Latest Drugwonks' Blog

A somewhat slanted viewpoint on off-label communication? You be the judge.

Under pressure, FDA to hold public meeting on off-label use

By Toni Clarke

May 6 (Reuters) - The U.S. Food and Drug Administration will hold a public meeting this summer to address drug company concern that restrictions on what they can say about off-label use of drugs violate their First Amendment right to free speech.

The meeting, announced last month by FDA chief counsel Elizabeth Dickinson, comes as a bill known as 21st Century Cures, designed to speed new drugs to market, is moving through Congress. Language in the bill is adding pressure on the agency to relax its guidelines.

Efforts by drug companies to change the rules gained steam after a 2012 decision from the Second Circuit Court of Appeals, which overturned the conviction of Alfred Caronia, a sales representative for Orphan Medical, which was later acquired by Jazz Pharmaceuticals Inc. After Caronia was caught talking to physicians about various off-label uses of the narcolepsy drug Xyrem, the court said the First Amendment protected truthful and non-misleading off-label speech.

Under current rules, physicians are allowed to prescribe medicines off-label for whatever condition they want. But drug companies are not allowed to promote them for uses that have not been approved by the FDA.

Pharmaceutical companies are citing the Caronia and similar rulings to pressure the FDA to let them talk more freely about off-label use.

"If you're a community physician it's hard to stay current," said Coleen Klasmeier, a partner at Sidley Austin LLP, which petitioned the on behalf of a coalition of pharmaceutical companies to "adequately justify and appropriately tailor its regulatory regime" in light of Caronia and similar rulings.

The coalition, known as the Medical Information Working Group, includes Pfizer Inc, Sanofi, Novartis AG, Johnson & Johnson, Eli Lilly and Co and GlaxoSmithKline Plc, among others.

At stake are billions of dollars in potential sales if manufacturers can persuade physicians to use their products for unapproved uses and a potentially significant weakening of the FDA's regulatory authority.

Karen Riley, an FDA spokeswoman, said the agency decided to hold a public meeting "because of the wide range of views held by different stakeholders and the importance of the underlying public health issues."


Drug companies have a long history of breaching the off-label rules. Over the past decade 17 companies paid more than $16 billion in settlements for off-label promotion, according to the American Medical Association, including Pfizer, GlaxoSmithKline and Eli Lilly.

In September, Shire Plc agreed to pay $56.5 million to settle charges it overstated the benefits of its attention deficit disorder drug Adderall XR and claimed, with little evidence, that it would prevent criminal behavior, traffic accidents and sexually transmitted disease.

"At my own medical center we have banned pharmaceutical reps from coming because we don't think they are a good source of information," said Dr. Rita Redberg, professor of medicine at the University of California, San Francisco, and editor of the medical journal JAMA Internal Medicine. "You don't ask the barber if you need a haircut."

Off-label use already accounts for 10 percent to 20 percent of prescribing, with that figure rising in oncology and pediatric rare diseases, according to the AMA, which said it "supports the important need for physicians to have access to accurate and unbiased information about off-label uses of drugs and devices, while ensuring that manufacturer-sponsored promotions remain under FDA regulation."


The FDA does allow companies to provide doctors with data from well-controlled clinical trials from reputable medical journals and reference texts (but not from early clinical trials or letters to editors) and they can talk about off-label use at medical conferences. They can also respond to unsolicited questions from physicians as long as the responses do not tout the benefits of a product without disclosing its risks.

Companies want to be able to discuss data that does not come from randomized clinical trials. They also want to be able to provide economic analyses to insurance companies showing why a drug should be covered.

"Let's say a drug is very expensive and very effective and doesn't have many side effects," Klasmeier said. "If you're a health plan and you are trying to decide whether to pay for the drug you want to know how it stacks up against others."

Industry pressure has "forced the FDA to think harder about this topic," said Peter Pitts, a former FDA associate commissioner for external relations, who is now president of the Center for Medicine in the Public Interest, a think-tank that receives funding from drug companies.

