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Hepatitis C, a Miracle Cure and Gilead’s Plan

Hepatitis C, a Miracle Cure and Gilead's PlanGilead aims to eradicate hepatitis C from the planet and has enlisted an entire nation as its demonstration lab.    In return, the Republic of Georgia has gotten the best possible price on Harvoni (ledipasvir-sofosbuvir), the company’s hepatitis C drug that lists at $1,150 a pill in the U.S.

The Black Sea nation wedged between Turkey and Russia does not pay a penny (or “tetri”) to Gilead as part of a five-year Hepatitis C Elimination Program launched in April with technical support from the U.S. Centers for Disease Control and Prevention (CDC).

Gilead donated an initial 5,000 courses of Sovaldi (sofosbuvir) and, this fall, began supplying Harvoni, which it began donating at a rate of 20,000 courses annually this fall upon its approval by Georgia.

The Georgian government is funding other costs associated with the program, such as screening, administration and monitoring.  Harvoni is a once-daily tablet while patients must use Sovaldi with other medications.

With just a population of five million, Georgia has the world’s third highest prevalence of HCV infection, exceeded only by Mongolia and Egypt.   As many as seven percent of the nation’s adults carry the virus, a blood infection which can destroy the liver.  Worldwide, HCV infects an estimated 130 – 150 million people and killed 700,000 in 2013.

By the end of August, the Georgians had completed a population based prevalence survey, registered 10,564 patients in the program, started treatment on 3,022 and recorded cures for 122 of 125 patients completing a 12-week regimen.  Some estimates place the total number of Georgians infected at 200,000.

Progress but Obstacles

Despite this early progress, the Georgians are facing obstacles inherent in the complexity of the disease and the variety of current therapies, including interferon, multiple anti-virals, Sovaldi and Harvoni.  These obstacles will hinder eradication there or anywhere else – as noted by “Alexandre,” a Georgian HCV patient interviewed by Georgia Today.

“I try not to worry,” said Alexandre, “My biggest concern is that our infectionists lack experience with hepatitis C management.  The disease emerged in the 80’s and despite a large number of variations in the treatment formula, it needs high professional experience.”

The virus, discovered in 1989, has six different genotypes, the prevalence of which varies from nation to nation.  Genotype 1 is most common in the United States at 75% of those infected.  In Georgia, genotype 1 drops to 43%, accompanied by genotype 2 at 20% and genotype 3 at 37%.

Disease progression by patient also differs, from spontaneous disappearance or easy treatment of the virus, to chronic hepatitis, cirrhosis, cancer and/or decompensated liver disease requiring a liver transplant.  Patients can also vary by age, comorbidities (e.g. heart disease, HIV), treatment history, risk factors and disease stage.  Hepatitis C can also be associated with heavy alcohol use, toxins, some medications, and certain medical conditions.

As a result, selecting the right treatment alternative typically requires – even in the United States — a specialist to type the virus, assess the patient, avoid harmful drug-drug interactions and monitor for potential side effects.  “Alexandre,” for example, suffered an allergic reaction from a prescribed adjunctive medication, ribavirin.  Patients must also strictly adhere to their medications or risk full recovery.

In the United States, the National Institutes of Health (NIH) is conducting a clinical trial in Washington, DC, to assess the effectiveness of treating hepatitis C with Harvoni in community clinics led by primary care physicians, nurse practitioners, and physician assistants.  Based on trials conducted by specialist teams, the Food and Drug Administration (FDA) approved Harvoni in October 2014, but only for genotype 1; approval for genotypes 4, 5 and 6 came in November 2015.

Miracle Cure for Hepatitis C

However, a solution for the specialist bottleneck is on the way — the first all oral, single tablet chronic HCV regimen for every genotype, simple to use regardless of prior treatment, disease stage or anti-viral resistance.  Potential side effects are modest, most commonly fatigue, nausea and headache.  “This is what a miracle looks like,” enthused one hepatitis C activist on Twitter.

Groundbreaking results from clinical studies of Gilead’s sofosbuvir (Sovaldi) – velpatasvir (SOF/VEL) combination recently appeared in the New England Journal of Medicine here, here and here, and in the Annals of Internal Medicine here and here.

