A highly effective treatment for hepatitis C would become more widely available to Minnesotans covered by Medicaid under a proposal adopted by a key state advisory committee Wednesday night.
Many Minnesota physicians and medical organizations say the state's Medicaid insurance program for the poor imposes barriers that are out of step with hepatitis C treatment advances, making it difficult for those infected to get revolutionary new drugs.
About 35,000 Minnesotans are infected with the disease, and although some will never develop symptoms, hepatitis can lead to costly complications, including liver failure. And with the opioid crisis moving from pain pills to injected drugs, there are concerns that untreated hepatitis C will spread to others through needle sharing.
"Hepatitis C infections have reached crisis levels in Minnesota," said Dr. Ryan Kelly, a family practitioner who helped lead the effort to change the state's policy. "Curing one person has profound upstream benefits to population health."
Many states have dropped prescribing barriers they had formerly imposed, the Star Tribune reported in January, because of medication advances and lower treatment cost. Some states have also changed policies in response to lawsuits from advocates.
"I am ecstatic that the state was able to have a conversation that ended in increasing access to people," Kelly said. "They reviewed the evidence and listened to real people with real experience working with people who are underserved."
The state's Medicaid formulary committee, an advisory group that helps set policy on prescription drugs, voted Wednesday night to remove a restriction which said the drug could be prescribed only by medical specialists, such as gastroenterologists. That move will allow primary care doctors to treat their patients in most cases.
"I do argue for the most part that it should be prescribed by primary care," said Dave Hoang, a clinical pharmacist with the Minnesota Department of Human Services (DHS), which runs the Medicaid program.
The committee also agreed to remove rules that required patients to be sober for at least six months before becoming eligible for the medications. But the committee expressed some concern that patients should be making progress toward addiction recovery, and will vote in a future meeting on how to enact that into a written policy.
"Based on the committee's recommendations last night, DHS will make revisions in the proposed criteria for prior authorization for hepatitis C," the agency said in a statement. The final recommendations will go before the committee in July or August and then the public will have 15 days to comment before the policy can be finalized.
DHS said Thursday that it did not recommend particular policy changes to the formulary committee, leaving the decision to them based on their reading of the clinical evidence. The committee did not take cost considerations into account.
Until five years ago, treatment for hepatitis C was almost as toxic as the disease itself and not always effective. That changed when a safer medication came on the market, bringing improved recovery rates but at a high cost: about $90,000 per patient.
As a result, many states, including Minnesota, adopted prescribing restrictions for cost and clinical reasons. Sobriety restrictions were used, partly to prevent people from becoming reinfected should they relapse. And the drug could only be used under certain conditions and with specialized testing, which led states to limit prescribing authority to hepatitis C specialists.
But since then, more drugs have come on the market and costs have come down. The new drugs also work on a variety of patients, and invasive testing is often unnecessary. It is likely that the new policy will require that some patients, such as those also infected with HIV, will still need to see a specialist.
If the changes are enacted, this would be the second time that Minnesota's Medicaid program has made changes to its prescribing policies, partly in response to concerns from doctors and others that bureaucratic hurdles were compounding the opioid crisis.
In September, Medicaid removed restrictions for prescribing the drug buprenorphine, which has become the gold standard to help treat opioid addiction. Among other things, the drug helps reduce opioid withdrawal cravings, but paperwork requirements sometimes created delays that kept the medication out of patients' hands at a time when they were ready to begin recovery.
The current effort to change the hepatitis C policy began last fall when Kelly approached DHS.
Since then, he's provided them with several research studies and lined up support from 42 health care professionals, as well as organizations such as the Minnesota Medical Association and the Minnesota chapters of the American College of Physicians and the American Society of Addiction Medicine.
Kelly said that while the effort required a lot of work, he found it important and worthwhile.
"To doctors who want their patients to get heard, do it and don't stop," he said.