In response to petitions from the coalition, the FDA noted that its regulatory framework was developed "in response to public health tragedies" but said it "recognized the evolving legal landscape in the area of the First Amendment" and promised to review its policies.

It has proposed adding clinical practice guidelines to the list of material companies can circulate. These are often developed by professional associations and may include treatment and dosing regimens that differ from what is on a drug's label.

It has also proposed allowing companies to distribute medical literature showing a product's side effects to be less than described in the label. Comments from the public in response to the proposal were overwhelmingly opposed, according to documents obtained and made public by the consumer watchdog Public Citizen.


Those moves have not been enough to appease the industry. Yet public health advocates fear that if the FDA yields further, companies may be able to circulate data which is truthful under the Caronia definition without being meaningful for patient health.

A 2012 study showed that up to 75 percent of published preclinical trial results could not be reproduced in subsequent trials. An earlier one showed that when scientists attempted to corroborate 34 claims from frequently cited published trials they were unable to do so 41 percent of the time.

"People do not realize that the consequences of this new ideological approach to the First Amendment will be measured in lives," Dr. Joshua Sharfstein, a former principal deputy commissioner at the FDA who is now associate dean at Johns Hopkins Bloomberg School of Public Health.

For example, doctors prescribed schizophrenia and bipolar disorder drugs for years to control behavior in elderly patients with dementia. Studies later showed they increased the rate of death in the elderly.

Premarin and Prempro, drugs to treat symptoms of menopause, were prescribed extensively to women for years on the assumption they would prevent increased coronary disease. The hypothesis was supported by some data but not by randomized, controlled clinical trials. When the drugs were eventually analyzed in a large government-sponsored trial they were found to increase the risk of stroke and heart attack.

If companies can market drugs for off-label uses there will be no incentive for them to conduct the clinical trials needed to show the products work and are safe, critics say.

"If off-label marketing is allowed then drugs will come to be used for a wide variety of conditions for which there has not been developed evidence of safety and efficacy," said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. "You take away those checks and balances and it's the wild, wild west."

From this morning's edition of Morning Consult ...

Seeking Clarity on Complexity

A new bill introduced by Rep. Michael Burgess (R-Texas), the Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 (H.R. 1576), is an effort to get ahead of the curve on complexity. Rep. Burgess’ legislation would have the Government Accountability Office (GAO) study some of the unique challenges presented by the Food and Drug Administrations’s evaluation of generic versions of complex drug products. These challenges are as important to serving the public health as they are complicated when it comes to regulation.

The phrase “complex drug products that have not been fully characterized” is further defined in the bill to mean a drug for which: (1) the active ingredient has molecular diversity; (2) scientific analytic methodologies are unable to fully identify the molecular structures and physiochemical properties of the active ingredient; and (3) the nature of the active ingredient is not understood sufficiently to identify both the molecular components of the drug that are involved in producing the therapeutic effect, and the mechanisms of action that produce such effect.

At this level of scientific complexity, the old rules don’t apply. The Burgess bill is a timely (in fact, overdue) recognition of this hard truth.

The issues under debate are within Section 7002(e) of the Biologics Price Competition and Innovation Act of 2009. They concern the statutory definition of “biological product.”

The bill sets out two broad questions for the GAO:

1. With respect to non-biological complex drug products (NBCDs) that have not been fully characterized (such as glatiramer acetate, as an example), whether the listing of such drugs as reference products in generic drug applications presents unique challenges in meeting approval standards that are significantly different than the challenges presented by generic drug applications that list small-molecule reference products.

2. With respect to biological products that are within the scope of the exception under section 7002(e)(2) of Public Law 111-148, whether the listing of such biological products as reference products in generic drug applications presents unique challenges in meeting approval standards that are significantly different than the challenges presented by generic drug applications that list small-molecule reference products.

