Boston Globe Editorial Board Calls for Wider Access to Hepatitis C Drugs

A July 29, 2016 piece from the Boston Globe’s editorial board calls for wider access to Hepatitis C (HCV) curative drugs. “Wider access to hepatitis C drugs is humane and pragmatic” highlights recent changes in Massachusetts and the MassHealth Medicaid program as the first step in eradicating HCV, and goes on to call for public education and increased screenings of high-risk populations.

CHLPI’s Faculty Director Robert Greenwald is quoted in the piece:

Massachusetts’ limits on hepatitis C medicines have been at odds with US Centers for Medicare and Medicaid Services’ policy, which mandates that Medicaid insurance plans cover the new drugs. MassHealth also has faced scrutiny from health care advocates, who note that the disease is especially prevalent among lower-income residents who don’t have other treatment options, or who are reluctant to seek preventive medical care. “We’re dealing with a population that has a history of exclusion and distrust of the health care system,” says Robert Greenwald, director of Harvard Law School’s Center for Health Law and Policy Innovation, and a prominent critic of limits on hepatitis C coverage.

 

Read “Wider access to hepatitis C drugs is humane and pragmatic” in full.

Read more news coverage of CHLPI’s advocacy efforts for to increase access to HCV medications.

CHLPI Litigation Director Quoted in Motley Fool on Hepatitis C Drug Pricing

Originally written by Cheryl Swanson for The Motley Fool.

Is your stomach ready for a big twist? Then you should know that the escalating battle over drug prices just got turned on its head.

For the past couple of years, states and insurers have successfully blocked patient access to many game-changing drugs because of their sky-high prices. While cancer-specific biotechs are not the only drugmakers affected, no class has taken a bigger hit than those providing next-generation treatment for hepatitis C at nosebleed prices.

Specifically, we’re talking about Gilead Sciences (NASDAQ:GILD), AbbVie Inc. (NYSE:ABBV), Merck & Co., Johnson & Johnson, and Bristol-Myers Squibb. These companies’ drugs eliminate the virus 90% of the time, but can cost anywhere between $54,600 to $94,500 for a course of treatment.

Hep-C is a life-threatening disease, so blocking access to these drugs could hurt many patients. The blocks are also stinging investors, many of whom thought these drugs would blast past analysts’ estimates for a long time to come. After all, even if you consider just the Medicaid portion of the hep-C market, sales were projected at $55 billion. Add in the rest of the market, both home and abroad, and how could a company like Gilead not be a huge winner for the foreseeable future?

Ouch! Who shrank the market?

Instead, the hep-C juggernaut ran into a huge roadblock — or, rather, a series of roadblocks. Even though Medicaid patients are prime candidates for the drugs, many states have refused to pay for them. Molina Healthcare (NYSE: MOH), for example, which administers Medicaid plans, found itself receiving no reimbursement for the expensive antivirals in 11 states . Not surprisingly, Molina reacted by providing coverage only when the disease was in its final stages, Stage 3 or 4, where the liver is “hard as a rock,” as Sanjeev Arora, a New Mexico physician, describes it. Arora further described treatment at that stage as “like closing the barn door after the horse has left.”

The erosion of the Medicaid market was devastating enough, but commercial insurers also jumped on the bandwagon. Back in 2014, UnitedHealth Group (NYSE:UNH) limited the antivirals to patients facing liver failure. Other insurers followed suit.

The upshot for investors is that market leader Gilead’s double-digit sales and profit growth came to a screeching halt last quarter, with its hep-C drug Harvoni badly missing expectations. AbbVie’s chief competing hep-C drug, Viekira, also came up well short of consensus estimates.

In fact, many analysts are now projecting that the hep-C market won’t just flatten; it’s headed for a cliff.

Don’t bet on it: Floodgates are reopening

So much for analysts’ projections. The hep-C world is about to change, again. Massachusetts is the latest state to reverse its policy. A few weeks ago, after losing multiple legal battles, the state threw in the towel and conceded that any Medicaid patient with hep-C qualifies for the antiviral drugs.

