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February 14, 2016

Posts in "Pharmaceuticals"

March 26, 2015

Appropriator Pushes for Good Deals on Drug Stockpile

The chairman of the House panel that oversees most discretionary federal health spending wants ensure that the government is negotiating the good deals for medicines held in the national stockpile of treatments for potential terrorist attacks and severe flu pandemic

“Private industry needs to give the federal government, I think, a break” on sales to the Strategic National Stockpile, Rep. Tom Cole R-Okla, the chairman of the House Labor-Health and Human Services-Education Appropriations Subcommittee, said at a Wednesday hearing.

While examining the fiscal 2016 budget request for the Centers for Disease Control and Prevention, Cole urged the agency’s leader to considering enlisting Congress if the agency needs to improve the government’s bargaining position. The fiscal 2016 budget for HHS includes $571 million for the stockpile, an increase of $37 million from the current level. These extra funds would allow CDC to replace some expiring products as well as maintain countermeasures used to respond to emergencies.

“If you need some help on that, I hope you are very forthcoming with Congress because in many cases the federal government is not only the largest purchaser, but has done a great deal of the initial scientific work” on these medicines, Cole told CDC Director Thomas Frieden at a Wednesday hearing. “This is not an area to unduly profit from in my view.”

The CDC is only part of a network of federal agencies involved in encouraging development of treatments for potential disaster and attacks, Frieden said. An Institute of Medicine meeting Thursday on countermeasures, for example, will include speakers from the Biomedical Advanced Research and Development Authority, the Food and Drug Administration and Defense Department, as well as representatives of vaccine makers, including Merck & Co. and Novartis AG.

The stockpile now holds about $6 billion worth of products, held at sites throughout the nation so that countermeasures could be delivered to any community within hours, Frieden said. CDC is working with the FDA to try to determine which products may remain effective beyond their official expiration date, he said. In answer to Cole’s question on pricing, Frieden allowed that it can be difficult when there is little competition for a treatment.

“We’re able to negotiate with manufacturers but sometimes there is only one manufacturer and that makes the negotiations challenging,” he said.

March 25, 2015

New Rules Seen for Drug Discount Program

The rapid expansion of the federal 340B discount drug program may require new legislation to make sure that its benefits reach the intended population, the neediest Americans, lawmakers said Tuesday.

Rep. Larry Bucshon, R-Ind., was among those who raised concerns at a House Energy and Commerce subcommittee hearing about the lack of firm directives to hospitals about how savings from the program should be used. Hospitals, clinics and other health agencies enrolled in the program saved about $3.8 billion in 2013 by acquiring steeply discount drugs, according to the Health Resources and Services Administration.

Hospitals are not required to divulge how they use the savings from the program, which was created in 1992 to aid medical facilities that serve as “safety nets” in less affluent communities. Some hospitals may use savings instead for general purposes, he said. While perfectly legal, Bucshon said this use of the savings runs counter to the purpose he sees for the program, which would be to expand health services and education.

“Clearly if we want to maintain a program that seems to be exploding in size and make sure that these patients continue to have access to this type of program, more aggressive oversight and probably congressional action may very well be needed,” Bucshon said .

More than 11,000 hospitals, clinics and other health organizations are participating in the 340B program, an increase of 30 percent since 2008, according to the Government Accountability Office. That growth, combined with questions about the role of contract pharmacies such as Walgreens, has lawmakers taking a closer look at the program. Rep. Joe Pitts, R-Pa., the chairman of the health subcommittee, said that it appears that Congress has follow-up work to do.

On the Senate side, the 340B program has attracted the attention of Sen. Charles E. Grassley, R-Iowa, a watchdog for federal medical spending. The inspector general for the Department of Health and Human Services last year said that some health organization participating in the program did not offer the discounted price to their uninsured patients whose medications were handled through the contract pharmacy arrangements.

In a sign that lawmakers are gearing up to propose 340B measures, they have asked the Medicare Payment Advisory Commission to has been asked to take a deeper look at the program, although it doesn’t fall strictly in its bailiwick.