The FDA has more or less said that they’ve got the situation in hand and can get the job done on a case-by-case basis. In a letter to former Rep. John Dingell (D-Mich.), the agency wrote:

“FDA believes that it is possible for manufacturers to develop generic versions of complex large-molecule drugs that can be demonstrated to have the “same” active ingredient as the reference listed drug and meet the requirements for generic approval under section 505(j) of the FD&C Act and FDA regulations … FDA currently believes that it may be possible, with some complex products, for an applicant to demonstrate that its proposed drug product meets the standards for approval as a generic drug under section 505(j).”

And maybe they can. But this is just the kind of regulatory unpredictability that many parties in the healthcare policy ecosystem are pointing to as a major hurdle to advancing 21st Century Cures. Greater predictability, in theory, will not only serve the public health, but also reassure those companies who want to make costly investments that there are rules to follow – and that those rules lead to outcomes that can be logically explained.

Significantly, the agency notes, “It is important to note that analytical methods, data analysis, and pharmaceutical manufacturing capability continue to evolve.”

Per the Burgess bill, if the GAO determines, after consulting with FDA and “appropriate public and private entities,” that the answer to the issues above is that “significantly different challenges are presented for patients when reference products are NBCDs that have not been fully characterized or when reference products are biological products that are within the scope of the exception under [BPCIA § 7002(e)(2)],” then that determination triggers a series of additional considerations, including:

  1. What degree of characterization of the proposed follow-on version and the reference product should be required in order to determine the safety and effectiveness of the generic version?
  2. What degree of similarity should be required to deem that the active ingredient of the proposed generic version is the same as the active ingredient of the reference product?
  3. What types of evidence should be required to demonstrate that the proposed generic version is bioequivalent to the reference product?
  4. What requirements should be established with respect to the comparability of the manufacturing process for the proposed generic version and the manufacturing process for the reference product?
  5. Whether and to what extent clinical evidence is needed to demonstrate that there is no difference in immunogenicity between the proposed generic version and the reference product; and
  6. Whether and to what extent other clinical evidence is needed to demonstrate that the proposed generic version is as safe and effective for patients as the reference product.

The GAO report addressing each of these issues would be due not later than two years after the enactment of the proposed Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015.

As Kurt Karst of Hyman, Phelps, & McNamara opines:

“With or without the passage of H.R. 1576, we’re likely to see some interesting questions and controversies crop up with the BPCIA’s transition provisions. For instance, what happens if FDA approves an A-rated generic version of a biological product that come March 2020 will be deemed a license under the PHS Act?  Does that A-rating transition into an interchangeable biological product or not given the statutory requirements for interchangeability?  And what about the applicability of pediatric exclusivity to patents currently listed in the Orange Book for biological products that will be deemed licensed under the PHS Act?  Does that exclusivity simply disappear given the BPCIA’s pediatric exclusivity limitation and lack of a patent listing mechanism?  Also, how will FDA treat any ANDAs or 505(b)(2) applications pending review on March 23, 2020?”

This level of complexity, left ad infinitum to “the discretion of the agency,” will be a boon for lawyers, a deterrent to the developers of lower-cost follow-on products, and result in higher costs for payers and patients. A dangerous triple play and, for Dr. Burgess, co-author of the BPCI Act, contrary to the spirit of the legislation.

Peter J. Pitts is  President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner. 

May 05, 2015, 02:00 pm

Congress must encourage the 21st Century Cures Initiative

By Peter J. Pitts

Over 200,000 American heart attack survivors will have another heart attack this year. Fortunately, the FDA recently approved Zontivity -- a medicine that prevents blood clots in people who have already suffered a heart attack. In clinical trials, the new drug significantly reduced the rate at which survivors experience another heart attack.

But this breakthrough came too late for the nearly 5 million Americans who died of heart disease during the eight years between when Zontivity first proved effective in clinical trials and when the FDA granted approval.

Times have changed. The "gold standard" of large-scale, long-term, and expensive clinical trials requires reinvention. That's why Congress should encourage the 21st Century Cures Initiative. Though still a work in progress, the bipartisan congressional initiative has the potential to streamline the drug approval process -- delivering breakthrough treatments to patients sooner and eliminating wasteful spending.