The new drug is on approval fast tracks in both the U.S. and Europe.  The FDA has assigned SOF/VEL a Breakthrough Therapy designation as an investigational medicine that may offer major advances in treatment over existing options.  It has also set a PDUFA approval target date of June 28, 2016.  Meanwhile, the European Medicines Agency (EMA) has granted SOF/VEL Accelerated Assessment.

“This drug regimen changes the standard of care in treating patients with HCV. We can now cure almost everyone with a very simple treatment,” explained Dr. Jordan Feld, MD, MPH, lead author of the NEJM studies, to the Toronto Star.

“Knowing which treatment to use for which patient required expertise, which made it much more difficult for non-specialists to treat hepatitis C.  With the single tablet that is effective for all strains of the virus, it’s hoped that family doctors, internists and nurses will step in to treat hepatitis C,” he added.

“There are some who believe that the future is a one-size-fits-all single pill, such that a primary care doctor could prescribe it without having to be concerned about genotype, viral load, or complications,” concurred Ronald Sokol, MD, of University of Colorado School of Medicine and Children’s Hospital Colorado during a liver disease conference in November 2015.

Weighing in, too, were two key CDC leaders via a NEJM editorial:  John Ward, MD, Director of the Viral Hepatitis Program and Jonathan Mermin, MD, MPH, Director, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP).  They said sofosbuvir–velpatasvir regimen could simplify HCV management, “paving the way for simple ‘test and cure’ strategies appropriate for primary care and other settings, such as addiction-treatment programs.”

In noting that this new medicine removes significant clinical obstacles to hepatitis C eradication on a global scale, Ward and Mermin are very concerned that financial and access barriers could be thwarting:

“The availability of simple, safe, and curative regimens creates opportunities for improving the health of the millions of patients living with HCV infection. At a population level, the effect of HCV medications will be determined by affordability and equitable access to HCV testing, care, and treatment. Only through these improvements can our focus be directed to what matters most: reducing the morbidity and mortality associated with HCV infection, stopping HCV transmission, and ultimately eliminating HCV as a public health threat in the United States and worldwide.”

Pricing the Miracle Cure

How do you price a new miracle cure for hepatitis C, serving both shareholders and patients?   Gilead likely is still working the problem, deploying a process much like the one it used to price Sovaldi.  The U.S. Senate Finance Committee revealed the process in a December 2015 report, which the Wall Street Journal described as providing “perhaps the most transparent look ever into pricing decisions in the modern drug business.”

Aside revenue maximizing accusations and price gouging insinuations by Sens. Ron Wyden (D-OR) and Chuck Grassley (R-IA), Gilead actually deployed a very deliberate pricing process.  It calculated the value added by Sovaldi compared to existing treatments and balanced that with forecast of patient “starts” (volume), potential payer access restrictions and clinical obstacles like the specialist bottleneck.

Then, amidst U.S. market competition and payer resistance for 2015 sales, it discounted both Solvadi and Harvoni by an average of 46% to an estimated $643 per tablet for Sovaldi and $536 per tablet for Harvoni.

In Europe, Gilead negotiated a $536 per tablet price for Sovaldi with both Germany and France, although the deal with France includes volume incentives.  Globally, list and negotiated prices tracked a nation’s ability to pay, as measured by gross domestic product, gross national income and health expenditure per capita.

Meanwhile, Gilead has signed licensing agreements with 11 Indian generic manufacturers to produce and distribute generics for Sovaldi and Harvoni in 101 developing countries.  In addition, it has signed agreements with three companies in Egypt and Pakistan for local distribution within those countries.

In May 2015, Médecins Sans Frontières/Doctors Without Borders (MSF) reported that one of the Indian generics makers was charging $189 per 28-day-supply bottle, or $567 for a full 12-week treatment course of sofosbuvir (Sovaldi).  However, it is unhappy with Gilead’s generic licensing strategy, saying that it prohibits licensees from selling in 50 middle-income countries and excludes additional generics makers who want licenses.

Setting the Stage for Launch

Notably, Gilead has already included its breakthrough SOF/VEL combination drug in these generic licensing arrangements, anticipating approvals from the FDA, EMA and regulatory bodies elsewhere.  Alluding to SOF/VEL and its forthcoming launch, MSF notes, “People living with HCV and governments around the world have high expectations.”