Drug manufacturers have complained that the relationship with contract pharmacies allow the health organizations participating in 340B to extend the sweep of this program, while hospitals maintain that savings from the program support programs for their patients,  Mark Miller, the executive director of MedPAC, said at a March 5 meeting.

“That’s kind of the crux of the argument, why people are even talking about 340B to begin with,” he said.

By Kerry Young Posted at 11:15 a.m.

March 11, 2015

Hepatitis Pills Contributed to 13 Percent Spike in Drug Spending

Costly new hepatitis pills helped drove a 13 percent increase in drug spending last year among insurer-managed plans in the United States, a rate not seen in more than a decade, according to a report from the pharmacy benefit manager Express Scripts.

A course of therapy to treat the liver-damaging hepatitis C virus could cost as much as $150,000 with the approvals of medicines such as Gilead Sciences Inc.’s Sovaldi and Harvoni and Johnson & Johnson’s Olysio, Express Scripts said in the report, released Tuesday. Driven as well by higher costs of specialty and compounded medicines, the estimated drug spend in general for each person in commercial-insured plans was $980 in 2014.

The new hepatitis C medicines are particularly challenging for government health plans and programs.

“With more than 750,000 patients with chronic hepatitis C receiving state-funded healthcare through either Medicaid or the prison system, the burden of paying for the cost of these hepatitis C treatment regimens falls disproportionately on state budgets, as opposed to commercial insurance plan budgets,” St. Louis-based  Express Scripts said.

The federal Bureau of Prisons also is facing a spike in its costs for caring for prisoners who have hepatitis C, or HCV, with the average cost to treat an inmate now seen at about $100,000, according to a Justice Department budget document.

“The BOP has historically treated approximately 250 HCV patients per year. Continuing this treatment rate would increase HCV treatment costs to $25 million per year,” the DOJ said in a fiscal 2016 budget justification. “These costs have been between $4 and $5 million over the last several years.”

Express Scripts noted that industry research suggests the newer hepatitis pills will raise costs for Medicare’s Part D drug program by $2.9 billion to $5.8 billion in 2015.

Gilead contends that purchasers already are pushing for deep discounts for its drugs for hepatitis C.

“Any change in the formulary coverage, reimbursement levels or discounts or rebates offered on our HCV products to payers may impact our anticipated revenues,” Foster City, California-based Gilead said in an annual report filed last month with the Securities and Exchange Commission. “We also expect pricing pressure in the HCV market to continue.”

The Senate Finance Committee, which oversees the Medicare and Medicaid programs, has questioned the price charged for Sovaldi, Gilead said in the filing. Cooperating with the committee’s request has proven “costly and time-consuming” and Gilead “cannot predict the outcome” of Senate Finance’s work in this matter. 

“It is possible that the inquiries could result in negative publicity or other negative actions that could harm our reputation, reduce demand for Sovaldi, Harvoni or” related products,” Gilead said.

By Kerry Young Posted at 10:20 a.m.

March 6, 2015

Medicare Panel Focuses on Discount Drug Program

Thursday’s snowstorm delayed a House hearing on the government’s 340B discount drug program, but Congress’ advisers on Medicare soldiered on with a separate discussion about the issue.

The Medicare Payment Advisory Commission plans to include a discussion of the 340B program in its regular June report to Congress, although the drug discount offerings fall somewhat outside of its jurisdiction.

“We are not yet close to the point of making recommendations,” said Glenn M. Hackbarth, MedPAC’s chairman, beginning a discussion about the program and Medicare’s drug purchase through its Part B benefit. “If we as a group elect to pursue recommendations, that would happen next cycle,” meaning that publication would not happen before 2016.

There has been great interest from lawmakers in the 340B program, which allows some hospitals and clinics to obtain pharmaceuticals at a steep discount. These discounts don’t have to be shared with patients. Eligible hospitals and other entities saved about $3.8 billion in fiscal 2013, according to the Health Resources and Services Administration, which administers the 340B program.

HRSA has been struggling in recent year to come up a comprehensive framework for the 340B program, which was created by Congress in the 1990s.