More efficient regulations could free up billions for new research and development. That's why the 21st Century Cures Initiative is proposing measures that accelerate the approval process by reducing "regulatory duplication and unnecessary delays."

The initiative's proposals could help to revolutionize the current drug approval process. Today, pharmaceutical companies test thousands of compounds in the lab until they identify one that shows promising medical applications. Next, they conduct "phase I" trials on healthy adult males to ensure a drug is safe.

Phase II trials provide an initial assessment of a drug's effectiveness in sick patients. Phase III, which involves thousands of volunteer patients, helps confirm the results of phase II trials. 

The draft legislation will allow FDA regulators to approve a groundbreaking drug if it proves effective after a phase II trial. That will deliver treatments to patients much sooner and eliminate the need for some phase III trials, which take years and account for 90 percent of the total development costs for drugs that eventually gain FDA approval. 

Had the law been in effect in 2007 when Zontivity passed its phase II trials, millions of patients could potentially have accessed the new treatment. Instead, barely 10,000 people received the drug during years of phase III trials. 

The 21st Century Cures Initiative will also spur new drug development by helping biotech companies "fail faster." Of all the potential medicines that enter phase I trials, only 8 percent ever receive FDA approval. The proposed legislation would expedite "adaptive clinical trials" which identify the failures -- the other 92 percent -- earlier. That prevents researchers from wasting time and money on drugs that ultimately don't pan out.

Identifying and scrapping those failures earlier in the research and development process will allow drug companies to redirect billions towards more promising treatments. If adaptive clinical trials can catch even 5 percent of eventual failures in phase I instead of phase III, pharmaceutical manufacturers will save at least $15 million per drug.

The proposed changes mark the beginning of a transition towards a true 21st century innovation system that eliminates traditional phase II and III trials altogether. In such a system, doctors, insurers, and drug makers could use the power of big data to chart a drug's effectiveness and patient outcomes as soon as it proves safe in phase I trials. Using crowd-sourced, real world data will deliver lifesaving treatments to patients years quicker than the current clinical trial process.

Congress should ensure that Americans have the best and latest drugs possible as quickly as possible. Passing the 21st Century Cures Initiative is the best way to do so.  

Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
To the Editor:

Allowing the Federal government to negotiate drug prices (Runaway Drug Prices, May 5, 2015) would result in prices going up and patient choice going down. That’s why the Non-Interference Clause, the legislation that prohibits Federal price negotiation was created in the first place. It’s interesting and important to note that the legislative language was drafted by Senators Ted Kennedy and Tom Daschle.

Is there a need to negotiate Medicare drug prices? The Congressional Budget Office found that between 2004 and 2013, Part D will cost an extraordinary 45 percent less than what was initially estimated and premiums for the program are roughly half of the government’s original projections.

These unprecedented results are largely due to Part D’s market-based structure. Beneficiaries are free to choose from a slate of private drug coverage plans, forcing insurers to compete to offer the best options to American seniors. It’s hardly surprising that the program has led to low prices and satisfied customers.

Through their own negotiations with drugmakers, private insurance plans that operate under Part D have already had great success in keeping pharmaceutical prices down. In fact, the CBO has observed that Part D plans have “secured rebates somewhat larger than the average rebates observed in commercial health plans.”

What’s more, the CBO has said that doing away with the non-interference clause “would have a negligible effect on federal spending.” In a report from 2009, they reiterated this view, explaining that such a reform would “have little, if any, effect on [drug] prices.”

In fact, allowing the feds to negotiate drug prices under Part D would likely have a negative effect on the program. The CBO predicts that when HHS forces pharmaceutical firms to lower the cost of a particular drug, this tactic brings with it “the threat of not allowing that drug to be prescribed.”

Senators Kennedy and Daschle knew what they were talking about. The President should pay close attention.

