WASHINGTON — A coalition of patient advocacy and medical groups — led by the American Cancer Society’s advocacy arm and joined by the American Medical Association — launched an advertising campaign Thursday to drum up opposition to a proposed change to Medicare they say will “put patients’ lives at risk.”

“When you limit drug therapies, you threaten lives,” reads the headline of the advertisement. It goes on to say the policy “could interfere with what doctors think is the best course of treatment for their patients and if finalized, could delay patients’ access to lifesaving innovative therapies.”

The ads will run in major national newspapers including the New York Times and the Washington Post, beginning Thursday, according to an email laying out the campaign for supporters obtained by STAT. Allison Miller, director of media advocacy at the ACS-CAN, said the campaign is “a six-figure ad buy” but declined to share the specific cost. In addition to ACS-CAN and AMA, the American Heart Association, Susan G. Komen for the Cure, the American Society of Clinical Oncology, and roughly four dozen other groups joined the campaign.

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The policies at the center of the groups’ concerns would allow private Medicare prescription drug plans to further restrict what drugs patients can use through methods like prior authorization or step therapy.

The Trump administration has heralded the changes, which have not yet been finalized, as an important part of its ongoing efforts to lower drug prices.

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The patient groups’ opposition gets at a fundamental challenge the administration must face in lowering drug prices. Currently, one of the ways insurance plans keep prices low for their members is by threatening not to cover drugs unless the manufacturer gives them a low enough price. Administration officials have praised these tactics and said that the government wants to encourage their use. But these tools also might make it more difficult for patients to get the drug their doctor thinks they need.

In particular, ACS-CAN and the other patient advocacy groups are concerned about changes to Medicare’s “protected classes,” which include drugs that treat AIDS, cancer, some mental illnesses, and seizure disorders like epilepsy. They also include drugs for patients who received transplants.

Under current rules, Medicare Part D plans must cover nearly every drug for these conditions, with some exceptions. That’s different than the rules for other diseases, where Medicare plans only need to cover two drugs per condition.

But even within these protected classes, Medicare plans are allowed to use certain tools to negotiate prices down with drug companies, according to an HHS manual. Those include prior authorization — where a drug is only covered if the doctor submits a special request — and step therapy — where a more expensive drug is only covered if a patient first tries a different cheaper drug but it doesn’t work.

Plans can only use those tools if a patient is not currently taking the drug. If a patient is already undergoing cancer treatment with a certain medicine, their Medicare provider can’t require prior authorization in the middle of the treatment.

In November, the Centers for Medicare and Medicaid Services put forward changes that would allow Medicare plans to use these tools for patients who are currently being treated. The changes would also apply to HIV drugs. Public comments are due on the proposed rule next Friday.

Some groups came out in vocal opposition to these provisions of the rule when it was first announced.

In a press release issued the day the proposed rule came out, The AIDS Institute said that the policy “will jeopardize our Nation’s efforts to provide treatment to Medicare beneficiaries living with HIV.”

Carl Schmid, the organization’s deputy executive director, explained that it’s dangerous to require prior authorization because that may make it harder for a patient to get their drugs quickly. And step therapy can be harmful because it might force patients to take drugs that aren’t appropriate for their specific type of HIV.

Schmid said he has met with health secretary Alex Azar and expressed his concerns with the proposal. His group also signed onto the ad campaign.

In December, Azar acknowledged some of these critiques.

“If … prior authorization requirements are getting in the way of take-up or adherence to HIV treatment, that would be of great concern to us,” Azar said on Dec. 11.

That same day, Azar announced that Schmid would co-chair the Presidential Advisory Council on HIV/AIDS. Schmid said that “it’s possible” the council could consider the issue, but the first meeting isn’t until March and he doesn’t know what is on the agenda yet.

The policy change doesn’t mandate that Medicare plans actually use prior authorization and step therapy for these types of medicines — it simply allows them to. And Sean Dickson, who studies drug pricing at the Pew Charitable Trusts, said other parts of the November proposal indicate that the Trump administration isn’t focusing on restricting access to HIV drugs.

The policy proposal says that the change would have a “meaningful impact” on drugs for some mental illnesses and seizure disorders, but that Medicare plans would have limited ability to use the tools for the other three classes, including for drugs for cancer and HIV.

“[It] does not appear that CMS anticipates this policy will be applied to anti-retrovirals, and … there are a number of beneficiary protections within the existing Medicare program and the proposal as written that would limit significant” use of these tools for HIV drugs, Dickson said.

Nicholas Florko contributed reporting. 

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  • If one believes, as I do, that access to the most effective health care and treatment is a basic human right, then the first step is to free the healthcare system from the malign influence of profit-making entities. Capitalism run amuck in the medical-industrial complex is wreaking havoc at every level of care. It’s time to put an end to the jockeying for power and profiteering at the expense of patients and their doctors.

  • When “institutions” rather than Doctors are allowed to dictate / limit treatment options and methods, they will for the sake of their bottom line for sure use these “options”. Stupefyingly unfair to sick people and families.
    Trump would not want to be restricted in choice of meds, and stumble for a few years with lesser drugs while his disease progresses beyond repair. So why subject others to this unfair treatment?
    The whole system needs a drastic overhaul. It is idiotic that in the big USA patients walk around with prescriptions they can not afford to fill, or are not allowed to fill. STOP the disgusting “lobbying expenses” by drug companies, force them to apply the savings to the cost of their drugs (not their royally lined pockets). The USA needs daring, gutsy, strong politicians – willing to overhaul the massively flawed health care system, including the outrageous American health care / hospital billing. Too bad that USA citizens don’t have the solution that others have : avoid the USA.

  • While I applaud the administration for tackling this subject, I do not quite agree with the pricing approach. Many drugs/indications are first released in the US , how do we price these? Choosing an arbitrary list of countries to benchmark prices is too simplistic

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