There have been complaints from hospitals about having to pay more than they should for medicines, and about a lack of accountability on the part of hospitals on how they have used the money saved.

“It’s a program that has been run rather loosely,” Hackbarth said.

The House Energy and Commerce Committee’s health panel had to reschedule a planned Thursday hearing on the program due to weather.

In a memo prepared for the postponed hearing, the Health subcommittee staff said that the Government Accountability Office and the Inspector General of the Department of Health and Human Services are both looking at the 340B program.

GAO’s work includes a look at how hospitals that qualify for the 340B discount program compare with those that don’t, according to memo. The inspector general of HHS is examing how much Medicare might save if it were able to share in the discounts offered through the 340B program, according to the memo.

February 12, 2015

Study: Higher Share of Plans Charging Patients Higher Fees for Certain Drugs

More health insurance plans on the exchanges are placing drugs to treat complex diseases at the highest cost-sharing tier in 2015 when compared to the previous year, according to a new analysis from the Avalere Health consulting firm.

“Enrolling in a plan that places all medications for a particular disease on the specialty tier can mean significant out-of-pocket costs for consumers, particularly if they do not qualify for cost sharing reductions,” said Caroline Pearson, vice president at Avalere, in a press release. “Plans that place some drugs in a class on lower tiers may allow consumers to find lower cost alternatives.”

Avalere found that some plans placed all of the drugs within five classes of medication on the specialty drug tier – which could mean higher co-insurance and costs for patients. The medications included those to treat multiple sclerosis, two classes of drugs to treat HIV/AIDS, and two classes of cancer drugs.

The report shows that 51 percent of exchange plans put all multiple sclerosis agents, including generics, in the highest tier in 2015, up from 42 percent in 2014. Meanwhile, 29 percent of plans – nearly double the amount in the previous year — placed protease inhibitors and available generics used for HIV/AIDS patients on the specialty tier, compared to 16 percent in 2014.

Oncology’s antiangiogenics was the only class of drugs to see a slight dip in 2015, but still remains high with 60 percent of plans placing all the medications in the top tier. The study notes that there are no generics for these cancer drugs or two other classes of drugs identified in the report.

Some patient advocacy groups seized on the new information, which they maintain is a trend that started among plans in 2014 and grew this year.

“We believe some insurers are purposefully designing plans in such a way that discourages patients, particularly those with chronic health care conditions, from signing up for them,” said  Carl Schmid, deputy executive director of the AIDS Institute. “This is clear discrimination and a violation of the Affordable Care Act.”

Kevin Counihan, the CEO of the federal marketplace, said on a call with reporters that he had not yet seen the Avalere report but intended to read it soon.

The AIDS Institute is urging the federal government to enforce non-discrimination provisions in the 2010 health care overhaul by making medications more affordable to all patients and providing a clear picture of what exchange plans in 2016 will look like for patients.

But Avalere noted that the total cost impact to a patient varies on multiple factors, including subsidies, out-of-pocket limits and overall plan benefit design.

“Plans continue to innovate on benefit design in the exchange markets,” said Dan Mendelson, CEO of Avalere, in a press release. “These designs are calibrated to optimize enrollment by delivering low and stable premiums – the primary metric that consumers use to select a plan.”

February 3, 2015

Medicare Mulls Expanded Coverage of HIV Tests

Medicare is considering expanding its coverage of the test for the human immunodeficiency virus so that it would pay for this screening for all people between ages 15 and 65.

The federal health program for the elderly and disabled last week announced a plan to widen coverage. An earlier policy had established payments for tests for people at increased risk for HIV infection, including men who have had sex with men and drug users and people who had blood transfusions between 1978 and 1985. Also covered are tests for pregnant women.

The AIDS Institute applauded the proposal, saying it expects to see a final decision memorandum from the Centers for Medicare and Medicaid Services in late April.

“The next step will be educating Medicare beneficiaries and the medical community about the importance of HIV testing, and the expanded coverage beneficiaries will soon have,” said Carl Schmid, deputy executive director of the institute in a statement.

