Report Shows Ties Between Patient Groups, Pharma in Ads Opposing Administration's Step Therapy Plan

March 5, 2019
Allison Inserro

A Kaiser Health News (KHN) analysis found that about one-half of the patient advocacy groups appearing in national ads opposing a Trump administration proposal to change how Medicare Part D covers drugs in protected classes have received pharmaceutical industry funding.

A Kaiser Health News (KHN) analysis found that about one-half of the patient advocacy groups appearing in national ads opposing a Trump administration proposal to change how Medicare Part D covers drugs in protected classes have received pharmaceutical industry funding.

KHN created a database that tracks the financial links between such groups and drug makers. Some critics have questioned whether the patient groups are truly representing patients or the views of their funders.

The ads, for instance, say that lives are in jeopardy and that care will be delayed if the proposed change happens.

For its part, CMS says the plan force lower drug costs for patients by applying step therapy for physician-administered and other Part B and Part D drugs. Step therapy, sometimes called “fail first,” requires a patient to try, and then to fail to respond adequately to, 1 or more less expensive alternative therapies before gaining access to the prescribed treatment. CMS has indicated that step therapy for Part D drugs could include a beneficiary starting treatment with a low-cost biosimilar before receiving a costlier reference biologic.

Currently, all drugs in protected classes must be included on Part D formularies, and that creates an incentive to keep prices high, CMS says. While all 6 classes would remain, Part D plans would have 3 ways in which they could seek to limit drug utilization:

  • They could use prior authorization and step therapy more widely, “including to determine use for protected class indications.”
  • They could exclude a protected-class drug from a formulary if the drug represents only a new formulation of an existing single-source drug or biologic product, regardless of whether the older formulation remains on the market.
  • They could exclude a protected class drug from a formulary if the price of the drug increased beyond a certain threshold over a specified look-back period.

CMS is reviewing comments and the changes will take effect in 2020.

One ad that has started running is from the American Cancer Society Cancer Action Network, KHN noted. It includes a list of 56 other patient advocacy groups, and includes a link to auto-populate emails to legislators and the administration.

KHN compared the list of groups in the ad with those in its database and found that about half of the groups on the list receive pharma donations; in 2015 they received more than $58 million, collectively.

Other researchers have discussed the ties between patient groups and industry funders.

In 2017, The New England Journal of Medicine published a study showing that in its sample of 101 patient advocacy organizations, at least 83% received financial support from drug, device, and biotechnology companies.1 However, only 27% had any conflict-of-interest policies published on their websites, and just 12% had any published policies regarding the management of institutional conflicts of interest.

“In the context of organization—industry relations, concerns have been raised that industry-supported patient-advocacy organizations have spoken out for access to drugs with questionable therapeutic benefit and remained silent on policy proposals, such as drug-pricing reforms, that might benefit their constituents,” noted the authors.

In response to the journal article, the National Health Council released a statement in 2017 saying its member organizations must adhere to a set of 38 standards, 16 of which address some of the concerns raised by the authors in regards to patient advocacy groups’ independence from drug company funders.

Reference

McCoy MS, Carniol M, Chockley K, Urwin J, Emanuel EJ, Schnidt H. Conflicts of interest for patient-advocacy organizations. N Engl J Med. 2017; 376:880-885 doi: 10.1056/NEJMsr1610625.