House Majority Leader Val Hoyle, D-Eugene, has slipped an amendment for pharmaceutical giant Eli Lilly into an unrelated healthcare bill that will protect its patented insulin drug against generic competition while Eli Lilly awaits approval of its own generic.
If House Bill 4110 becomes law with the Eli Lilly amendment attached, Type I and Type II diabetics would not have easy access to any generic insulin until a 2013 law restricting biosimilar drugs expires in 2016.
The amendment to House Bill 4110 adds insulin to the list of biological drugs protected by Senate Bill 460, which became law last year. “It defines insulin as a biologic and generic insulin as a biosimilar,” said Cindy Laubacher of Express Scripts, the giant pharmacy benefit management company. “Insulin is currently defined by federal law as a drug, much like your cholesterol medication.”
Eli Lilly holds the patent for the diabetes drug Humulin, a genetically engineered insulin that grossed $1.3 billion for the company in 2013.
SB 460 requires pharmacists to get express permission from a physician before they can dispense so-called biosimilar drugs, which are generic equivalents of complex biologics such as Interferons, used to treat multiple sclerosis, cancer and Hepatitis C.
Such permission would become such a hassle for pharmacists that it would likely prevent them from dispensing any biosimilar drugs. Bill Cross, the lobbyist for the Oregon State Pharmacy Association, said pharmacists and other early opponents of SB 460 agreed to a compromise that causes the law to expire in 2016 because it will be years before generic biologics are approved by the U.S. Food & Drug Administration.
But that is not true of an insulin drug like Lantus, which will likely have a generic in 2016 if not 2015. Insulin is technically a biological drug, but its chemical compound is not as complicated as Interferons, and it was not included in SB 460.
Cross said the amendment violates a promise all parties made when they agreed to the SB 460 compromise last year. “This will end up costing our customers more,” he said.
Hoyle’s amendment was slapped onto House Bill 4110 in the House Rules Committee where it passed on a 7-0 vote on Monday. The bill was then sent to the legislative budget committee on Tuesday, where it awaits approval before a vote on the House floor. Hoyle, who chairs the Rules Committee and controls its business, did not respond by press time when asked to comment about the amendment.
Relief for County Jails in Jeopardy
If the amended HB 4110 doesn’t pass, it would doom the underlying bill, which requires insurers to pay for medical coverage of people they insure if that person is in police custody awaiting trial. The bill could save Multnomah County alone more than $1 million, since county jail systems are now required to pay all the medical bills for inmates, even if they have health insurance.
“I think it’s going to kill the bill,” Rep. Mitch Greenlick, D-Portland, the chairman of the House Health Care Committee, told The Lund Report. “My hope is that all that stuff would get stripped out, and we go back to the original bill which is needed for those counties.”
The vast majority of jail inmates are either uninsured or on Medicaid, but 9 percent of people in county jails have private health insurance, according to Nancy Griffith, the Multnomah County Corrections Health Director. Chief Deputy Sheriff Drew Brosh testified that Multnomah County spends $14 million providing healthcare to inmates in the county jail.
Greenlick, who backed the original legislation, said current law allows insurance companies to deny payment of health bills for people in police custody, even though insurers would have to pay if the arrested person were released on bail.
He voted to move HB 4110 from the Health Committee to the Rules Committee last week so the counties who backed the bill might reach a more amenable compromise with health insurance companies, who opposed it.
The ranking Republican on the Health Committee, Rep. Jim Thompson of Dallas, agreed that the amendment was an example of a decent bill getting larded down with unrelated and poisonous amendments in what’s been a surprisingly acrimonious session. “In a short session when the leadership espoused no controversial legislation, these amendments are complicating simple bills.”
As for the merits of the amendment, he said it wasn’t Oregon’s business to interfere with the business of the FDA. “It’s the usual follow-the-money, who’s going to win? who’s going to lose?” he suggested.
But Rep. Bill Kennemer, R-Oregon City, who supported the amendment in the Rules Committee, said he voted for the bill after being told it would protect innovation of new diabetes drugs, not because it would stifle competition for existing drugs. “That’s a new addition for their argument,” Kennemer told The Lund Report. “I was not aware it was intended to protect a patent.”
Nate Miles, a vice president at Eli Lilly, testified Monday that categorizing insulin as a biologic was merely clearing up a discrepancy in SB 460 that should have included insulin. Miles said the Oregon law cited one federal categorization of biological drugs, but not the other.
In the last election cycle, Eli Lilly spent more on Hoyle’s campaign than on any other state legislator, giving her $9,000. Hoyle received $15,000 altogether from pharmaceutical companies, ranking her third among lawmakers and first among Democrats.
SB 460 had been pushed by biologic drug manufacturer Genentech, which has facilities in Hillsboro. Genentech gave sizable donations to the campaigns of two other powerful Democrats -- Sen. Laurie Monnes Anderson of Gresham, chairwoman of the Senate Health Committee, and House Speaker Tina Kotek of Portland.
Local Tussle, Global Battle
The tussle in the Oregon state capitol is part of a global struggle between rival pharmaceutical companies, all trying to corner the lucrative insulin market.
Diabetics now have the choice between three brand-name insulin drugs from Sanofi-Aventis, Eli Lilly and Novo Nordisk.
The patent for the Sanofi drug, Lantus, is set to expire next year, and last month, Sanofi sued Eli Lilly for patent infringement. Eli Lilly had been developing a generic of Lantus, to have ready for the market next year, according to Reuters. Lantus accounts for one-fifth of Sanofi’s sales and one-third of its profits.
But the lawsuit triggered an automatic 30-month hold, preventing the Eli Lilly generic from coming to the market before July 2016. Meanwhile, the drug company Merck has announced the late-stage clinical development of its own generic, which could jump the queue and be on the market before Eli Lilly’s generic.
The Merck drug could have generic insulin approved by the FDA and be available as early as next year, although drug market analysts told Reuters that 2016 is more likely.
Co-chairs Bates and Nathanson and members of the Ways & Means Subcommittee On Human Services,This committee must strip Representative Hoyle's -4 amendment from HB 4110.
Healthcare is a political football and healthcare providers are never the quarterbacks or receivers. Indeed, they seem to never be on the playing field! As a retired endocrinologist, I am tired of PhRMA lobbyists stealing the ball.
This coalition correctly worries that the -4 amendment "will result in increased costs for patients and plan sponsors in the long term and create access barriers for lower cost options." The -4 amendment is incongruous with the triple aim of health care reforms in Oregon.
- Improving the patient experience of care (including quality and satisfaction)
- Improving the health of populations
- Reducing the per capita cost of healthcare
Under federal law, insulin is not designated a biologic and Oregon should not create its own taxonomy. From the FDA: Frequently Asked Questions About Therapeutic Biological Products: "Note that hormones such as insulin, glucagon, and human growth hormone are regulated as drugs under the FDC Act, not biological products under the PHS Act."
While Eli Lilly is the pharmaceutical company behind this -4 amendment, they acquired worldwide rights to Genenetch's recombinant human insulin in 1982. Recombinant human insulin was the first biotechnology therapeutic approved by the FDA (1978) and subsequently marketed.
Please strip the -4 amendments to HB 4110.