Gilead expands PrEP assistance; feds call for more hep C coverage
by Liz Highleyman
Gilead Sciences recently changed its co-pay assistance program for Truvada (tenofovir/emtricitabine) for HIV pre-exposure prophylaxis – better know as PrEP – allowing participants to use their full annual allocation upfront to meet an insurance deductible.
"This program change enables greater flexibility for individuals in need of co-pay assistance for Truvada for PrEP and ensures the assistance we provide for Truvada is consistent, regardless of whether an individual needs access for prevention or for treatment," Gilead spokesman Ryan McKeel told the Bay Area Reporter.
As of November 6, the annual co-pay allocation of $3,600 can now be applied as participants choose, rather than being limited to $300 per month. This means a person can pay a larger amount early in the year to cover an annual deductible, which will help people whose monthly medication expenses are low once the deductible is met.
Gilead's Cara Miller added that the change was made in response to discussions with advocates about how to make the co-pay program work for more people with diverse insurance requirements.
Community advocates expressed support for the new provisions.
The change "will indefinitely help thousands who'd given up on ever being able to afford this revolutionary prevention tool," said David Evans of Project Inform, who was among the activists calling for more generous patient support. "We'd like it to cover all deductibles and we'd like for young people still on their parents' insurance to be able to discreetly access the drug through Gilead's medication assistance program, but we will keep fighting for that and this recent change is a really good step."
"Truvada is expensive and high deductibles have made it difficult or impossible for many people to get on PrEP," David Knopf, a moderator for the widely used PrEP Facts Facebook group, told the B.A.R. "This is great news for those individuals, of course, and great news for HIV prevention."
In addition to the co-pay card for people with insurance, Gilead's Advancing Access medication assistance program helps uninsured people obtain Truvada. Changes to that program now allow participants to pick up medication at retail pharmacies rather than using a specific specialty pharmacy.
Detailed information about both programs is available online at http://start.truvada.com/individual/truvadaprep-copay.
Medicaid should cover hep C treatment
While HIV advocates praised Gilead's PrEP assistance expansion, others criticized the high cost of the company's hepatitis C medications, which they say limits access to treatment.
Gilead's Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir), as well as other new interferon-free treatments produced by other companies, can cure more than 90 percent of people with chronic hepatitis C in two to six months.
Doctors and researchers at the American Association for the Study of Liver Diseases' annual meeting last week in San Francisco emphasized the importance of prompt hepatitis C treatment.
Meanwhile, outside the conference at Moscone Center, activists with the San Francisco Hepatitis C Task Force, the Oasis Clinic in Oakland, and others held two protests calling on Gilead to lower drug prices and broaden its hepatitis C patient assistance program, as well as asking legislators to help improve treatment access.
The high cost of the drugs and the large number of people living with hepatitis C virus (HCV) – estimated at more than 3 million in the U.S. – has led many private insurers and public payers to restrict coverage by limiting treatment to people who already have advanced liver disease, requiring a period of abstinence from alcohol and drugs, or allowing only certain medical specialists to prescribe therapy.
But guidelines from AASLD and the Infectious Diseases Society of America state that almost everyone with hepatitis C should be considered eligible for treatment.
"Unfortunately, many insurers – both private and public – are delaying access to new HCV treatments to patients until their disease has progressed and the liver is further damaged," according to an AASLD statement released at the conference. "There is no medical evidence to justify that position and much to justify treating all patients."
"New direct-acting antivirals for hepatitis C will reduce hepatocellular carcinoma risk by treating patients before end-stage cirrhosis," AASLD president Gyongyi Szabo told reporters. "If we treat patients who already have cirrhosis, we can make the liver a little better, but the risk of liver cancer will remain."
On November 5 the federal Centers for Medicare and Medicaid Services (known as CMS) issued a letter to state Medicaid program directors stating that they are expected to cover the new therapies without undue restrictions.
CMS also sent letters to the pharmaceutical companies that make these drugs – which include AbbVie, Johnson and Johnson, and Merck in addition to Gilead – asking about discount purchasing arrangements to ensure wider access.
"[CMS] appreciates the work that manufacturers have done to bring new curative therapies to the market for our consumers, especially when such treatments address a major public health concern such as HCV," the letter reads. "CMS is committed to ensuring that pharmaceutical treatments are available to Medicaid beneficiaries, when medically necessary. As the agency works with states on these matters, now and in the future, we cannot do that without addressing affordability concerns."
Hepatitis C advocates applauded the developments.
"We are extremely gratified to see this strong guidance to state Medicaid programs regarding what NVHR considers highly discriminatory restrictions on access to hepatitis C curative therapy," said Ryan Clary of the National Viral Hepatitis Roundtable. "Some of the most egregious restrictions are directly counter to expert medical guidance on treating hepatitis C ... it is vital that the treatment of people with active substance use disorders be informed by evidence, not stigma or conjecture."