Peter J. Pitts

Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest

In years past, pharmaceutical companies had to check themselves before conveying off-label product information – even though many of those uses had long since become standards of care. But in recent months, the FDA has signaled a willingness to open the off-label floodgates – at least somewhat. What does is all mean?

Have a look at this new article from the May edition of Medical Marketing & Media for some thoughts and clarification.

From the good folks at Inside Health Policy

Senators Question FDA's Authority To Use 'Placeholder' Biosimilar Name

Senate health committee chair Lamar Alexander (R-TN) led a group of Republican senators in expressing anxiety about unresolved questions concerning FDA's implementation of the biosimilar pathway, saying the agency's “failure” to resolve fundamental questions -- such as naming -- before approving the first biosimilar last month “raises a number of serious concerns.” The senators especially take aim at FDA's authority around using a “placeholder” name for the first biosimilar approved in March.

 The lawmakers say: “FDA has not provided sufficient guidance on important issues relating to the review and approval of license applications for biosimilar products, such as naming, interchangeability, and production of patent information.”

 Alexander was joined by Republican Sens. Michael Enzi (WY), Richard Burr (NC), Johnny Isakson (GA), Mark Kirk (IL), Orrin Hatch (UT), Pat Roberts (KS) and Bill Cassidy (LA).

The lawmakers especially question FDA's use of a “placeholder” name for the first approved biosimilar -- Sandoz's filgrastim drug product, which carries the placeholder name filgrastim-sndz.

 “It is unclear to us what it means for a nonproprietary name to be a 'placeholder,' what authority FDA has to make such a designation, or what treatment a 'placeholder' name will receive once FDA formalizes a naming policy,” they say. “In addition, we are concerned that hospitals, consumers, patients, doctors, and others may be confused by a name that appears temporary or not fully approved.”

 The senators ask FDA a series of questions regarding its implementation of the Biologics Price Competition and Innovation Act, including questions for clarification around what a “placeholder” nonproprietary name is, what the process is for changing such a name and the estimated economic impact of such a change.

They further ask what guidelines FDA staff members have been following in reviewing biosimilar applications, and whether staff members have been instructed to either follow or not follow recommendation in any of the draft guidance documents that FDA has published.

 Additionally, the lawmakers inquire as to what circumstances FDA considers necessary for a biosimilar product to disclose in its labeling that it has or has not been found to be interchangeable with the reference product or other biosimilar products that share the same reference product. “Why did FDA (a) withdraw the draft guidance it published on this issue and (b) approve labeling for a biosimilar product that contains no such disclosure?” ask the senators.

 They ask FDA to list the guidance documents regarding biosimilar or interchangeable products FDA currently intends to publish and on what timeline. FDA's drug center guidance agenda includes five planned guidances for 2015, including: additional questions and answers regarding implementation of the BPCIA; considerations in demonstrating interchangeability; labeling for biosimilar biological products; nonproprietary naming for biological products; and statistical approaches to evaluation of analytical similarity data to support a demonstration of biosimilarity.

 The lawmakers also wonder why FDA has declined to provide guidance regarding whether the so-called patent dance provisions in the pathway are mandatory. A court decision out of the U.S. District Court for the Northern District of California last month ruled that the provisions were optional. The case is now on appeal and set to be heard June 3.

 Finally, the lawmakers what to know how FDA is communicating with and educating patients in regards to biosimilars, including issues such as biosimilarity, extrapolation and interchangeability.

 “We also urge FDA to prioritize the publication of final guidance on the issues identified above, and to improve the transparency of its biosimilar review and approval process going forward,” state the senators.

Per a report in BioCentury, the FDA has added to its agenda of new and revised draft guidances that its Center for Drug Evaluation and Research (CDER) intends to publish in 2015 an item titled "Nonproprietary naming for biological products," intended to clarify the agency's thinking on biosimilar naming.

Stay tuned.

FDA could approve drugs for new uses on less data: draft law

 (Reuters) - Draft U.S. legislation released on Wednesday could make it easier for drug companies to win Food and Drug Administration approval of products for new uses.