However, MSF suggests governments do not have to wait for “patent and regulatory barriers” to come down, especially in middle-income countries.  To secure access to affordable treatment, MSF advises:

“Through measures taken at the domestic level, or through collective engagement at the international level, low-cost generic medicines – which cost a fraction of the high prices charged by Gilead – could be provided.”

Already, another group, Initiative for Medicines, Access & Knowledge, is challenging Gilead patents or patent applications in China, Argentina, Brazil, Russia and Ukraine.

The Republic of Georgia is among the 50 middle-income countries MSF wants included in Gilead’s voluntary licensing program – “or else.”  Rather than expand its licensing program to these countries, Gilead reveals a different strategy with its Georgian demonstration project – one of engagement with these nation’s governments coupled with financial assistance from multilateral organizations.

“We will take the Georgia data to other countries around the world to really make the case that investment can fundamentally change the disease over time,” explained Gregg Alton, Gilead’s executive vice president, corporate and medical affairs.   “Gilead cannot cure hepatitis C globally on our backs alone.”

Launching the Miracle Cure

Just another pharmaceutical product launch, SOF/VEL will not be.  Instead, look for Gilead to announce a global campaign to eradicate hepatitis C, answering the global call of patients, health systems, governments, multilateral organizations and even the Economist newspaper.

Photographs will show generics produced and ready to ship, videos will document compelling patient stories in Georgia, agreements will chart the expansion of Georgia-like demonstrations and support from multilateral organizations.  Perhaps, even MSF and Gilead leaders will stand together at the press conference.

In the U.S. and the developed world, shifting to a primary care screen and treat model, removing the specialist bottleneck, should provide an increase in patient starts justifying list and negotiated prices much lower than those of Sovaldi and Harvoni.

Watch, too, for the rollout of education campaigns to increase screening and diagnosis, and special initiatives in prisons and among substance abusers, recognizing that about half of all those with HCV have yet to be diagnosed.  Again, at the press conference, expect representatives from government, medical societies and the big pharmacy benefit managers to stand with Gilead.

Stay tuned!

Repatha’s Path to Patients: Via Value?

amgen repatha

Amgen’s Repatha is “well tolerated” and a “welcome alternative” for some, admits the U.K.’s National Institute for Health and Care Excellence (NICE).  Yet, the British cost watchdog this week told Britain’s National Health Service (NHS) not to pay for the new super cholesterol reducer.

Repatha, one of the new class of biologic specialty drugs called PCSK9 inhibitors, reduces ‘bad’ low-density lipoprotein (LDL) cholesterol by 54 to 77%.  The European Commission and the U.S. Food and Drug Administration (FDA) approved Repatha and another PCSK9 drug, Praluent, this summer.

More Repatha Data

In a draft guidance set for final review in January, NICE disagreed with some of Amgen’s economic calculations and assumptions.  More significantly, it said direct evidence of Repatha’s impact on cardiovascular disease (CVD) outcomes was lacking and thus an “important limitation” and “key area of uncertainty.”

NICE could have used Repatha’s cholesterol-reducing results as a surrogate for CVD outcomes, based on biologic and epidemiologic studies of statins’ cholesterol-lowering impact on these outcomes.   In fact, the draft guidance allowed, “it was reasonable to infer that evolocumab (Repatha) would reduce CVD.”

However, NICE instead proposed a guidance review for February 2018, when results will be available from the long term, FOURNIER study documenting Repatha’s impact on CVD outcomes.   Short-term- study meta-analyses suggest considerable Repatha CVD effectiveness, possibly reducing mortality odds by 50%.

Pay for Performance

Meanwhile, a week earlier, back in the U.S., Harvard Pilgrim Health Plan decided not to wait for documented CVD outcomes.  In an exclusive agreement with Amgen, the plan negotiated a discount on the drug’s annual $14,100 wholesale price, plus additional discounts if Repatha delivers LDL reductions less than those observed during clinical trials.

Further discounts accrue if utilization exceeds certain limits, incenting Amgen to focus on patients who have an inherited disorder resulting in high levels of LDL cholesterol or have high-risk atherosclerotic cardiovascular disease conditions, such as heart attack or stroke, that have been resistant to treatment.

Harvard Pilgrim’s chief medical officer, Michael Sherman, told the Boston Globe that slightly less than one percent of the plan’s 1.2 million members would be eligible for Repatha.  He added that it was likely that even fewer would opt for the drug because it comes as a once or twice monthly injectable rather than a once daily pill.  The plan will also deploy rigorous utilization controls.