Massachusetts is just one state, but similar actions have occurred in Florida, New York, Washington, and Delaware in the past few months. Pressured by an almost endless list of advocacy groups, insurers are also breaking down. Anthem’s (NYSE:ANTM) Blue Cross and Blue Shield plans in 14 states quietly reversed course and began authorizing treatment to people “in all stages of fibrosis” (liver scarring) last December. UnitedHealth did an about-face on Jan. 1. The nation’s largest insurer now provides greatly expanded coverage for these drugs.

And not just states and insurers are reopening the floodgates. In March, the Department of Veterans Affairs said it will treat any veteran with hep-C with the new drugs, regardless of the stage of illness — extending therapy to nearly 130,000 veterans.

Even more stunning, Medicare followed their lead. In the face of a challenge by an Arizona man named Walter Blanco, who was twice denied access, the agency recently enacted a similar policy.

Hep-C investors are still in for volatility

But while easier access to therapy is great news for all hep-C drugmakers, don’t expect an immediate big bump in revenue for any of them.

For one thing, states will demand deep pricing discounts. Gilead has already been forced to discount its average hep-C drug by almost 46%, and state-negotiated discounts are likely to be greater. They could bring pricing down to $30,000 or less, according to Kevin Costello, from Harvard’s Center for Health Law & Policy Innovation.

Second, as many as 50% of hep-C patients aren’t even aware they have the disease.

Third, one company still almost completely dominates this market, with AbbVie a distant second. Gilead owns 90% of the market, and the recently approved Epclusa, which can treat all six genotypes of hep-C, should keep it the front-runner.

Best investing bets? Biotechs providing drugs that are “medical necessities”

Beyond hep-C, the recent events have implications for all biotech and specialty pharma investors. With healthcare costs soaring, pharmas developing me-too drugs that offer marginal benefits are in trouble. Something’s gotta give, and these drugs are likely to be destined for payers’ chopping blocks.

A better bet are companies providing drugs that are medical necessities. Restrictive policies against those drugs probably won’t survive the legal challenges, according to Nicholas Bagley, a professor of law at the University of Michigan. “I think the writing is on the wall, and plaintiffs are likely to prevail in these lawsuits,” he said.

In other words, despite their extreme prices, companies with drugs that save lives should find the wind at their backs again soon. And if you’re looking for one good pick based on this trend, there’s really no choice. Market leader Gilead is now trading at a stupid cheap forward earnings multiple of 6.95.

Here’s the bottom line: Tens of thousands of people with hep C are about to gain access to treatments that can cure them. I’d say that’s good news for everyone. And it doesn’t hurt that this twist in the wind may eventually add a lot of lift to some well-chosen portfolios.

Reducing Food Waste Through Consumer Education, Part 2

Written by Jabari Brown,  J.D. Candidate 2017 at the University of Oregon School of Law, and Summer 2016 intern in the Harvard Law School Food Law and Policy Clinic

Read the first part of “Reducing Food Waste Through Consumer Education”

NCL campaignConsumer education that creates awareness around food waste consequences combined with information on recognizing and implementing the steps we can take at home to store, preserve, use, and reuse the food we buy, cook, and eat on a daily basis is essential in food waste reduction. The NRDC agrees that there is a human, personal element to changing behavior and attitudes around food waste.  For instance, the NRDC recently collaborated with the Ad Council to launch a campaign aimed at reducing food waste. It may seem odd to think of a commercial as a key component of a larger legal effort, but public awareness campaigns have been remarkably successful in the past at changing human attitudes and behavior. According to the Ad Council, 68% of Americans report they have tried to prevent someone from driving after drinking since the Ad Council’s “friends don’t let friends drive drunk” campaign started in 1983. The organization has had similar results with other campaigns, raising over $4.3 billion for the United Negro College Fund supporting their minority education campaign, facilitating 34,000 calls made to the Family Violence Prevention hotline in the first year of their domestic violence reduction campaign, and reducing the annual acreage damaged by wildfire by almost 40% since 1944 with the “Smokey the Bear” wildfire prevention campaign.

