If you thought that having a drug approved for NASH/MASH was the last barrier to treatment you were wrong. Now the insurance industry gets its turn to control patient care. The insurers are starting to publish their formulary for Rezdiffra and we will see if they care about you or their profits.
This is the state of play, in a research setting, the "gold standard" for determining fibrosis has long been a liver biopsy. In its deliberations, the FDA considered whether that would be an appropriate standard to set for the patient care function and decided it was not so they did not make that part of the drug label. That means that your doctor can use other kinds of tests to determine whether the drug is appropriate for you.
That brings us to the insurance industry. You may know that your insurance company has more power than your physician regarding what drugs you can use. Most of us can't afford to pay the cost of the drugs so we buy insurance to protect us from bankruptcy or dying for lack of access to needed therapy. The ugly part of the transaction is that the insurance company is not obligated to pay for drugs your doc prescribes. Each of them create a "formulary" which is a list of drugs they will pay for and how much.
In the case of Rezdiffra, the insurers are starting to publish those policies and we are very concerned that some are placing their bonuses ahead of patient care. The strategy is to require a biopsy prior to approval of coverage even though the FDA did not require that. This effectively throttles distribution of the drug as most patients are not diagnosed with biopsy and the industry is not prepared to perform that many biopsies even if required. It gives them a way to deny coverage which we do not believe is appropriate and will result in more people advancing to end stage disease than is necessary.
Some examples: of care systems requiring biopsy so far
- The VA serve the military community with a large at risk population
- CVS/Caremark, the largest pharmacy chain with a growing benefits management arm requires biopsy or MRE for approval
- Not yet formally announced, but we are told that Tricare, insurance for government workers, will require biopsy.
It is early so we expect there will be others, but this early effort to minimize patient uptake is a concern.
From the medical side, in fairness, there is still much to be done. Standards of Care guidance needs to be updated by the medical societies. More robust definition of diagnostic criteria are needed. Characterization of non-invasive tests needs to be accelerated. Education of patients and physicians is needed.
The advocacy community is working to try to stem this effort to limit access and while we sympathize with the managers worried about cash flow we do not agree with the biopsy policy and view it as harmful for our community.
As part of that effort, we do need data from the patient community.
If you haven't already joined our survey about the care patients are receiving, I invite you to consider helping us. We seek to document how patients are being served by their docs in this important time of change for our patient community.
The State of Steatotic (Fatty) Liver Care in America is an annual survey of liver patients seeking to understand what their experience with doctors treating the disease has been. We need your input to help us advise doctors where we, the patients, feel the care given needs to improve. Please click the link below to go to the survey. It is completely anonymous.
What you should expect, it will take about 20 minutes and there are 50 questions. LABORIOUS, I know. I hate surveys myself but this is to help us, the patient community, not some company, so please give it your attention.
CLICK THIS LINK TO GO TO THE SURVEY
If you prefer, this is a link to Spanish Verson
If you would like to read the 2023 report the link below will take you to that one.