Sherman was coy when EP Vantage asked for more details on Harvard Pilgrim’s Repatha discount.  Was it close to an annual ‘care value price” – $7,735 for a cost effectiveness threshold of a willingness to pay $150,000 per quality adjusted life year (QALY)calculated by the Institute for Clinical and Economic Review (ICER) for the New England Comparative Effectiveness Public Advisory Council in which Harvard Pilgrim participates?1

“We’re not anywhere near that,” Sherman told Jon Gardner of EP Vantage.  “Ultimately, it was more about a negotiation, versus fundamentally agreeing that there’s a dollar value to [a QALY], which is where I’d like to be.  Maybe when there are other drugs on the market and more competition, we may get there.”

Express Scripts’ Deals

Mum, too, about exact pricing has been Express Scripts, which placed both Praluent and Repatha on its National Preferred Formulary in October after securing discounts from Amgen and the makers of Praluent, Sanofi and Regeneron.

This was after a July declaration by Express Scripts President Tim Wentworth, “while these drugs are being viewed as breakthroughs, they also have the potential to wreak financial havoc on clients who do not proactively manage.”

At Express Scripts, utilization management will come through a new Cholesterol Care Value program featuring “rigorous documentation” to ensure use only by clinically appropriate patients, who will get help with properly injecting the drugs and remaining adherent.

For plan sponsors enrolled in the CCV program, Express Scripts will cap total 2016 costs for the drugs.  It expects to spend $750 million on the drugs next year, lower than previous forecasts.  Among those earlier predictions was a ‘sky is falling’ alarm from CVS, which said costs could reach $150 billion annually if all coronary disease patients were included.

Before Express Scripts struck its PCSK9 deals, the company’s chief medical officer, Steve Miller, said the company would reference the ICER findings in its “negotiations with manufacturers.”  Apparently pleased with the result, Miller said the company received the best price possible and complimented the manufacturers for “collaborative discussions.”

During negotiations, Amgen, Sanofi, and Regeneron presumably repeated for Express Scripts their critique of the ICER methodology, specifically that it underestimated CVD risk, was not applicable to the population most likely to receive PCSK9’s and overestimated the population size likely to be treated with PCSK9’s.

Value Controversies

Amgen also explained that an alternative cost effectiveness model, which it is developing in alignment with the NICE model, confirms PCSK9 as cost effective at a QALY threshold of $150,000 or below.  In other words, Amgen believes the ICER ‘care value price’ of $7,735 (see above) should more accurately be $14,100.  The company notes that $150,000 is the value threshold recommended by the American College of Cardiology and the American Heart Association.

Meanwhile, back in the U.K., differential pricing is in play where the Repatha list price is £4,448.60 ($6,802.13), excluding an undisclosed patient access scheme discount.    Including the discount, the price Amgen proposed to NICE resulted in value thresholds ranging from a high of £78,879 ($119,903) to a most cost effective low of £22,902 ($34,813), depending on patient subpopulation and indication.

In stark contrast to the U.S., the QALY threshold over which NICE is less likely to recommend treatments for use in the NHS is typically between £20,000 ($30,393) and £30,000 ($45,590).  For the potential Repatha patients where the QALY threshold was within this range, NICE still decided to wait two years for more studies, the results of which are highly likely to show a CVD benefit.

Perhaps there is another reason for caution at NICE.  It is coming under pressure to lower the threshold to £13,000 ($19,759) – very different from the increasingly standard $150,000 in the U.S.  University of York’s Prof. Karl Claxton says that the current NICE threshold diverts funds from local health authorities and medical procedures, which he claims are more cost effective than new, expensive drugs.

Value or Values

NICE chief executive Sir Andrew Dillon countered, saying, “We need to think carefully about what’s being valued.”

“Concentrating only on QALYs means we are in danger of losing sight of other things that people, health systems and the government value very highly. This includes encouraging an innovative UK research base, or perhaps valuing more highly specific treatments that may be the only option for people with certain conditions,” Dillon added.

To advance Sir Andrew’s point, what is being valued depends on our values.  On that score, the negotiators at Amgen, Sanofi, Regeneron, Express Scripts and Harvard Pilgrim appear to have struck the right balance.