The campaign to reduce food waste has to be dynamic, flashy, and ubiquitous. Expiration date labels need to be clear, with language as direct as possible. But in the end, a standardized date labeling is not enough, nor is consumer education. Only the successful combination of the two will bring us closer to a zero-waste system. We collectively need to shift our thinking. If we all were aware of how much money we throw out each meal and how much our leftovers contribute to climate change, we may choose to save our leftover chicken bones for stock or box up the remainder of our restaurant dinner for a snack later. We need to implement innovative solutions that integrate the new tools of intelligent technology with the old wisdom of grandma’s banana bread. The solution starts with a national dialogue and ends when our national food waste percentage is zero.

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Image from www.minneapolismn.gov/solid-waste

How much food do you waste on a daily basis?

Interested in more? See the short film “EXPIRED Food Waste in America,” a Harvard Food Law and Policy Clinic collaborative effort to promote awareness of how date labels contribute to food waste.

CHLPI Submits Comments on MassHealth 1115 Waiver Proposal

On July 15, 2016, CHLPI submitted two comment letters to Massachusetts’ Executive Office of Health & Human Services (EOHHS) regarding its proposal to amend the state Medicaid program’s (MassHealth’s) Section 1115 Demonstration Waiver. Under the proposed waiver, MassHealth will transition away from siloed fee-for-service care by establishing provider-led Accountable Care Organizations (ACOs). These ACOs will be responsible for the quality, coordination, and total cost of patient care. In order to improve care, ACOs will receive flexible spending funds to address social determinants such as nutrition, housing, and transportation.

In its first comment, CHLPI and Community Servings urged EOHHS to design flexible spending program requirements to give ACOs the flexibility and responsibility to use these funds on services that best meet the unique needs of their patient populations. In its second comment, CHLPI addressed several waiver provisions that would restrict the ability of MassHealth members to freely choose and move between MassHealth’s managed care organization (MCO), ACO, and Primary Care Clinician (PCC) plans. CHLPI encouraged EOHHS to eliminate or adjust these provisions to avoid punishing patients whose evolving health needs require them to choose the PCC plan or move between plans over the course of a year.

Read the first comment submitted CHLPI and Community Servings.

Read the second comment submitted by CHLPI.

New Guidance from the Public Health Institute and CDC on Food System Assessments Directs Hospital Staff to CHLPI Food Bank Resource

Tackling Hunger report coverOn July 22, 2016, the Tackling Hunger Project, a partnership between the Public Health Institute and the Centers for Disease Control and Prevention, released Making Food Systems Part of Your Community Health Needs Assessment: Practical Guidance from the TACKLING HUNGER Project. The Guide offers practical tools to hospitals on how to incorporate an assessment of their local food systems and rates of community food insecurity into their triannual Community Health Needs Assessment (CHNA). Conducting a CHNA is a requirement for nonprofit hospitals as they seek to demonstrate that they are providing an adequate “community benefit” and therefore should maintain tax-exempt status.

The Guide contains practical advice on how to measure food insecurity at the community level and how to identify local food system stakeholders and invite them to be part of the CHNA process. It also points hospitals to resources that can help them form partnerships with community-based food and nutrition resource providers, including Food Banks as Partners in Health Promotion: Creating Connections for Client & Community Health (developed by CHLPI together with Feeding America, a national network of thousands of food banks and food pantries). The publication of this Guide is an important step in helping hospitals effectively address the significant impact that food insecurity has on the health of their patients and broader communities.

 

Reducing Food Waste Through Consumer Education, Part 1

Written by Jabari Brown,  J.D. Candidate 2017 at the University of Oregon School of Law, and Summer 2016 intern in the Harvard Law School Food Law and Policy Clinic

Food-Piles

Image from epa.gov.

As we waste food, we waste money. Overall, our nation wastes a total of 40% of all food produced. The problem of food waste is both a national and individual issue. Across the nation, 1.3% of our GDP, or $218b, is thrown out each year in the form of wasted food, according to the ReFed Report, which provides a roadmap to reducing U.S. food waste by 20 percent. Out of this total, food thrown out at home represents 0.85% of our GDP, or $144b.

