ICER Weekly View 11-16-18

From the desk of Mitchell Stein


Good morning. Happy almost gobble gobble – wishing you all Happy Thanksgiving now as we’ll be taking next week off to cook and stuff ourselves (stuff yourself indiscriminately, but if you stuff your turkey, safety first, make sure the stuffing gets to 165). But before we go, we have some news to discuss. This week we’ll look at:

ICER in the News – Evidence Report on biologic treatments for asthma associated with type 2 inflammation and/or allergic asthma, Final Evidence Report for long-term prophylaxis against hereditary angioedema attacks, NBC on drug spending, Orilissa for uterine fibroids

Inside the Beltway – Incoming Dem chair talks Medicare drug negotiations, FDA directors talk changes/look towards the future, elections conclusions don’t mean an end to issue ad spending, and Michigan gets CMS Medicaid waiver

Industry Trends – New Express Scripts formulary, Austin Frakt on drug cost history, new ways to pay for drugs, drug industry profitability, APMI’s Executive Director profiled, biosimilar obstacles, employers limit drug coupons, price/access drug issues in China, research transparency, and headline problems in the coverage of Vitamin D/Fish Oil studies

Now, on to the news.

ICER in the News

This week, ICER released an Evidence Report assessing the comparative clinical effectiveness and value of biologic treatments for asthma associated with type 2 inflammation and/or allergic asthma. The report focuses on dupilumab (Dupixent, Sanofi/Regeneron), omalizumab (Xolair, Genentech/Novartis), mepolizumab (Nucala, GlaxoSmithKline), reslizumab (Cinqair, Teva), and benralizumab (Fasenra, AstraZeneca). ICER previously reviewed mepolizumab for its use in severe eosinophilic asthma and dupilumab for its use in atopic dermatitis.

“All five biologics modestly reduce asthma exacerbations and improve daily quality of life,” said David Rind, MD, ICER’s Chief Medical Officer. “However, the treatments’ net prices appear to be far out of alignment with these incremental clinical benefits, and the entire therapy class would need to see price discounts of at least 50% to reach commonly cited thresholds for cost-effectiveness.” This Evidence Report will be the subject of an upcoming public meeting of the Midwest Comparative Effectiveness Public Advisory Council, in St. Louis, MO on November 29, 2018.

The release of the report was covered in BioPharmaDive and thePharmaLetter.

Institute for Clinical and Economic Review Report Finds Biologic Treatments for Uncontrolled Asthma Would Require More Than a 50% Price Discount to Reach Common Thresholds for Cost-Effectiveness

ICER released a Final Evidence Report and Report-at-a-Glance assessing the comparative clinical effectiveness and value of therapies for long-term prophylaxis against hereditary angioedema (HAE) attacks. HAE is an ultra-rare condition characterized by attacks of deep tissue swelling within the skin and/or mucosa. In its report, ICER assessed three therapies for the prevention of HAE attacks: lanadelumab (Takhzyro, Shire Plc), and two C1 inhibitors (Haegarda, CSL Behring GmbH; and Cinryze, Shire Plc).

ICER’s report was reviewed at an October 2018 public meeting of the California Technology Assessment Forum (CTAF). During the meeting, CTAF found that the evidence demonstrated a net health benefit for using the C1 inhibitors as long-term prophylaxis, but that the evidence was insufficient to distinguish between Cinryze and Haegarda. Because of concerns about risks with a new therapy, the committee also found that current evidence was not adequate to determine whether long-term prophylaxis with lanadelumab is superior to on-demand therapy alone.

Institute for Clinical and Economic Review Issues Final Report on Long-Term Prophylaxis for Hereditary Angioedema, Provides Policy Recommendations to Improve Cost-Effectiveness

ICER’s work on rheumatoid arthritis is referenced in this NBC News article on drug spending.

More people are getting cheap generic drugs, but spending is still up

Pricey, name-brand prescription medications continue driving up drug spending even though more patients are getting cheaper generics, according to a study released Wednesday. And the spending is not necessarily driven by the hugely expensive but startlingly effective cancer drugs that are grabbing headlines.

PMLive reports on results for Orilissa that could add FDA approval for a second indication for the drug. The report mentions ICER’s work on the drug as a treatment for endometriosis.

AbbVie preps uterine fibroid filing after phase 3 win

Second approval for Orilissa would boost blockbuster prospects Armed with new phase 3 data, AbbVie is planning to file Orilissa for uterine fibroids, just a few weeks after getting approval for the drug in endometriosis pain.

Pharmaceutical News

Inside the Beltway/State Regulatory Developments

Despite the prospect of partisan gridlock, The Hill reports that incoming Dem chair of the House committee overseeing drug prices (House Energy and Commerce Committee) wants to move forward with Medicare price negotiation legislation.

Incoming Dem chairman: Medicare negotiating drug prices is a priority

Rep. Frank Pallone Jr.

RAPS reports on remarks by three FDA directors at an industry conference.

Pazdur, Marks and Woodcock Discuss FDA Changes, What’s Coming

Three of the US Food and Drug Administration’s (FDA) directors – Richard Pazdur, Peter Marks and Janet Woodcock – took the stage Wednesday at Prevision Policy’s Biopharma Congress to discuss all things FDA – from why the agency is viewed more positively now than in the past to what needs to happen in each of their centers.

The elections may be over, but ad spending on issues has only just begun. The Hill reports that the Campaign for Sustainable Rx Pricing announced a six-figure ad buy to pressure Congress on drug pricing reforms.

