Drug companies have poured billions of dollars into precision medicine research and development. They’re discovering mutations that help us treat cancers more precisely and creating therapies that target specific patient subsets. We’re beginning to see cancers being treated by targeting the mutation instead of what organ the cancer developed from. Incredible things are happening in oncology. However, patients are learning that their insurance may not cover some of these advances. This is becoming evident as precision oncology grows and PBMs tighten their belts on what they deem “medically necessary.”Recently, KFF Health News published a story about this disconnect.
Why your cancer isn’t covered even if the drug exists.
Mason Henderson was a young man from Texas who was diagnosed with a very rare form of brain cancer. After many surgeries, radiation, chemo, and a clinical trial, his cancer continued to grow. Doctors identified another treatment he could try. Lynparza is a cancer drug created by AstraZeneca/Merck.
There was reason to believe this drug may have worked for his cancer based on the mutation it carried. But there was one problem. The drug was not approved to treat his form of cancer.
Masons PBM (Liviniti) would not cover the drug, and his family’s insurance company also denied the drug. The price to buy the drug out of pocket was said to be around $8,700 a month.
Doctors are trying to find a solution for a patient with a very rare form of brain cancer. There is a drug available that can possibly treat the cancer. His cancer is growing, and his options are running out. Accessing the drug became an uphill battle.
It took about 6 weeks for Mason to gain access to the drug through Astellas patient assistance program. He was able to take the drug for close to 2 months before passing away on May 4th.
I don’t know if gaining access to the drug earlier would have saved his life. I’m not going to sit here and say it would have. But why does it take so long to get these types of decisions resolved when a patient has a terminal illness?
Why are we developing drugs that target mutations in cancer cells, yet insurance won’t cover them when the drug is readily available?
Pharmacy Benefit Managers are slowing down precision medicine.
PBMs are meant to assist with managing your prescription benefits and lower the cost of your drugs. Depending on your health plan, they may also manage your formulary and prior authorization. They can play a big role in your prescription benefits.
When patients need high-cost specialty drugs, these programs can become a roadblock to getting them.
Having some evidence to back up a drug’s use is reasonable. We only have so many resources to spend on healthcare, and pharma companies will push their drug to be used on as many indications as possible. We should expect them to have evidence to back up their expensive drugs.
However, there’s a fine line between fighting misuse and creating hurdles for patients to receive treatments they may benefit from.
With advances in precision oncology, we’re starting to see that line blur.
Most coverage requires the cancer to meet a certain level of clinical evidence. FDA approval and studies that show the drug is effective at treating that cancer. These are all valid points we should follow. But what happens when a cancer has a mutation that can potentially be treated by a drug that we know may be effective on that cancer?
But there isn’t enough data because the cancer is too rare to conduct a study on?
Should we deny the patient that drug because we don’t have all of the data? Or should we be changing our definition of what “medically necessary” means?
These are questions we should be asking ourselves as we begin to divide cancers into more subcategories based on their genomics.
Some requests should not be treated as an add-on to your formulary.
They should have their own set of guidelines.
Prior Authorization should not stand in the way of treating cancer.
Prior authorization has become one of the most debated topics in healthcare. Insurance companies argue it reduces misuse and controls costs. Doctors will say it delays treatment and hinders their ability to care for patients.
There’s truth to both arguments. But when you have a patient who has cancer that can grow at an exponential rate? Should we still be following these steps?
When a patient has a terminal illness, time becomes a factor that can affect their outcome. Each day spent appealing a coverage decision or requesting more information from a provider could be costing a patient valuable time.
There should be faster turnaround times for patients with life-threatening conditions. Why aren’t we providing quick reviews by oncologists who know more about molecular cancers? Why can’t we get an answer from a molecular tumor board and use that information to help cover these drugs? Why aren’t insurance companies giving a clear explanation for denying these types of requests?
And why do we have to rely on the media for answers?
Maybe the denial was correct, but we need better ways to review these requests.
**Having a fast prior auth process doesn’t always mean you’re providing quality care. **
Medical Necessity should not have a defined meaning.
One of the main topics we should be looking at from this story is what we consider “medically necessary.”
