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When a patient or an advocate assumes that all is hunky dory, with their application for approval of an expensive specialty drug and that there is no need to check on the application, then a big nasty surprise is likely to occur.

Here’s A Case Study Of A Big Nasty Surprise:

Stan is a 28 year old grad student whose bone marrow stopped working. This is called aplastic anemia. The bone marrow is supposed to produce red cells, white cells and platelets on a regular basis. His marrow became hypo-cellular and non productive. He needed transfusions each week.

The other complicating factor with Stan was a rare disorder called paroxysmal nocturnal hemoglobinuria or PNH.  The combination of aplastic anemia (AA) plus PNH required the use of special medications that are very costly. The family was not able to afford the medications. The family and the doctors applied to the government agency responsible for funding these special medications.

The doctors faxed in an application for the drug (Soliris). The agency asked for more information. The doctors faxed in the information which was requested. Then everyone waited. One week. Two weeks. Three weeks. Nothing was happening.

Everyone assumed that the process for the approval was proceeding. WRONG. Remember, DON’T TAKE NOTHING FOR GRANTED.

Our job at Rupert Case Management is to advocate for our clients. So we phoned the government agency. It took many calls. They don’t readily answer the phone. So we persisted.  As Tiffany, one of our nurse case managers stated, PERSISTENCE is what it takes to advocate for our clients and get results that count.

Here’s what we found. The fax machine at the agency was not working , so their copies of the records from the doctors were illegible. Accordingly, the agency could not proceed with the approval process. If the doctors sent more records by fax, those records would also be illegible. The agency could not receive medical records by email because that was a breach of patient privacy. This glitch had effectively stopped the approval process.

Here Is What Happened:

We took the initiative. With the patient’s approval, we emailed the medical records to the one email address that the agency had published.  We also asked someone at the agency to call us URGENTLY. And someone did call us. They had gotten the new records. They could read them. Then we asked to speak to a clinical person. Now we were moving from realm of an admin person to a clinical person.

To move the process towards approval, a clinical person should tell the patient’s story to another clinical person. They agreed to that conversation.  We spoke to the clinical pharmacist at the agency. He got it. But he had to send the medical records to an outside hematologist for approval. We asked if we could speak to the hematologist.

Nope. We couldn’t get to speak to this clinical person. But what if his fax machine doesn’t work.  We aren’t giving up yet. We are going to find out who this hematologist is and we are going to call him/her to ask  if Stan’s medical records that were received were legible.

Remember these points:

In order for your advocacy efforts to result in a real benefit for the patient needing specialty drugs which can be very expensive, the advocate must touch base with all the relevant persons at the agency who are responsible for the approval process and get confirmation from them that the information has been received and that approval process is moving forward.

Furthermore, the advocate must ensure that all the criteria for approval of the drug have been met.  It is important for an advocate who is clinical to talk to a clinical person at the agency to communicate the technical details of the case, the authenticity of the need and the sense of urgency in order to expedite the approval process.