January 29, 2015

CDC Survey: Skipping Drug Doses to Save Money

The high cost of prescription drugs forces some people to adjust drug dosage save money. The Centers for Disease Control and Prevention, in its annual health survey, asked about ways people reduce impact of the cost of prescription drugs. The survey keyed on 18 percent of respondents who paid for drugs out-of-pocket. Overall, the report found that 8 percent did not take their medication, 15 percent asked for a lower-cost drug, while others sought drugs out of the country or used alternative therapies.

Adults under 65 years old are more likely to avoid taking prescribed medication to save money, with uninsured persons more likely to skip doses than people covered by Medicaid or private health insurance.

By Paul Jenks Posted at 10:15 a.m.

January 28, 2015

Draft Proposal Seeks to Spur Medical Breakthroughs

The House Energy and Commerce Committee on Tuesday unveiled a discussion draft (view summary) of a long-awaited plan (view accompanying white paper) to spur medical breakthroughs. The early version of the measure — dubbed the 21st Century Cures Act — seeks to promote the development of new medical advances for drugs and medical devices through an overhaul of the product and federal agency regulatory process and modernizing the development and examination of new treatments in clinical trials.

The discussion draft is billed as a starting point and the committee release noted that the inclusion of a policy should not be considered an endorsement. Democrats on the committee did not immediately endorse the draft proposal and rallied around a separate effort initiated this week (HR 531) to ramp up funding additional basic research at the National Institutes of Health.

January 23, 2015

Regulating Precision Medicine

President Obama touted a very precisely-worded initiative in his State of the Union address this week, a “precision medicine initiative.” While the speech offered no further details on the plan, the concept hinges on the mapping genomes and learning more about the genetic mechanisms of tumors and other aspects of disease development. Patients would be treated based on their individual genetic profiles, enabling professionals to customize drug treatments instead of taking a one-size-fits-all approach.

However, CQ HealthBeat’s Georgina Gustin reports (subscription) that some policymakers are questioning whether the Food and Drug Administration (FDA) is capable of evaluating the safety and efficacy of the next-generation  of precision medicines. The key for the FDA lies in collecting vast amounts of genetic data and handling what could be a flood of applications for promising cures. Some members of Congress say that the pace of approvals already is too slow – and some patient advocacy groups are looking to lawmakers to speed things further.

January 21, 2015

Pharmacists Press for Care Coordination Role

Pharmacist are seeking to forge a broader role in health care delivery system and several states are aiding them by loosening some regulatory burdens. However, the pharmacists are still primarily restricted to distributing prescriptions and are not recognized in the Medicare program as a provider of other services similar to nurse practitioners and chiropractors. Carolyn Phenicie in CQ’s State Report describes how some states are allowing increased collaboration between physicians and pharmacists for medication management programs.

Separately, pharmacists have gained a voice in Congress. Georgia Republican Rep. Earl L. “Buddy” Carter is believed to be the first pharmacist, who has owned his own drug store, to ever serve in Congress. CQ Roll Call’s Melissa Attias reports (subscription) that Carter will seek to allow pharmacy care coordination services under the Medicare program.

By Paul Jenks Posted at 9:58 a.m.

SOTU: 21st Century Cures Effort Gains Support

President Obama, in his State of the Union address on Tuesday evening urged a “precision medicine initiative” that would advance efforts to address cures for diseases like cancer and diabetes. While the president offered no specific details on the initiative, congressional reaction to the speech interpreted a likely intersection with ongoing development in the House Energy and Commerce Committee of a medical research and drug product approval process overhaul package.

Committee chairman, Michigan Republican Fred Upton touted the work on a looming legislative measure, dubbed “21st Century Cures“, which seeks to speed the discovery, development, and delivery cycle of medical advances. Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander of Tennessee immediately tied the president’s initiative suggestion with the looming “21st Century Cures” effort.

State of the Union excerpt (view transcript):

21st century businesses will rely on American science and technology, research and development. I want the country that eliminated polio and mapped the human genome to lead a new era of medicine: one that delivers the right treatment at the right time.

In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable. Tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes and to give all of us access to the personalized information we need to keep ourselves and our families healthier.

