Post-exposure prophylaxis (PEP) for HIV, which consists of immediate treatment for possible exposure to HIV to prevent infection, has been the standard of care for quite a few years.
And now, pre-exposure prophylaxis (PrEP) provides an ongoing method of protection against HIV infection. In May 2013, the U.S. Centers for Disease Control and Prevention (CDC) issued guidelines for its use in high-risk populations. In June 2014, PrEP was again cited by CDC as an important part of HIV prevention efforts. Later that month, New York Governor Cuomo chose "providing access to Pre-Exposure Prophylaxis (PrEP) for high-risk persons to keep them HIV negative" as one of the three cornerstones of his plan to end the HIV epidemic in New York state. And in July, the World Health Organization (WHO) issued guidelines recommending oral PrEP for those at high risk.
Given all this, what is the greatest impediment to scaling up PEP and PrEP as HIV prevention efforts? It's not the refusal of patients to seek new ways to protect themselves. Nor is it the lamebrained disinformation efforts of those whose factory model of HIV care depends on having a continuing epidemic.
The greatest threat to successful HIV prevention in the U.S. is the so-called health insurance industry.
We have known for some time that insurance company policies are creating havoc for many HIV-positive people seeking to get medication. Routine denials, forcing people to use inefficient mail-order companies in which the insurer has a controlling investment if not outright ownership and pushing people to go on generic versions of outdated and more toxic medications are only a few ways that insurance company policies have interfered with adequate treatment. Every doctor can tell stories of patients who missed medications simply because of insurance company foul-ups.
Now the insurance companies are setting up roadblocks that virtually ensure that significant numbers of people who seek medication to prevent HIV infection won't get it in the timely manner that is required. Or if they do, they won't be insured a steady supply.
Let me share just a few stories with you:
PEP: Out of Pocket or Out of Luck
Some of you read of my own experiences trying to get PEP. On a holiday weekend last summer, I had a possible exposure to HIV. I was in a resort area and called several pharmacies to find Isentress [raltegravir] and Truvada [tenofovir/FTC], the current first-line recommended treatment. The only one that had a supply on hand was a Rite Aid pharmacy. I assumed my insurance would pay in this emergency situation.
When the pharmacist tried to submit, he was told he had to call United. He did so, and was told he needed to speak to someone for prior approval for the drugs. He was put on hold.
I also called and was told it required prior approval.
We waited on hold for 40 minutes.
At that point he decided to try calling the prior approval phone number he had on file, only to find out that they were closed for the holiday weekend. At no time were we told that there was anything unusual required with this request.
I ended up paying over $200 for two days' supply of medications.
The next day, I tried to get coverage for the medications. First, I was told I needed to use mail-order. I had to explain that this was an urgent situation that could not wait.
I was transferred for preapproval, but then had to be transferred to another place for approval to use a local pharmacy. I got all those approvals and asked if I could just use my local pharmacy and was told that was fine.
When my pharmacy tried to put the medications through, though, they were told I had to use a "specialty pharmacy," and that only Walgreens or Duane Reade qualified. Let's not even talk about the restraint of trade issues involved here.
I sent the prescriptions to Duane Reade. When I went to get the drugs, it turned out they only had approval for the Truvada and not the Isentress. So it was back into endless-hold land with United and OptumRx to get the Isentress approved.
I started the process at 10 a.m.; it took until after 7 p.m. to get the medications. How fortunate that I could afford to lay out the money so I had enough medication to cover me and start it within the 36 hours when it would be effective!
Trying to get reimbursed by the insurance company for the money I spent was another saga.
There were two denials, which I appealed. I was finally able to get them to approve it, but then OptumRx, for some unknown reason, decided to slice off $10 from the promised reimbursement.
At that point I threw up my hands and gave up.
How much sooner would someone give up who did not have money, was not used to dealing with insurance company nightmares on a daily basis and did not have the medical background to fight the people issuing the denials? How many people would end up seroconverting because of that?
Urgent = Five Days
Several weeks ago, I had a patient who had a condom break during receptive anal intercourse with someone who was positive with an unknown viral load. We called for prior authorization, this time to Cigna. I was told I had to fill out a form, which I did and then sent to their special "urgent department." This was on a Thursday. We had to call again on Friday and finally got approval -- so much for urgency.
The patient was unable to get it at his pharmacy. Calling back again, we were told we needed an override to get it at a local pharmacy and not from the "specialty mail order pharmacy." We then obtained that override.
When the patient went to get the medication, he was told that only one medication was approved, not both.
We called the pharmacy company again and were told that because the two medications (Truvada and Isentress) were in the same class, they would only approve one for local pickup. We explained the need for the three-drug therapy and asked for an additional override, and were told that the patient's insurance did not allow it and the pharmacy benefit company was not able to override it. A supervisor told us we had to speak to Cigna.
We called Cigna and were told that they did not oversee the patient's drug plan because it was purchased directly from the pharmacy provider. Is this starting to sound like what happened with subprime mortgages?
We called the pharmacy plan again and spoke to another supervisor who said that we needed to call the HR department at the patient's company and then gave us a number to call that did not work.
Finally, five days after we initiated this process, the patient was able to get a supervisor at the pharmacy benefit company to call the HR department of his company and authorize an override.
Fortunately, through all of this, the pharmacy nearest our office, with which we have a good relationship, agreed to lend the patient the pills he needed so that he could take PEP in a timely fashion. If not, he was at serious risk of contracting HIV infection.
PrEP: Prescription for Nail-Biting
Now, the same problems are happening with PrEP.
For example, United and Oxford are requiring all patients to get preapproval. They will then allow them to get the first month of medications at a local pharmacy. They do not tell patients that, after that first month, all renewals must be through Optum Rx, which they own.
When patients go to get a refill, they find their local pharmacy cannot fill it. Often, at that point, people have only one or two pills left. United is almost guaranteeing that these people will run out of meds, placing them at increased risk of getting infected with HIV.
Even when everything is in place with the mail order, United will only allow a 30-day supply and will not issue renewals on medications if a call is placed more than seven days before the end of the month. Given the usual delays and mistakes, it almost guarantees a nail-biter situation down to the last one to two pills before getting new meds. And if a patient forgets to call early enough? No medication at all.
The HIV epidemic is still a crisis in this country. Every authority in the world is trying to find ways to improve prevention efforts. Our health agencies look at this as an emergency situation. Why then is our insurance industry allowed to promulgate self-serving, anti-competitive practices that virtually guarantee that infections that could easily be prevented with readily-accessible medications will, instead, come to pass?
As of Sept. 4, 2014, UnitedHealthcare will no longer be able to force HIV-positive people to use mail-order pharmacies. This is a result of a settlement of a class-action lawsuit filed in California. This does not apply to HIV-negative people trying to stay negative. What will it take to force the insurance industry to treat HIV prevention as the emergency it is, and to stop creating systems that promote increased infections?