notice is intended strictly for market research. The purpose of this Sources Sought notice is to determine interest and capability of Other than Small Businesses and Small Businesses, including VIP-Verified Veteran-Owned Small Business (VOSB) or Service-Disabled Veteran-Owned Small Business (SDVOSB) prospective vendors relative to the North American Industry Classification System (NAICS) Code 325412 (Pharmaceutical Preparation Manufacturing) and the SBA size standard is 1,300 employees. PSC Code is 6505- Drugs and Biologicals. Potential Offerors must be registered in the System for Award Management (SAM) to be eligible for an award at: https://sam.gov/content/home. Potential Offerors must also have a current Online Representations and Certification Application on file with SAM. The Department of Veteran Affairs, Jesse Brown VA Medical Center, 820 South Damen Avenue, Chicago, IL 60612-4223 has the requirement need for a Lenalidomide, or Revlimid Dose-Brand name only for the Pharmacy Dept. The Government is requesting that Other Than Small Businesses and Small Businesses, including VIP-Verified VOSB or SDVOSB sources respond if it can provide the following products on a Brand Name Only (Lenalidomide, or Revlimid Dose) . The Statement of Work for the above is listed below: STATEMENT OF WORK Department of Veterans Affairs Jesse Brown VA Medical Center 820 South Damen Avenue Chicago, IL 60612-4223 Contracting Officer s Representative (COR) COR Name: Will be provided to the winning vendor after the solicitation VA Name: Jesse Brown VA Medical Center VA Address: 820 South Damen Avenue Chicago, IL 60612-4223 E-Mail Address: Will be provided after the solicitation Vendor Name: To be determined (TBD) Vendor POC Name & email To be determined Contract Title: Lenalidomide/Revlimid Dose Brand name or Equal Introduction: Jesse Brown VA Medical Center, Pharmacy Service Dept. has the requirement need for a Lenalidomide, or Revlimid dose/pharmaceutical end product Brand name or equal purchase for the purchase/delivery to Veteran in lieu of prescription. Only pharmacies certified with Lenalidomide REMS can dispense the products to patients who are enrolled and meet the conditions of Lenalidomide REMS. Background: Lenalidomide Capsule is a prescription medicine, used to treat adults with: multiple myeloma (MM). a condition called myelodysplastic syndromes (MDS). Lenalidomide Capsule is for the type of MDS with a chromosome problem where part of chromosome 5 is missing. This type of MDS is known as deletion 5q MDS. People with this type of MDS may have low red blood cell counts that require treatment with blood transfusions. mantle cell lymphoma (MCL) when the disease comes back or becomes worse after treatment with 2 prior medicines, one of which included bortezomib. MCL is a cancer of a type of white blood cell called lymphocytes that are in the lymph nodes. follicular lymphoma (FL) or marginal zone lymphoma (MZL) **To avoid embryo-fetal exposure, lenalidomide is only available through a restricted distribution program called the Lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program. The Lenalidomide REMS program requires prescribers and pharmacies be certified and patients to enroll and comply with all program requirements. Prescribers and pharmacies certified with Lenalidomide REMS can prescribe and dispense the product to patients who are enrolled and meet all the conditions of the Lenalidomide REMS program. The Lenalidomide REMS program has a pharmacy network with a limited number of certified pharmacies and is close to new pharmacy applicants. Scope: The dispensing of Lenalidomide by Vendor-TBD. Contractor Requirements in lieu of Prescription written by provider: Prescription Ordering & Dispensing Process** The Healthcare Provider (HCP) instructs female patients to complete initial patient survey. HCP completes the survey. HCP completes the Lenalidomide Prescription Form for VA and includes the patient s cell number if possible. HCP obtains the Lenalidomide REMS authorization number and includes it on the prescription form. Note- Vendor-TBD requires the number of capsules per dose, daily frequency, and description of complete cycle be included in the directions. Example: Take 1 capsule by mouth once daily on days 1-21 of a 28-day cycle. HCP forwards the prescription to the VA pharmacy. HCP advises the patient that a representative from Vendor-TBD will be in contact. The VA pharmacy reviews the form and ensures the VA pharmacy address, shipping VA ORDERING SUMMARY 3 If there is a