Patient groups decry Medicare Part D proposal, saying it will restrict critical access

A coalition of patient groups is raising an alarm against the Trump administration's latest proposal aimed at tackling high prescription costs, saying the effort aimed at Medicare Part D's "protected class" of drugs could instead dramatically impact patient access to crucial therapies.

Anti-rejection drugs for patients who've received transplants, antiretrovirals for patients with HIV and anticonvulsants for patients with epilepsy are just a few of the therapies that could get more restricted, according to the Partnership for Part D Access coalition of patient organizations.

"While on its face, the proposal the administration has put out seems to make tweaks, we as a patient community have concerns that there are significant changes that would dramatically impact access," said Catherine Finley, a partner at the lobbying firm Thorn Run Partners who works with the coalition. The partnership includes the National Alliance on Mental Illness, the Michael J. Fox Foundation, the National Kidney Foundation and the American Society of Consultant Pharmacists.

They released a report produced by Avelere on Thursday (PDF) they say shows Medicare Part D plans are already successfully using tools including prior access to curb access to the costliest drugs, driving patients to less expensive generics.

RELATED: Trump administration proposal would allow Part D plans to negotiate prices of drugs in 'protected' classes

Among its findings: 91% of the Medicare Part D prescriptions filled in 2016 were for generics despite making up only 35% of medications in the protected class.

Other findings in the analysis: 

  • 40% of the time, plan sponsors employ utilization management tools across the six protected classes.
  • 78% of the time, Medicare Part D plans put branded products on high tiers, meaning they are subject to higher cost sharing and authorization for coverage.

"It paints a very different but a very factual basis for what's happening in Part D around protected classes that's very different than some of the other stories lines you've heard and can't back it up with Medicare Part D data," said Chad Worz with the American Society of Consultant Pharmacists.

Unveiling the Part D proposal earlier this week, CMS Administrator Seema Verma said the "protected class" of drugs under Medicare Part D has grown 63% since the policy was first created. Because those drugs have to be covered, it thwarts competition from suitable and cheaper alternatives. "As a result, beneficiaries taking these drugs have not seen these discounts that beneficiaries taking other drugs experience. This is not fair," Verma said.

Verma said the proposals would create certain exceptions to current constraints on protected drugs, allowing Part D sponsors broader use of prior authorization and step therapy. It would also allow plans to exclude from their formularies protected class drugs that have price increases greater than the rate of inflation or certain drug formulations that are not a significant innovation over the original product. 

CMS is seeking public comment on the proposals by Jan. 25.

The coalition of patient groups called that thinking about finding the cheapest drugs shortsighted.

"We acknowledge obviously there are particular classes of medications that have high volume. Some drugs may be more expensive, they may be newer to market like antipsychotics," Finley said. "But there is also good data out there that shows if you can put someone on the right medication on the Medicare and Medicaid programs, that actually saves money."

Sometimes those new drug formulations represent significant innovation to the patients who rely on them even if the actual drug itself has not changed significantly, patient groups said.

RELATED: Trump administration unveils plan to lower Medicare Part B prices by basing costs on other countries' pricing

For instance, an innovation that allows a therapy to be administered in a way that will allow it to last for 90 days at a time can transform how well a person with schizophrenia manages their condition rather than expecting them to take a daily pill, said Andrew Sperling, director of federal legislative advocacy at the National Alliance on Mental Illness.

Verma told reporters in a call this week patient access to drugs would not be curbed under the proposal, saying it includes protections for patients and allows them to choose a new plan if their plan no longer covers their drug.

Worz said that's just not how it works in reality for consumers.

"By shifting from plan to plan, you open yourself up as a beneficiary to going back and redoing a step therapy, going back and experiencing a less effective medication whether its from a compliance standpoint or an efficacy standpoint," he said. Remaining stabilized on the correct drug is critical for a patient who has received a kidney transplant or who has HIV.

"The six protected classes have the benefit of not putting the beneficiary through that and that's what we want to maintain," Worz said. "These guidelines are threatening that."