ACR's 2018 Health Policy Statements Address Biologics, Biosimilars, and the High Cost of Drugs

The American College of Rheumatology (ACR) has updated its health policy statements for 2018, and biosimilars featured heavily in the organization’s concerns for the year ahead.

ACR underscored its support of biosimilars, which it recently voiced in detail in the group’s white paper on biosimilars, saying that the organization is “committed to advocating for a smooth transition to an era of less expensive biologics that provide safe, effective treatments that are accessible to more people.” ACR says that it remains opposed to forced switching of patients’ therapy, and also opposes legislation or regulation that permits a pharmacist to substitute a biologic or biosimilar for another (unless the pharmacist is acting in accordance with a collaborative practice agreement with the prescriber). In jurisdictions where such legislation exists, providers must retain the right to demand that a prescription be dispensed as written, says ACR.

The organization also calls for biologic medicine administration to be reimbursed at the complex rate under Medicare Part B, saying that, in recent years, a growing number of contractors have stopped reimbursing at this rate without consulting with physicians, as required by law. “Reduced reimbursement and coverage for medically necessary care and treatment will force doctors to reduce services they offer. Therefore, without proper coverage of these treatments, access to therapy is threatened.”

ACR says that specialty tiers for biologic medicines that require high patient cost sharing also pose a barrier to care, and that federal, state, and local legislation should restrict such tiering by commercial insurance carriers. Other legislative tools to reduce out-of-pocket costs, such as caps on total annual out-of-pocket spending, should be explored.

The organization also expresses concerns about patient assistance programs for high-cost drugs like biologics and biosimilars; while having the benefit of providing access to critical treatments for patients who otherwise would be unable to afford their medicines, patient assistance programs insulate patients from drug costs and may distort demand for lower-cost therapies, such as biosimilars. “As such, these programs may be best paired with other measures to reduce drug list prices, and are suboptimal compared to basic cost coverage strategies,” says the ACR.

However, as long as Medicare does not cover the cost of crucial treatments, the ACR says that it will support increased access to these programs for Medicare Part D beneficiaries, and will support legislation that would allow Part B and Part D beneficiaries to receive financial copay assistance as part of these programs. It also opposes insurance restrictions preventing the application of funds from assistance programs to patients’ deductibles and out-of-pocket minimums.

Finally, in order to address the high cost of medicines, ACR supports legislation that would allow Medicare to negotiate directly with pharmaceutical companies to achieve more affordable pricing of drugs, and says that there must be increased transparency in how drug companies, pharmacy benefit managers, and payers determine the costs of medicines.