Responding to the Trump administration’s drug pricing proposals, the ACR released a set of principles it hopes will help guide any drug policy changes.1 The principles underscore what is critically needed for rheumatologists to provide the best and safest care to their patients, many of whom require ongoing treatment for chronic conditions.
“The ACR has prioritized this issue and has grave concerns regarding reduced patient access to care as a consequence of the administration’s drug pricing proposal,” says Colin Edgerton, MD, chair of the ACR’s Committee on Rheumatologic Care (CORC).
5 Principles
The principles underscore the importance of patient access to affordable, high-quality drugs. The ACR listed five key principles to ensure such access:
- Provide patients access to high-quality rheumatology treatments to control disease activity and prevent disability, permanent damage to joints and other organ systems, and early death;
- Reduce and streamline utilization management tools used in the drug distribution system, including Medicare Part D, which delay and prevent patients from accessing medicines;
- Ensure patients’ safe access to Medicare Part B treatments in monitored settings;
- Promote the use of treatment guidelines, when available, adapted for individualized treatment decisions made by doctors and patients; and
- Improve the FDA’s capacity and manufacturers’ ability to bring safe, effective biosimilars to market to maximize access to treatment by lowering costs.
The Blueprint
In the American Patients First Drug Pricing Blueprint issued in May, the Trump administration laid out a number of questions on how to lower U.S. drug prices.2 According to Angus Worthing, MD, the ACR’s Government Affairs Committee chair, the blueprint identifies four problems and four solutions.
The four problems:
- High list prices;
- Government programs overpaying because they lack negotiation tools;
- High out-of-pocket costs; and
- Foreign free-riding.
The four solutions:
- Improved competition;
- Better negotiation;
- Incentives for lower list prices; and
- Lower out-of-pocket costs.
“There are some good ideas here and some possibly bad,” says Dr. Worthing, “It is clear that, in some way, rheumatology could be changed by these proposals, which is why the ACR will continue to respond vigorously.”
Good & Bad Ideas
One possible good idea, according to Dr. Worthing, is forcing payers to pass negotiated drug savings on to patients. One provision in the blueprint allows insurers and pharmacy benefit managers (PBMs) under Medicare Part D to share more of the rebates they get from pharmaceutical companies to patients.
That said, another provision in the blueprint, which allows private insurers more negotiating power on drugs delivered to a doctor’s office or hospital through Medicare Part B, may potentially be a bad idea, he says. The provision could result in “inserting step therapy and other utilization management techniques into Medicare Part B [physician-administered] drugs into the Part D system, restricting Medicare drug formularies by allowing payers to approve one drug [instead of two] per class, and recreating a competitive acquisition program for Part B drugs that was previously unworkable,” he says.
One particular challenge highlighted by Dr. Worthing is getting biosimilars into formularies governed by private insurers and PBMs. For Dr. Worthing, getting biosimilars into the U.S. market as soon as possible is critical to ensure affordable, high-quality drugs for people with chronic diseases, and getting them onto formularies essential.
Overall, he underscored the importance of biosimilars to help control drug prices and access to care. “I would humbly submit that the one thing we and our patients can do right now about drug prices is to become more comfortable with biosimilars,” he says.
ACR at Work
The ACR developed its set of principles to encourage federal officials to consider those drug pricing policies that will safeguard access to high-quality medicines for patients, particularly those with chronic diseases for whom access mandates affordability.
The ACR plans to formally respond by mid-July to the American Patients First Drug Pricing Blueprint.
Mary Beth Nierengarten is a freelance medical journalist based in Minneapolis.
Resources
- American College of Rheumatology. ACR Principles on Prescription Drug Prices and Access to Treatment. https://www.rheumatology.org/Portals/0/Files/ACR-Principles-Prescription-Drug-Prices-and-Access-to-Treatment.pdf.
- S. Department of Health & Human Services. American Patients First. 2018 May. https://www.hhs.gov/sites/default/files/AmericanPatientsFirst.pdf.