It follows that the solutions require both national and individual efforts. One of the most cost effective changes we can make on the household level is to standardize expiration date labels.  The Dating Game report, published by the Harvard Law School Food and Law Policy Clinic (FLPC) and National Resources Defense Council (NRDC), found that consumer confusion over expiration date labels is a primary contributor to food waste. With our current expiration date system, it is hard to tell if a piece of cheese will be spoiled, or simply taste less fresh after a certain period of time. Expiration dates on food have no national regulatory standard and agencies have failed to exercise their statutory authority to create a uniform standard. The current system of date labeling is regulated state-by-state. There is little distinction between quality and safety.

Interestingly, most foods, when stored properly, are safe to eat for a long time past the expiration date, yet this information is not clearly communicated to consumers. Some foods are unsafe to eat past their expiration date, but unstandardized date labels and lack of consumer education cause confusion as to which foods are safe or unsafe to eat after their label date. So, there needs to be a combination of both – a national standard for expiration date labels followed with robust consumer education – to address national food waste.

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FLPC Director Emily Broad Leib at a press conference in support of the Food Date Labeling Act with Congresswoman Chellie Pingree (l) and Senator Richard Blumenthal (r).

Efforts are underway to revamp this esoteric, piecemeal approach to date labeling. Emily Broad Leib, Director of FLPC, testified at the first ever House Agricultural Committee Hearing held on the issue of food waste on May 25th, 2016, and was joined by a host of industry, non-profit, and Congressional professionals who all agreed that national, uniform labeling standards for expiration dates are a good thing. Just a few days prior to the hearing, Senator Richard Blumenthal (D-CT) and Congresswoman Chellie Pingree (D-ME) introduced the Food Date Labeling Act. This act aims to reduce food waste by establishing a national, uniform system for food expiration date labels and following through with consumer education. Creating uniform labels while eliminating consumer confusion is an active, essential step toward reducing food waste.

While watching the hearing, I immediately thought: how can consumers be educated about the meaning of date labels in a way that reduces food waste? Even with a simple labeling solution, we owe strong consideration to the human element. During the House hearing, Congressman Scott from Georgia’s 13th district touched on this point when he asked, “How do you change human behavior?” Congressman Walz agreed, “This is an attitude issue as much as it is a logistics [issue].” Implied in these statements is the concern that a new label alone will not change consumers’ behavior with respect to food waste, something more is needed.

Part 2 to be posted Monday.

How Dated Food Labels Contribute to Food Waste

‘Best if used by.’ ‘Sell by.’ How can you tell whether your food is still good? Why labels are so confusing and what may help.


At the May 2016 Food Waste Summit in Washington, D.C., Tom Vilsack, the U.S. secretary of agriculture, told a story about his adult son going through the Vilsacks’ refrigerator and throwing out everything that was past the date on its packaging—even if it was frozen. The secretary’s point: If his own son doesn’t understand what the dates mean, who does?

The answer: not many of us. In a recent survey led by the Harvard Food Law and Policy Clinic, almost 85 percent of consumers said that they’d thrown out food based on the date on the package.

With the exception of baby formula, there are no federal regulations on date labeling. Forty-one states and the District of Columbia require date labeling on certain food items, nine states do not, and no two states have the same law. Often the “best if used by,” “sell by,” and “use by” designations are just manufacturers’ best guesses about how long their food will taste its freshest. Supermarkets may also use the dates as a guide when stocking shelves. But the dates have nothing to do with how safe the food is.

The result? Take something as basic as milk. In most states the “sell by” date for milk is 21 to 24 days after pasteurization. But in Montana, milk can no longer be sold 12 days after pasteurization, a point made in the film “Expired,” which shows milk being taken off supermarket shelves and poured down the drain—even though it would be deemed just fine in most of the rest of the country.

More clarity on what dates on food labels mean may be coming, as Congress considers the Food Date Labeling Act. “One of the most common arguments people seem to have at home is about whether or not food should be thrown out just because the date on the label has passed,” says Rep. Chellie Pingree, D-Maine, who introduced the bill with Sen. Richard Blumenthal, D-Conn. “It’s time to settle that argument, end the confusion, and stop throwing away perfectly good food.”

