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Colorado Expands HCV HCV Frmulary Coverage - Colorado Department of Health Care Policy and Financing Preferred Drug List (PDL) - Effective October 1, 2016
  Preferred Drug Lidt - formulary pdf here
Colorado to expand coverage for Hep C patients, but some still won't get the expensive drug
Colorado will increase access toalife-saving, expensive hepatitis C drug, covering needy patients in earlier stages of liver disease than were previously considered, the state Medicaid department said Thursday.
The decision comes after criticism from the ACLU ColoradoandDenver Health medical center and a recommendation from the state drug review board, which provides guidance ondrug coverage forthe state insurance program for needy Coloradans.
The state has paid for the 12-weekdrug treatment- which hasa 90 percent cure rate - only for patients who were in the final two stages of liver disease. Under the new policy, Medicaid patients can receive the drug if their liver damage has advanced to the second out of five stages - zero meaning no liver damage and four diagnosed as cirrhosis.
The policy also expands coverage to women who plan to become pregnant within the next year, regardless of the stage of their liver scarring. And it loosens a previous restriction barring anyone who used alcohol or illegal drugs within the previoussix months. Now people with a history of chronic substance abuse will have to enroll in drug treatment counseling at least one month before receiving the hepatitis C regime. Critics of the old policy pointed to the factthat mostnew cases of hepatitis C involvedpeople who are substance abusers andshare needles. Treating people who are spreading the virus through needles is the "most important way to stop the spread and slow this epidemic around the country," saidDr. Sarah Rowan, associate director of HIV and viral hepatitis prevention at Denver Public Health.
Rowan called the new policy a "huge improvement" and a "great step in the right direction" but said she hopes the state moves toward covering all Medicaid beneficiaries with the virus, as private insurance already does.
The ACLU, which has threatened a lawsuit, argued it is illegal to withhold treatment until people suffer "irreparable liver damage" because of the high cost of the drug. "This is a definite improvement over the past restrictions, but unfortunately it doesn't go far enough," said ACLU legal director Mark Silverstein. "It still leaves many people with hepatitis C without treatment - treatment that is medically necessary and is being denied for reasons that are not medical reasons."
State officials, though, said they are relying on clinical judgment within the department and from other physicians, and that some people with hepatitis C never advance beyond the first stage.
"We believe this is a reasonable policy," said Dr. Judy Zerzan, chief medical officer of the state Department of Health Care Policy and Financing.
The state now counts14,400 Coloradans with Medicaid who are infected with the blood-borne virus. An estimated 70 percent of those have liver disease at stage two or higher. Based on data from other states, Colorado officials estimate about 20 percent of Medicaid patients with hepatitis C will seek treatment within the next year, at a cost of about $47.5 million in state funds. Zerzan said the average treatment cost per person so far has been $86,700. That includes state and federal funds but does not factor in rebates from the drug manufacturers, which the Medicaid department does not disclose for proprietary reasons. [from Jules: after discounts/rebates medicaid costs these days appear in this range $30,000--45,000. The VA appears to have negotiated the best prices; each state medicaid negotiate on its own. Its not only a consideration of the price, but state medicaids and federal government are unable to understand that over the long term of many years it is extremely cost effective to cure the disease which eliminates the long term costs of healthcare for these patients & saves many more billions of dollars than it costs. In addition consider HIV where ART regimens cost $15,000-$20,000 a year but is not curable but a lifetime disease which over 30 years a patient cost the the healthcare system including additional medications & doctor visits etc is $500,000 or more).] So far, Colorado's Medicaid department has treated 413 people with the drug at a cost of $35.8 million, not including those undisclosed rebates. About 80 patients were treated in the past two months, an uptick Zerzan attributed to publicity about the drug coverage issue.
The cost of the treatment regime is expected to come down during the next few months and years, as competing drugs enter the market.
Until a few years ago, the best treatment for hepatitis C includedtoxicinjections that went on for a year, had an estimated cure rate of only 50 percent and included side effects such asbone pain, memory loss, depression and nausea. That all changed when a drug called Sovaldi was approved in 2013, providing 12 weeks of therapy without the excruciating side effects and a 90 percent success rate.
Colorado board recommends expanded coverage for hepatitis C drug ACLU threatens lawsuit over coverage policy
August 17, 2016
A stateboard recommended Tuesday night that more needy Coloradansreceive potentially curative treatments for hepatitis C.
But the board stopped short of recommending that the treatments - new drugs that have been shown to have a 90 percent cure rate - be extended to all Coloradans on Medicaid. And that means the American Civil Liberties Union may file a federal lawsuit against the state to force it to provide treatment to everyone.
"It's not just the right thing to do," Mark Silverstein, the legal director for the ACLU in Colorado said at Tuesday's meeting. "It's also what's legally required." The recommendation came after more than two hours of debate by Colorado's Medicaid Drug Utilization Review Board, which provides guidancefor how the state should provide medication to needy patients. A final decision on the hepatitis C treatments ultimately will come next month from the state Department of Health Care Policy and Financing. Hepatitis C is a virus that attacks the liver and can lead to prolonged illness anddeath. Starting in 2011, federal authorities began approving new anti-viral drugs for hepatitis Cthat were seen as breakthroughs with low side effects and high cure rates. There is one hitch: They're expensive.
Because of the cost, the state pays for the breakthrough drugs only if a patient is in the final two stages of liver damage, known as F3 and F4. The state has so far spent $26.6 million treating 326 hepatitis C patients. Private health insurance and Medicare cover the drug for all hepatitis C patients.
The review board on Tuesday recommended that the state cover the new drugs for all Medicaid patients at a lower stage of liver damage, F2. The board also said the state should cover the drugs for all women at any stage of liver damage who are of child-bearing age - to prevent transmission of the disease to newborn children.
But those recommendations were not without debate.
Supporters of expanding access presented an economic analysis Tuesday that argued Colorado would save money in the long run by curing all hepatitis C patients early in their infection and eliminating the treatment costs later.
"I think the investment now makes sense down the road," said Dr. Jim Regan, a board member.
But others worried whether the state could afford the initial investment. There are more than 9,000 hepatitis C patients on the state's Medicaid rolls, but it's unknownhow many would use the new drugs or how much should be budgeted each year to provide them. "If resources were unlimited that would absolutely be ideal,"Dr. Kerstin Froyd, another board member, said of covering all patients. "But they are not."
The ACLU's Silverstein, meanwhile, said federal law requires the state to provide Medicaid patients with all medically necessary care - which he said the new hepatitis C drugs are. If the state does not provide the drugs to all patients, he said the ACLU would likely file a federal lawsuit.

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