Immune Response BioPharma, Inc. (c) TM 2010-2020          www.immuneresponse.net

Immune Response BioPharma, Inc. (c) TM 2010-2020

Clinical Trials: visit  www.clinicaltrials.gov

Expanded Access Program Open Enrollment: Right to Try

500 MS Patients NeuroVax TM   MS Vaccine Reserve Spot enroll via $1 fee paypal & Complete Forms

                                               Second Dose No CoPay Regardless of Insurance Coverage 

500 HIV Patients Remune TM  HIV Vaccine Reserve Spot enroll $1 fee paypal & Complete Forms

 

Compensation $3000.00 Each for Completing 4 Remune Doses & Completing 3 NeuroVax Doses

 

 

Expanding Patient Access to Immune Response BioPharma's Investigational Medicines

When results from clinical trials suggest that one of our investigational medicines may offer benefits for patients facing life-threatening conditions,Immune Response Bio is committed to bringing that medicine to those patients as quickly and equitably as possible. Participation in clinical trials should be the primary route by which patients get access to investigational medicines and contribute to the collection of safety and efficacy data needed to support regulatory approval worldwide. These FDA clinical studies are needed to demonstrate that the medicine meets the standards for safety and efficacy that government regulatory agencies have established for granting approval. Gaining regulatory approval for a medicine is the best way to bring rapid access to the greatest number of patients who may benefit.

For patients with a serious or life-threatening disease who are ineligible or unable to participate in a clinical trial, use of an expanded access program may be an option. Depending on country regulations and the program criteria, access to investigational medicines may be provided through an FDA Expanded Access Programs (EAP) (known as compassionate use programs in certain jurisdictions), or Country-Specific Authorization to Use cohorts.

Decision Criteria for Considering an EAP

The following criteria must be met before Immune Response BioPharma will consider establishing an EAP for a Immune Response investigational product:

*There is an unmet medical need that cannot be met by existing products ie failed current therapy no immune based

*The benefit-risk profile of the drug/vaccine in the indication and the patient population is positive risk to reward

*There is a good understanding of the likely indication to be approved

*There are definite plans to file and commercialize the drug in the region

*The program will be fairly and equitably available to the population of the region in question

*The program is compliant with State & local rules and laws Right to Try Legislation Passed by US Congress

*There are adequate supplies of investigational product to meet the needs of the EAP without impairing the FDA clinical trials program

*The program must be discontinued as soon as feasible when approval of the drug is achieved in the country

* Patients 0-99 Ages may enroll in the Remune HIV Vaccine Expanded Access Study including pediatric 

* Adults 18-99 Ages may enroll in the NeuroVax MS Multiple Sclerosis Vaccine Expanded Access Study per U.S. Congressional statutes all pediatric MS population must be allowed in adult MS studies thus with parent or guardian authorization and IRBP approval pediatric populations will be allowed into the EAP Right to Try program

* Patients must meet all criteria for participating in the EAP Right to Try Program IRBP has the right to deny any potential participant for just cause; including safety, ineligible, health condition, adverse events, terminal disease beyond any benefit, PCP or Treating MS or HIV specialist recommends against participation or any reason IRBP feels the patient risk to reward ratio will not benefit the patient

* Insurance Antigen Coverage: CMS Medicaid/Medicare helps pay for antigens if both of these apply:

They're prepared by a doctor; They're given by a properly instructed person (who could be the patient) under appropriate supervision one can expect Remune to be covered under the Antigen rule and also the vaccine shot rule for illness treatment

Carriers such as Cigna & others have expressed interest in Voluntarily coverage for Remune IRBP expects Remune to be Covered & as well NeuroVax MS Vaccine under vaccination treatment coverages. Compensation paid by check or debit card

* Shots: Vaccinations are Required Coverage Medicare helps pay for some other vaccines when they're directly related to the treatment of an injury or illness. One can reasonabley expect Remune & NeuroVax HIV & MS immunotherapy treatment to be covered by insurance https://www.medicare.gov/coverage/prescription-drugs-outpatient.html#collapse-5965

* Remune Cost Effective Quarterly Dosing 3 months/$3k =$1k month HIV vaccine cost $12k per year out of pocket max $6k