They are ensuring that the patients clinically most in need of Repatha and Praluent get the drugs by focusing on just those patients, while also providing financial support to those who might not otherwise get the drugs because of economic need.2

In human terms, only 28 people would need to be treated over five years to prevent a heart attack, stroke or death.  A “relatively low” number ICER admitted in its report.  Viewed another way by ICER, among CVD patients with high cholesterol, taking a statin and a PCSK9 together would prevent 5,621,800 heart attacks, strokes or deaths over a lifetime horizon.

Meanwhile, the U.K. waits.

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  1. When ICER initially announced its findings in early September, it highlighted and got the most headlines for an even lower, “value based price benchmark” of $2,177.  The key constraining assumption:  That health care costs should not grow any faster than growth in the overall national economy, which it estimated at +1% GDP growth.  After a series of calculations and further assumptions, ICER declared that the total annual cost of any single new drug could not exceed $904 million.  In other words, rationing.
  2. Groups such as AARP and editorial writers call for more public transparency in pricing agreements between payers like Express Scripts and manufacturers like Amgen.  However, the confidentiality to which buyers and sellers agree helps sustain a sort of differential pricing and access system within the U.S., i.e. ensuring the patients in clinical and financial need get the drugs they need.  Express Scripts negotiating with a manufacturer surely is a fair match.  However, where the match is not fair, i.e. when the buyer is a consumer, such as a consumer with a high deductible, then transparency is needed along with financial assistance.

High Drug Prices: What Would Donald Trump Say?

Trump_Debate

In a new poll released yesterday, the Kaiser Family Foundation reported that large majorities of Americans, regardless of political party, think drug prices are unreasonably high, drug companies put profits before patients, and government should limit the cost of high priced drugs and negotiate lower prices for Medicare.

However, the same poll found that 76% of Republicans preferred market competition over government regulation to lower drug prices.  In addition, while 74% of Republicans say the government should directly negotiate Medicare drug prices, a smaller number – 56% — believe it can be effective.

Perhaps this explains why Republican candidates for President have not addressed high drug prices, preferring instead to focus on Obamacare repeal, as reported by Politico.  Neither Scott Walker nor Marco Rubio have included drug prices in their Obamacare replacement proposals.

Will Donald Trump take on high drug prices?  If he does, what would he say?  Whatever he says about an issue quickly frames how other Republican candidates and the news media speak about it.  Such is Trump’s dominance of the daily news cycle.   That alone makes the question relevant and the answer useful.

He is also more in tune with the Republican base than the party’s establishment may want to admit, as   political commentator Ezra Klein observed earlier this week.  Trump is the only Republican candidate who opposes cuts in Medicare, Social Security and Medicaid, a long-held position he directly links to making American strong again.

Interviewed on Larry King in 1999, he said, “What’s the purpose of a country if you’re not going to have defense and healthcare.  If you can’t take care of your sick in the country, forget it, it’s all over. I mean, it’s no good.”   He told the Iowa Freedom Summit earlier this year, “I want to make the country rich so that Social Security can be afforded, and Medicare and Medicaid.”

Recently, on Meet the Press, he said, “I want people to be taken care of from a health-care standpoint. But to do that, we have to be strong. I want to save Social Security without cuts. I want a strong country. And to me, conservative means a strong country with very little debt.”

In fact, Trump comes across as a Robin Hood, putting himself on the side of American citizens, taking money from wealthy countries he says rightfully belongs to us, fighting government corruption and stupidity, and expelling illegal aliens (to use his terminology).   He is also a deal maker, exploiting leverage or creating advantage to get what he wants.

What, then, would Donald Trump say about high drug prices?  To answer that question, here is an imagined Meet the Press conversation between host Chuck Todd (imagined) and Donald Trump (imagined).   It suggests Donald Trump could easily take high cost drugs to a place neither the other Republican candidates nor the drug industry want to go.

 

Chuck Todd (Imagined):

Mr. Trump, in a new poll, 70% of Republicans want the government to limit how much pharmaceutical companies can charge for high-cost cancer drugs.  What would you do about the high cost of prescription drugs?

Donald Trump (Imagined):
Repeal Obamacare and replace it with something terrific.  It’s a disaster.  It’s virtually useless and big lie.  Deductibles are through the roof and costs are going up.