Most insurance companies will look at what type of cancer you have and if there are studies to back up that drug can be used to treat that cancer. While that may be true for most types of cancer. It may not be for everyone.
Let’s say a patient has a mutation that a drug we currently sell can target. There are studies that show it can help patients with that mutation but there is not enough data to cover that cancer. Because not enough people have that type of cancer.
Doctors will argue that we should cover the drug because it has helped others with that mutation. We can argue that we don’t have enough evidence to say it will work for this specific patient.
Both of those are correct. We need to find a way to reimburse these drugs that gives patients the best chance of surviving.
By not covering these drugs based on FDA approval alone, we can create tiers that help us decide whether to cover a drug. With a tumor board review, studies showing the drug can help patients with that mutation, and other factors, we can start building cases to cover these drugs.
The FDA has already allowed coverage for drugs that can treat multiple types of cancer as long as they carry the mutation. ASCO has also begun looking into this topic and has published studies showing these drugs can help other types of cancer as well.
There’s no reason we shouldn’t be covering these drugs when we know they can help other types of cancer.
Medically necessary” should be based on what helps the patient most. Not on what we can cover most easily.
Pharma companies need to step up, too.
While we blame PBM’s and Insurance companies for these denials. Pharma companies need to step up, too.
They are the ones creating these drugs and selling them to patients and providers so they can treat many types of cancers. If they think their drug can help someone with a specific mutation, they should provide data to back that up.
Whether that be through clinical trials or other forms of study. Pharma should be helping us collect that information as well.
Another point to bring up is how much these drugs cost. $8,700 a month is not cheap for a patient to pay or for insurance companies to reimburse. So when pharma comes to us and wants us to cover their drug for a type of cancer that they are unsure of. we should question them.
Patient Assistance Programs are a great tool to have when a drug can not be covered. But we should not rely on them when we disagree with pharma on a drug’s indication.
Pharma needs to help us find a way to cover these drugs if they want us to accept precision medicine.
The next fight for precision medicine will not happen in the lab.
Drug companies have spent years trying to find more precise targets to treat cancer with. Once we find those targets, we need to make sure we are giving them to the right patients.
We may need to change the way we reimburse these drugs if we want to keep up with precision medicine.
As we learn more about molecular cancers, fewer patients will qualify for each drug. This will leave us with less data to cover them. We will need new ways to help these patients access these drugs.
Maybe we can start reimbursing these drugs based on real-world evidence? Have pharma and payers agree to reimburse the drug until a certain number of patients take it, then decide whether we want to continue reimbursing it. There are many things we can do to help these patients receive these drugs.
All of these solutions have downsides. But I think it’s worth exploring if we want to keep advancing precision medicine.
We should not be spending billions of dollars to come up with these drugs and not be able to give them to our patients.
We need to find better ways to manage utilization.
Everyone wants to talk about how innovation is changing healthcare. Drug companies are innovating. Cancer Centers are innovating. Diagnostics are innovating. Investors are putting money into precision oncology.
So where is the innovation with reimbursement?
How are we innovating our prior auth process to fit these new types of cancer? What steps are we taking to ensure these drugs are covered? How are we communicating with our members that their cancer is not covered by our plan?
Who will be held responsible if we don’t decide in time?
These are questions we should be asking ourselves if we want to move forward with precision medicine.
PBMs and Insurance companies need to find a way to cover these drugs while still managing utilization. “Medically necessary” should not be something we base our decisions on when treating cancer.
We need to keep looking at studies and evidence that can help our patients while allowing more flexibility when treating rarer forms of cancer.
Mason’s case did not show us that the drug would have saved his life. But it showed us there is still room for improvement in how we cover these drugs.
His mother summed it up best.
“Cancer doesn’t wait for your insurance to come through. “
Maybe it’s time we started thinking about that when we are creating our coverage policies.
Maybe it’s time we allowed for more flexibility when it comes to precision medicine.
If we want to offer precision medicine to our patients. We need to cover our patients with precision.
Source: Rare Brain Cancer, Tumor Genetics, Drug Coverage, AstraZeneca, Lynparza and Texas | KFF Health News