* Remune & NeuroVax 2nd Dose No Co-Pay No Out of Pocket Cost Regardless of Insurance Coverage for First 500 Patients

* Compensation of $3000.00 for completing 4 Remune Doses one year & $3000 for completing 3 NeuroVax Doses three months  

Process for Seeking Access: Physician will purchase vaccine from IRBP & bill insurance any balance owed is to doctor's office

Patient empowerment, Patients may sign up directly for the expanded access progam directly via the expanded access clinical studies webpage on www.immuneresponsebio.com after consulting with their primary care physician that they want to particiapte in the rght to try program. Patients should consult with their healthcare provider about their eligibility to enroll in any of Immune Response clinical trials and expanded access programs. To get more information about available Immune Response Bio clinical trials, vist www.immuneresponse.net or email info@immuneresponsebiopharma.com or call 917-275-7931

If the physician feels that the patient is not able to participate in an available clinical trial and that an expanded access program may be suitable for the patient, the physician should contact Immune Response Bio to make the request on behalf of the patient. This will enable the physician to work with experts within the company to determine the appropriate course of action. Physicians seeking help on behalf of their patients in the U.S. may contact Immune Response Bio at 917-275-7931. If a program exists, information will be provided to the requestor at the time of the call. If no program exists, the request will be acknowledged and noted. Physicians' or office can directly enroll the patient on behalf of the patient via the website. Physician will purchase vaccine.

Patients will enroll via Immune Response BioPharma's website and complete forms including ICF an informed consent form, an LOA from IRBP a Letter of Authorization, and FDA forms all EAP programs will be conducted under FDA guidelines and FDA criteria, FDA Expanded Access rules & regulations, including treatment IND's, individual IND's, IRBP may utilize a hybrid of current FDA Expanded Access program with current recently passed Right to Try Legislation. Patients maybe required to pay for medication at a reasonable reimbursement cost, IRBP will submit reimursement to patients insurance but no guarantee the coverage will be provided or afforded by their carrier or CMS Medicare, Medicaird or any other government insurance or private carrier coverage is up to the local determination and the insurance carrier. Patient balance if any will be owed to physicians office.

Costs per dose is estimated at $3k per injection & may range between $3000 per injection depending upon number of patients enrolled and cost sharing of full enrollment at 500 patients per study. The $1 reservation fee is refundable via paypal is a spot in the clinical studies to ensure fairness in signing up for the vaccines on a first come first served basis. Once enough patients have enrolled and enrollement has been completed at the 500th patient the vaccine will be made to order for the study participants. Patients enrolled will pay $1500 half of the study medication cost once all 500 patients have been enrolled and the medication will be made to order for the patient and the other half an additional $1500 will be billed to the patient once delivered to the physicians office. IRBP will bill the insurance carrier for reimburmant thus the patient may have a zero copay depending upon coverage. Physician's office will purchase vaccine directly from IRBP and bill insurance on behalf of patient. 

Patient will provide a copy of their insurance card, a photo copy of a governent identification card such as a drivers licence and will be responsible for balance of vaccine cost if insurance does not cover drug/vaccine cost, and agree to all protocol regimin including monitoring of drug/vaccine safety criteria which include blood tests and  MRI's via their current doctor or physicians office and the data will be provided to Immune Response BioPharma as part of safety and efficacy collection of the drug/vaccine profile. Patient will report any adverse events to their physician monitoring their expanded access drug/vaccine use immediately.

* Antigen Coverage: Medicare helps pay for antigens if both of these apply:

They're prepared by a doctor; They're given by a properly instructed person (who could be the patient) under appropriate supervision 

* Carriers such as Cigna & others have expressed interest in Voluntarily coverage for Remune IRBP expects Remune to be Covered & as well NeuroVax MS Vaccine under vaccination treatment coverages

* Shots: Vaccinations are Required Coverage Medicare helps pay for some other vaccines when they're directly related to the treatment of an injury or illness. One can reasonabley expect Remune & NeuroVax HIV & MS immunotherapy treatment to be covered by insurance https://www.medicare.gov/coverage/prescription-drugs-outpatient.html#collapse-5965