 

Chuck Todd (Imagined):

How would repealing Obamacare lower drug costs?  They’re growing faster than other health costs – mainly because of the new specialty drugs – but they still only account for 10% of all health spending.

Donald Trump (Imagined):

Chuck, the drug company lobbyists did a fantastic job when Congress passed Obamacare.  They out-negotiated the President and got a great deal.  They supported Obamacare and agreed to help pay for it.  In return, they got more customers and higher prices.   When I repeal and replace Obamacare, the pharma companies will have to negotiate with me.

 

Chuck Todd (Imagined):

Does that mean you support letting the government directly negotiate with drug companies over the prices it pays for Medicare drugs?

Donald Trump (Imagined):

Medicare is the largest single buyer of prescription drugs.  In business, a best customer gets the best deal.  When I buy televisions for my hotels, which I sadly can’t get in the US but that’s another issue, I use that leverage for a great price.  Yes I’d negotiate better prices with the drug companies.  But, it’d be different, like a business, not as price controls or more regulations in disguise.   You’ll be very pleased, very pleased with how I do it.

 

Chuck Todd (Imagined):

But, what about the cost of drugs not covered by Medicare….these new cancer drugs that cost thousands of dollars.  In fact, the doctors who treat cancer are campaigning for lower prices.

Donald Trump (Imagined):

Chuck, I’ve got a deal where everyone wins.  I love the drug companies.  They’ve made great discoveries and cured many people.  I want the drug companies to create jobs in the US, making new drugs.  That takes money.  They hold almost a half-trillion dollars outside the United States because the taxes on bringing it home are too high.   Bring those dollars home, use them for jobs, discover new cures, keep prices under control and I’ll lower the taxes.

 

Chuck Todd (Imagined): 

Republicans also think Americans should be able to buy prescription drugs imported from Canada, and by a wider margin than Democrats:  75% Republicans vs. 69% Democrats.  What do you think of that?

Donald Trump (Imagined):

The problem is much bigger.  What our pharmaceutical industry accomplishes is tremendous.  It benefits the entire world but prices are highest in the United States.   Per person, we spend twice as much as other wealthy nations.    It’s time other nations paid their fair share.  As you know, rich nations like Saudi Arabia must pay us back for what the Defense Department spends on protecting them.  Canada, the European Union and other wealthy nations should help pay for our National Institutes of Health.  The American taxpayer funds 85% of basic research.  We have to stop subsidizing their health care.

 

Chuck Todd (Imagined)

The drug industry says that it needs to charge high prices because it takes so long to bring a drug to market.  Would you make any changes at the FDA?

Donald Trump (Imagined)

The FDA needs to do a better job on safety, especially after a drug is on the market.  Take vaccines, I don’t think kids should get them all at once.  Spread them out.  It doesn’t hurt anybody other than probably the pharmaceutical companies because they probably make more money putting it into one shot.    I want more approvals and more competition.  That will bring prices down.

 

Chuck Todd (Imagined):

Speaking of health care.  Earlier, you said you would repeal and replace Obamacare.  How would you replace Obamacare?

Donald Trump (Imagined):

I believe in universal healthcare. I believe in whatever it takes to make people well and better.  What’s the purpose of a country if you’re not going to have defense and healthcare?  We can have something far better for the people, and far less expensive, both for the people and for the country.  And believe me there are plans that are so much better for everybody.  And everybody can be covered.  I’m not saying leave 50-percent of the people out.

 

Chuck Todd (Imagined):

How would you pay for it?

Donald Trump (Imagined)

Get tough with the big players like China and OPEC that are ripping us off so we can recapture hundreds of billions of dollars to pay our bills, take care of our people, and get us on a path toward serious debt reduction. We must take care of our own people—we must make our country strong and rich again so that Social Security, Medicare, and Medicaid will no longer be thought of as a problem. We must save these programs through strength, power, and wealth.

 

Chuck Todd (Imagined):

During the debate, you seemed to speak favorably about single payer systems in Scotland and elsewhere.  Do you favor a single payer system in the United States?

Donald Trump (Imagined):

No.   What we need in the United States is free market plan that provides consumer choice, keeps plans portable and affordable and returns authority to the states. We also must break the insurance company monopolies and allow individuals to purchase health insurance across state lines.