Drug pricing group launches six-figure ad buy pressuring Congress to act

The TV and digital the Campaign for Sustainable Rx Pricing, a coalition of insurers, hospitals and other groups, come at a time when hopes are high for action on drug prices. Democrats have vowed to take steps to reduce drug prices, and they will control the House next year.

Michigan becomes the second state to receive CMS permission for its Medicaid program to utilize outcomes-based drug payments (FierceHealthcare).

CMS approves value-based drug payments in Michigan’s Medicaid program

The Centers for Medicare & Medicaid Services (CMS) will allow Michigan’s Medicaid program to enter into outcomes-based drug payments with manufacturers. CMS Administrator Seema Verma announced her agency had approved an amendment to the state’s program on Wednesday during remarks at the Biopharma Congress in Washington, D.C.

Industry Trends

Express Scripts announced a new “flex” formulary designed to take advantage of cheaper alternatives to some brand-name drugs (FiercePharma).

Express Scripts ramps up list-price pressure with newfangled ‘Flex’ formulary

During a yearslong examination of drug prices, there’s been no shortage of criticism for growing list prices, and in recent months, some companies have heard the talk and lowered their prices. Now, top PBM Express Scripts is rolling out a new formulary to help support the moves-and the plan could heap more pressure on players in competitive drug classes.

In his latest NY Times column, Austin Frakt (New England CEPAC member) looks at the history of drug prices in the US. How and why they diverged from the rest of the world, and what changes may (or may not) be on the horizon

Something Happened to U.S. Drug Costs in the 1990s

The New Health Care Two decades ago, the costs began rising well beyond that of other nations, and in recent years have shot up again. What can explain it? There was a time when America approximated other wealthy countries in drug spending. But in the late 1990s, U.S. spending took off.

NPR discusses the need for new ways to pay for expensive drugs.

A Search For New Ways To Pay For Drugs That Cost A Mint

Researchers expect that three dozen new drugs will come on the market over the next few years with astronomical prices – some likely topping a million dollars per patient. The drugmaker Novartis has told investors it might be able to charge $4 million to $5 million for one of its potential products, a treatment for a rare disease called spinal muscular atrophy.

Axios’s Bob Herman looks at the profitability of pharma vs. the rest of the health care system. While an informative look, it is worth noting that non-profit hospitals, while understandably not included, represent a significant portion of health care spending (despite operating under a different financial model).

Pharma’s grip on the health care economy

Ten companies controlled half of the health care industry’s $50 billion of global profit in the third quarter of this year, according to an analysis of financial documents for 112 publicly traded health care corporations.

STAT profiles the Executive Director of Alliance to Protect Medical Innovation.

An industry outsider tries to salvage pharma’s bruised reputation – STAT

W ASHINGTON – Patrick O’Connor wants to emphasize that he’s not running a shadowy pharma front group. That’s why he’s attached his name to the group, the Alliance to Protect Medical Innovation, even as most of its donors have remained in the dark. It’s why he keeps repeating that the industry trade group PhRMA is not involved.

RAPS’ Zachary Brennan reports on a review of the state of biosimilars and the obstacles inherent in the US system (Think I talk about biosimilars too much? Can’t stop, won’t stop.)

Review Addresses Obstacles to US Biosimilar Entry and Uptake

Posted 12 November 2018 | By Zachary Brennan Although 14 biosimilars have now been approved by the US Food and Drug Administration (FDA), only six have reached the market and questions about the viability of the biosimilar industry in the US have been raised.

Walmart and Home Depot embrace strategies to limit the use of drug coupons (Reuters).

Walmart, Home Depot adopt health insurer tactic in drug copay battle

NEW YORK (Reuters) – Walmart () and Home Depot (), two of the top 10 U.S. employers, have embraced a health insurance strategy that punishes drugmakers for using discount cards to keep patients from switching or stopping their medications. Large U.S.

The US is not the only country with a drug price/access issue. In China, despite the country being in the midst of updating their health coverage system, the residents struggle with the price of drugs, sometimes turning to desperate measures (NY Times).

In China, Desperate Patients Smuggle Drugs. Or Make Their Own.

Despite health insurance, terminally ill patients have to hunt around the world and on the internet for ways to stay alive. JINZHOU, China – Zhang Zhejun used a fat plastic straw to gently tap the pale yellow pharmaceutical powder onto a piece of silver foil that lay on an electronic scale.

We have to learn from our mistakes. And by we, I mean drug researchers collectively. The problem is many “failures” don’t get reported so are doomed to be repeated. In this Nature piece, officers of the European Medicines Agency (EMA) discuss the EMA’s attempts to address the situation.

Be open about drug failures to speed up research

Self-help and business books are replete with advice for learning from failures. The biomedical community must do just that if it is to ease the burden from intractable conditions such as Alzheimer’s disease. It can take 20 years or more to get a drug to market, from testing compounds in animals to running late-stage (phase III) clinical trials in thousands of subjects.

And finally, health care is complicated, part 573. Note how the first two headlines (NY Times, Reuters) are technically correct, yet seem to contradict one another. The third headline, from the Associated Press, strikes a more measured tone.

Vitamin D and Fish Oils Are Ineffective for Preventing Cancer and Heart Disease

The largest study to test vitamin D and omega-3 pills in healthy adults found they did little to prevent cardiovascular disease, but hinted at benefits for groups including African-Americans.

Fish oil cuts heart attack risk, vitamin D lowers odds of cancer death

(Reuters Health) – A large U.S. study designed to gauge the health benefits of vitamin D and fish oil supplements concludes that the omega-3 oil can dramatically reduce the odds of a heart attack while vitamin D’s benefits seem to come from lowering the risk of death from cancer.

Heart meeting features fish oil, vitamin D, cholesterol news 
@mhstein  |

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