Islets for US 
Collaborative 

Information for Organ Procurement Organizations

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Why is islet transplantation NOT reimbursed as any other standard of care procedure in the US?

 

Current Regulations Regarding Pancreatic Islet Transplantation in the US. 

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Although pancreatic islet allotransplantation for patients with T1DM has been performed in the USA for last 16 years, it is still considered an experimental procedure.

This means, that islet transplantation as a procedure has not been and still is covered by any insurance company.

 

CMS does not pay for islet transplantation at all therefore CMS should NOT require from OPO to charge full clinical organ acquisition fee ($25,000- $50,000) from Research Transplant Centers performing still experimental procedure! 

Transplant center cannot afford paying such a high fee in addition to huge cost of islet isolation, reagents, hospital stay etc. from own research funding. Therefore, OPOs should charge the same research organ acquisition fees, which OPOs apply to any to any other organ recovered for research. 

 

Over 16 years ago, the FDA started to regulate pancreatic islets isolated for the purpose of the clinical transplantation as a biological product (as a drug), in contrast to organs for transplantation (which are not regulated by the FDA).

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Therefore, before islet transplantation can be covered as a standard of care procedure, human islets as a biological product need to be approved by FDA first,  as any other new medication before it goes on the market. Accordingly, islet researchers organized phase 1/2 and phase 3 clinical trials to prove safety and effectiveness of the treatment with islets transplanted by treated as a biological product. Research grants from NIH and JDFR have provided funding those required studies but only for 60 patients.

 

Now, those trials are accomplished and we have exciting data proving safety and effectiveness of the islet transplantation can be completed in the most experienced transplant centers. However, the next step required by FDA, is for each center to apply individually for a Biological  License to be certified to process human islets for clinical transplantation. It is exactly the same requirement, as for any pharmaceutical company before introducing new drug into the market.

 

The enormous cost, logistical challenges and risk of liability have precluded Universities involved in the trials from submitting such application for the last 5 years. As a result, islet transplantation has remained as an experimental procedure, performed on rare occasion, as it is not reimbursed by any insurance in the US. Furthermore, lack of research funding allowing that encompasses the extremely high cost related to the procedure ($30,000-$50,000 organ recovery fee, patient hospitalization, immunosuppression and other transplant related medications) stunts further development of the field and may lead to extinction of the procedure. 

 

In contrast, such regulatory barriers do not exists in other countries. Islets for transplants are regulated as any other organ transplantation without oversight by FDA like agencies. in Canada, Europe and Australia and is covered by national insurance.

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Why do we look for partnerships with Organ Procurement Organizations? 

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Having exciting outcomes with islet transplants alone (see our patient stories), we would like also to prove safety and effectiveness of islet transplantation in a different group of T1DM patients, those who have already received kidney transplant and are established on stable immunosuppression. We believe, that islet transplantation would substantially improve patient's glucose control and quality of life by preventing progression of secondary diabetic related complications without major surgery related to a whole pancreas transplantation.. 

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As we know, organ acquisition fees paid by transplant centers allows OPOs to recover the cost of their activity.

Transplant centers then recover their cost from insurance after completion of the clinical transplant.

However, such mechanism of financing does not exist for islet transplantation.

 

The entire cost related to islet transplantation, including organ acquisition fee is NOT reimbursed by the insurance, as it is fully supported ONLY by research funding. 

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What are we asking for?

 

Since islet transplantation can only be performed as a research/experimental procedure,

we feel that it is our obligation to propose and ask our partners  and leaders of OPOs to apply research rates when a pancreas is utilized for islet transplantation instead of the full clinical rate for donor pancreas acquisition fee that is applied for whole pancreas transplant. . 

 

At the same time, we would like to highlight that:

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• Pancreas allocation for whole organ transplantation still remains the priority for donor pancreas placement. Only when donor pancreas is declined by all pancreas transplant centers, it will then be allocated to the islet center for transplant in the frame of a clinical study approved by the FDA and IRB. 

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• Additionally, optimal pancreas donor characteristic for islet transplantation is very different than for whole organ transplantation and allocation for islet would not compete with allocation for pancreas transplant but be supplementary  (see donor criteria below). 

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Rationale:

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1. Research rate for organ recovery has been introduced to promote research, improvement  and progress in the field of transplantation and to honor our donors wish to contribute to the research and development of new therapies. 

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2. Currently, human pancreata rejected for whole organ transplant are frequently wasted, taken to the grave, simply because extremely high clinical organ acquisition fees are required by OPOs and are cost prohibitive to research centers.

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3. A common misconception is that organ acquisition fees for islet transplantation recovered by the transplant center through insurance reimbursment, when in fact, they are NOT recovered in any way. Organ  acquisition fee comes directly out of the center's research funding, precluding completely or  limiting the number of transplants that can take place. 

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4. Fortunately, there have been a few OPOs understanding the current situation and have tried to help our patients and contribute to progress in research. We and our patients are grateful for thist. We hope that more OPOs would be able to help as well to benefits everyone. 

 

Benefits for everyone:

 

Partnership of  OPOs and islet Tx centers with application of a research rates for the pancreas recovery for islet transplant would benefit everyone involved:

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1. Patients would benefit from novel procedures and approaches in the controlled environment of clinical trials approved by the FDA and IRB.

2. Transplant field would benefit by promotion of  progress  and innovation.. 

3. OPOs- as more organs would be utilized to the fullest potential, more funds are recovered from procurements leading  to more robust activity. 

 

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Criteria for pancreas donor for islet transplantation 

 

Exclusion criteria:

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1. High CDC risk 

2. HCV, HIV or HBV positive 

3. Diabetes or A1c>6

4. BMI <20

5. Age <18 and >65

6. Sepsis

7. Pancreas pathology, trauma or transection during liver recovery

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Preferred criteria (donors, who are especially desired):

1. Obese, (BMI>28)

2. Tall male

2. Heavy drinkers

3. Age >22 but below 60

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