Currently a company with a drug approved for lung cancer must conduct additional studies if it wants to market it for breast cancer.

A bill drafted by the House Energy & Commerce Committee's health panel would eliminate the need for randomized, controlled clinical trials, the gold standard for assessing whether a product is safe and effective.

Instead companies could submit data from observational studies, in which researchers have no control over the experiment, ongoing surveillance studies and other clinical experience.

"Calling for the FDA to use this data is pretty revolutionary," said Peter Pitts, a former FDA associate commissioner for external relations and co-founder of the industry-funded Center for Medicine in the Public Interest. "In the past this kind of data was not considered gold standard."

If included in the final version of the bill, known as 21st Century Cures, "it really would allow the FDA to have a broader view of how the drugs work in the real world," he added.

In addition, the FDA would be allowed to approve new indications based on a review of clinical data summaries, rather than full packages, potentially speeding up the approval time.

The bill would also require the agency to consider using real world experience as opposed to randomized trials to support or satisfy requirements for post-market studies.

The FDA frequently approves drugs based on "surrogate" endpoints that are expected to reflect clinical benefits. If a drug causes a tumor to shrink there is an expectation it could also delay progression of the disease or prolong life.

But companies are required to conduct additional trials to confirm that the expected benefit actually materializes. The bill would reduce the need for such trials.

It would also make it easier for companies to provide economic analyses to insurance companies and others involved in reimbursement. A company with a high-priced drug might want to show why it is more economical than others in the long run.

A prior version of the bill was circulated for discussion earlier this year. A parallel bill is being developed in the Senate.

The second iteration of the 21st Century Cures discussion draft comes with some added attractions – most specifically a bi-partisan authorship.

Hill chatter made it clear that Rep. Frank Pallone was holding back any “D” support until the draft called for additional NIH funding. And, lo and behold, that language is now Title I -- front and center. Whether or not that’s a boondoggle is another discussion (for another time).

As to the actual updated discussion draft, it’s better than its predecessor in many ways, not the least of which is its recognition of the FDA as part of the solution rather than part of the problem -- and that real world data should play a role in informing agency decisions. Efficacy and effectiveness.

Some items of particular interest:

Section 1121: Clinical Trial Data System

This section would create a third party scientific research sharing system for trials solely funded by the federal government in order to allow the use and analysis of data beyond each individual research project.

Section 1141: Council for 21st Century Cures

This section would establish a public-private partnership to accelerate the discovery, development, and delivery in the United States of innovative cures, treatments, and preventive measures for patients.

Section 2001: Development and Use of Patient-Experience Data to Enhance Structured Risk-Benefit Assessment Framework

Because no one understands a particular condition or disease better than patients living with it, this section would require FDA to establish a structured framework for the meaningful incorporation of patient experience data into the regulatory decision-making process, including the assessment of desired benefits and tolerable risks associated with new treatments.

Section 2062: Utilizing Evidence From Clinical Experience

This section would require FDA to establish a program to evaluate the potential use of evidence from clinical experience to help support the approval of a new indication for a drug and to help support or satisfy post-approval study requirements. In parallel, FDA would identify and execute pilot demonstrations to extend existing use of the Sentinel System to support these efforts.

Section 2082-2083: Expanded Access

This sectionwould place transparency requirements on certain drug companies regarding their expanded access programs (programs for patients to access drugs before they are approved) and require FDA to finalize guidance regarding how it interprets and uses adverse drug event data resulting from drug use under such expanded access programs.

Section 2101: Facilitating Dissemination of Healthcare Economic Information

This section would add  clarity and facilitate dissemination of healthcare economic information, as defined in the section, to payers, formulary committees, or other similar entities.

Section 2263: Reagan Udall Foundation

This section would ensure that the Reagan Udall Foundation has access to the expertise and human capital it needs to fulfill its statutory mission of advancing FDA’s scientific priorities.

The full draft can be found here.

The section-by-section draft can be found here.