The legislation proposes two labels to be used nationally: one that indicates quality, when food is at its peak freshness, and another that indicates safety, the date past which food is considered unsafe to eat. The wording has yet to be decided, but in the Harvard survey, more consumers understood that “best if used by” means quality and “expires on” signals safety, according to Emily Broad Leib, the clinic’s director.

In the meantime, another way to tell whether food is still edible is to trust your own senses. If it seems off to you, it probably is. Food that’s getting funky is likely to look, smell, and taste bad before it becomes unsafe. (Foodborne illness comes from contamination, not from the natural process of decay.)

If you have questions about your food, download the Department of Agriculture’s FoodKeeper app or go to foodsafety.gov/keep/foodkeeperapp. You’ll find advice on how best to store your food to maximize freshness and flavor.

How to Feed 350 Food Waste Experts

Originally published on Sustainable America’s blog and written by Katrina Kazda

A rescued-food breakfast at the Save Food for People Conference

A rescued-food breakfast at the Save Food for People Conference

In late June, nearly 350 entrepreneurs, practitioners, policymakers, and activists from across the country gathered at Harvard Law School for the Reduce and Recover: Save Food for People Conference to further dialogue on reaching a national food waste reduction goal of 50% by 2030 as set by the U.S. Environmental Protection Agency (EPA) and the U.S. Department of Agriculture.

True to its name, the conference wanted to turn the conversation into action by “eating what we preach,” as Emily Broad Leib, director of the Harvard Food Law and Policy Clinic, put it. So, as the conference was being planned, Sustainable America worked with Harvard’s catering vendor, Restaurant Associates, to see what it would take to prepare some of the meals with food that would otherwise go to waste.

We’re happy to report that almost all of the meals served at the conference — nearly 1,000 meals in total— were prepared from rescued food.

Rescued tomato and onion saladA few examples of menu items include a Caesar salad made using lettuce from Sid Wainer & Sons Imperfectly Delicious Produce program and day-old-bread croutons. A chef’s soup of the day was made from vegetable trim. A fresh tomato and onion salad was prepared from leftover tomatoes from the law school’s cafe and over-ordered onions; desserts were saved from recent commencement celebrations.

Boston-based Spoiler Alert, a tech platform that helps businesses manage surplus food and reduce food waste, helped source excess food — breads, fruits and yogurt — for breakfast from local companies Boston Organics, Daily Table and Iggy’s Bread of the World.

Each meal represented the variety and breadth of wasted food in our nation’s food system—from over-ordering and over-processing to farm seconds and prep trim. The food was extremely well received by conference attendees. They were thrilled with the quality, variety and flavor and were happy to be walking the walk as they talked the talk on wasted food. To continue the effort, Harvard Food Law and Policy Clinic staff are now hoping to work with the school’s administration to establish an ongoing food donation program to feed the hungry.

Convened by the Harvard Food Law and Policy Clinic, EPA,Massachusetts Department of Environmental Protection, andRecyclingWorks Massachusetts, the conference focused on the top two tiers of EPA’s Food Recovery Hierarchy: “source reduction” and “feed hungry people.” Speakers highlighted innovative solutions from New England and across the nation to reduce wasted food and recover edible food for people.

CHLPI’s Litigation Director Quoted in Article on HCV Medication Access

A July 2, 2016 article from Judith Graham looks at the recent wave of state Medicaid programs to increase access to Hepatitis C medications in the light of potential litigation from the Center for Health Law and Policy Innovation, its partners, and other organizations.

“Help with the high cost of hepatitis C drugs,” which ran in both USA Today and Kaiser Health News, looks at recent changes in access in Florida, New York, Delaware, Washington, and most recently, Massachusetts.

Excerpt from article:

“Costello’s (Kevin Costello, director of litigation at Harvard Law School’s Center for Health Law & Policy Innovation) center was a key player in the lawsuits in Washington state and Delaware and plans to bring similar actions elsewhere. ‘A 50 state solution is what we’re looking for,’ he said.”

Read the full article “Help with the high cost of hepatitis C drugs” in USA Today.

State lowers requirements for MassHealth patients to get hepatitis C drugs

Originally published in Boston Business Journal on July 1, 2016 by Jessica Bartlett.

