Watson confirms generic OxyContin patent challenge
MORRISTOWN, N.J. — Generic drug maker Watson Pharmaceuticals is hoping to become the first to market a version of a popular opioid painkiller.
Watson said it had filed applications with the Food and Drug Administration seeking approval for a generic version of Purdue Pharma’s OxyContin (oxycodone) extended-release tablets in the 10-, 15-, 20-, 30-, 40-, 60- and 80-mg strengths.
Purdue filed suit against Watson last week in the U.S. District Courts for the Southern District of New York, the District of Delaware and the Southern District of Florida, seeking to prevent Watson from marketing its version before the expiration of five patents scheduled to expire in 2017 and 2025, according to FDA records.
If Watson wins approval from the FDA, it will be entitled to 180 days in which to directly compete with Purdue’s version. OxyContin had sales of about $3.1 billion in 2010, according to IMS Health.
In other news, Watson said it received a “favorable” ruling from the U.S. Court of Appeals for the Federal Circuit in its efforts to market a generic version of Teva Women’s Health’s contraceptive Seasonique (levonorgestrel/ethinyl estradiol [0.15 mg/0.03 mg] and ethinyl estradiol [0.01 mg]). The court reversed and remanded for trial a March 31 summary judgment order from the U.S. District Court for the District of Nevada regarding Watson’s challenge to U.S. Patent No. 7.320,969; Watson had filed an approval application with the FDA for a version of the drug containing a Paragraph IV certification, a legal assertion that the ‘969 patent, which is scheduled to expire in January 2024, was invalid, unenforceable or not infringed.
Drug shortages continue to rise, report finds
NEW YORK — For many patients, the inability to pay for drugs is enough of a problem, but what if the drugs they need aren’t available at all?
According to a new report by the Premier Healthcare Alliance, more than 240 drugs were hard to find or entirely unavailable, while more than 400 generic versions of branded drugs were backordered for more than five days. Premier said shortages had more than tripled since 2005, with the frequency and effects rising to critical levels and affecting all segments of health care.
More than three-quarters of the drugs that experienced shortages last year were sterile injectables, particularly those used in emergency situations, according to the report.
According to a Premier survey of 311 pharmacy experts at 228 retail pharmacies, infusion and oncology centers, surgery centers, long-term care centers and hospitals, 89% of respondents experienced shortages that may have caused a medication safety issue or patient-care error, 80% experienced shortages resulting in a delay or cancellation of patient care intervention and 98% experienced shortages that increased costs.
Changing Medicare eligibility age shifts costs to employers, younger seniors
MENLO PARK, Calif. — Raising Medicare’s eligibility age from 65 to 67 years in 2014 would generate an estimated $7.6 billion in net savings to the federal government, but also would result in an estimated net increase of $5.6 billion in out-of-pocket costs for 65- and 66-year-olds, as well as $4.5 billion in employer retiree healthcare costs, according to a new Kaiser Family Foundation projection of the potential change suggested by several deficit-reduction plans.
"Raising Medicare’s age of eligibility would obviously reduce Medicare spending, but also would shift costs onto seniors and employers, and increase costs elsewhere on the federal ledger," stated Kaiser Family Foundation VP Tricia Neuman, who leads the new Kaiser Project on Medicare’s Future. "This analysis drives home the tough policy choices that lie ahead when Washington gets serious about reducing the federal deficit."
Several major deficit-reduction and entitlement reform proposals include raising Medicare’s age of eligibility to 67 years old as a way of improving Medicare’s solvency. The new Kaiser study is the first to estimate the expected effects on seniors’ out-of-pocket costs and other stakeholders in light of last year’s health-reform law.
The study also estimated that the change in Medicare eligibility would raise premiums by 3% for those who remain on Medicare and for those who obtain coverage through health reform’s new insurance exchanges. The study assumed both full implementation of the health-reform law and the higher eligibility age in 2014 in order to estimate the full effect of both the law and the policy proposal.
Among the estimated 5 million affected 65- and 66-year-olds, about 3-in-4 would pay an average of $2,400 more for their health care in 2014 than they would have paid if covered under Medicare, the study estimated. Nearly 1-in-4, however, are expected to have lower out-of-pocket spending, mainly due to the health-reform law’s coverage expansions through Medicaid and the premium tax credits available to low- and moderate-income Americans.
In the absence of the health-reform law, raising Medicare’s age of eligibility would result in an increase in the uninsured, according to other studies, as many older Americans would have difficulty finding affordable coverage in the individual market in the absence of Medicare.
With health reform, virtually all 65- and 66-year-olds would be expected to obtain alternative sources of coverage. According to the new analysis, 42% are projected to obtain coverage through employer-sponsored plans, 38% through plans offered through health reform’s insurance exchanges and 20% through the expansion of Medicaid for low-income adults.
The study projected that raising the age of Medicare eligibility to age 67 years in 2014 would result in $31.1 billion in gross Medicare savings in 2014 because Medicare no longer would be covering 65- and 66-year-olds. The gross savings are estimated to be partially offset by increases in federal spending for individuals who would be covered by Medicaid ($8.9 billion) and for individuals receiving premium tax credits in the exchanges ($7.5 billion). The gross savings also would be offset by a $7 billion reduction in Medicare premium receipts from 65- and 66-year-olds who no longer would be enrolled in the program.
In addition, the study found that healthcare costs for employers would increase by an estimated $4.5 billion in 2014 as employer plans become the primary payer for 65- and 66-year-olds who no longer would be eligible for Medicare, rather than provide supplemental coverage that wraps around Medicare.
Other key findings from the study include:
Premiums for people younger than 65 years purchasing coverage through health reform’s insurance exchanges would rise by an estimated 3%, as a result of adding 65- and 66-year-olds to the exchanges;
Similarly, Medicare Part B premiums would rise by an estimated 3%, as the youngest seniors are removed from the Medicare risk pool, resulting in higher per-beneficiary costs for those remaining on Medicare; and
Costs to states would increase by an estimated $700 million overall. This reflects higher state Medicaid costs associated with 65- and 66-year-olds who otherwise would be dual eligibles (covered by both Medicare and Medicaid) and also from higher costs associated with higher Medicare premiums for remaining dual eligible beneficiaries for whom Medicaid pays the Medicare premiums. Those higher costs are offset in part by some affected beneficiaries qualifying for full federal funding under health reform’s Medicaid expansion.
The study, "Raising the Age of Medicare Eligibility: A Fresh Look Following Implementation of Health Reform," is the first in a new series of Kaiser Family Foundation studies examining the effects of proposed Medicare changes on the program’s beneficiaries, the federal budget and other stakeholders as part of the Kaiser Project on Medicare’s Future.
The study is authored by researchers from the Kaiser Family Foundation and Actuarial Research and is available online.