The Colorado House Health and Insurance Committee unanimously passed House Bill 1183, an amendment to the state’s Medicaid protocols for step therapy, on Tuesday.
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Step therapy is a prior authorization protocol that requires patients try at least one medication selected by their insurer before the plan will grant coverage for the drug originally prescribed by the healthcare provider. It’s intended to avoid the use of certain high-cost and/or high-risk medications when they’re not needed.
The bill would require the Department of Health Care Policy and Financing (HCPF) to grant an exception to step therapy for serious and complex medical conditions if the prescribing provider submits a prior authorization request. Under the amended measure, HCPF would be required to provide a response to the exception request within 24 hours.
“Our bill aims to align Health First Colorado Medicaid’s existing step therapy protocols with commercial plans that we enacted last year with [House Bill 1370] to reduce administrative burden for healthcare professionals, save money on unnecessary care, and improve health outcomes for Medicaid recipients living with complex medical conditions,” said the bill’s co-sponsor Rep. Emily Sirota (D – Denver) during the bill’s hearing.
“These are common sense criteria for step therapy exceptions which will help cut red tape and smooth out the process for providers [and] HCPF, and ensure that Coloradans on Medicaid have the same protections across types of healthcare coverage.”
The bill’s sponsors contend that step therapy can lead to worsening symptoms and delayed care for patients. The Medicaid exemptions would follow the same criteria required of commercial health plans under current Colorado law, which makes allowances for contraindicated drugs and adverse side effects or reactions. The provider must submit clinical justification based on the patient’s medical history for the exemption to be approved.
More than 25 organizations including physicians, patient advocacy organizations, pharmacists, and HCPF are endorsing the amended version of the bill, which clarifies HCPF’s existing authority on step therapy protocols.
HCPF utilizes the protocol as a cost-containment tool and worked with sponsors on amending the bill’s initial version to address its concerns around processing timelines and bypassing current protocols that are proven effective.
“To clarify, in the initial draft of the bill, we had a couple [of] concerns, including the bill’s requirements that would mandate coverage when a patient is stabilized on any non-preferred drug,” said Jim Leonard, deputy director of the pharmacy office at HCPF, testifying before the committee. “That is already the policy for 16 of our drug categories on the preferred drug list, which treat the most complex health conditions—such as antipsychotics, anticonvulsants—but there are over 100 different drug categories on our preferred drug list.
And to require a blanket coverage policy for all non-preferred drugs would bypass the department’s established expert-based committee advice from the pharmacy and therapeutics committee and the drug utilization review boards that we have currently in place to help us make those evidence-based decisions. Consequently, that proposed requirement would inappropriately impede our ability to responsibly manage the high cost of specialty drugs, including drugs that are currently under development for which we can’t even come up with a cost estimate at this time.”
Another amendment clarifies that “biosimilar” drugs can be used under the state’s step therapy protocols. These drugs are approved by the FDA to be interchangeable with an approved biologic, a drug or vaccine made from a living organism.
“‘Interchangeable’ is a designation that is sought by the manufacturer, and the FDA does not delineate scientifically any difference really between [biosimilars and biologics],” said Brett Michelin, senior director of state government affairs at the Association of Accessible Medicines.
“The savings that the state and patients tend to derive from utilizing biosimilars over biologics has been proven already. On average, when a biosimilar comes to the market, the price of the biologic drug [drops] by 25%. And that’s on top of the fact that the biosimilar is already on average 50% lower than the reference product.”
During the meeting, committee members also approved HBs 1195 and 1070, which would allow for automated drug dispensing machines at drug outlets and shorten the clinical work requirements around licensing professional counselors and marriage therapists from two years to one, respectively.