Doctors could possibly be held liable for not switching HIV patients from TDF-based treatments to safer TAF-based ones, especially if they do so without obtaining a patient's informed consent. However, it is unlikely that insurance companies would be held liable for not making the switch.
The duty of a doctor to disclose information
Doctors have a legal duty to disclose pertinent information to their patients. The information that they have to disclose includes:
- Side effects and dangers associated with a drug,
- Potential risks from a line of treatment, and
- Other information that a patient would reasonably need to provide informed consent to treatment.
Of course, doctors cannot keep up to date on every medical development in their field, so there are limits to the information that they need to disclose. Additionally, there is a degree of uncertainty in many medical developments that can reduce their need to disclose information. For example, when the risks of taking a new drug are not conclusive, it could eliminate a doctor's need to disclose it.
The key, though, is providing enough information so a patient can provide their informed consent to a line of medical treatment.
Can a doctor be held liable for not switching HIV drugs without a patient's informed consent?
If a doctor chooses not to switch a patient from TDF-based HIV drugs to TAF-based drugs, and does not get their patient's informed consent for the decision, the doctor may be held liable.
In these cases, the doctor has made a decision about the patient's health without soliciting the patient's input. This breaches the legal duty that doctors have to disclose information, and could amount to medical malpractice.
Can a doctor be held liable if they do not know there are safer HIV drugs available?
A more difficult situation to answer would be if the doctor did not know there are safer HIV drugs on the market.
This seems unlikely to happen, given the fact that Gilead has aggressively pushed doctors to switch patients to its newer TAF drugs.
However, this situation could lead to a doctor being held liable if their lack of knowledge amounted to medical negligence. Such negligence would violate their legal duty to provide reasonable medical care.
Given the fact that TAF-based HIV drugs have been on the market for several years, now, and numerous medical studies have said they are safer than TDF-based treatments, the lack of knowledge could amount to the medical negligence that would make a doctor liable.
Can an insurance company be held liable for not switching their coverage to include TAF drugs?
Insurance companies are very rarely held liable for not switching the drugs they cover to safer alternatives. Instead, the law has favored a hands-off approach. However, the problem is likely a moot point in the case of switching coverage from TDF-based HIV medication to pills based on the safer TAF drug.
Insurance companies use a formulary, or a list of drugs that they cover. They change the drugs that are on that formulary all the time. These changes reflect a host of factors, including:
- The arrival of generic drugs,
- Price increases of drugs on the formulary,
- Lower prices for alternative drugs that are not on the formulary, and
- Newly-released drugs that provide better or safer treatment.
The drugs included on an insurance company's formulary are not regulated by the law. Instead, formularies are market-regulated. This relies on the idea that patients who do not like an insurance company's formulary will get a different insurance provider, forcing insurance companies to provide strong formularies to attract customers.
When it comes to switching formularies to include coverage for TAF-based HIV drugs, insurance companies are largely insulated from lawsuits if they decide not to make the switch.
Instead, patients are either expected to switch to a different insurance company, or appeal the decision not to switch to safer TAF versions of their medication. Appealing can be done by:
- Asking for a formulary exception. This often requires having your doctor provide a statement that the off-formulary drug is medically necessary, and that alternatives are less safe;
- Appealing the denial of a formulary exception. If the insurance company denies the exception, you can appeal it under the terms of your insurance agreement; or
- Filing for an independent review of the decision. Most states have independent review procedures that allow state agencies to review insurance denials, including denials of formulary exceptions. In states that do not conduct these reviews, the federal Department of Health and Human Services can do it.
However, it seems unlikely that insurance companies would refuse to switch from TDF to TAF-based HIV treatments, given their similar pricing.
For example, a month's supply of three popular TAF-based drugs is slightly less expensive than their older, TDF-based counterparts:
TDF-Based HIV Drug
TAF-Based HIV Drug
Truvada - $1,844
Descovy - $1,843
Complera - $2,944
Odefsey - $2,914
Stribild - $3,392
Genvoya - $3,214
Because insurance companies are not committing to covering more expensive drugs, it seems unlikely that they would not switch from TDF-based HIV treatments to treatments that are based on the drug TAF.