specialty pharmacy, specialty distributor, 3PL or other distribution partner mentioned in this document, it is the responsibility of the FSS contract holder to ensure the party complies with the details outlined above. address and contact information are populated. The VA pharmacy faxes the form to Vendor-TBD, Fax# TBD. The Vendor-TBD intake team reviews prescription form for completeness and a pharmacist verifies all data entry. The pharmacy will call the VA pharmacy contact listed on the intake form for any missing information. Vendor-TBD calls the patient to complete patient counseling. The pharmacy will make three attempts to call the patient over the course of 5 business days and will notify the VA pharmacy if the patient could not be reached. Vendor-TBD obtains the confirmation number. Vendor-TBD ships lenalidomide to the VA pharmacy or directly to the patient as indicated on the prescription form. The prescription is shipped out for next day arrival with signature required. *Prescriptions cannot be sent to a patient s P.O. box. The VA pharmacy will provide the Lenalidomide Medication Guide to the patient if the prescription is sent to the VA pharmacy. Vendor-TBD will fax or email a delivery confirmation summary to the ordering VA pharmacy within three business days for any prescription shipped directly to the patient. As a specialty pharmacy, Vendor-TBD offers: Clinical support from a pharmacist Industry-leading time to first fill Financial assistance coordination Ongoing adherence support Exceptional patient care and caregiver support Refill reminders via the patient s preferred method of communication Quick, free prescription delivery Contract Type: The Lenalidomide REMS program has a pharmacy network with a limited number of certified pharmacies and is closed to new pharmacy applicants. The certified pharmacy authorized to dispense Brand or Equal Lenalidomide to VA patients is Vendor-TBD. Vendor-TBD will dispense Lenalidomide. Period of Performance: 12 months after the award Place of Performance: Prescription ordered by Jesse Brown VA Medical Center, Pharmacy Services located at: 820 South Damen Avenue, Chicago, IL 60612-4223 and medication shall be dispensed by Vendor-TBD. Delivery: - The contractor shall be responsible for the delivery of medication to specified location upon ordering in accordance with the requirements outlined. - The medication should be provided in the required quantities and formulation as specified. - The contractor must ensure proper handling, storage, and transportation conditions (temperature control if required) of the medication to maintain its integrity and compliance with all applicable regulations. - Shipping Fees to this FOB Destination shall not exceed $250. Hours of Operation: Monday Friday 08:00am 08:00pm EST Registered pharmacist is available 24/7 The Contractor shall: Report a missing delivery confirmation summary. Long hold times or incorrect information provided to the patient or VA pharmacy by the Patient Contact Center. Advice of a STAT patient prescription (include STAT in the subject line). Request prescription status information if the patient has not received medication or the VA has not been notified of an unresponsive patient within 8 days of the initial fax. If additional follow-up is still needed, pharmacies can contact the vendor TBD representative. Deliver the product to our on-site Warehouse Dept in Jesse Brown VA Medical Center, 820 South Damen Avenue, Chicago, IL 60612-4223. Coordination of all products and services to ship and deliver the requested pharmaceutical end-product (Lenalidomide, or Revlimid) from the manufacturer until final acceptance by the VA Point of Contact. Make coordination with the Contracting Officer s Representative (COR), or the requesting Program Office/end-user for the lead time/delivery of this requested end-product. Line Item Information:     Lenalidomide/Revlimid Dose-Brand Name or Equal Item # Description & Part Number* Qty Price Extended Amount 1 LENALIDOMIDE 2.5MG ORAL CAP-(Part# to be determined (TBD)) 0 $TBD  2 LENALIDOMIDE 5MG ORAL CAP-(Part# to be determined (TBD)) 0 $TBD  3 LENALIDOMIDE 10MG ORAL CAP-(Part# to be determined (TBD)) 1596 $TBD $TBD 4 LENALIDOMIDE 15MG ORAL CAP-(Part# to be determined (TBD)) 0 $TBD  5 LENALIDOMIDE 20MG ORAL CAP-(Part# to be determined (TBD)) 0 $TBD  6 LENALIDOMIDE 25MG ORAL CAP--(Part# to be determined (TBD)) 210 $TBD   Estimate for new starts:   $TBD       SUBTOTAL (Products)   $TBD     Services Brief Description of Service* Period of Performance $s per Period Estimated Amount  Prescriptions Dispensed By Month or Year Payment processing and invoicing for prescriptions dispensed Month   by Vendor-TBD will be e-invoice through the    Tungsten Network using the purchase order number provided    on the prescription form. VHA Contracting recommends    providing estimated annual usage to the local contracting office    to obtain a bulk purchase order. Prescriptions are mailed to    directly to Veteran.    