And the one-pager here.

Many items of interest – and the devil is in the details. Stay tuned.

United Health Takes Novel Approach To Controlling Access To New Medicines

From The Hill:

UnitedHealth to Congress: Let cancer patients eat gauze
By Jonathan Wilcox

Investors are cheering the news that UnitedHealth Group, the nation’s largest health insurer, reported first quarter 2015 revenues of almost $36 billion, a 13 percent increase from last year that “beat the street” by exceeding forecasts.  The company said revenues are expected to reach $143 billion this year, and specifically credited “more effective and more modern approaches” for the windfall.

What are UnitedHealth’s “more effective and more modern approaches”?  Stripped of the self-congratulatory press releases, this dividend translates into something more worrisome for the tens of thousands of cancer patients dealing with rising copays, restricted coverage and all too often, access denied completely.

That’s why cancer advocacy organizations are taking action, pressing Congress and state legislatures to cap co-pays on specialty medicines and ensure equality of access and insurance coverage for all anticancer regimens.  To date, 39 states have enacted oral chemotherapy access laws, while 15 states and the District of Columbia have either introduced or passed bills to limit what patients pay for specialty medicines. 
Ask patients where these actions are necessary and you’re likely to hear about the detested practice of health plans requiring patients to use medication after medication until their insurance company agrees to pay for the drug actually prescribed by their doctor.  Insurers have a benign term for this: “step therapy.”  But cancer advocacy organizations call it something else: “fail first.”

Not only is this practice unjust, multiple studies show it increases costs to the health care system – particularly for hospital and emergency-room care — while compromising patient treatment.

Another onerous strategy is placing newer medicines (especially biologics) into “specialty tiers” – another dressed-up code word for patients having to pay up to 50 percent of the total cost of these therapies.  This can cause patients to spend thousands of dollars for a single drug that is medically necessary, opt for less effective drugs or choose not to fill their prescriptions at all. 

Then, there is the ritual of insurers covering the costs of intravenous or injectable chemotherapy drugs when patients are treated in a physician’s office or hospital, but not a major portion of the costs when patients take oral cancer drugs at home.  The insurance preference for invasive infusions and harsher side effects is simply unfathomable to many patients.

According to the latest estimates, as much as 25 percent of oral anticancer medicine costs is shifted to patients in higher co-pays – as much as hundreds or thousands of dollars per month.  As a result, almost 10 percent of insured patients don’t fill their initial prescriptions for these medications.  They want to – they just can’t afford to.  

Ten percent of cancer patients denied access to treatments their doctors prescribe and they need is no rounding error – it’s a national crisis. 

Despite these facts, UnitedHealth and other insurers are blocking patients’ path to novel therapies because they say the price of new, targeted medicines is “not sustainable.”  This may make short-term sense for the bottom line and the stock price, but it is hurting patients and damaging the broader economy.

But there is a simple solution for UnitedHealth and other health plans to solve this crisis. According to an analysis released last month by the Millman financial consulting firm, capping copays for many plans would increase premiums by less than 0.5 percent. For other plans, there are market-based ways to offset costs by increasing the copays for doctor visits by just $5.

These solutions also pay back: According to one analysis, innovative treatments and breakthrough cancer medicines are associated with 50 million life years saved over the last 15 years.  The improved outcomes and increased survivability have reduced spending on hospital and physician care, amount to an economic gain of $1.2 million per person, and countless additional tax payments as employees live and work longer.   

Right now a patient revolution is going on in this country, but it need not be at war with the insurance industry.  By all means, let UnitedHealth grow its business and expand its bottom line.  We don’t want to take away the insurance industry’s profits – all we ask is that while doing very well from patient premiums, insurers do some good for patient access, too.

Wilcox is the Public Policy director of Vital Options International, a national non-profit organization focusing on improving the lives of all Americans living with cancer. He is a fellow with the University of Southern California’s Unruh Institute of Politics and was a speechwriter for California Gov. Pete Wilson (R).

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog