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March 5, 2015

Posts in "Pharmaceuticals"

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.

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.



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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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

Get breaking news alerts and more from Roll Call in your inbox or on your iPhone.

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.

Senate Committee Offers to Help Fight Prescription Drug Abuse

A reported epidemic of abuse of prescription drugs, which is largely focused on the misuse of prescription painkillers, will continue to focus the attention of the Senate Health, Education, Labor and Pensions Committee next year. Concern about the issue is one topic that enjoys broad bipartisan support within the committee but the panel is short on new ideas for legislative action.

Instead, the bulk of the members of committee on Wednesday wrote to the Department of Health and Human Services, the American Medical Association and groups representing state and local health departments, encouraging continued efforts to stem prescription drug abuse and urged them to tell the committee of any necessary legislative requirements.


By Paul Jenks Posted at 10:54 a.m.

November 21, 2014

Rule Updates Clinical Trial Data Disclosure; Watchdog Group Questions NIH Role in Research Protection Update

The Department of Health and Human Services today published a notice of proposed rules on reporting requirements for clinical trials on new drug products. The rules clarify requirements on posting clinical trial results on the federal website – The site contains information on more than 178,000 clinical trials and seeks to prevent duplication of trials and can quickly signal concerns about unsafe or ineffective drugs.

The website is a joint project of the Food and Drug Administration and the National Institutes of Health. However, a public watchdog group this week questioned continuing role of the NIH in the development broader looming rules on human medical research protections. The group, Public Citizen, claims that NIH is the largest federal sponsor and conductor medical research on human subjects and involvement in rule revisions poses a conflict of interest.

November 14, 2014

Big Pharma Swap Meet

Pharmaceutical companies usually do not naturally grow into giant conglomerates all by themselves. The Economist magazine this week explains the unique way most drug manufactures grow: by merging and swapping. The world biggest drug companies are the product of a series of mergers. The drug development cycle is long and risky and drug companies are always varying and adjusting the mix of products to remain profitable. Lately, companies have taken to swapping products with other manufactures in order to concentrate on specific types of drug products.


November 4, 2014

Report Touts Savings from Biosimilar Drugs

The Food and Drug Administration is currently mulling the approval process for drugs that are similar to developed biologic drugs. However, the process is complex. Biologic drugs, unlike traditional chemical drugs — such as aspirin — are derived from living cells, which poses difficulties in replicating and reviewing an alternative version of the drug. The copy of the biologic drug is normally dubbed a ‘biosimilar’.

The drug manufacturer, Novartis AG, which may be the first firm to win U.S. approval of a copycat biotechnology drug, paid the RAND Corp. to look at potential domestic savings from the medicines. The RAND study, which was released on Monday, found that the introduction of biosimilar drugs would reduce direct spending on biologics in the U.S. by $44.2 billion from 2014 to 2024.

CQ HealthBeat’s (@CQHealthTweet) Kerry Young reported (subscription) on Monday that FDA is still reviewing comments on the biosimilar drug regulatory process. Separately, a guest opinion in Roll Call on Monday from Marcia Boyle, the chief of an immunodeficiency disease patient group, urged the FDA to carefully consider patient safety concerns since “even a minor difference between a biosimilar drug and the original biologic product, known as its innovator biologic, could have a significant adverse health impact for a patient.”




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