Harvoni, a Hepatitis C-curing drug supplanting Sovaldi, will be sold at a discounted rate to Harvard Pilgrim customers thanks to new competition in the market.For half a million patients on MassHealth, access to hepatitis C-curing drugs has been limited.

The state has required MassHealth patients, who were being cared for on a budgeted basis, to have severe liver damage in order to qualify to receive the expensive medication, and were also required to be sober.

That will change with an announcement by the state yesterday that it has removed both of those requirements, and forged agreements with two drugmakers to lower the price. That will allow all Medicaid members to receive access to the disease-curing medication without increasing the cost to insurers.

“The MassHealth negotiating team led by Assistant Secretary Dan Tsai was committed to extending access at no net increase to the Commonwealth,” said Secretary of the Executive Office of Health and Human Services Marylou Sudders in a release. “We will continue to push drug companies to give us the very best prices on new treatments as they come on the market.”

Currently, majority of MassHealth members, cared for under a fee-for-service program, already had access to hepatitis C drugs like Harvoni and Sovaldi without having severe liver damage. Yet over 500,000 MassHealth patients cared for on a budget by Medicaid insurers had more restrictions. Harvard Law School had been pushing for Massachusetts and other states to treat all Medicaid patients equally, and had sued Washington’s Medicaid program that required patients to qualify for the drug.

“It’s an important first step in the campaign to eradicate (hepatitis C) in the commonwealth,” said Kevin Costello, litigation director for the the Center for Health Law and Policy Innovation at Harvard Law School. “Other advocates will be watching to make sure the policy reform is made meaningful at a patient by patient level.” Massachusetts is one of 10 states that have removed restrictions to hepatitis C treatments, Costello said.

The agreement negotiates rebates for Gilead’s (Nasdaq: GILD) hepatitis C drugs Harvoni and Sovaldi. The state also negotiated a rebate for Bristol-Meyers Squibb’s drug Daklinza.

Approximately 80 percent of MassHealth members infected with hepatitis C will take Harvoni. The other 20 percent of infected patients will use either Sovaldi or Daklinza. Some commercial insurers have also negotiated discounts for the Gilead drugs.

The agreement does not include Gilead’s recently approved Hep C drug, Epclusa, which is effective on more patients and is at a lower cost. The state said it would continue to try to negotiate rebates going forward.

Despite the lowered price, the state and Medicaid insurers will likely spend the same amount of money on the drugs due to the increased access.

From when the first hepatitis C cure came to market in December 2013 to January 2016, MassHealth had covered 2,830 members needing the drug. Medicaid insurers treated another 1,600 people.

In total, the cost for the hepatitis C drugs for those members was approximately $318 million, which primarily accounted for the high price of the drugs — which run up to $94,500 for a full course of treatment before discounts — and didn’t include other hepatitis C-related treatments or outpatient services related to the disease.

“This rebate agreement will expand access to much-needed medication for people suffering from Hepatitis C, and it will save millions in taxpayer dollars,” said Attorney General Maura Healey, in a release. “We are working hard with Gilead to improve the affordability of Sovaldi and Harvoni, and we are pleased the company has shown a commitment to increasing access to these drugs.”

The federal government touted the agreement and hoped that more states would negotiate rebates with manufacturers to lower the price of the Hep C treatments.

“While we are encouraged that competition in the marketplace has resulted in significant reductions in price over the past year, CMS remains concerned that the cost of Hepatitis C medications remains high, placing a significant financial burden on states,” said Andy Slavitt, Acting Administrator for the Centers for Medicare & Medicaid Services, in a statement. “We call on manufacturers and pharmacy benefit managers to continue to find innovative ways to make them more affordable to state Medicaid programs and the beneficiaries they serve.”

MassHealth has 1.85 million members. The Centers for Disease Control and Prevention has estimated that approximately 1 to 1.5 percent of the general population is infected with hepatitis C. While the agreement will enable more patients to receive hepatitis C treatment, Costello said there is still work to be done.

“I hope (this is) followed by meaningful outreach to bring people to be engaged in treatment, provider education to get the word out that this is now available and should be utilized …” Costello said, “There’s a whole host of parallel steps that can be taken by the commonwealth to make sure it’s doing everything it can to eradicate HCV.”

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