Contract Expiration Date: TBD         SUBTOTAL (Services)   $ -  Grand TOTAL $TBD KICKOFF MEETING (if necessary) The awardee and VA Facility POC (End-User/Requestor) will meet one week after awarding the delivery order to coordinate delivery schedule. The meeting can be held via a phone call, Outlook teams meeting, or face-to-face, if applicable. Payments: Payments shall be made upon delivery and acceptance by individual medical centers. The contractor shall use the purchase order (PO) number when submitting for payment through Tungsten network website https://portal.tungsten-network.com. The list of DRAFT characteristics is intended to be descriptive, not restrictive, of the supplies/services that are required. If your company is interested and capable of providing the required supplies/services, please provide the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Submit your capabilities statement illustrating how your organization can/cannot meet the list of SOW requirements. For instances where your company cannot meet the SOW requirement(s), please explain. For instances where your company can meet the SOW requirement(s), please show how your company meets/exceeds each requirement. (2) Please review the list of SOW requirements and provide any additional feedback or suggestions. If none, please reply as N/A. (3) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran-Owned Small Business (SDVOSB), Veteran-Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc. (4) Is your company considered small under the NAICS code identified in this RFI? (5) Are you the manufacturer, authorized distributor, and/or can your company provide a solution to the required supplies/services described in the list of SOW? (6) If you are a large business, do you have any designated/authorized distributors? If so, please provide their company name, telephone, point of contact and size status (if available). (7) If you re a small business and you are an authorized distributor/reseller for the items identified above, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified. (8) Limitations on Subcontracting: How does your business ensure compliance with the limitations on subcontracting as outlined in 13 CFR § 125.6? (9) Are the items you are identifying/providing considered Commercial of the Shelf (COTS) items as defined in FAR Part 2.101 under commercial items? (10) Non-Manufacturer Rule: If applicable, can you confirm your business complies with the Non-Manufacturer rule? Specifically, does your company: Provide a product from a small business manufacturer or processor? Not exceed 500 employees? Primarily engage in the retail or wholesale trade and normally sell the type of item being supplied? Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice? (11) Please indicate whether your product conforms to the requirements of the Buy American Act? (12) What is your lead time to deliver a single unit with all components? Is there scale in lead time with greater quantities? Please elaborate. (13) What is estimated life span of your solution? What support/services does that entail? (14) Does your proposed equipment have FDA clearance? Please specify what FDA clearance(s) have been obtained. (15) Does your organization offer a leasing solution? Please elaborate. (16) Does your company have a Federal Supply Schedule (FSS) GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract? If so, please provide the contract number(s). (17) If you are an FSS GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract holder, are all the items/solutions you are providing information about available on your schedule/contract? Please state if all or some items are available on the contract. (18) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. (19) Please provide your SAM.gov Unique Entity ID/Cage Code number. Responses due are to be submitted by e-mail only to: arneil.genus@va.gov. The information requested must be received no later than Thursday, November 20, 2025, 3:00 PM CST.
Data sourced from SAM.gov.
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