January 15, 2015

Clinical Trials: Senators Encourage Access, Report Urges Sharing

Clinical trials for new drug products may offer hope for patients with rare conditions. Physicians and patients may seek to be a part of a clinical trial. However, prior to 2010, compensation offered to participants in a clinical trial impacted eligibility for the Medicaid program. A measure offered this month by the leadership of the Senate Finance Committee (S 139, plus HR 209) seeks to continue allowing Medicaid patients access to drug trials. The legislation extends beyond this year the income exclusion for people who participate in rare disease clinical trials.

Meanwhile, clinical trials are a pivotal element of the drug testing and approval process. The Institute of Medicine on Wednesday weighed in with a report urging improved data sharing from U.S. and international clinical trials. However, clinical trial data includes patient details and potential privacy concerns and early release of data, prior to final analysis, could be misinterpreted. The report offers guidance on handing possible problems with sharing of data and focuses on structural and technological barriers within the complex clinical trial process.



By Paul Jenks Posted at 8:08 a.m.

January 8, 2015

FDA Panel Weighs in on a Biosimilar Cancer Drug

A Food and Drug Administration advisory panel on Wednesday unanimously recommended the approval of the first biosimilar  — or copycat — drug product.  A possible final FDA decision on the application will impact one of the largest markets for medical products. The drugs are similar but not exact copies of the original biotech drugs and FDA action follows congressional instructions to begin the process of approving biosimilar drugs.

CQ HealthBeat’s (@CQHealthTweet) Kerry Young  reports (subscription) that the panel offered guidance on a version of a cancer drug that helps patients produce infection-fighting white blood cells. If the drug is approved it will likely be followed by other biosimilar drugs, which reportedly could save $250 billion in health costs over the next decade. The drug industry is closely watching the decision, which also could offer suggestions on whether the copycat drugs should be allowed the same scientific label and non-proprietary drug name.

View also: Report Touts Savings from Biosimilar Drugs

The 114th: CQ Roll Call’s Guide to the New Congress

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By Paul Jenks Posted at 8:28 a.m.

January 7, 2015

Medical Cures Bill Poised to Speed New Antibiotic Development

The House Energy and Commerce Committee has spent the last year developing a bipartisan proposal to eliminate federal rule roadblocks and entice research to speed medical breakthroughs. The committee is expected to unveil the proposal, dubbed “21st Century Cures,” later this month after a dozen hearings last year on various possible elements of the bill.

CQ Roll Call’s Melissa Attias reports (subscription) that the package could include a new approval pathway for antibiotics to fight drug-resistant bacteria. The antibiotic provisions would establish a new approval process for anti-bacterial and anti-fungal drugs that are aimed at treating a serious or life-threatening disease in a limited group of patients to fill an unmet medical need. The process would allow the treatments to be studied in smaller clinical trials, addressing concerns that large-scale trials are often impossible given the limited number of people with those infections. However, opponents of the bill worry about the safety risks of compromising the Food and Drug Administration drug approval process.

The 114th: CQ Roll Call’s Guide to the New Congress

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December 18, 2014

FDA Looks to Eliminate Some Drug Label Papers

Prescription drug packages include not only medicine but also an array of folded printed instructions and warning notices, all of which are tightly regulated by the Food and Drug Administration. However, the drug regulatory agency wants to eliminate some of the dense reading material. In a rule proposal set for publication on Thursday, the FDA proposes eliminating drug-labeling information provided for those who prescribe the drug, such as physicians and pharmacists. Printed label instructions designed for consumers are not the subject of the rule proposal.

The proposal is not primarily focused on reducing the volume of drug inserts but to make sure the drug prescriber has access to the most current information on the drug. A printed sheet of information is likely immediately out-of-date and health care professionals are urged to seek electronic files on prescribing information. The proposal suggests that the drug label should note directions on finding the electronic label information and acknowledges some disadvantages cited in a 2013 Government Accountability Office report on the use of electronic drug labels.

The FDA estimates drug industry savings of $52-164 million by eliminating the labels or inserts and added pharmacy costs of $47-89 million.


By Paul Jenks Posted at 12:55 p.m.

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